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1. Association of urinary EGF, FABP3, and VCAM1 levels with the progression of early diabetic kidney disease

Author

Felix Keller, Sara Denicolò, Johannes Leierer, Maren Kruus, Andreas Heinzel, Michael Kammer, Wenjun Ju, Viji Nair, Frederic Burdet, Mark Ibberson, Rajasree Menon, Edgar Otto, Ye Ji Choi, Laura Pyle, Patricia Ladd, Petter M. Bjornstad, Susanne Eder, Laszlo Rosivall, Patrick Barry Mark, Andrzej Wiecek, Hiddo J. Lamber Heerspink, Matthias Kretzler, Rainer Oberbauer, Gert Mayer, and Paul Perco

Subjects
Dermatology, RL1-803, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Introduction Diabetic kidney disease (DKD) is a common cause of chronic kidney disease with around 25-40% of patients with diabetes being affected. The course of DKD is variable and estimated glomerular filtration rate (eGFR) and albuminuria, the currently used clinical markers, are not able to accurately predict the individual disease trajectory, in particular in early stages of the disease. The aim of this study was to assess the association of urine levels of selected protein biomarkers with the progression of DKD at an early stage of disease. Methods We measured 22 protein biomarkers using the Mesoscale Discovery platform in 461 urine samples of the PROVALID cohort, an observational study of patients with type 2 diabetes mellitus followed at the primary health care level for a minimum of four years. Odds ratios (OR) were estimated for the effect of marker values above median on fast progression using unadjusted and adjusted logistic regression models. RNA expression at the single cell level in kidney biopsy samples obtained from a cohort of young persons with type 2 diabetes mellitus was in addition determined for markers showing significant associations with disease progression. Results Increased urinary levels of epidermal growth factor (EGF) were linked to lower odds of fast progression (defined as annual eGFR decline greater than 2.58 ml/min per 1.73 m2) with an odds ratio (OR) of 0.60 (95% CI 0.46, 0.78). The association with outcome was even stronger when adjusting for a set of 14 baseline clinical parameters including age, biological sex, eGFR, body mass index, albuminuria, and HbA1c. Elevated urinary levels of fatty acid binding protein 3 (FABP3) and vascular cell adhesion molecule 1 (VCAM1) were each significantly associated with fast progression with an OR of 1.44 (95% CI 1.11, 1.87) and an OR of 1.41 (95% CI 1.08, 1.83), respectively. Enriched expression of EGF and FABP3 was observed in distal convoluted tubular cells and VCAM1 in parietal epithelial cells at single cell level from biopsies of patients with early DKD. Conclusion In summary we show that lower urinary levels of EGF and higher urinary levels of FABP3 and VCAM1 are significantly associated with DKD progression in early-stage disease.

Published
2024
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2. International Variability of Renal and Cardiovascular Outcomes and Mortality in Patients with Type 2 Diabetes Mellitus in Europe

Author

Stefanie Thöni, Felix Keller, Sara Denicolò, Susanne Eder, Lukas Buchwinkler, László Rosivall, Andrzej Wiecek, Patrick Barry Mark, Peter Rossing, Hiddo L. Heerspink, and Gert Mayer

Subjects
epidemiology, outcome, diabetes mellitus, diabetic nephropathy, cardiovascular disease, Dermatology, RL1-803, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Introduction: Type 2 diabetes and its complications represent a huge burden to public health. With this prospective, observational cohort study, we aimed to estimate and to compare the incidence rate (IR) of renal and cardiovascular outcomes and all-cause mortality in patients with type 2 diabetes in different European countries. Methods: The renal endpoint was a composite of a sustained decline in estimated GFR of at least 40%, a sustained increase in albuminuria of at least 30% including a transition in albuminuria class, progression to kidney failure with replacement therapy, or death from renal causes. The cardiovascular endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Results: 3,131 participants from four European countries (Austria, Hungary, The Netherlands, and Scotland) with a median follow-up time of 4.4 years were included. IRs were adjusted for several risk factors including sex, age, estimated GFR, albuminuria, HbA1c, blood pressure, and duration of type 2 diabetes. Across countries, the adjusted IR for the renal endpoint was significantly higher in Hungary and Austria, and the adjusted IR for the cardiovascular endpoint was significantly higher in Scotland and Austria. All-cause mortality was significantly higher in Scotland compared to all other countries. Conclusion: Our findings show how the longitudinal outcome of patients with type 2 diabetes varies significantly across European countries even after accounting for the distribution of underlying risk factors.

Published
2023
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3. Methodological challenges and biases in the field of cognitive function among patients with chronic kidney disease

Author

Konstantinos Giannakou, Aleksandra Golenia, Sophie Liabeuf, Jolanta Malyszko, Francesco Mattace-Raso, Ana Farinha, Goce Spasovski, Gaye Hafez, Andrzej Wiecek, Giovanna Capolongo, Giovambattista Capasso, Ziad A. Massy, and Marion Pépin

Subjects
chronic kidney disease, CKD, cognitive function, cognitive impairment, biases, methodological challenges, Medicine (General), R5-920
Abstract

Chronic kidney disease (CKD) affects approximately 850 million people globally and is associated with an increased risk of cognitive impairment. The prevalence of cognitive impairment among CKD patients ranges from 30 to 60%, and the link between CKD and cognitive impairment is partially understood. Methodological challenges and biases in studying cognitive function in CKD patients need to be addressed to improve diagnosis, treatment, and management of cognitive impairment in this population. Here, we review the methodological challenges and study design issues, including observational studies’ limitations, internal validity, and different types of bias that can impact the validity of research findings. Understanding the unique challenges and biases associated with studying cognitive function in CKD patients can help to identify potential sources of error and improve the quality of future research, leading to more accurate diagnoses and better treatment plans for CKD patients.

Published
2023
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4. The Prevalence of Metabolic Acidosis in Patients with Different Stages of Chronic Kidney Disease: Single-Centre Study

Author

Piotr Kuczera, Dorota Ciaston-Mogilska, Barbara Oslizlo, Anna Hycki, Andrzej Wiecek, and Marcin Adamczak

Subjects
metabolic acidosis, chronic kidney disease, Dermatology, RL1-803, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Background: Metabolic acidosis (MA) is one of the most common consequences of CKD. MA is also a risk factor of CKD progression and increased mortality in these patients. Aim: The aim of this retrospective, cross-sectional study was to assess the prevalence of MA in different stages of CKD and renal replacement therapy (RRT) modalities – haemodialysis (HD) and peritoneal dialysis (PD). Additionally, the relationship between the prevalence of MA and aetiology of kidney disease was analysed. Methods: One thousand five patients in different stages of CKD, or modalities of RRT were enrolled into this single-centre cross-sectional study. Forty-one patients were ruled out because of oral bicarbonate supplementation. In the remaining 964 patients (698 CKD stages 1–5, 226 HD, 40 PD), venous blood HCO3− concentration, as well as serum Cr and urea concentrations were assessed. MA was diagnosed when blood HCO3− concentration was below 22 mmol/L. Results: The prevalence of MA increased among all stages of CKD. Patients on HD had lower prevalence of MA in comparison with CKD 5 patients with no RRT (38.5 vs. 56.0%; p = 0.02) In PD patients, the prevalence of MA was significantly lower than in HD patients (2.5 vs. 38.5%; p < 0.001). In the whole study group, there were no significant differences in the prevalence of MA between different aetiologies of CKD (glomerulonephritis 24%, hypertension 23%, diabetes 25%, and tubule-interstitial diseases 24%). Also, when only patients in stages CKD 3–5 were compared, no significant differences in the prevalence of acidosis were found (glomerulonephritis 28%, hypertension 22%, diabetes 24%, and tubule-interstitial 21%). Conclusions: (1) MA is more frequent in patients with more advanced stages of CKD. (2) RRT reduces the prevalence of MA. (3) In PD patients, MA is rare. (4) Aetiology of CKD seems not to have a significant impact on MA prevalence.

Published
2020
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5. Is Metabolic Acidosis a Novel Risk Factor for a Long-Term Graft Survival in Patients after Kidney Transplantation?

Author

Damian Gojowy, Katarzyna Skiba, Magdalena Bartmanska, Aureliusz Kolonko, Andrzej Wiecek, and Marcin Adamczak

Subjects
metabolic acidosis, kidney transplantation, chronic kidney disease, prognosis, risk factor, Dermatology, RL1-803, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Background: Results of both experimental and clinical studies suggest that metabolic acidosis (MA) contributes to the progression of chronic kidney disease (CKD) and mortality in CKD patients. It is unknown whether the same relationship exists in kidney transplantation (KTx) patients. The aim of this observational study was to examine this relationship between MA and both mortality and renal outcomes in patients after KTx. Methods: Four hundred eighty-six (290 male; 196 female) patients aged 48 ± 12 years, at least 1 year after KTx, were analyzed. Blood HCO3– was measured, and patients were then observed over 3 years. MA was defined as the blood HCO3– concentration

Published
2020
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6. Different Relevance of Peripheral, Central or Nighttime Blood Pressure Measurements in the Prediction of Chronic Kidney Disease Progression in Patients with Mild or No-Proteinuria

Author

Piotr Kuczera, Katarzyna Kwiecień, Marcin Adamczak, Teresa Bączkowska, Jolanta Gozdowska, Katarzyna Madziarska, Hanna Augustyniak-Bartosik, Marian Klinger, Magdalena Durlik, Eberhard Ritz, and Andrzej Wiecek

Subjects
Central blood pressure, Ambulatory blood pressure monitoring, Chronic kidney disease, Dermatology, RL1-803, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Background/Aims: Arterial hypertension is one of the leading factors aggravating the course of chronic kidney disease (CKD). It seems that the novel parameters used in the assessment of the blood pressure (BP) load (i.e. central blood pressure, nighttime blood pressure) may be more precise in predicting the cardiovascular risk and the progression of CKD in comparison with the traditional peripheral blood pressure measurements in the office conditions. The aim of the study was to assess the impact of the central, or nighttime blood pressure on the progression of CKD in patients with mild or no-proteinuria (autosomal, dominant polycystic kidney disease or IgA nephropathy). Methods: In each of the enrolled 46 patients with CKD stage 3 or 4, serum creatinine concentration was assessed, eGFR (MDRD) was calculated, also central blood pressure and pulse wave velocity (PWV) was assessed and the 24-hour ambulatory blood pressure monitoring (ABPM) was conducted at the beginning of the study and then repeated after one-year observation period. Results: During the observation period mean eGFR decreased from 44.1 (33.2-50.6) mL/min to 36.7 (29.7-46.3) mL/min. No significant differences were observed in the peripheral blood pressure or central blood pressure parameters. After one-year observation period the values of diastolic blood pressure dipping during the night significantly decreased from 16 (13-19) mmHg to 12 (10-15) mmHg; p< 0.05. The values of systolic dipping during the night or the mean BP values recorded in ABPM did not change significantly. Additionally, no significant differences in the PWV values were found. In the multivariate regression model the change of serum creatinine concentration was explained by the initial diastolic dipping values. Conclusion: 1. In patients with CKD stages 3 or 4 and mild or no- proteinuria, peripheral and central blood pressure did not change significantly during a one-year observation period despite the significant decline of eGFR and seems not to participate in the CKD progression. 2. Reduced magnitude of the diastolic dipping, which reflects the increase of diastolic blood pressure load during the nighttime, may play an important role in the pathogenesis of deterioration of kidney function in these patients.

Published
2018
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7. A Prospective Cohort Study in Patients with Type 2 Diabetes Mellitus for Validation of Biomarkers (PROVALID) – Study Design and Baseline Characteristics

Author

Susanne Eder, Johannes Leierer, Julia Kerschbaum, Laszlo Rosivall, Andrzej Wiecek, Dick de Zeeuw, Patrick B. Mark, Georg Heinze, Peter Rossing, Hiddo L. Heerspink, and Gert Mayer

Subjects
Diabetes mellitus type 2, Diabetic kidney disease, Epidemiology, Treatment, Health care practice, Dermatology, RL1-803, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Background/Aims: The prevalence of diabetes mellitus type 2 and kidney disease in these patients varies widely between European countries. Methods: In addition to store bio-samples the “Prospective cohort study in patients with type 2 diabetes mellitus for validation of biomarkers” collects information on history, physical status, laboratory measurements and medication in 4000 patients with diabetes mellitus type 2, being taken care of at the primary level of healthcare in 5 European countries (Austria, Hungary, Netherlands, Poland and Scotland). Next to comparing the rate of loss of eGFR between the countries, a further objective of the PROVALID study is to determine the 5-year cumulative incidence of renal and cardiovascular outcomes. Results: The mean age of the population recruited is 62.9±10 years, 54.6% are male and the mean BMI is 30.9±5.4 kg/m2. Metabolic control (median HBA1c 6.8 % (6.2; 7.5)) is achieved via administration of metformin in 67.4% of the patients and insulin in 30.3%. Median systolic and diastolic blood pressure at recruitment is 135 (125; 146) and 80 (72; 85) mmHg, 65.4% of subjects received RAAS blocking agents. Mean eGFR is 80.7±29.2 ml/min/1.73m2 and median baseline albumin/creatinine ratio 8.3 mg (IQR: 3.8 and 25.1). Conclusion: PROVALID will provide information on incidence and progression of renal and cardiovascular disease and therapy in patients with type 2 diabetes mellitus in different European countries. Thus, in contrast to many other cohort studies we will be able to associate national clinical practise pattern with outcome in this highly vulnerable patient population.

Published
2018
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8. Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial

Author

Markus Ketteler, Andrzej Wiecek, Alexander R Rosenkranz, Claudia Ose, Jan Rekowski, Horst Lorenz, Burkhard Hellmann, Michael Karus, Michaela Ruhmann, and Richard Ammer

Subjects
Transplantation, Nephrology, Medizin
Abstract

Background We previously reported that modified-release nicotinamide (NAMR) was superior to placebo in reducing serum phosphate concentrations over 12 weeks in a large cohort of haemodialysis patients with hyperphosphataemia. Here we report outcomes after 52 weeks of treatment. Methods NOPHOS was a phase 3, international, randomized, controlled, double-blind trial with a parallel group design. NAMR (250–1500 mg/day) was investigated in comparison to placebo as an add-on therapy to an individual therapy with approved phosphate binders. Results In the intention-to-treat population (NAMR: n = 539; placebo: n = 183), serum phosphate was significantly lower in the NAMR group compared with the placebo group at week 24 (5.40 ± 1.55 versus 5.79 ± 1.37 mg/dl, P Conclusions NAMR combined with phosphate binders significantly reduced serum phosphate over the first 24 weeks of treatment, but the treatment effect was not maintained up to week 52. Non-compliance may have contributed to reduced long-term efficacy. Several newly identified safety signals warrant further evaluation.

Published
2022
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9. Serum Anti-Müllerian Hormone Concentration in Young Women with Chronic Kidney Disease on Hemodialysis, and After Successful Kidney Transplantation

Author

Ewelina Sikora-Grabka, Marcin Adamczak, Piotr Kuczera, Magdalena Szotowska, Paweł Madej, and Andrzej Wiecek

Subjects
Anti-Müllerian hormone, Chronic kidney disease, Hemodialysis, Kidney transplantation, Dermatology, RL1-803, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Background/Aims: In women with chronic kidney disease (CKD) fertility abnormalities occur frequently. Anti-Müllerian hormone (AMH) inhibits excessive recruitment of primordial follicles. The aim of the study was to evaluate the serum AMH concentration in women on hemodialysis and after kidney transplantation (KTx). Methods: 46 hemodialysed women and 14 with CKD about to undergo kidney transplantation were enrolled into the study. The control group consisted of 40 healthy women. In all subjects serum concentration of AMH was determined (in chronic hemodialysis women and in control group once, and in women after KTx immediately before surgery, and 3 times after the transplantation). Results: Serum AMH concentration in hemodialysed women and in the control group did not differ significantly, while in hemodialysed women with regular menstrual cycles it was significantly lower than in the control group: 2.20 (1.08-3.55ng/ml) and 3.30 (1.80-6.10ng/ml) respectively, (p=0.02). In the KTx group, a significant decrease in serum AMH concentration was found from 3.30ng/ml (2.20-6.50ng/ml) at baseline to 1.90ng/ml (1.30-2.40ng/ml) at 6 months after KTx (p=0.007). Conclusions: 1. Significantly lower serum AMH concentration was found in the regularly menstruating CKD women on hemodialysis in comparison with the healthy controls. 2. Serum AMH decreased significantly after successful KTx.

Published
2016
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10. The molecular phenotypes of injury, steatohepatitis, and fibrosis in liver transplant biopsies in the INTERLIVER study

Author

Michał Grąt, Bartosz Foroncewicz, Philip F. Halloran, Rosa Miquel, Krzysztof Jurczyk, Michał Ciszek, Sandy Feng, Aldo J. Montano-Loza, Iman Francis, Dilip Moonka, Grzegorz Piecha, Krzysztof Mucha, Olga Tronina, Agnieszka Perkowska-Ptasińska, Katelynn S. Madill-Thomsen, Marta Wawrzynowicz-Syczewska, Goran B. Klintmalm, Trevor Reichman, Marek Myślak, Andrzej Wiecek, Maciej Krasnodębski, Magdalena Durlik, Alberto Sanchez-Fueyo, Chandra Bhati, Marwan S Abouljoud, Geoff McCaughan, Krzysztof Zieniewicz, and Leszek Pączek

Subjects
Graft Rejection, Pathology, medicine.medical_specialty, Microarray, Biopsy, Inflammation, Fibrosis, Parenchyma, Humans, Immunology and Allergy, Medicine, Pharmacology (medical), Transplantation, medicine.diagnostic_test, business.industry, medicine.disease, Phenotype, Liver Transplantation, Fatty Liver, Liver, Liver function, Steatohepatitis, medicine.symptom, business
Abstract

To extend previous molecular analyses of rejection in liver transplant biopsies in the INTERLIVER study (ClinicalTrials.gov #NCT03193151), the present study aimed to define the gene expression selective for parenchymal injury, fibrosis, and steatohepatitis. We analyzed genome-wide microarray measurements from 337 liver transplant biopsies from 13 centers. We examined expression of genes previously annotated as increased in injury and fibrosis using principal component analysis (PCA). PC1 reflected parenchymal injury and related inflammation in the early posttransplant period, slowly regressing over many months. PC2 separated early injury from late fibrosis. Positive PC3 identified a distinct mildly inflamed state correlating with histologic steatohepatitis. Injury PCs correlated with liver function and histologic abnormalities. A classifier trained on histologic steatohepatitis predicted histologic steatohepatitis with cross-validated AUC = 0.83, and was associated with pathways reflecting metabolic abnormalities distinct from fibrosis. PC2 predicted histologic fibrosis (AUC = 0.80), as did a molecular fibrosis classifier (AUC = 0.74). The fibrosis classifier correlated with matrix remodeling pathways with minimal overlap with those selective for steatohepatitis, although some biopsies had both. Genome-wide assessment of liver transplant biopsies can not only detect molecular changes induced by rejection but also those correlating with parenchymal injury, steatohepatitis, and fibrosis, offering potential insights into disease mechanisms for primary diseases.

Published
2022
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11. Lessons learned during the war in Ukraine: a report from the Renal Disaster Relief Task Force of the ERA

Author

Serhan Tuğlular, Valerie Luyckx, Raymond Vanholder, Andrej Skoberne, Andrzej Wiecek, İonut Nistor, Ewa Pawlowicz-Szlarska, Rukshana Shroff, Dmytro Ivanov, Kai-Uwe Eckardt, Edita Noruisiene, Daniel Gallego, Olena Loboda, Mehmet S Sever, and Tuğlular S., Luyckx V., Vanholder R., Skoberne A., Wiecek A., Nistor İ., Pawlowicz-Szlarska E., Shroff R., Ivanov D., Eckardt K., et al.

Subjects
kidney patients, Transplantation, conflicts, Nephrology, dialysis, war, disasters
Abstract

People living with kidney disease are among the most vulnerable at times of natural or man-made disasters. In addition to their unpredictable course, armed conflicts impose a major threat given the disruption of infrastructure, sanitation and access to food, water and medical care. The ongoing war in Ukraine has once more demonstrated the importance of preparedness, organization, coordination and solidarity during disasters. People living with kidney disease face serious challenges given their dependence on life-sustaining treatment, irrespective of whether they remain in the war zone or are displaced internally or externally. This especially affects those requiring kidney replacement therapy, dialysis or transplantation, but also patients with other kidney diseases and the medical staff who care for them. Soon after the war started, the European Renal Association assigned a Renal Disaster Relief Task Force dedicated to support the people living with kidney disease and the nephrology community in Ukraine. This report summarizes the major challenges faced, actions taken and lessons learned by this task force. We anticipate that the experience will help to increase preparedness and mitigate the devastating effects of armed conflicts on the kidney community in the future and propose to establish an international collaboration to extend this effort to other parts of the world facing similar challenges.

Published
2023
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12. Intact FGF23 predicts serum phosphate improvement after combined nicotinamide and phosphate binder treatment in hemodialysis patients

Author

Daniela Egli-Spichtig, Ahmad Kamal Hamid, Eva Maria Pastor Arroyo, Markus Ketteler, Andrzej Wiecek, Alexander R Rosenkranz, Andreas Pasch, Horst Lorenz, Burkhard Hellmann, Michael Karus, Richard Ammer, Isabel Rubio-Aliaga, and Carsten A Wagner

Subjects
Transplantation, Nephrology
Abstract

Background Hyperphosphatemia is associated with increased mortality and cardiovascular morbidity of end-stage kidney failure (ESKF) patients. Managing serum phosphate in ESKF patients is challenging and mostly based on limiting intestinal phosphate absorption with low phosphate diets and phosphate binders (PB). In a multi-centric, double-blinded, placebo-controlled study cohort of maintenance hemodialysis patients with hyperphosphatemia, we demonstrated the efficacy of nicotinamide modified release (NAMR) formulation treatment in addition to standard PB therapy in decreasing serum phosphate. Here we aimed to assess the relationship between phosphate, FGF23, inflammation and iron metabolism in this cohort. Methods We measured the plasma concentrations of intact fibroblast growth factor 23 (iFGF23) and selected proinflammatory cytokines at baseline and Week 12 after initiating treatment. Results We observed a strong correlation between iFGF23 and cFGF23 (C-terminal fragment plus iFGF23). We identified iFGF23 as a better predictor of changes in serum phosphate induced by NAMR and PB treatment compared with cFGF23. Recursive partitioning revealed at baseline and Week 12, that iFGF23 and cFGF23 together with T50 propensity were the most important predictors of serum phosphate, whereas intact parathyroid hormone (iPTH) played a minor role in this model. Furthermore, we found serum phosphate and iPTH as the best predictors of iFGF23 and cFGF23. Sex, age, body mass index, and markers of inflammation and iron metabolism had only a minor impact in predicting FGF23. Conclusion Lowering serum phosphate in ESKF patients may depend highly on iFGF23 which is correlated to cFGF23 levels. Serum phosphate was the most important predictor of plasma FGF23 in this ESKF cohort.

Published
2023
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13. Changes of Serum Total and Free Testosterone Concentrations in Male Chronic Hemodialysis Patients with Secondary Hyperparathyroidism in Response to Cinacalcet Treatment

Author

Piotr Kuczera, Marcin Adamczak, and Andrzej Wiecek

Subjects
Secondary hyperparathyroidism, Cinacalcet, Testosterone, Dermatology, RL1-803, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Background/Aims: Calcium sensing receptor (CaSR) is expressed, among others also in testis. Cinacalcet binds to the CaSR, increases sensitivity of CaSR to serum calcium and is used in the treatment of secondary hyperparathyroidism (sHPT) in chronic hemodialysis patients (HDP). In most of male HDP, serum testosterone concentration is lower than in healthy males. The aim of this study was to assess the influence of six-month treatment with cinacalcet on the serum total and free testosterone concentration in male HDP with sHPT. Methods: 38 male, hemodialysed CKD patients with sHPT (PTH>300 pg/ml) were enrolled into the study. In each patient serum PTH, total testosterone (TT) and free testosterone (FT) concentrations were assessed before the first dose of cinacalcet and then after 3 and 6 months of treatment. The results are presented as means with 95% confidence interval. Results: In 33 patients who completed the study cinacalcet treatment caused significant decrease of serum PTH from 1143 pg/ml (828 - 1458 pg/ml) at the baseline, to 809 pg/ml (487 - 1132pg/ml) after 3 month of treatment (p = 0.002), and to 607 pg/ml (281 - 934pg/ml; p Conclusion: Treatment with cinacalcet decreases serum total and free testosterone concentration in male hemodialysed patients with chronic kidney disease and secondary hyperparathyroidism.

Published
2016
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14. The ASCEND-ND trial: study design and participant characteristics

Author

Vlado Perkovic, Allison Blackorby, Borut Cizman, Kevin Carroll, Alexander R Cobitz, Rich Davies, Tara L DiMino, Vivekanand Jha, Kirsten L Johansen, Renato D Lopes, Lata Kler, Iain C Macdougall, John J V McMurray, Amy M Meadowcroft, Gregorio T Obrador, Scott Solomon, Lin Taft, Christoph Wanner, Sushrut S Waikar, David C Wheeler, Andrzej Wiecek, and Ajay K Singh

Subjects
Male, Transplantation, Iron, Anemia, Prolyl-Hydroxylase Inhibitors, Hemoglobins, Renal Dialysis, Nephrology, hemic and lymphatic diseases, Hematinics, Humans, Female, Darbepoetin alfa, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Renal Insufficiency, Chronic, Erythropoietin, Aged
Abstract

Background Anaemia is common in chronic kidney disease (CKD) and assessment of the risks and benefits of new therapies is important. Methods The Anaemia Study in CKD: Erythropoiesis via a Novel prolyl hydroxylase inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) trial includes adult patients with CKD Stages 3–5, not using erythropoiesis-stimulating agents (ESAs) with screening haemoglobin (Hb) 8–10 g/dL or receiving ESAs with screening Hb of 8–12 g/dL. Participants were randomized to daprodustat or darbepoetin alfa (1:1) in an open-label trial (steering committee- and sponsor-blinded), with blinded endpoint assessment. The co-primary endpoints are mean change in Hb between baseline and evaluation period (average over Weeks 28–52) and time to first adjudicated major adverse cardiovascular (CV) event. Baseline characteristics were compared with those of participants in similar anaemia trials. Results Overall, 3872 patients were randomized from 39 countries (median age 67 years, 56% female, 56% White, 27% Asian and 10% Black). The median baseline Hb was 9.9 g/dL, blood pressure was 135/74 mmHg and estimated glomerular filtration rate was 18 mL/min/1.73 m2. Among randomized patients, 53% were ESA non-users, 57% had diabetes and 37% had a history of CV disease. At baseline, 61% of participants were using renin–angiotensin system blockers, 55% were taking statins and 49% were taking oral iron. Baseline demographics were similar to those in other large non-dialysis anaemia trials. Conclusion ASCEND-ND will define the efficacy and safety of daprodustat compared with darbepoetin alfa in the treatment of patients with anaemia associated with CKD not on dialysis.

Published
2021
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15. A randomized multicenter trial on a lung ultrasound-guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk

Author

Thierry Hannedouche, Giovanni Tripepi, Olga Balafa, Aikaterini Papagianni, Carmine Zoccali, Radovan Hojs, Claudia Torino, Rosa Sicari, Luna Gargani, Itzchak Slotki, Linda Shavit, Alberto Martínez-Castelao, Alexandre Seidowsky, Francesca Mallamaci, Krzysztof Letachowicz, Enrico Fiaccadori, Dimitrie Siriopol, Yuri Battaglia, Ziad A. Massy, Patrick Rossignol, Gérard M. London, Friedo W. Dekker, Kostas C. Siamopoulos, Pantelis Sarafidis, Robert Ekart, Thomas Bachelet, Kitty J. Jager, Adrian Covic, Giuseppe Regolisti, Marie-Jeanne Coudert-Krier, Aristeidis Stavroulopoulos, Andrzej Wiecek, Sarah Seiler-Mußler, Fabio Lizzi, Rocco Tripepi, Danilo Fliser, Carolina Polo-Torcal, Marian Klinger, Agata Miskiewicz, Eugenio Picano, Medical Informatics, ACS - Pulmonary hypertension & thrombosis, APH - Aging & Later Life, APH - Quality of Care, and APH - Global Health

Subjects
cardiovascular risk, medicine.medical_specialty, medicine.medical_treatment, Population, lung congestion, law.invention, Kidney Failure, Randomized controlled trial, Renal Dialysis, Risk Factors, law, Multicenter trial, Internal medicine, Humans, Medicine, Chronic, Risk factor, ESRD, education, Lung, Ultrasonography, Interventional, Dialysis, Ultrasonography, lung ultrasound, education.field_of_study, Interventional, business.industry, Hazard ratio, chronic kidney failure, medicine.disease, heart failure hemodialysis, Heart Disease Risk Factors, Cardiovascular Diseases, Nephrology, Heart failure, Quality of Life, Kidney Failure, Chronic, Hemodialysis, business
Abstract

Lung congestion is a risk factor for all-cause and cardiovascular mortality in patients on chronic hemodialysis, and its estimation by ultrasound may be useful to guide ultrafiltration and drug therapy in this population. In an international, multi-center randomized controlled trial (NCT02310061) we investigated whether a lung ultrasound-guided treatment strategy improved a composite end point (all-cause death, non-fatal myocardial infarction, decompensated heart failure) vs usual care in patients receiving chronic hemodialysis with high cardiovascular risk. Patient-Reported Outcomes (Depression and the Standard Form 36 Quality of Life Questionnaire, SF36) were assessed as secondary outcomes. A total of 367 patients were enrolled: 183 in the active arm and 180 in the control arm. In the active arm, the pre-dialysis lung scan was used to titrate ultrafiltration during dialysis and drug treatment. Three hundred and seven patients completed the study: 152 in the active arm and 155 in the control arm. During a mean follow-up of 1.49 years, lung congestion was significantly more frequently relieved in the active (78%) than in the control (56%) arm and the intervention was safe. The primary composite end point did not significantly differ between the two study arms (Hazard Ratio 0.88; 95% Confidence Interval: 0.63-1.24). The risk for all-cause and cardiovascular hospitalization and the changes of left ventricular mass and function did not differ among the two groups. A post hoc analysis for recurrent episodes of decompensated heart failure (0.37; 0.15-0.93) and cardiovascular events (0.63; 0.41-0.97) showed a risk reduction for these outcomes in the active arm. There were no differences in patient-reported outcomes between groups. Thus, in patients on chronic hemodialysis with high cardiovascular risk, a treatment strategy guided by lung ultrasound effectively relieved lung congestion but was not more effective than usual care in improving the primary or secondary end points of the trial.

Published
2021

16. Armed conflicts and kidney patients: A consensus statement from the renal disaster relief task force of the ERA

Author

Mehmet S Sever, Raymond Vanholder, Valerie Luyckx, Kai-Uwe Eckardt, Mykola Kolesnyk, Andrzej Wiecek, Ewa Pawlowicz-Szlarska, Daniel Gallego, Rukshana Shroff, Andrej Škoberne, Ionut Nistor, Mohamed Sekkarie, Dmytro Ivanov, Edita Noruišiene, Serhan Tuglular, Sever M. S. , Vanholder R., Luyckx V., Eckardt K., Kolesnyk M., Wiecek A., Pawlowicz-Szlarska E., Gallego D., Shroff R., Skoberne A., et al., and University of Zurich

Subjects
Internal Diseases, Urology, 610 Medicine & health, Sağlık Bilimleri, İç Hastalıkları, Clinical Medicine (MED), disasters, Transplantasyon, conflicts, UROLOGY & NEPHROLOGY, Health Sciences, Klinik Tıp (MED), ÜROLOJİ VE NEFROLOJİ, wars, kidney patients, Transplantation, Internal Medicine Sciences, Klinik Tıp, 10060 Epidemiology, Biostatistics and Prevention Institute (EBPI), Dahili Tıp Bilimleri, CLINICAL MEDICINE, Tıp, Nefroloji, 10036 Medical Clinic, Nephrology, Üroloji, Medicine, dialysis
Abstract

During conflicts, people with kidney disease, either those remaining in the affected zones or those who are displaced, may be exposed to additional threats because of medical and logistical challenges. Acute kidney injury developing on the battlefield, in field hospitals or in higher-level hospital settings is characterized by poor outcomes. People with chronic kidney disease may experience treatment interruptions, contributing to worsening kidney function. Patients living on dialysis or with a functioning graft may experience limitations of dialysis possibilities or availability of immunosuppressive medications, increasing the risk of severe complications including death. When patients must flee, these threats are compounded by unhealthy and insecure conditions both during displacement and/or at their destination. Measures to attenuate these risks may only be partially effective. Local preparedness for overall and medical/kidney-related disaster response is essential. Due to limitations in supply, adjustments in dialysis frequency or dose, switching between hemodialysis and peritoneal dialysis and changes in immunosuppressive regimens may be required. Telemedicine (if possible) may be useful to support inexperienced local physicians in managing medical and logistical challenges. Limited treatment possibilities during warfare may necessitate referral of patients to distant higher-level hospitals, once urgent care has been initiated. Preparation for disasters should occur ahead of time. Inclusion of disaster nephrology in medical and nursing curricula and training of patients, families and others on self-care and medical practice in austere settings may enhance awareness and preparedness, support best practices adapted to the demanding circumstances and prepare non-professionals to lend support.

Published
2023
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17. Administration of Cyclosporine A in Pregnant Rats - the Effect on Blood Pressure and on the Glomerular Number in Their Offspring

Author

Natalia Slabiak-Blaz, Marcin Adamczak, Nadezda Gut, Aniela Grajoszek, Jens R. Nyengaard, Eberhard Ritz, and Andrzej Wiecek

Subjects
Hypertension, Kidney development, Chronic kidney disease, Pregnant rats, Cyclosporine A, Glomerular number, Dermatology, RL1-803, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Background/Aims: Cyclosporine A (CsA) is a commonly used immunosuppressive agent. In some patients treatment with CsA has to be continued during pregnancy. The aim of the study was to assess in an experimental model whether the exposure to CsA during fetal life influences the number and volume of glomeruli, kidney function and blood pressure in the offspring. Methods: Eight pregnant female Sprague-Dawley rats were allocated to 2 treatment regimens: with CsA or solvent. Blood pressure was measured in the offspring at 7 and 11 weeks of age and albuminuria was determined at 11 weeks of age. In the kidney the number and mean volume of glomeruli was assessed using stereological methods. Results: In the offspring of pregnant rats treated with CsA the number of glomeruli was significantly lower and the mean volume of glomeruli was higher when compared to the offspring of pregnant rats receiving solvent. Systolic and diastolic blood pressures as well as albuminuria were significantly higher in the offspring of mothers treated with CsA during gestation compared to the offspring from the control group. Conclusions: Exposure of rats to CsA during fetal life impairs kidney development, thus potentially predisposing to chronic kidney disease and hypertension in the adult life.

Published
2015
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18. Analysis of on-treatment cancer safety events with daprodustat versus conventional erythropoiesis-stimulating agents—post hoc analyses of the ASCEND-ND and ASCEND-D trials

Author

Ajay K Singh, Finnian R Mc Causland, Brian L Claggett, Christoph Wanner, Andrzej Wiecek, Michael B Atkins, Kevin Carroll, Vlado Perkovic, John J V McMurray, Janet Wittes, Steven Snapinn, Allison Blackorby, Amy Meadowcroft, Tara Barker, Tara DiMino, Stephen Mallett, Alexander R Cobitz, and Scott D Solomon

Subjects
Transplantation, Nephrology
Abstract

Background The prespecified on-treatment analysis of ASCEND-ND (NCT02876835) raised concerns about a higher relative risk of cancer-related adverse events (AEs) with daprodustat vs darbepoetin in patients with anaemia of CKD. This concern was not observed in dialysis patients in ASCEND-D (NCT02879305). Methods ASCEND-ND randomized 3872 patients to daprodustat or darbepoetin. ASCEND-D randomized 2964 patients to daprodustat or conventional erythropoiesis-stimulating agents (ESAs). In both studies ESA comparators used different dosing intervals (3/week, 1/week, every 2 or every 4 weeks). The prespecified on-treatment approach examined relative risks for cancer AEs up to the last dose date + 1 day. In these analyses, owing to different dosing intervals between arms, Cox models were used to estimate the daprodustat effect by various follow-up periods (censoring at last dose date, last dose date + dosing intervals, or end of study). Results In ASCEND-ND, the safety of daprodustat vs darbepoetin on cancer-related AEs depended on the duration of follow-up after last dose date: hazard ratio (HR) 1.04 [95% confidence interval (CI) 0.77, 1.40] at end of study [HR 1.12 (95% CI 0.81, 1.56) for last dose date + dosing interval; HR 1.50 (95% CI 1.04, 2.15) for last dose date + 1 day]. In ASCEND-D, no excess risk of cancer-related AEs was observed with any model examined. Conclusions Prespecified on-treatment analyses for cancer-related AEs appeared to result in biased risk estimates in ASCEND-ND by preferentially under-counting events from patients assigned to darbepoetin. Analyses accounting for longer darbepoetin dosing intervals, or extending follow-up, resulted in attenuation of effect estimates towards neutrality, similar to ASCEND-D, where ESA comparator dosing intervals are closer to daprodustat. Trial registration The ASCEND-ND trial is registered with ClinicalTrials.gov (NCT02876835); the ASCEND-D trial is registered with ClinicalTrials.gov (NCT02879305).

Published
2022
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19. Serum testosterone concentrations in male patients with end-stage kidney disease treated with haemodialysis

Author

Andrzej Wiecek, Piotr Kuczera, and Marcin Adamczak

Subjects
Adult, Male, Infertility, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Osteoporosis, Gastroenterology, Pathogenesis, Young Adult, Endocrinology, Renal Dialysis, Internal medicine, medicine, Humans, Testosterone, Renal Insufficiency, Chronic, Interleukin 6, biology, Interleukin-6, business.industry, Hypogonadism, medicine.disease, Male patient, biology.protein, Kidney Failure, Chronic, Hemodialysis, business, Kidney disease
Abstract

Introduction: Testosterone deficiency is frequently found in male patients with chronic kidney disease (CKD) and may participate in the pathogenesis of osteoporosis, sarcopaenia, anaemia, impotence, infertility, and other comorbidities observed in these patients. The aim of the study was the evaluation of the frequency of testosterone deficiency in male patients with CKD on maintenance haemodialysis (HD). Material and methods: In 79 male HD patients, serum total (TT), free (FT) testosterone, C-reactive protein (CRP), and interleukin 6 (IL-6) serum concentrations were assessed before an HD procedure. Patients were divided into three subgroups based on age categories: 19-39 years (18 patients), 40–59 years (34 patients), and ≥ 60 years (27 patients). TT insufficiency and deficiency were diagnosed when the serum TT concentration was below 4.0 ng/mL and 2.9 ng/mL, respectively. FT deficiency was diagnosed in patients with serum FT concentration below 8.9, 6.6, and 4.9 pg/mL in the abovementioned age subgroups, respectively. Results: In the abovementioned age subgroups the serum TT concentration was 5.9 (4.6–7.1), 4.8 (3.9–5.4), and 4.6 (3.9–5.3) ng/mL, respectively. The serum FT concentration was 7.9 (5.2–10.1), 6.1 (5.1–7.2), and 6.0 (5.0–7.1) pg/mL, respectively. In the whole group TT insufficiency was found in 40%, TT deficiency in 15% of patients, and FT deficiency in 50% of patients. Significant negative correlations were found between both serum TT and FT concentrations and age (r = –0.23, p = 0.05 and r = –0.27, p = 0.02, respectively). Additionally, negative correlations were found between both serum TT and FT and IL-6 concentrations (r = –0.43, p < 0.05 and r = –0.29, p < 0.05), respectively. Conclusions: 1. Testosterone deficiency is common in male patients with chronic kidney disease treated with HD. 2. In HD patients the serum testosterone concentration decreases with age. 3. Chronic inflammation may participate in the pathogenesis of testosterone deficiency in haemodialysis patients.

Published
2021
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20. Cognitive disorders in patients with chronic kidney disease: specificities of clinical assessment

Author

Michelangela Barbieri, Aleksandra Klimkowicz-Mrowiec, Goce Spasovski, Liliana Garneata, Sophie Liabeuf, Carmen Antonia Mocanu, Carmine Zoccali, Sol Carriazo, Olivier Godefroy, Konstantinos Giannakou, Mustafa Arici, Andrzej Wiecek, Evgueniy Vazelov, Tomasz Grodzicki, Marion Pépin, Ziad A. Massy, Giuseppe Paolisso, Pilar Delgado, Davide Viggiano, Maie Bachman, Justina Kurganaite, Ana Carina Ferreira, Inga Arune Bumblyte, Hôpital Ambroise Paré [AP-HP], Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Hospital Curry Cabral [Lisbon, Portugal], Universidade Nova de Lisboa = NOVA University Lisbon (NOVA), Hacettepe University = Hacettepe Üniversitesi, Tallinn University of Technology (TTÜ), University of the Study of Campania Luigi Vanvitelli, Lithuanian University of health Sciences [Kaunas], Fundacion Jimenez Diaz [Madrid] (FJD), Universitat Autònoma de Barcelona (UAB), University of Medicine and Pharmacy 'Carol Davila' Bucharest (UMPCD), European University of Cyprus, Laboratoire de Neurosciences Fonctionnelles et Pathologies - UR UPJV 4559 (LNFP), Université de Picardie Jules Verne (UPJV), CHU Amiens-Picardie, Uniwersytet Jagielloński w Krakowie = Jagiellonian University (UJ), Mécanismes physiopathologiques et conséquences des calcifications vasculaires - UR UPJV 7517 (MP3CV), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, Medical University of Sofia [Bulgarie], Medical University of Silesia (SUM), CONNECT Action (Cognitive Decline in Nephro-Neurology European Cooperative Target): Giovambattista Capasso, Alexandre Andrade, Maie Bachmann, Inga Bumblyte, Adrian Constantin Covic, Pilar Delgado, Nicole Endlich, Andreas Engvig, Denis Fouque, Casper Franssen, Sebastian Frische, Liliana Garneata, Loreto Gesualdo, Konstantinos Giannakou, Dimitrios Goumenos, Ayşe Tuğba Kartal, Laila-Yasmin Mani, Hans-Peter Marti, Christopher Mayer, Rikke Nielsen, Vesna Pešić, Merita Rroji, Giorgos Sakkas, Goce Spasovski, Kate I Stevens, Evgueniy Vazelov, Davide Viggiano, Lefteris Zacharia, Ana Carina Ferreira, Jolanta Malyszko, Ewout Hoorn, Andreja Figurek, Robert Unwin, Carsten Wagner, Christoph Wanner, Annette Bruchfeld, Marion Pepin, Andrzej Wiecek, Dorothea Nitsch, Ivo Fridolin, Gaye Hafez, Maria José Soler Romeo, Michelangela Barbieri, Bojan Batinić, Laura Carrasco, Sol Carriazo, Ron Gansevoort, Gianvito Martino, Francesco Mattace Raso, Ionut Nistor, Alberto Ortiz, Giuseppe Paolisso, Daiva Rastenytė, Gabriel Stefan, Gioacchino Tedeschi, Ziad Massy, Boris Bikbov, Karl Hans Endlich, Olivier Godefroy, Jean-Marc Chillon, Anastassia Kossioni, Justina Kurganaite, Norberto Perico, Giuseppe Remuzzi, Tomasz Grodzicki, Francesco Trepiccione, Carmine Zoccali, Mustafa Arici, Peter Blankestijn, Kai-Uwe Eckardt, Danilo Fliser, Eugenio Gutiérrez Jiménez, Maximilian Konig, Ivan Rychlik, Michela Deleidi, George Reusz, DESSAIVRE, Louise, Internal Medicine, Pepin, M., Ferreira, A. C., Arici, M., Bachman, M., Barbieri, M., Bumblyte, I. A., Carriazo, S., Delgado, P., Garneata, L., Giannakou, K., Godefroy, O., Grodzicki, T., Klimkowicz-Mrowiec, A., Kurganaite, J., Liabeuf, S., Mocanu, C. A., Paolisso, G., Spasovski, G., Vazelov, E. S., Viggiano, D., Zoccali, C., Massy, Z. A., and Wiecek, A.

Subjects
medicine.medical_specialty, Review, urologic and male genital diseases, comprehensive battery, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Pharmacotherapy, medicine, Cognitive decline, Intensive care medicine, Cognitive impairment, AcademicSubjects/MED00340, Kidney transplantation, cognitive impairment, Transplantation, business.industry, [SDV.NEU.SC]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Cognitive Sciences, Cognition, cognitive screening test, clinical assessment, medicine.disease, [SDV.MHEP.UN] Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Cognitive test, Nephrology, business, Neurocognitive, chronic kidney disease, [SDV.NEU.SC] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Cognitive Sciences, Kidney disease
Abstract

Neurocognitive disorders are frequent among chronic kidney disease (CKD) patients. Identifying and characterizing cognitive impairment (CI) can help to assess the ability of adherence to CKD risk reduction strategy, identify potentially reversible causes of cognitive decline, modify pharmacotherapy, educate the patient and caregiver and provide appropriate patient and caregiver support. Numerous factors are associated with the development and progression of CI in CKD patients and various conditions can influence the results of cognitive assessment in these patients. Here we review clinical warning signs that should lead to cognitive screening; conditions frequent in CKD at risk to interfere with cognitive testing or performance, including specificities of cognitive assessment in dialysis patients or after kidney transplantation; and available tests for screening and observed cognitive patterns in CKD patients., Graphical Abstract Graphical abstract

Published
2022
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21. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial

Author

Christoph Wanner, Gregorio T. Obrador, Sushrut S. Waikar, Kevin Carroll, Iain C. Macdougall, Rich Davies, Borut Cizman, Scott D. Solomon, David C. Wheeler, Alexander R. Cobitz, Andrzej Wiecek, Vivekanand Jha, Kirsten L. Johansen, Lata Kler, Allison Blackorby, Vlado Perkovic, Ajay K. Singh, Renato D. Lopes, John J.V. McMurray, and Amy Meadowcroft

Subjects
Male, medicine.medical_specialty, Darbepoetin alfa, Anemia, medicine.medical_treatment, Peritoneal dialysis, Hemoglobins, Renal Dialysis, Internal medicine, Diabetes mellitus, medicine, Humans, Renal Insufficiency, Chronic, Erythropoietin, Dialysis, Transplantation, business.industry, Epoetin alfa, Middle Aged, medicine.disease, Recombinant Proteins, Epoetin Alfa, Clinical trial, Nephrology, Hematinics, Female, business, medicine.drug, Kidney disease
Abstract

Background The Anemia Studies in chronic kidney disease (CKD): Erythropoiesis via a Novel prolyl hydroxylase inhibitor Daprodustat-Dialysis (ASCEND-D) trial will test the hypothesis that daprodustat is noninferior to comparator epoetin alfa or darbepoetin alfa for two co-primary endpoints: hemoglobin (Hb) efficacy and cardiovascular (CV) safety. Methods We report the trial design, key demographic, clinical and laboratory findings, and baseline therapies of 2964 patients randomized in the open-label (sponsor-blinded) active-controlled, parallel-group, randomized ASCEND-D clinical trial. We also compare baseline characteristics of ASCEND-D patients with patients who are on dialysis (CKD G5D) enrolled in other large CV outcome trials (CVOTs) and in the most relevant registries. Results The median age of patients was 58 years, 43% were female; 67% were White and 16% were Black. The median Hb at baseline was 10.4 g/dL. Among randomized patients, 89% were receiving hemodialysis and 11% peritoneal dialysis. Among key comorbidities, 42% reported a history of diabetes mellitus and 45% a history of CV disease. Median blood pressure was 134/74 mmHg. The median weekly dose of epoetin was 5751 units. Intravenous and oral iron uses were noted in 64 and 11% of patients, respectively. Baseline demographics were similar to patients with CKD G5D enrolled in other CVOTs and renal patient registries. Conclusions ASCEND-D will evaluate the efficacy and safety of daprodustat compared with epoetin alfa or darbepoetin alfa in the treatment of patients with anemia with CKD G5D. This trial is registered with ClinicalTrials.gov: NCT02879305. EudraCT Number: 2016-000541-31; Sponsor Protocol Number: 200807.

Published
2021
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22. Efficacy and Safety of a Novel Nicotinamide Modified-Release Formulation in the Treatment of Refractory Hyperphosphatemia in Patients Receiving Hemodialysis—A Randomized Clinical Trial

Author

Richard Ammer, Alexander R. Rosenkranz, Jan Rekowski, Andrzej Wiecek, Markus Ketteler, Michael Karus, Andreas Pasch, and Burkhard Hellmann

Subjects
medicine.medical_specialty, mineral and bone disease, medicine.medical_treatment, Population, Medizin, 030232 urology & nephrology, nicotinamide, 030204 cardiovascular system & hematology, Placebo, phosphate binder combination therapy, Gastroenterology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, Hyperphosphatemia, 0302 clinical medicine, Randomized controlled trial, Refractory, Clinical Research, law, Internal medicine, medicine, hyperphosphatemia, education, education.field_of_study, hemodialysis, Nicotinamide, business.industry, randomized controlled trial, medicine.disease, Confidence interval, chemistry, Nephrology, Hemodialysis, business
Abstract

Introduction Despite widespread use of phosphate binders (PBs), phosphate control is insufficient in many hemodialysis patients. Preliminary clinical observations suggest that nicotinamide may act synergistically with PBs to improve phosphate control. Methods This multinational, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of nicotinamide modified release (NAMR) in combination with oral PB in a large cohort of hemodialysis patients with abnormal serum phosphate concentration (>4.5 mg/dl) despite treatment with PB. Patients entered a proof-of-efficacy phase (12 weeks [W12]) in which adjustments of relevant comedication were not permitted, followed by a safety extension phase for up to 52 weeks. Here, we report the results of the first phase. Results The intention-to-treat (ITT) population consisted of 539 patients in the NAMR and 183 patients in the placebo group. NAMR and placebo were orally administered once daily (250–1500 mg/d). Mean age of patients was 61.8 years, and 63.0% were men. In the confirmatory analysis that estimated the difference in serum phosphate concentration after 12 weeks, NAMR proved superior over placebo with a significant difference of –0.51 mg/dl (95% confidence interval [CI] –0.72, –0.29; P < 0.0001). This effect was associated with significantly lower intact parathyroid hormone (iPTH) values (NAMR: 292.4±300.4 pg/ml vs. placebo: 337.0±302.7 pg/ml; P = 0.04) and an improved calcification propensity (T50 time; NAMR: 23.8±97.1 minutes vs. placebo: 2.3±100.7 minutes; P = 0.02). Diarrhea and pruritus were more frequent in the NAMR group. Conclusion NAMR combined with oral PB significantly improved phosphate control in hemodialysis patients., Graphical abstract

Published
2021
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23. EDTAKI: a Nephrology and Public Policy Committee platform call for more European involvement in acute kidney injury

Author

Hans-Joachim Anders, Ziad A. Massy, Danilo Fliser, Nicholas Carlson, Nicholas M. Selby, José António Lopes, Andrzej Wiecek, Alberto Ortiz, Ana Belen Sanz, Mehmet Kanbay, Eric Rondeau, Raymond Vanholder, Patrick T. Murray, Ghent University Hospital, European Kidney Health Alliance (EKHA), CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université (SU), Ludwig-Maximilians University Hospital (LMU Munich), Rigshospitalet [Copenhagen], Copenhagen University Hospital, Saarland University Medical Center [Homburg, Germany] (SUMC), Koç University, Centro Hospitalar Universitário Lisboa Norte [Lisbon, Portugal] (CHULN), University College Dublin [Dublin] (UCD), Universidad Autónoma de Madrid (UAM), University of Nottingham, UK (UON), Medical University of Silesia (SUM), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, and Hôpital Ambroise Paré [AP-HP]

Subjects
Male, Nephrology, Transplantation, medicine.medical_specialty, business.industry, [SDV]Life Sciences [q-bio], networking, NPPC, Public policy, Public Policy, Acute Kidney Injury, Clinical nephrology, Gross domestic product, Nephrologists, AKI, Renal Dialysis, Internal medicine, Family medicine, medicine, Humans, Female, Nephrology and Public Policy Committee, business
Abstract

Background Acute kidney injury (AKI) is an often neglected but crucial element of clinical nephrology. The aim of the Nephrology and Public Policy Committee (NPPC) of the European Renal Association–European Dialysis and Transplant Association is to promote several key aspects of European nephrology. One of the targets proposed by the NPPC was to advance European nephrology involvement in AKI. Methods We undertook a literature analysis to define the current position of European nephrology in the field of AKI compared with other regions and to determine how different European countries compare with each other. Results It appeared that vis-à-vis countries with a comparable socio-economic status (the USA, Australia, New Zealand and Canada), the European contribution was almost 50% less. Within Europe, Central and Eastern Europe and countries with a lower gross domestic product showed lower scientific output. Nephrologists contributed to less than half of the output. There was no trend of a change over the last decade. Conclusions There is room to improve the contribution of European nephrology in the field of AKI. We propose a model on how to promote clinical collaboration on AKI across Europe and the creation of a pan-European nephrology network of interested units to improve clinical outcomes, increase nephrologist involvement and awareness outside nephrology and stimulate research on AKI in Europe. Accordingly, we also propose a list of research priorities and stress the need for more European funding of AKI research.

Published
2021
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24. Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase III randomised controlled NOPHOS trial

Author

Markus, Ketteler, Andrzej, Wiecek, Alexander R, Rosenkranz, Claudia, Ose, Jan, Rekowski, Horst, Lorenz, Burkhard, Hellmann, Michael, Karus, Michaela, Ruhmann, and Richard, Ammer

Abstract

We previously reported that modified-release nicotinamide (NAMR) was superior to placebo in reducing serum phosphate concentrations over 12 weeks in a large cohort of haemodialysis patients with hyperphosphataemia. Here, we report outcomes after 52 weeks of treatment.NOPHOS was a phase III, international, randomised, controlled, double-blind trial in parallel group design. NAMR (250-1500 mg/d) was investigated in comparison to placebo as an add-on therapy to an individual therapy with approved phosphate binders.In the intention-to-treat population (NAMR: N = 539, placebo: N = 183), serum phosphate was significantly lower in the NAMR group compared to the placebo group at W24 (5.40 ± 1.55 mg/dl vs. 5.79 ± 1.37 mg/dl, P 0.001) with a mean difference of -0.39 mg/dl [95% CI -0.66, -0.13], but was comparable between the groups at W52 (mean difference -0.08 [95% CI -0.36, 0.20]). In the completer population (N = 358), statistical significance in favour of NAMR was reached at W24 and W52. The treatment effect was reduced in patients with high baseline serum intact parathyroid hormone (iPTH) compared to patients with low baseline serum iPTH. Compliant patients in the NAMR group had a more pronounced and sustained reduction in serum phosphate than non-compliant patients. NAMR treatment was associated with a significantly increased risk of thrombocytopenia, pruritus, anaemia, and diarrhoea. Herpes zoster occurred exclusively in patients randomised to NAMR.NAMR combined with phosphate binders significantly reduced serum phosphate over the first 24 weeks of treatment, but the treatment effect was not maintained up to W52. Non-compliance may have contributed to reduced long-term efficacy. Several newly identified safety signals warrant further evaluation.

Published
2022

25. The Effect of Sodium Restricted Diet on Plasma Visfatin Levels in Hypertensive Patients with Visceral Obesity

Author

Sylwia Rotkegel, Jerzy Chudek, Urszula Spiechowicz-Zaton, Rafal Ficek, Marcin Adamczak, and Andrzej Wiecek

Subjects
Visfatin, Renin-angiotensin-aldosterone system, Hypertension, Dermatology, RL1-803, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Aim/Background: Experimental and clinical studies revealed contradictory data concerning the influence of renin-angiotensin-aldosterone (RAA) system activation on visfatin release. The aim of the present study was the assessment of the effect of dietary sodium restriction with RAA system activation on visfatin level in hypertensive and normotensive patients with visceral obesity. Methods: The study included 24 hypertensive patients with visceral obesity (12 women) and 22 normotensive subjects with visceral obesity (11 women) constituting the control group. Plasma renin activity, plasma insulin, aldosterone and visfatin levels were determined twice, on normal-salt diet after 6-8 h in recumbent position and the second time after 3 days of dietary sodium restriction and upright position for 2 h. Dietary compliance was controlled by 24 h natriuresis measurement. Results: Hypertensive patients had significantly higher plasma visfatin level than the control group [11.0 (8.5-13.5) vs. 6.8 (6.0-7.6) ng/ml, p=0.003]. Dietary sodium restriction and upright position caused significant increase in PRA and plasma aldosterone level in both groups. While, plasma visfatin level remained unaffected. In the combined group plasma visfatin levels correlated with BMI (r=0.398), waist circumference (r=0.391), glucose (r=0.328), insulin (r=0.663), HOMA-IR (r=0.698), triglycerides (r=0.500) and CRP (r=0.546) but not with percentage of fat mass, percentage of trunk fat, and blood pressure values. Conclusions: 1) Increased plasma visfatin concentration may play a significant role in the pathogenesis of hypertension in patients with visceral obesity. 2) RAA system activation by dietary sodium restriction and upright position has no effect on plasma visfatin levels in subjects with visceral obesity.

Published
2013
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26. Early Complications After Kidney Transplantation in Patients Aged 60 Years and Older: A Single-Center, Paired-Kidney Analysis

Author

Damian Skrabaka, Jacek Ziaja, Aureliusz Kolonko, Aleksander Owczarek, Jarosław Czerwiński, Andrzej Wiecek, Szymon Franczyk, Z Valenta, Robert Król, and Sylwia Sekta

Subjects
Adult, Male, medicine.medical_specialty, Population, Transplants, Kidney, Single Center, Postoperative Complications, Renal Dialysis, Internal medicine, Diabetes mellitus, medicine, Humans, education, Kidney transplantation, Aged, Retrospective Studies, Transplantation, education.field_of_study, business.industry, Incidence, Incidence (epidemiology), Graft Survival, Age Factors, Retrospective cohort study, Middle Aged, medicine.disease, Kidney Transplantation, medicine.anatomical_structure, Creatinine, Female, Surgery, business, Body mass index
Abstract

As the population ages, the number of people suffering from cardiovascular diseases (CVD) and diabetes mellitus (DM) increases. The coexistence of these diseases can affect the results of kidney transplantation (KT) in the elderly. The aim of this study was to analyze surgical and nonsurgical complications in the early period after KT and to identify the factors that influence their development in recipients aged ≥ 60 years compared to younger recipients 60 years.One hundred seventy-five recipients of KT ≥ 60 years and 175 recipients of KT 60 years who received kidneys from the same deceased donor were enrolled into the study. The incidence of surgical and nonsurgical complications, factors that may influence their development, early graft function, and patient and kidney-graft survival were analyzed during a 3-month follow-up period. Donor sources complied with the Helsinki Congress and Istanbul Declaration and organs were not procured from prisoners and individuals who were coerced or paid.Older recipients were characterized by higher body mass index ± SD (26.1 ± 3.5 vs 24.7 ± 3.4 kg/mDespite higher co-incidence of CVD and DM, the risk of surgical and nonsurgical complications in elderly recipients is comparable to younger recipients in the early period after KT.

Published
2020
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27. Simultaneously Transplanted Pancreas Improves Salivation and Reduces Oral Fungal Infections Incidence in Type 1 Diabetic Renal Transplant Recipients

Author

Andrzej Wiecek, Aleksander Owczarek, Damian Niedzielski, Rafał Wiench, Mikołaj Musiał, Iwona Niedzielska, Piotr Choręza, Dariusz Skaba, Jacek Ziaja, Aureliusz Kolonko, Robert Król, and Agnieszka Machorowska-Pieniążek

Subjects
Adult, Male, medicine.medical_specialty, Saliva, medicine.medical_treatment, Salivary Gland Diseases, Pancreas transplantation, Oral hygiene, Gastroenterology, Diabetes Complications, Transplanted pancreas, Internal medicine, Diabetes mellitus, Humans, Medicine, Kidney transplantation, Transplantation, Kidney, business.industry, Incidence, Incidence (epidemiology), Middle Aged, medicine.disease, Kidney Transplantation, Diabetes Mellitus, Type 1, medicine.anatomical_structure, Mycoses, Kidney Failure, Chronic, Female, Surgery, Pancreas Transplantation, Mouth Diseases, Salivation, business
Abstract

Background Long-lasting diabetes mellitus may lead to numerous pathologies in the oral cavity. The aim of the study was to assess the condition of the oral cavity, caries intensity, salivary parameters, and incidence of oral fungal infections in patients with type 1 diabetes (T1D) and end-stage renal disease (ESRD) after kidney transplantation (KTx) or simultaneous kidney and pancreas transplantation (SPK). Methods Twenty-one patients after SPK, 18 T1D patients after KTx, and 14 kidney recipients without diabetes (control group) were included in the study. Donor sources complied with Helsinki Congress and the Declaration of Istanbul. Results Approximal plague index in SPK (80% [68%-90%]) was comparable to KTx (80% [37.5%-92.5%]) but higher than in control group (46% [35%-50%]). All 3 groups did not differ in terms of decayed-missing-filled tooth index: 22.3 ± 4.8 vs 22.5 ± 4.5 vs 19.1 ± 4.9, respectively. Normal saliva resting secretion and consistency were more common in SPK (71.4% and 52%, respectively) than in KTx (27.8% and 50.0%, respectively). Stimulated saliva volume in the SPK, KTx and controls, pH value, and buffering capacity were comparable. In KTx higher incidence of Candida albicans infection (55.6%) compared with SPK (23.8%) and controls (no infection) was observed. Conclusions Simultaneously transplanted pancreas improves salivation and reduces the incidence of oral fungal infections in T1D kidney recipients. The severity of caries is higher and oral hygiene is worse in T1D kidney recipients compared with patients after KTx without diabetes.

Published
2020
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28. The molecular diagnosis of rejection in liver transplant biopsies: First results of the INTERLIVER study

Author

Rosa Miquel, Chandra Bhati, Katelynn S. Madill-Thomsen, Goran B. Klintmalm, Olga Tronina, Maciej Krasnodębski, Krzysztof Zieniewicz, Leszek Pączek, Marta Wawrzynowicz-Syczewska, Grzegorz Piecha, Andrzej Wiecek, Michał Grąt, Trevor Reichman, Marwan S Abouljoud, Sandy Feng, Iman Francis, Geoff McCaughan, Michał Ciszek, Agnieszka Perkowska-Ptasińska, Dilip Moonka, Bartosz Foroncewicz, Philip F. Halloran, Krzysztof Jurczyk, Krzysztof Mucha, Alberto Sanchez-Fueyo, Marek Myślak, Aldo J. Montano-Loza, and Magdalena Durlik

Subjects
Pathology, medicine.medical_specialty, Population, 030230 surgery, 03 medical and health sciences, 0302 clinical medicine, Fibrosis, Biopsy, medicine, Immunology and Allergy, Pharmacology (medical), education, Transplantation, Kidney, education.field_of_study, Lung, biology, medicine.diagnostic_test, business.industry, Histology, medicine.disease, medicine.anatomical_structure, biology.protein, Liver function, Antibody, business
Abstract

Molecular diagnosis of rejection is emerging in kidney, heart, and lung transplant biopsies and could offer insights for liver transplant biopsies. We measured gene expression by microarrays in 235 liver transplant biopsies from 10 centers. Unsupervised archetypal analysis based on expression of previously annotated rejection-related transcripts identified 4 groups: normal "R1normal " (N = 129), T cell-mediated rejection (TCMR) "R2TCMR " (N = 37), early injury "R3injury " (N = 61), and fibrosis "R4late " (N = 8). Groups differed in median time posttransplant, for example, R3injury 99 days vs R4late 3117 days. R2TCMR biopsies expressed typical TCMR-related transcripts, for example, intense IFNG-induced effects. R3injury displayed increased expression of parenchymal injury transcripts (eg, hypoxia-inducible factor EGLN1). R4late biopsies showed immunoglobulin transcripts and injury-related transcripts. R2TCMR correlated with histologic rejection although with many discrepancies, and R4late with fibrosis. R2TCMR , R3injury , and R4late correlated with liver function abnormalities. Supervised classifiers trained on histologic rejection showed less agreement with histology than unsupervised R2TCMR scores. No confirmed cases of clinical antibody-mediated rejection (ABMR) were present in the population, and strategies that previously revealed ABMR in kidney and heart transplants failed to reveal a liver ABMR phenotype. In conclusion, molecular analysis of liver transplant biopsies detects rejection, has the potential to resolve ambiguities, and could assist with immunosuppressive management.

Published
2020
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29. Early graft function and intrarenal resistant index after kidney transplantation using Biolasol—A new solid organ preservation fluid

Author

Aureliusz Kolonko, Robert Król, Lech Cierpka, Michał Skrzypek, Andrzej Wiecek, and Jerzy Chudek

Subjects
Male, medicine.medical_specialty, Organ Preservation Solutions, 0206 medical engineering, Biomedical Engineering, Urology, Transplants, Medicine (miscellaneous), Bioengineering, 02 engineering and technology, 030204 cardiovascular system & hematology, Kidney, Kidney Function Tests, Graft function, Biomaterials, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, medicine, Humans, Kidney transplantation, Creatinine, business.industry, Organ Preservation, General Medicine, Middle Aged, medicine.disease, Kidney Transplantation, 020601 biomedical engineering, Transplantation, medicine.anatomical_structure, chemistry, Propensity score matching, Cohort, Female, Solid organ, business
Abstract

Biolasol is a newly developed preserving solution for cold organ storage prior to transplantation. To date, only animal model experiments results are available. The aim of this single-center analysis was to summarize the clinical experience concerning the early post-transplant course of kidney grafts preserved with Biolasol in comparison with other preservation solutions. Before transplantation, 173 kidney grafts were preserved using Biolasol and 240 organs with other solutions (University of Wisconsin-UW, Institute Georges Lopez-IGL-1, or StoreProtect Plus solutions). Early graft function was defined based on serum creatinine concentration at day 3 (3 mg/dL-immediate graft function, IGF or3 mg/dL-slow graft function, SGF) or the need of dialysis therapy during first post-operative week (delayed graft function, DGF). The analysis included intrarenal resistive indices measured by Doppler sonography early after transplantation and before discharge from the hospital. IGF was more frequent in patients with organs preserved with IGL-1 (33.5%) and StoreProtect Plus (38.8%) than Biolasol (18.5%), whereas there was no difference in the occurrence of DGF. Both initial and discharge median resistance index values were significantly higher in the Biolasol subgroup (0.77 and 0.75) than in all three other subgroups (P values for all comparisons.001), also after 1:1 propensity score matching for baseline characteristics. Multiple logistic regression analysis based on the propensity score-matched cohort revealed that the use of Biolasol solution [OR 0.59 (0.35-0.98); P .05] independently decreased the occurrence of IGF. In our single-center clinical experience, kidney preservation using Biolasol solution was associated with significantly higher intrarenal resistant index in comparison with other preservation fluids, as well as worse early graft function than in the IGL-1 and the StoreProtect Plus subgroups. Long-term follow-up is needed in order to assess the kidney graft and patient survival.

Published
2020
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30. Clostridium difficile infection in patients after solid organ transplantations

Author

Sylwia Dudzicz, Marcin Adamczak, and Andrzej Wiecek

Subjects
Microbiology (medical), medicine.medical_specialty, genetic structures, business.industry, lcsh:R, immunosuppressive therapy, lcsh:Medicine, Clostridium difficile, Gastroenterology, Clostridium difficile infections, 03 medical and health sciences, 0302 clinical medicine, Infectious Diseases, Internal medicine, Medicine, 030211 gastroenterology & hepatology, In patient, Lactobacillus plantarum 299v, 030212 general & internal medicine, Solid organ, business, solid organ transplantations
Abstract

Clostridium difficile is the most common identified pathogen causing nosocomial and antibiotic-associated diarrhea. The incidence of Clostridium difficile infection (CDI) has increased over the last decades. The occurrence of severe and recurrent CDI is also more often recently observed. Patients after solid organs transplantation are more prone to Clostridium difficile infection that the general population. This is associated mainly with immunosuppressive therapy, more frequent hospitalizations and frequent antibiotic therapy. Due to the growing number of CDI, it is important to correctly diagnose this infection and to implement the proper treatment. The main drugs used to treat CDI are vancomycin and fidaxomicin. In the case of CDI recurrence, fecal microbiota transplantation remains to be considered. The rationale use of antibiotics and avoiding proton pump inhibitors may also prevent CDI. Results of recent observational study suggest that one of the probiotics – Lactobacillus plantarum 299v prevents CDI in patients during immunosuppressive therapy. The efficacy and safety of using probiotics in CDI prophylaxis in this group of patients requires, however, further studies.

Published
2020

31. Systematic and Multidisciplinary Evaluation of Fibromuscular Dysplasia Patients Reveals High Prevalence of Previously Undetected Fibromuscular Dysplasia Lesions and Affects Clinical Decisions

Author

Andrzej Tykarski, Adam Witkowski, K. Madej, Andrzej Januszewicz, Piotr Hoffman, Elżbieta Florczak, Olgierd Rowiński, Małgorzata Szczerbo-Trojanowska, P. Talarowska, K. Kowalczyk, Iwona Kurkowska-Jastrzębska, K. Hanus, Anna Klisiewicz, Paweł Kwiatek, Lukasz Stryczynski, Andrzej Wiecek, Marek Kabat, Magdalena Januszewicz, Mieczysław Litwin, Jacek Kadziela, Aleksander Prejbisz, Sławomir Nazarewski, Ewa Warchoł-Celińska, Mikołaj Smólski, Ilona Michałowska, Mariola Pęczkowska, Ludomir Stefańczyk, Piotr Dobrowolski, Krystyna Widecka, Lukasz Swiatlowski, and K. Jozwik-Plebanek

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Computed Tomography Angiography, medicine.medical_treatment, Clinical Decision-Making, Fibromuscular dysplasia, 030204 cardiovascular system & hematology, Renovascular hypertension, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Aneurysm, Occlusion, Internal Medicine, Fibromuscular Dysplasia, Humans, Medicine, Whole Body Imaging, Aorta, Abdominal, Prospective Studies, Registries, cardiovascular diseases, Embolization, Child, Aged, Aged, 80 and over, business.industry, Vascular disease, Arterial stenosis, Cerebral Arteries, Middle Aged, medicine.disease, Stenosis, Carotid Arteries, cardiovascular system, Female, Radiology, business, 030217 neurology & neurosurgery
Abstract

Fibromuscular dysplasia (FMD), regarded as a generalized vascular disease, may affect all vascular beds and may result in arterial stenosis, occlusion, aneurysm, or dissection. It has been proposed to systematically evaluate all vascular beds in patients with FMD, regardless of initial FMD involvement. However, the impact of this approach on clinical decisions and on management is unknown. Within the prospective ARCADIA-POL study (Assessment of Renal and Cervical Artery Dysplasia–Poland), we evaluated 232 patients with FMD lesions confirmed in at least one vascular bed, out of 343 patients included in the registry. All patients underwent a detailed clinical evaluation including computed tomography angiography of intracranial and cervical arteries, as well as computed tomography angiography of the abdominal aorta, its branches, and upper and lower extremity arteries. In the study group, FMD lesions were most frequently found in renal arteries (87.5%). FMD was also found in cerebrovascular (24.6%), mesenteric (13.8%), and upper (3.0%) and lower extremity (9.9 %) arteries. Newly diagnosed FMD lesions were found in 34.1% of the patients, and previously undetected vascular complications were found in 25% of the patients. Among all FMD patients included in the study, one out of every 4 evaluated patients qualified for interventional treatment due to newly diagnosed FMD lesions or vascular complications. The ARCADIA-POL study shows for the first time that the systematic and multidisciplinary evaluation of patients with FMD based on a whole-body computed tomography angiography scan has an impact on their clinical management. This proved the necessity of the systematic evaluation of all vascular beds in patients with FMD, regardless of initial FMD involvement.

Published
2020
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32. Diagnosis and treatment of type 2 diabetes mellitus in patients with chronic kidney disease and eGFR < 60 mL/min — a position statement of the Polish Society of Nephrology Working Group on Metabolic and Endocrine Disorders in Kidney Diseases

Author

Agnieszka Witkowska, Marcin Adamczak, Tomasz Stompór, Oktawia Mazanowska, Anna Masajtis-Zagajewska, Katarzyna Maziarska, and Andrzej Wiecek

Subjects
Nephrology, medicine.medical_specialty, Kidney, business.industry, Endocrinology, Diabetes and Metabolism, Type 2 Diabetes Mellitus, Renal function, medicine.disease, Endocrinology, Insulin resistance, medicine.anatomical_structure, Diabetes Mellitus, Type 2, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Poland, Renal Insufficiency, Chronic, Adverse effect, business, Societies, Medical, Glomerular Filtration Rate, Kidney disease
Abstract

Diabetes mellitus is one the most frequent co-morbid conditions in patients with chronic kidney disease (CKD), frequently leading to chronic kidney failure. Progression of CKD accelerates several metabolic disorders, predominantly those related to abnormalities of carbohydrate metabolism. Patients with CKD are usually characterised by an insulin resistance additionally aggravated by several co-morbid conditions (for example chronic low-grade inflammation). Treatment with anti-diabetic medications in patients with CKD remains a challenge because, along with the disease progression, the dosing of several drugs needs to be adjusted to the reduced kidney function (especially those that are excreted intact with urine or as active metabolites). Progression of CKD also increases the risk of hypoglycaemia in patients treated with anti-diabetic drugs, and other adverse drug reactions may occur more frequently. Usefulness of the new generation drugs has not yet been verified in patients with advanced kidney disease (although some of them act through kidney-related mechanisms). The current position statement of the Polish Society of Nephrology Working Group provides practical recommendations for the diagnosis and treatment of type 2 diabetes mellitus in patients with CKD and reduced kidney function.

Published
2020
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33. Efficacy and Safety of Daprodustat for Treatment of Anemia of Chronic Kidney Disease in Incident Dialysis Patients: A Randomized Clinical Trial

Author

Ajay K. Singh, Borut Cizman, Kevin Carroll, John J. V. McMurray, Vlado Perkovic, Vivekanand Jha, Kirsten L. Johansen, Renato D. Lopes, Iain C. Macdougall, Gregorio T. Obrador, Sushrut S. Waikar, Christoph Wanner, David C. Wheeler, Andrzej Wiecek, Nicole Stankus, Frank Strutz, Allison Blackorby, Alexander R. Cobitz, Amy M. Meadowcroft, Gitanjali Paul, Prerna Ranganathan, Sangeeta Sedani, and Scott Solomon

Subjects
Male, Iron, Glycine, Anemia, Middle Aged, Hemoglobins, Treatment Outcome, Renal Dialysis, Barbiturates, Internal Medicine, Hematinics, Humans, Darbepoetin alfa, Female, Prospective Studies, Renal Insufficiency, Chronic, Erythropoietin
Abstract

Daprodustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, is being evaluated as an oral alternative to conventional erythropoiesis-stimulating agent (ESA) therapy. Few studies of anemia treatment in an incident dialysis (ID) population have been reported.To evaluate the efficacy and safety of daprodustat vs darbepoetin alfa in treating anemia of chronic kidney disease in ID patients.This prospective, randomized, open-label clinical trial was conducted from May 11, 2017, through September 24, 2020, in 90 centers across 14 countries. Patients with advanced CKD were eligible if they planned to start dialysis within 6 weeks from screening or had started and received hemodialysis (HD) or peritoneal dialysis (PD) within 90 days before randomization, had a screening hemoglobin (Hb) concentration of 8.0 to 10.5 g/dL (to convert to grams per liter, multiply by 10) and a randomization Hb of 8.0 to 11.0 g/dL, were ESA-naive or had received limited ESA treatment, and were iron-replete.Randomized 1:1 to daprodustat or darbepoetin alfa.The primary analysis in the intent-to-treat population evaluated the mean change in Hb concentration from baseline to evaluation period (weeks 28-52) to assess noninferiority of daprodustat vs darbepoetin alfa (noninferiority margin, -0.75 g/dL). The mean monthly intravenous (IV) iron dose from baseline to week 52 was the principal secondary end point. Rates of treatment-emergent and serious adverse events (AEs) were also compared between treatment groups to assess safety and tolerability.A total of 312 patients (median [IQR] age, 55 [45-65] years; 194 [62%] male) were randomized to either daprodustat (157 patients; median [IQR] age, 52.0 [45-63] years; 96 [61%] male) or darbepoetin alfa (155 patients; median [IQR] age, 56.0 [45-67] years; 98 [63%] male); 306 patients (98%) completed the trial. The mean (SD) Hb concentration during the evaluation period was 10.5 (1.0) g/dL for the daprodustat and 10.6 (0.9) g/dL for the darbepoetin alfa group, with an adjusted mean treatment difference of -0.10 g/dL (95% CI, -0.34 to 0.14 g/dL), indicating noninferiority. There was a reduction in mean monthly IV iron use from baseline to week 52 in both treatment groups; however, daprodustat was not superior compared with darbepoetin alfa in reducing monthly IV iron use (adjusted mean treatment difference, 19.4 mg [95% CI, -11.0 to 49.9 mg]). Adverse event rates were 76% for daprodustat vs 72% for darbepoetin alfa.This randomized clinical trial found that daprodustat was noninferior to darbepoetin alfa in treating anemia of CKD and may represent a potential oral alternative to a conventional ESA in the ID population.ClinicalTrials.gov Identifier: NCT03029208.

Published
2022

34. Clonal Hematopoiesis of Indeterminate Potential and Diabetic Kidney Disease: A Nested Case-Control Study

Author

Sara Denicolò, Verena Vogi, Felix Keller, Stefanie Thöni, Susanne Eder, Hiddo J.L. Heerspink, László Rosivall, Andrzej Wiecek, Patrick B. Mark, Paul Perco, Johannes Leierer, Andreas Kronbichler, Marion Steger, Simon Schwendinger, Johannes Zschocke, Gert Mayer, Emina Jukic, Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), and Groningen Kidney Center (GKC)

Subjects
Nephrology, inflammation, type 2 diabetes mellitus, clonal hematopoiesis of indeterminate potential, chronic kidney disease, cytokines, diabetic kidney disease
Abstract

Introduction: \ud The disease trajectory of diabetic kidney disease (DKD) shows a high interindividual variability not sufficiently explained by conventional risk factors. Clonal hematopoiesis of indeterminate potential (CHIP) is a proposed novel cardiovascular risk factor. Increased kidney fibrosis and glomerulosclerosis were described in mouse models of CHIP. Here, we aim to analyze whether CHIP affects the incidence or progression of DKD.\ud \ud Methods: \ud A total of 1419 eligible participants of the PROVALID Study were the basis for a nested case-control (NCC) design. A total of 64 participants who reached a prespecified composite endpoint within the observation period (initiation of kidney replacement therapy, death from kidney failure, sustained 40% decline in estimated glomerular filtration rate or sustained progression to macroalbuminuria) were identified and matched to 4 controls resulting in an NCC sample of 294 individuals. CHIP was assessed via targeted amplicon sequencing of 46 genes in peripheral blood. Furthermore, inflammatory cytokines were analyzed in plasma via a multiplex assay.\ud \ud Results: \ud The estimated prevalence of CHIP was 28.91% (95% CI 22.91%–34.91%). In contrast to other known risk factors (albuminuria, hemoglobin A1c, heart failure, and smoking) and elevated microinflammation, CHIP was not associated with incident or progressive DKD (hazard ratio [HR] 1.06 [95% CI 0.57–1.96]).\ud \ud Conclusions: \ud In this NCC study, common risk factors as well as elevated microinflammation but not CHIP were associated with kidney function decline in type 2 diabetes mellitus.

Published
2022

35. List of contributors

Author

Marcin Adamczak, Maria Ida Amabile, Ibironke W. Apata, Mugurel Apetrii, Carla Maria Avesani, Udo Bahner, James L. Bailey, Anip Bansal, Christophe Barba, Ezequiel Bellorin-Font, Rachelle Bross, Amanda Brown-Tortorici, Michel Burnier, Jerrilynn Denise Burrowes, Juan Jesús Carrero, MacKenzie K. Cervantes, Steven Chadban, Vimal Chadha, Maria Chan, Winnie Chan, Charles Chazot, Janet M. Chiang, Michel Chonchol, Lydia Chwastiak, Adrian Covic, Lilian Cuppari, Neera K. Dahl, Biagio Di Iorio, Francesca Di Mario, Wilfred Druml, Ramanath Dukkipati, Gholamreza Fazeli, Enrico Fiaccadori, Fredric Finkelstein, Denis Fouque, Harold A. Franch, Allon N. Friedman, Pranav S. Garimella, Richard J. Glassock, David S. Goldfarb, Ailema González-Ortiz, Nimrit Goraya, Orlando M. Gutiérrez, Norio Hanafusa, August Heidland, Olof Heimbürger, Raimund Hirschberg, T. Alp Ikizler, Kirsten Johansen, Richard J. Johnson, Shivam Joshi, Kamyar Kalantar-Zadeh, Duk-Hee Kang, George A. Kaysen, Jun-Chul Kim, Brandon Kistler, Laetitia Koppe, Joel D. Kopple, Csaba P. Kovesdy, Holly J. Kramer, Kiyoshi Kurokawa, Bengt Lindholm, Kevin J. Martin, Steve Martino, Stefania Marzocco, Shaul G. Massry, Ziad A. Massy, William E. Mitch, Toshio Miyata, Alessio Molfino, Hamid Moradi, Takahiko Nakagawa, Yoko Narasaki, Nancy Puzziferri, Noel Quinn, Dominic S. Raj, Kalani L. Raphael, Renu Regunathan-Shenk, Connie M. Rhee, Eberhard Ritz, Alice Sabatino, Mark J. Sarnak, Julia Scialla, Lothar Seefried, John Sellinger, Anuja Shah, Neal B. Shah, Sudhir V. Shah, Manisha Singh, Leonardo Spatola, Robert C. Stanton, Alison L. Steiber, Peter Stenvinkel, David E. St-Jules, Thomas W. Storer, Keiichi Sumida, Elizabeth J. Sussman-Dabach, Sundararaman Swaminathan, John Sy, Ekamol Tantisattamo, Nosratola D. Vaziri, Alexandra Voinescu, Angela Yee-Moon Wang, Bradley A. Warady, Daniel E. Weiner, Donald E. Wesson, Andrzej Wiecek, Mark E. Williams, Bruce M. Wolfe, Biruh T. Workeneh, and Ying-Yong Zhao

Published
2022
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36. Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial

Author

Markus P Schlaich, Marc Bellet, Michael A Weber, Parisa Danaietash, George L Bakris, John M Flack, Roland F Dreier, Mouna Sassi-Sayadi, Lloyd P Haskell, Krzysztof Narkiewicz, Ji-Guang Wang, Christopher Reid, Markus Schlaich, Ivor Katz, Andrew Ajani, Sinjini Biswas, Murray Esler, Grahame Elder, Simon Roger, David Colquhoun, John Mooney, Tine De Backer, Alexandre Persu, Martin Chaumont, Jean-Marie Krzesinski, Thomas Vanassche, Ginette Girard, Lew Pliamm, Ernesto Schiffrin, Fatima Merali, George Dresser, Michel Vallee, Shivinder Jolly, Stephen Chow, Jiguang Wang, Jianjun Mu, Jing Yu, Hong Yuan, Yingqing Feng, Xin Zhang, Jianhong Xie, Ling Lin, Miroslav Soucek, Jiri Widimsky, Renata Cifkova, Jan Vaclavik, Martin Ullrych, Martin Lukac, Ivan Rychlik, Thomas Guldager Lauridsen, Ilkka Kantola, Jyrki Taurio, Olavi Ukkola, Olivier Ormezzano, Philippe Gosse, Michel Azizi, Pierre-Yves Courand, Pascal Delsart, Jean Michel Tartiere, Felix Mahfoud, Roland Schmieder, Johannes Stegbauer, Philipp Lurz, Michael Koziolek, Christian Ott, Nicole Toursarkissian, Konstantinos Tsioufis, Konstantinos Kyfnidis, Athanasios Manolis, Sotirios Patsilinakos, Pantelis Zebekakis, Apostolos Karavidas, Pall Denes, Katalin Bezzegh, Marianna Zsom, Laszlo Kovacs, Yehonatan Sharabi, Mazen Elias, Ivetta Sukholutsky, Chaim Yosefy, Irina Kenis, Shaul Atar, Massimo Volpe, Muiesan Maria Lorenza, Stefano Taddei, Guido Grassi, Franco Veglio, Jung Woo Son, Jang-Young Kim, Joong-Il Park, Chang Hoon Lee, Hae-Young Lee, Rasa Raugaliene, Jolanta Elena Marcinkeviciene, Roma Kavaliauskiene, Jaap Deinum, Abraham Kroon, Bert-Jan van den Born, Andrzej Januszewicz, Andrzej Tykarski, Jolanta Walczewska, Zbigniew Gaciong, Andrzej Wiecek, Marzena Chrostowska, Andrzej Kleinrok, Jan Krekora, Grzegorz Kania, Anna Podrazka-Szczepaniak, Cezary Golawski, Maciej Podziewski, Barbara Kaczmarek, Grzegorz Skoczylas, Andrzej Wilkolaski, Iwona Wozniak, Marzena Janik-Palazzolo, Barbara Rewerska, Aleksandra Konradi, Yuriy Shvarts, Tamara Pecherina, Konstantin Nikolaev, Gapon Liudmila, Olga Orlikova, Viktor Mordovin, Natalia Petrochenkova, Gadel Kamalov, Elena Kosmacheva, Vadim Tyrenko, Vladimir Gorbunov, Andrey Obrezan, Tatiana Supryadkina, Irina Ler, Oleg Kotenko, Anatoly Kuzin, Fernando Martínez García, Josep Redon, Anna Oliveras, Luis Beltran Romero, Valerii Shatylo, Leonid Rudenko, Andriy Bazylevych, Yurii Rudyk, Oleksandr Karpenko, Mykola Stanislavchuk, Vira Tseluyko, Mykola Kushnir, Ervin Asanov, Yuriy Sirenko, Andriy Yagensky, David Collier, Pankaj Gupta, David Webb, Mary MacLeod, James McLay, Aaron Peace, Samir Arora, Patricia Buchanan, Robert Harris, Ronald Degarmo, Mario Guillen, Adam Karns, Joel Neutel, Yogesh Paliwal, Karlton Pettis, Phillip D. Toth, Jeffrey M. Wayne, Michael Bain Butcher, Phillip M. Diller, Suzanne Oparil, David Calhoun, Donald Brautigam, John Flack, Jesse M. Goldman, Arash Rashidi, Nabeel Aslam, William Haley, Nabil Andrawis, Brian Lang, Randy Miller, James Powell, Robert Dewhurst, James Pritchard, Dinesh Khanna, Dennis Tang, Nashwa Gabra, Jean Park, Conigliaro Jones, Cranford Scott, Blanca Luna, Murtaza Mussaji, Ravi Bhagwat, Michael Bauer, John McGinty, Rajesh Nambiar, Renee Sangrigoli, William Ross Davis, William Eaves, Frank McGrew, Ahmed Awad, Eric Bolster, David Scott, Paramjit Kalirao, Pascal Dabel, Wesley Calhoun, Steven Gouge, Mark Warren, Mary Katherine Lawrence, Aamir Jamal, Mohamed El-Shahawy, Carlos Mercado, Jayant Kumar, Pedro Velasquez-Mieyer, Robert Busch, Todd Lewis, Lisa Rich, Public and occupational health, Vascular Medicine, ACS - Atherosclerosis & ischemic syndromes, APH - Global Health, APH - Personalized Medicine, ACS - Heart failure & arrhythmias, Schlaich, M, Bellet, M, Weber, M, Danaietash, P, Bakris, G, Flack, J, Dreier, R, Sassi-Sayadi, M, Haskell, L, Narkiewicz, K, Wang, J, Reid, C, Katz, I, Ajani, A, Biswas, S, Esler, M, Elder, G, Roger, S, Colquhoun, D, Mooney, J, De Backer, T, Persu, A, Chaumont, M, Krzesinski, J, Vanabsche, T, Girard, G, Pliamm, L, Schiffrin, E, Merali, F, Dresser, G, Vallee, M, Jolly, S, Chow, S, Mu, J, Yu, J, Yuan, H, Feng, Y, Zhang, X, Xie, J, Lin, L, Soucek, M, Widimsky, J, Cifkova, R, Vaclavik, J, Ullrych, M, Lukac, M, Rychlik, I, Guldager Lauridsen, T, Kantola, I, Taurio, J, Ukkola, O, Ormezzano, O, Gosse, P, Azizi, M, Courand, P, Delsart, P, Tartiere, J, Mahfoud, F, Schmieder, R, Stegbauer, J, Lurz, P, Koziolek, M, Ott, C, Toursarkissian, N, Tsioufis, K, Kyfnidis, K, Manolis, A, Patsilinakos, S, Zebekakis, P, Karavidas, A, Denes, P, Bezzegh, K, Zsom, M, Kovacs, L, Sharabi, Y, Elias, M, Sukholutsky, I, Yosefy, C, Kenis, I, Atar, S, Volpe, M, Lorenza, M, Taddei, S, Grassi, G, Veglio, F, Son, J, Kim, J, Park, J, Lee, C, Lee, H, Raugaliene, R, Marcinkeviciene, J, Kavaliauskiene, R, Deinum, J, Kroon, A, van den Born, B, Januszewicz, A, Tykarski, A, Walczewska, J, Gaciong, Z, Wiecek, A, Chrostowska, M, Kleinrok, A, Krekora, J, Kania, G, Podrazka-Szczepaniak, A, Golawski, C, Podziewski, M, Kaczmarek, B, Skoczylas, G, Wilkolaski, A, Wozniak, I, Janik-Palazzolo, M, Rewerska, B, Konradi, A, Shvarts, Y, Pecherina, T, Nikolaev, K, Liudmila, G, Orlikova, O, Mordovin, V, Petrochenkova, N, Kamalov, G, Kosmacheva, E, Tyrenko, V, Gorbunov, V, Obrezan, A, Supryadkina, T, Ler, I, Kotenko, O, Kuzin, A, Martinez, F, Redon, J, Oliveras, A, Beltran Romero, L, Shatylo, V, Rudenko, L, Bazylevych, A, Rudyk, Y, Karpenko, O, Stanislavchuk, M, Tseluyko, V, Kushnir, M, Asanov, E, Sirenko, Y, Yagensky, A, Collier, D, Gupta, P, Webb, D, Macleod, M, Mclay, J, Peace, A, Arora, S, Buchanan, P, Harris, R, Degarmo, R, Guillen, M, Karns, A, Neutel, J, Paliwal, Y, Pettis, K, Toth, P, Wayne, J, Butcher, B, Diller, P, Oparil, S, Calhoun, D, Brautigam, D, Goldman, J, Rashidi, A, Aslam, N, Haley, W, Andrawis, N, Lang, B, Miller, R, Powell, J, Dewhurst, R, Pritchard, J, Khanna, D, Tang, D, Gabra, N, Jones, C, Scott, C, Luna, B, Mussaji, M, Bhagwat, R, Bauer, M, Mcginty, J, Nambiar, R, Sangrigoli, R, Ross Davis, W, Eaves, W, Mcgrew, F, Awad, A, Bolster, E, Scott, D, Kalirao, P, Dabel, P, Calhoun, W, Gouge, S, Warren, M, Lawrence, M, Jamal, A, El-Shahawy, M, Mercado, C, Kumar, J, Velasquez-Mieyer, P, Busch, R, Lewis, T, and Rich, L

Subjects
Endothelin Receptor Antagonists, Treatment Outcome, Double-Blind Method, Hypertension, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Humans, General Medicine, Blood Pressure Monitoring, Ambulatory, resistant hypertension, Dual endothelin antagonist aprocitentan, Antihypertensive Agents
Abstract

Contains fulltext : 286841.pdf (Publisher’s version ) (Closed access) BACKGROUND: Resistant hypertension is associated with increased cardiovascular risk. The endothelin pathway has been implicated in the pathogenesis of hypertension, but it is currently not targeted therapeutically, thereby leaving this relevant pathophysiological pathway unopposed with currently available drugs. The aim of the study was to assess the blood pressure lowering efficacy of the dual endothelin antagonist aprocitentan in patients with resistant hypertension. METHODS: PRECISION was a multicentre, blinded, randomised, parallel-group, phase 3 study, which was done in hospitals or research centres in Europe, North America, Asia, and Australia. Patients were eligible for randomisation if their sitting systolic blood pressure was 140 mm Hg or higher despite taking standardised background therapy consisting of three antihypertensive drugs, including a diuretic. The study consisted of three sequential parts: part 1 was the 4-week double-blind, randomised, and placebo-controlled part, in which patients received aprocitentan 12·5 mg, aprocitentan 25 mg, or placebo in a 1:1:1 ratio; part 2 was a 32-week single (patient)-blind part, in which all patients received aprocitentan 25 mg; and part 3 was a 12-week double-blind, randomised, and placebo-controlled withdrawal part, in which patients were re-randomised to aprocitentan 25 mg or placebo in a 1:1 ratio. The primary and key secondary endpoints were changes in unattended office systolic blood pressure from baseline to week 4 and from withdrawal baseline to week 40, respectively. Secondary endpoints included 24-h ambulatory blood pressure changes. The study is registered on ClinicalTrials.gov, NCT03541174. FINDINGS: The PRECISION study was done from June 18, 2018, to April 25, 2022. 1965 individuals were screened and 730 were randomly assigned. Of these 730 patients, 704 (96%) completed part 1 of the study; of these, 613 (87%) completed part 2 and, of these, 577 (94%) completed part 3 of the study. The least square mean (SE) change in office systolic blood pressure at 4 weeks was -15·3 (SE 0·9) mm Hg for aprocitentan 12·5 mg, -15·2 (0·9) mm Hg for aprocitentan 25 mg, and -11·5 (0·9) mm Hg for placebo, for a difference versus placebo of -3·8 (1·3) mm Hg (97·5% CI -6·8 to -0·8, p=0·0042) and -3·7 (1·3) mm Hg (-6·7 to -0·8; p=0·0046), respectively. The respective difference for 24 h ambulatory systolic blood pressure was -4·2 mm Hg (95% CI -6·2 to -2·1) and -5·9 mm Hg (-7·9 to -3·8). After 4 weeks of withdrawal, office systolic blood pressure significantly increased with placebo versus aprocitentan (5·8 mm Hg, 95% CI 3·7 to 7·9, p

Published
2022

37. Clinical insights into the role of immunosuppression and its disturbances in solid organ transplant recipients with coronavirus disease 2019

Author

Agnieszka Kuczaj, Aureliusz Kolonko, Andrzej Wiecek, Natalia Słabiak-Błaż, Joanna Musialik, Piotr Przybyłowski, and Tomasz Hrapkowicz

Subjects
Heart transplantation, medicine.medical_specialty, Kidney, business.industry, medicine.medical_treatment, Renal function, Immunosuppression, Tacrolimus, surgical procedures, operative, medicine.anatomical_structure, Interquartile range, Internal medicine, Cohort, Internal Medicine, medicine, Liver function, business
Abstract

Background The ongoing COVID-19 pandemic has disproportionately affected patients who have undergone solid organ transplantation. Objectives To analyze a cohort of transplant recipients in our practice who developed COVID-19, with a focus on immunosuppressive regimen, tacrolimus blood levels, clinical course, and patient and graft outcomes. Methods During the first 12 months of the pandemic, we identified patients diagnosed with SARS-CoV-2 infection among our ambulatory cohort, including kidney, liver, and heart transplant recipients. Baseline and follow-up data concerning graft function, immunosuppression details, and patient and graft outcomes were analyzed. Results Of 2091 ambulatory patients, 201 (9.6%) with diagnosed SARS-CoV-2 infection were identified, including 112 kidney, 56 heart, and 33 liver transplant recipients. COVID-19 cases were significantly more common among those who had recently undergone kidney (during 2015-2020) or heart transplantation (during 2020) than earlier recipients. Additionally, blood levels of tacrolimus measured during or shortly after COVID-19 in 23 kidney graft recipients were significantly increased (median increase, 76.1%; interquartile range: 47.4%-109.4%) relative to pre-dose trough levels, but liver function values were not concomitantly elevated, necessitating a tacrolimus dose reduction in 73.9% of these patients. Conclusions In our cohort of transplant recipients, we found substantial disturbances of tacrolimus metabolism in kidney recipients, which may play a role in the worsening of kidney function during SARS-CoV-2 infection. In addition, we found that infections were more common with recent kidney or heart transplantation, and results suggest the potential importance of immunosuppressive regimen strength for SARS-CoV-2 infection-related morbidity.

Published
2021
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38. Type 1 Diabetic Patients After Simultaneous Pancreas and Kidney Transplantation Have Less Intense Periodontal Inflammation Compared to Kidney Recipients Treated with Insulin

Author

Aleksander Owczarek, Andrzej Wiecek, Rafał Wiench, Mikołaj Musiał, Aureliusz Kolonko, Piotr Choręza, Damian Niedzielski, Dariusz Skaba, Elżbieta Świętochowska, Iwona Niedzielska, Robert Król, Agnieszka Machorowska-Pieniążek, and Jacek Ziaja

Subjects
medicine.medical_specialty, medicine.medical_treatment, Pancreas transplantation, Kidney, Gastroenterology, Internal medicine, Diabetes mellitus, Medicine, Humans, Insulin, Pancreas, Kidney transplantation, Periodontal Diseases, Periodontitis, Inflammation, Transplantation, Type 1 diabetes, Original Paper, business.industry, General Medicine, Gingival Crevicular Fluid, medicine.disease, Kidney Transplantation, Diabetes Mellitus, Type 1, Clinical attachment loss, Resistin, Pancreas Transplantation, business
Abstract

BACKGROUND Long-term diabetes predisposes to pathological changes in periodontal tissues. Improvement in this respect can be expected in patients after pancreas transplantation. The aim of this study was to assess and compare the intensity of periodontium pathological lesions and inflammation markers concentration in gingival crevicular fluid (GCF) in patients with type 1 diabetes (T1D) after kidney (KTx) or simultaneous pancreas and kidney transplantation (SPK). MATERIAL AND METHODS The study included 20 T1D patients after SPK and 16 after KTx, and 15 non-diabetic kidney recipients (control). Periodontal clinical parameters and concentration of selected biochemical markers of inflammation in GCF were assessed. The following tests were used in statistical data analysis: Shapiro-Wilk test, the t test, the Mann-Whitney U tests, one-way ANOVA with Tukey's post hoc test, and χ² test (also with Yate's correction). Moreover, linear regression and Pearson or Spearman correlation coefficient was used. RESULTS There were no differences in modified Sulcus Bleeding Index (mSBI) and GCF volume between the SPK group and control group, whereas values of these parameters in the KTx group were higher than in the SPK and control groups. Maximal clinical attachment loss and pocket depth and Periotest values were higher in diabetic recipients compared to controls, and did not differ between SPK and KTx. The concentration of IL-1s, MMP-8, resistin, TNFalpha, and YKL40 in the GCF in the KTx group was higher than in the SPK and control groups. In the combined group of T1D patients, there was a correlation between blood HbA1c and mSBI, GCF volume, and resistin, TNF-alpha and YKL40 concentrations, and between resistin concentration and mSBI. CONCLUSIONS T1D patients after SPK show lower levels of inflammatory markers in GCF and present reduced intensity of periodontitis compared to kidney recipients treated with insulin. The severity of morphological changes in periodontium in T1D patients after KTx or SPK is higher than in non-diabetic kidney recipients.

Published
2021

40. Heterogeneous contributions of change in population distribution of body mass index to change in obesity and underweight

Author

Maryam Sharafkhah, Emanuel Zitt, Majid Ezzati, Luxia Zhang, Young-Ho Khang, Ellina Rakhimova, Kairit Mikkel, Tiina Vlasoff, Eruke E. Egbagbe, Sidsel Graff-Iversen, Ilona Nenko, Magdalena Klimek, Mathilde Savy, Sanjib Kumar Sharma, Alfonso Siani, Luís Lopes, Vanina Bongard, Gregor Jurak, Jacqueline F. Price, Christina-Paulina Lambrinou, Maria Lc Iurilli, Rainford J. Wilks, Bontha V. Babu, Fereidoun Azizi, Harunobu Nakamura, Marialaura Bonaccio, Angela Döring, Zhenyu Zhang, Naser Ahmadi, Jolanta Słowikowska-Hilczer, Ana Paula Carlos Cândido, Clive Osmond, Thirunavukkarasu Sathish, Robert J. Adams, Themistoklis Tzotzas, Reina Engle-Stone, Atul Trivedi, Shoichiro Tsugane, Niels Møller, Jorge Bezerra, Dénes Molnár, Muhammad Fadhli Mohd Yusoff, Badreya Al-Lahou, J. Jaime Miranda, Bahram Mohajer, Sigmund A. Anderssen, Lital Keinan Boker, Eero Kajantie, Martin Gulliford, Maties Torrent, Sumit Bharadwaj, Toshiharu Ninomiya, Zbigniew Gaciong, Nayu Ikeda, Li Juan Wu, Adrian Richter, Licia Iacoviello, Marc J. Gunter, Wenbin Wei, Norsyamlina Che Abdul Rahim, Eman Aly, Ambady Ramachandran, Nils Lehmann, Soile E. Puhakka, Giovanni Veronesi, Hongsheng Bi, Eiji Oda, Jia Li Duan, Per Tynelius, José María Huerta, Janne Schurmann Tolstrup, Rodrigo M. Carrillo-Larco, Rosangela Fernandes Lucena Batista, Victoria E Soto-Rojas, Hanno Ulmer, Shukri F. Mohamed, Anthony Kafatos, Suyeon Park, Mohsen Ibrahim, Hamed Pouraram, Bin Zhou, May Soe Aung, Lars Bo Andersen, Erfan Ghasemi, René Charles Sylva, Himanshu K. Chaturvedi, Luc Dauchet, Ahmad Ali Zainuddin, Angela Chetrit, Dan Zhu, Valérie Deschamps, Ko Ko Zaw, Peter Vollenweider, Tomas Vega, Yves Martin-Prével, Mahfuzar Rahman, Dorja Vočanec, Roman Topor-Madry, Vinay Nangia, Herculina S. Kruger, Asher Fawwad, Emily Sonestedt, Elena Pahomova, Aleksander Giwercman, Elżbieta Dziankowska-Zaborszczyk, Cecilia Björkelund, Tatjana Hejgaard, Maria Puiu, Maria Benedetta Donati, Andrew Wong, Carlos P. Boissonnet, Santosh K. Bhargava, Patrick Kolsteren, Dermot O'Reilly, Bahareh Kheiri, Wolfgang Kratzer, Susanne R. de Rooij, H. Bas Bueno-de-Mesquita, Günther Fink, José R. Banegas, Michele Monroy-Valle, Drude Molbo, Mahmudur Rahman, Hynek Pikhart, Rafael N. Pichardo, Massimo Salvetti, Hui Cai, Sarah Filippi, Georg Posch, Hung-Kwan So, Yonghua Hu, Katsuyasu Kouda, Joana Carvalho, Gailute Bernotiene, Hannu Uusitalo, Thein Thein Htay, Felix Kaducu, Maigeng Zhou, Lars Ängquist, Thi Tuyet-Hanh Tran, Charles Lunogelo, Michel Joffres, Sabina Zambon, Ronald D. Gregor, Vayia Rarra, Seyed Mohammad Hashemi-Shahri, Loreto Santa Marina, Galina Obreja, Rudolf Kaaks, Aya Mostafa, Maria do Carmo Franco, Beata Gurzkowska, Chien-Jen Chen, Marie Moitry, Nizal Sarrafzadegan, Xiangjun Wang, Diego Giulliano Destro Christofaro, Imperia Brajkovich, Fangfang Chen, Francesco Panza, Ling Yang, Holly E. Syddall, Cecily Kelleher, Michael Tornaritis, Ningli Wang, Lutgarde Thijs, Marjolein Visser, Angelika Schaffrath Rosario, María José Tormo, Jostein Steene-Johannessen, Norbert Amougou, Emmanuella Magriplis, Mar Alvarez-Pedrerol, Jingli Gao, Stig E. Bojesen, Giuseppe Grosso, Seongjun Ha, Lauren Lissner, Mikhail Benet, Anastasia Markaki, Sanjay Rampal, Antônio Augusto Moura da Silva, Maria Lorenza Muiesan, Angelique Chan, Yvonne T. van der Schouw, Annamari Lundqvist, Philippe Amouyel, Kristyna Zejglicova, Charalambos Hadjigeorgiou, João Breda, Jørgen Meisfjord, Fatima Zahra Laamiri, Carl Lachat, Kai-Uwe Saum, Vilma Irazola, Leng Huat Foo, Óscar Lopes, Dickman Gareta, Flavio Nervi, Imre Janszky, Ruzena Kubinova, Terho Lehtimäki, Mario V. Capanzana, Moyses Szklo, Ramfis Nieto-Martínez, Viswanathan Mohan, Shuohua Chen, Arvind Pandey, Luigi Palmieri, Roya Kelishadi, Srinivasan Kannan, Jie Mi, Robert Beaglehole, Liliana Dacica, Jyrki K. Virtanen, Mohan Deepa, Peter Ueda, Isti Ilmiati Fujiati, Hermann Pohlabeln, Morten Sodemann, Jytte Halkjær, Zbigniew Kułaga, Sophie Visvikis-Siest, Farshad Farzadfar, Mohsen Azimi-Nezhad, Henry Völzke, Karolina Milkowska, Zahra Mohammadi, Belgin Ünal, Magda Gasull, George S. Stergiou, Marshall K. Tulloch-Reid, Seppo Koskinen, James E. Bennett, Marcela González-Gross, Virginija Dulskiene, Idris Guessous, Assembekov Batyrbek, Kamarul Imran Musa, Jeannette Lee, Josep Redon, Bihungum Bista, Luisa M Macieira, Johan Sundström, Andres Metspalu, Lariane M Ono, Flora A. Ukoli, Salar Rahimikazerooni, Andrea Gualtieri, Trevor S. Ferguson, Félicité Tchibindat, Eliza Cinteza, Ha Tp Do, Tajana Zeljkovic Vrkic, Tuyen D Le, Alison J. Hayes, Abdul Basit, Chandini Nekkantti, Teresa Norat, Eunice Ugel, Gulmira Aitmurzaeva, Mariachiara Di Cesare, Abdul Hamid Zargar, Vincenzo Solfrizzi, Garry L. Jennings, Aline Meirhaeghe, Kaare Christensen, Päivi Mäki, Xu Lin, Ali Esmaeili, Joanna Baran, Aneta Grajda, Renata Cifkova, Alexandre C. Pereira, Martin Bobak, Iuliia A Rusakova, Keiu Nelis, Damian K Francis, Guansheng Ma, Axel C. Carlsson, Alejandro Diaz, Alireza Ansari-Moghaddam, N Capkova, Zumin Shi, Maria Turley, Imelda A. Agdeppa, Helena I. S. Nogueira, Marcia Scazufca, Katharina Maruszczak, Natascia Rinaldo, Paulo A. Lotufo, Nuno Lunet, Thor Aspelund, Caroline H.D. Fall, Antonio Cabrera de León, Ahmad Faudzi Yusoff, Holger Theobald, Beatriz D'Agord Schaan, Pedro Marques-Vidal, William A. Neal, Mihai Gafencu, Tandi E. Matsha, Ana B. Crujeiras, Ahmad Reza Dorosty, Alain Morejon, Weili Yan, Dominique Hange, Bekbolat Zholdin, Frédéric Gottrand, Jorge Mota, Jana Námešná, Stevo Popovic, Louise Eriksen, Line Lund Kårhus, Cihangir Erem, Juergen Breckenkamp, Mathilde Kersting, Yi Song, Martin McKee, Aleksandra Gomula, Rafaela Rosário, Enzo Manzato, S. Goya Wannamethee, Sounnia Mediene Benchekor, Azim Nejatizadeh, Krishna Kumar Aryal, Juan P. González-Rivas, Vedrana Sember, Stephen T. McGarvey, Jukka T. Salonen, Patrick Pasquet, Patricia Varona-Pérez, Amelia C. Crampin, Ramin Heshmat, Violeta Iotova, Juvenal Soares Dias-da-Costa, Oye Gureje, Aletta E. Schutte, João Luiz Bastos, Anelise Reis Gaya, Konrad Jamrozik, Dalia Luksiene, Amina Barkat, Maria Paula Santos, José Camolas, Azli Baharudin, Diego Vanuzzo, Doris Stöckl, Rosalynn Siantar, Jouko Saramies, Albertino Damasceno, Davood Khalili, Simona Bo, Martina Müller-Nurasyid, Dominique Cottel, Markku Peltonen, Fikru Tullu, Ana Isabel Rito, Angélica Ochoa-Avilés, Annette J. Dobson, Christopher T. Cowell, Charumathi Sabanayagam, Rildo de Souza Wanderley Júnior, Oanh T. H. Trinh, Farahnaz Joukar, Mostafa K. Mohamed, Mostafa Qorbani, Jeongseon Kim, Helmut Schröder, Machi Suka, Natasja M. van Schoor, Jussi Kauhanen, Teresa Haugsgjerd, Goodarz Danaei, M. Fernanda Lima-Costa, Yong Tao, Elisabetta L. Romeo, Grazyna Jasienska, Victor Guillermo Sequera, Kazem Mohammad, Yanina Zócalo, Fernanda Cunha Soares, Jianfeng Wu, Mohammad Esmaeel Motlagh, María Elena Díaz-Sánchez, Monika Zuziak, Eldridge Ferrer, Anette Varbo, Leila Beltrami Moreira, Jeremy M. Jacobs, Kenneth James, Elena Sacchini, Pascal Bovet, Mahboubeh Parsaeian, Tania Lopez, Ya Xing Wang, Wojciech Drygas, Jody C Miller, Svetlana A. Shalnova, Maria Elisa Zapata, Chung T Nguyen, Nimmathota Arlappa, Edwige Landais, Thorkild I. A. Sørensen, Jeannette Klimont, Amirabbas Momenan, Erik J. Timmermans, Mari-Liis Tammesoo, Jost B. Jonas, Stefania Toselli, Maria Teresa Anselmo Olinto, Bahman Cheraghian, Kouamelan Doua, Esteban Carmuega, Marjeta Mišigoj-Duraković, Bo Werner, M. Arfan Ikram, Breige A. McNulty, Christa Meisinger, Clara Homs, Namuna Shrestha, Alina Kerimkulova, Youcef Laid, Claes Ohlsson, Alicia Matijasevich, Alison J Price, Ala'a Alkerwi, Kristine H. Allin, Lorenza Pilotto, Mohannad Al Nsour, Ingunn Holden Bergh, Marianna Noale, Heba Fouad, Vilnis Dzerve, Novie O. Younger-Coleman, Peter Willeit, Andrea R. V. R. Horimoto, Freda Pitakaka, Habiba Ben Romdhane, Savvas C. Savva, Rajeev Gupta, Jennifer Servais, Cristina Padez, Sarah P. Garnett, Maria del Cristo Rodriguez-Perez, Michala Lustigová, Tien Yin Wong, Rosa Haghshenas, Jonathan Giovannelli, Christina Howitt, Marleen E. Hendriks, Fadia AlBuhairan, Huashuai Chen, Gretchen A Stevens, Luís B. Sardinha, David Goltzman, Jenny M. Kindblom, Karina Mary de Paiva, Yousef Khader, Eric Monterrubio-Flores, Rajendra Pradeepa, Yi-Ting Lin, Martin Neovius, Juan Francisco Miquel, Ellis Owusu-Dabo, Anil Poudyal, Marzieh Katibeh, Tanja Stocks, Veronica Mocanu, Ulla Roggenbuck, Robespierre Ribeiro, Gabriele Eiben, Mary Simon, Christine Cameron, Hamid Hakimi, Kamel Ajlouni, Jakub Stokwiszewski, Iulia Jurca Simina, Pietro Amedeo Modesti, Frederick C. W. Wu, Peter Kristensen, Charles Mondo, Felix Gutzwiller, Mariana Sbaraini, Martijn Huisman, Betina H. Thuesen, Queenie Chan, Antonisamy Belavendra, Artur Mazur, Ulf Ekelund, Laura A. Rodríguez-Villamizar, Marcos André Moura-dos-Santos, Jean Ferrières, Farhad Zamani, Shina Avi, Yves Kameli, Luis Paulo Gomes Mascarenhas, Aluísio J D Barros, Thomas Meinertz Dantoft, Hossein Poustchi, Farid Najafi, Giovanni de Gaetano, Azaliia M Tuliakova, Vera Lanska, Tint Swe Latt, Matthias Bopp, Abbas Rezaianzadeh, Rod Jackson, Johan Van der Heyden, Reecha Sofat, Koen Van Herck, Allan G. Hill, Con Burns, Emanuela Pettenuzzo, Ming-Dong Wang, Stela McLachlan, Ulrike Gehring, Ranko Stevanovic, Nagalla Balakrishna, Lekhraj Rampal, Marjolijn C. E. Bragt, Saeid Eslami, Napoleón Pérez-Farinós, G. K. Mini, Viktoria Anna Kovacs, Rosemarie Martin, Nahla Hwalla, Wei Zheng, Hoang Van Minh, Edward D Janus, Laetitia Huiart, Farhad Pourfarzi, Sudha Ramachandra Rao, Fred Paccaud, Marcia Makdisse, Aye Aye Sein, Enrique Gutiérrez-González, Yang Yang, Anneke Blokstra, Henrike Galenkamp, Jaume Marrugat, Nazan Yardim, Wan Nazaimoon Wan Mohamud, Jesús Ibarluzea, Julio Zuñiga Cisneros, Laura Lauria, Argyro Karakosta, Dragana P Jovic, Jun Hata, Elio Riboli, Piotr Bandosz, Xun Tang, Parvina Mukhtorova, Jean Dallongeville, Jean-Bernard Ruidavets, Anne Tjønneland, Guillermo Frontera, Rahul Malhotra, Thomas Ferrao, Aleksandra Piwońska, Dusan Grafnetter, Mette Rasmussen, Daniel Weghuber, Sherali Rakhmatulloev, Martine Vrijheid, Johann Willeit, Motahareh Kheradmand, Małgorzata Mossakowska, Lechaba Tshepo, Dongfeng Gu, Hyeon Chang Kim, Vilmundur Gudnason, Maria Forsner, Peter Bjerregaard, Leon A. Simons, Rachael McLean, Japhet Killewo, Ramón Suárez-Medina, Y Nikitin, Eng Joo Tan, Jean Claude Mbanya, Aroor Bhagyalaxmi, Renata Kuciene, Kairat Davletov, Jose Eugenio Lozano, Afshin Ostovar, Niloofar Peykari, Guy De Backer, Soheir H Ahmed, Nicholas J. Wareham, Sai Yin Ho, Constanta Huidumac Petrescu, Maria Hassapidou, Iris Pigeot, Myriam Galfo, Susana Cararo Confortin, Blanca Sandra Ruiz-Betancourt, W. M. Monique Verschuren, Catterina Ferreccio, Fabio Galvano, Leila Houti, Daniel Bia, Annika Rosengren, Marcin Rutkowski, Biruta Velika, Joana Araújo, Fernando Rigo, Angela Spinelli, Scott B. McLean, Shirin Djalalinia, Marie Kunešová, Boban Mugoša, Sania Nishtar, Mangesh S. Pednekar, Shahla AlDhukair, Helle-Mai Loit, Antonis Zampelas, Altan Onat, Maciej Banach, Shohreh Naderimagham, Hajer Aounallah-Skhiri, Maja Bæksgaard Jørgensen, Yin Guo, Ewelina Czenczek-Lewandowska, Parasmani Dasgupta, Elvis Oa Wambiya, Inge Huybrechts, Raimund Erbel, Jari Jokelainen, Ana P. Ortiz, Stefan Kiechl, Emmanuel Cohen, Caleb Ochimana, Shynar Abdrakhmanova, Laura Censi, Iqbal Bata, Geetha R Menon, Snehalatha Chamukuttan, Pedro Plans-Rubio, Domenico Palli, Ana Azevedo, Slawomir Koziel, Benoît Salanave, Parinaz Mehdipour, Shu Ti Chiou, Lela Sturua, Lubica Ticha, Felipe Vogt Cureau, Jin Soo Moon, Ming-Hui Zhao, Urho M. Kujala, Nathalie Michels, Ertugrul Celikcan, Jaakko Tuomilehto, Judith Benedics, Tobias F. Rinke de Wit, Agnès Le Port, Reza Homayounfar, Andrea Rodriguez-Martinez, Tai Hing Lam, Yn-Tz Sung, Jürgen König, Kodavanti Mallikharjuna Rao, Hazzaa M. Al-Hazzaa, Karen Morgan, Bogdan Wojtyniak, Cynthia M. Pérez, Ilse Khouw, Manoli Garcia-de-la-Hera, Dong Wook Shin, Genc Burazeri, Ausra Petrauskiene, Charles Sossa Jérome, Kenisha Russell Jonsson, José Boggia, Daniela Galeone, Alice Bonilla-Vargas, Han Cg Kemper, Rahman Shiri, Stefaan Demarest, Else Karin Grøholt, San-Lin You, Adelheid Weber, Juha Auvinen, Aida Pilav, Sibel Gogen, Suzanne N Morin, Wan Mohamad Wan Bebakar, Viviane Cunha Cardoso, Kavumpurathu Raman Thankappan, Hana Zamrazilová, Frank Claessens, Karien Stronks, Helen Gonçalves, Tahir Aris, Luis Revilla, Sérgio Viana Peixoto, Zhamilya Battakova, Jing Liu, Eliza Markidou Ioannidou, Leticia Hernandez Cadena, Priscilla Duboz, Sandjaja, Tiina Laatikainen, Rafel Ramos, Sareh Eghtesad, Judith Simons, Orn Olafsson, E. Shyong Tai, Louise A. Baur, Nihal Thomas, Aung Soe Htet, Bente Sparboe-Nilsen, Paul Elliott, Soon-Woo Park, Angel R. Gonzalez, Ying-Wei Wang, Rob M. van Dam, Ryutaro Ohtsuka, Ludmila Sevcikova, Suhaila Abdul Ghaffar, Lynell V Maniego, Fariborz Mansour-Ghanaei, Maria Dorobantu, Giovanni Viegi, Xiaoguang Yang, Honor Bixby, Prakash C. Gupta, Ofra Kalter-Leibovici, Eugene Sobngwi, Ričardas Radišauskas, Jurate Medzioniene, Roy A Wong-McClure, Kim F. Michaelsen, Antonia Trichopoulou, Tania Tello, Francesco Branca, Johanna Gunnlaugsdottir, Els Clays, Wei-Yen Lim, Suzanne C. Ho, Toomas Veidebaum, Rebecca Goldsmith, Margot González-León, Matthias Nauck, Alibek Mereke, Marta Buoncristiano, Jakob Tarp, Rosalba Rojas-Martínez, Maya Tanrygulyyeva, Reza Malekzadeh, Abdonas Tamosiunas, Dimitrios Poulimeneas, Pedro Ordunez, Isabelle Herter-Aeberli, Khanh Le Nguyen Bao, Anne Juolevi, Vassilis Zafiropulos, Emanuela Gualdi-Russo, Jordi Sunyer, Manu Raj, Chaoqiang Jiang, Sofia Malyutina, Efthymios Kapantais, Maria Lazo-Porras, Maung Maung Than Htike, Michael Hobbs, Ranjit Mohan Anjana, Merike Liivak, Johan G. Eriksson, Margarita Samoutian, Andreia N. Pizarro, Mohammed Rasoul Tarawneh, Jean Woo, Kaspar Staub, Maria Teresa Menzano, Mojtaba Farjam, Adroaldo Cesar Araujo Gaya, Mohammad El-khateeb, Zulfiqar A Bhutta, Mukharram M. Bikbov, Hsien-Ho Lin, Oscar Noboa, Thomas Waldhör, Garry Brian, Simona Costanzo, Frank Tanser, Nor Azwany Yaacob, Michelle Cilia, Ivo Rakovac, Bill Stavreski, Ioannis Pagkalos, Ivan Pećin, Carlo M. Barbagallo, Abla M. Sibai, Yuna He, Matsuda Fumihiko, Bharathi Viswanathan, Ali Reza Safarpour, Wei Cheng Lo, Abdullatif Husseini, Jiang He, Liv Elin Torheim, Nipa Rojroongwasinkul, Aicha Soumare, Astrid Petersmann, Tomasz Grodzicki, Davide Noto, Panayiotis K. Yiallouros, Kelias P. Msyamboza, William R. Tebar, Yingfeng Zheng, Eha Nurk, Bhawesh Koirala, Ana Jelakovic, Suhad Bahijri, Freja B Kampmann, Qi Sheng You, Marika Ferrari, María-Elena González-Villalpando, Aline Wagner, Olfa Saidi, Anwar Batieha, Eduardo Capuano, Coimbatore Subramaniam Shanthirani, Dong Wook Kim, Albina A Fakhretdinova, Tom Wilsgaard, Maria Avdicova, Moesijanti Soekatri, Chiara Donfrancesco, Salim Mohanna, Paola Russo, Uruwan Yamborisut, Rafael dos Santos Henrique, Martin Nankap, Allan Linneberg, Khairil Si-Ramlee, Kirsten Mehlig, Christina Mavrogianni, Raluca Pop, Lèlita Santos, Graziella Bruno, Valentina Peterkova, Iná S. Santos, Georg Lappas, Alberto Palloni, Malay K. Mridha, Andrzej Pajak, Marta García-Solano, Stefaan De Henauw, Daniel Ferrante, Rute Santos, Anders Grøntved, Lucjan Szponar, Mihaela Vladulescu, Chien-An Sun, Jan A. Staessen, Paula Duarte de Oliveira, Norazizah Ibrahim Wong, Maria Nordendahl, Elaine M. Dennison, Jeonghee Lee, Diego Salmerón, Ida Maria Schmidt, Gao Pei, Noushin Mohammadifard, Igor Spiroski, Fernando Rodríguez-Artalejo, Xu Ma, Elin Pettersen Sørgjerd, Valéria Regecová, Cláudia S. Minderico, Johanna A. Otero, Jamila Abubakar Garba, Vesselka Duleva, Rui Ornelas, Ilpo Huhtaniemi, Cesar G. Victora, Lijuan Liu, Rody G. Sy, Mahmood Moosazadeh, Ali Ahmadi, Antonio Pedro Graça, Natalia Nowak-Szczepanska, Miao Li Chee, Michael Sjöström, Charles Agyemang, Shiqi Zhen, Xiu-Hua Guo, Pawel Kurjata, Jardena J. Puder, Mehrdad Azmin, Neil Murphy, Kaosar Afsana, Alireza Sadjadi, Johanna M. Geleijnse, Prashant Mathur, Elysée Claude Bika Lele, Raphael Mendes Ritti-Dias, Yannis Manios, Majid Shirani, Rosemary B. Duda, Liis Nelis, Jurate Klumbiene, Zhengming Chen, Wichai Aekplakorn, Alun Evans, Andrzej Wiecek, Lars Lind, Denise Eldemire-Shearer, Bernardo L. Horta, Macia Enguerran, Seyed Rasoul Zakavi, Daniel Fernández-Bergés, Kumiko Ohara, Ursula Kiechl-Kohlendorfer, Hermann Brenner, Przemyslaw Slusarczyk, Espen Bjertness, Jutta Stieber, Augusto Di Castelnuovo, Joel G. R. Roy, Aryeh D. Stein, Ruth Frikke-Schmidt, Vera Musil, Amaneh Shayanrad, Marcel Goldberg, Ramon O. Jimenez, Mohammad Reza Fattahi, Jolanda Hyska, Amir Houshang Mehrparvar, Elin Kolle, Mohamed Bamoshmoosh, Michelle Holdsworth, Felipe F. Casanueva, Børge G. Nordestgaard, Niels Wedderkopp, Eva Corpeleijn, Elias F. Gudmundsson, Antonio Mistretta, Daniel Lemogoum, Larissa Pruner Marques, Slavica Sović, Olli T. Raitakari, Marco Aurélio Peres, Alexandra Cucu, Gregorio Varela-Moreiras, Janine Clarke, Andrea Gazzinelli, Mieczysław Litwin, Sara Schramm, Xenophon Theodoridis, Harshpal Singh Sachdev, Mohammad Reza Mirjalili, Dimitrios Papandreou, Peter T. Katzmarzyk, Benjamin Acosta-Cazares, Ben Schöttker, Prabhdeep Kaur, Norlaila Mustafa, Shariq Rashid Masoodi, Sadaf G. 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Duante, Sheikh Mohammed Shariful Islam, Quang Ngoc La, Ricky Eddie, Petra Rust, Daniela Rodrigues, Dirk De Bacquer, Karen Sparrenberger, Agneta Sjöberg, Thet Thet Mu, Katarzyna Dereń, Cora L. Craig, Jorge Motta, Janina Petkeviciene, Boyd Swinburn, Paibul Suriyawongpaisal, Visnja Djordjic, Ramón Alberto Rascón-Pacheco, Pradeep Joshi, Daan Kromhout, Marius B. Bjertness, Stefano Marventano, Juel Jarani, Alireza Khosravi, Eva Martos, David De Ridder, Lizzy M. Brewster, Nico Dragano, Liam Smeeth, Kenji Shibuya, Emma Ruiz Moreno, Hashem Jaddou, Grzegorz Sobek, Dimitrios Trichopoulos, Marvin Cervantes-Loaiza, Abu Am Hanif, Elaine M. Murtagh, Carlos A. Aguilar-Salinas, Graziella D'Arrigo, Kyungwon Oh, Heiner Boeing, Regina Heidinger-Felso, André Luiz Sena Guimarães, Balkish M. Naidu, Avula Laxmaiah, Ana M. B. Menezes, Marie Eliasen, Francesco Pistelli, Yuan He, Dusko Bjelica, José A. 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Machado-Rodrigues, Fatemeh Malekzadeh, Shouling Wu, Jennifer L. Baker, Clicerio González-Villalpando, Eleonora d'Orsi, Irene G. M. van Valkengoed, Anna Fijałkowska, Wen-Harn Pan, Gregor Starc, Meghnath Dhimal, Murat Topbaş, George Moschonis, Robert Eggertsen, Abdullah Alkandari, Quang Ngoc Nguyen, Janette Walton, Elnaz Faramarzi, Saeed Dastgiri, Lien Braeckevelt, Nasheeta Peer, Radka Taxová Braunerová, Mohamed M. Ali, Steiner Krokstad, Harald Geiger, Morteza Shamshirgaran, Lela Shengelia, María Ángeles Dal Re Saavedra, Silvana Donoso, Khem Bahadur Karki, Timothy J. Key, Maria G. Grammatikopoulou, Susana Vale, Felix K. Assah, Juan A Rivera, Peter H. Whincup, Oana-Florentina Gheorghe-Fronea, Cassiano Ricardo Rech, Paul Ferdinand M. Reganit, Rachakulla Hari Kumar, Jaakko Mursu, Luis A. Moreno, Glen Gironella, Jelena Kos, Tilema Cama, Haakon E. Meyer, Jun Ma, Raphael E. Arku, Ziad Abdeen, Dianna J. Magliano, Jitendra Jonnagaddala, Konstantinos Gkiouras, Paola Nardone, Alberto Barceló, Tomi-Pekka Tuomainen, Francesco Gianfagna, Stefania Maggi, Mohammad Hossein Somi, Behrooz Hamzeh, Miquel Porta, Vesna Jureša, Alexander D. Deev, David Faeh, Antonio Bernabe-Ortiz, Sirkka Keinänen-Kiukaanniemi, Ian Hambleton, Stefan Savin, Andre Pascal Kengne, R. Krishna Kumar, Kurt Widhalm, Marco M Ferrario, Parisa Amiri, Anjani Kumar Jha, Thamara Hubler Figueiró, Jana Kratenova, Claudia M. Hormiga, Maria Tsigga, Zivka Dika, Indrapal I. Meshram, Ei Ei K. Nang, Ian Rouse, Rusidah Selamat, Paul Korrovits, Grethe S. Tell, Julie Taylor, Anabela Mota-Pinto, Paolo Vineis, Kotsedi D Monyeki, Khuong Quynh Long, Frank J Rühli, Shelly R. McFarlane, Sara Santos Sanz, Edyta Łuszczki, Maria G. Stathopoulou, Tara Coppinger, Karin De Ridder, Lucie Viet, Anna Bugge, Mehdi Yaseri, Safiah Md Yusof, Sandra C. Fuchs, Muhammad Islam, Irfan Nuhoglu, Rui Providência, Bernard Maire, Leandra Abarca-Gómez, Sinead Brophy, Maria Ruiz-Castell, Daniela Pierannunzio, Cristina Taddei, Gowri Mahasampath, Gustavo Velasquez-Melendez, Hanna Tolonen, Sudhir Kowlessur, Bagher Larijani, Laura Torres-Collado, Susi Kriemler, Ali Akbar Shayesteh, Cynthia Robitaille, Jorge Escobedo-de la Peña, Yufang Bi, Chinh Nguyen Huu, Line Tang Møllehave, Vincent Jr DeGennaro, Noor Ani Ahmad, Anar Dushpanova, Agustinus Soemantri, Susana Sans, Ionela Pascanu, Gwenaëlle Le Coroller, Inger Ariansen, Kodanda R Kanala, Gert B. M. Mensink, Abhijit Sen, Sergej M. Ostojic, Hanan F. Abdul Rahim, Hélène Delisle, Francisco J. Félix-Redondo, Yadlapalli S. Kusuma, Michael Knoflach, Moein Yoosefi, Tanja G. M. Vrijkotte, Wolfgang Ahrens, Osvaldo Santos, Bethlehem D. Solomon, Erik Lykke Mortensen, Nikhil D. 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Chan School of Public Health, Middlesex University [London], Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Montpellier Interdisciplinary center on Sustainable Agri-food systems (Social and nutritional sciences) (UMR MoISA), Centre de Coopération Internationale en Recherche Agronomique pour le Développement (Cirad)-Institut de Recherche pour le Développement (IRD)-Centre International de Hautes Etudes Agronomiques Méditerranéennes - Institut Agronomique Méditerranéen de Montpellier (CIHEAM-IAMM), Centre International de Hautes Études Agronomiques Méditerranéennes (CIHEAM)-Centre International de Hautes Études Agronomiques Méditerranéennes (CIHEAM)-Institut national d’études supérieures agronomiques de Montpellier (Montpellier SupAgro), Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Interactions Gène-Environnement en Physiopathologie Cardio-Vasculaire (IGE-PCV), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Wellcome TrustEuropean Commission, Clinical Developmental Psychology, APH - Mental Health, Sociology, The Social Context of Aging (SoCA), Nutrition and Health, Iurilli, Maria LC [0000-0003-0409-1635], Zhou, Bin [0000-0002-1741-8628], Ezzati, Majid [0000-0002-2109-8081], Apollo - University of Cambridge Repository, Epidemiology and Data Science, APH - Aging & Later Life, APH - Societal Participation & Health, Public and occupational health, APH - Health Behaviors & Chronic Diseases, VU University medical center, APH 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Medical Research Center, Luxembourg Institute of Health, Bispebjerg and Frederiksberg Hospital, Barcelona Institute for Global Health CIBERESP, World Health Organization Regional Office for the Eastern Mediterranean, Bombay Hospital and Medical Research Centre, Research Center for Social Determinants of Health, UMR CNRS-MNHN 7206 Eco-anthropologie, University of Lille, Lille University Hospital, Western Norway University of Applied Sciences, Norwegian School of Sport Sciences, Madras Diabetes Research Foundation, Zahedan University of Medical Sciences, National Institute of Public Health, Institute of Public Health of the University of Porto, Norwegian Institute of Public Health, University of Massachusetts Amherst, Abt Associates, University of Iceland, University of Yaoundé1, Federal University of Pelotas, University of Medicine 1, Oulu University Hospital, Banska Bystrica Regional Authority of Public Health, Tel- Aviv University, Hebrew University of Jerusalem, University of Porto 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Huiart , Constanta Huidumac Petrescu , Martijn Huisman , Abdullatif Husseini , Chinh Nguyen Huu , Inge Huybrechts , Nahla Hwalla , Jolanda Hyska , Licia Iacoviello , Jesús M Ibarluzea , Mohsen M Ibrahim , Norazizah Ibrahim Wong , M Arfan Ikram , Violeta Iotova , Vilma E Irazola , Takafumi Ishida , Muhammad Islam , Sheikh Mohammed Shariful Islam , Masanori Iwasaki , Jeremy M Jacobs , Hashem Y Jaddou , Tazeen Jafar , Kenneth James , Kazi M Jamil , Konrad Jamrozik , Imre Janszky , Edward Janus , Juel Jarani , Marjo-Riitta Jarvelin , Grazyna Jasienska , Ana Jelakovic , Bojan Jelakovic , Garry Jennings , Anjani Kumar Jha , Chao Qiang Jiang , Ramon O Jimenez , Karl-Heinz Jöckel , Michel Joffres , Mattias Johansson , Jari J Jokelainen , Jost B Jonas , Jitendra Jonnagaddala , Torben Jørgensen , Pradeep Joshi , Farahnaz Joukar , Dragana P Jovic , Jacek J Jóźwiak , Anne Juolevi , Gregor Jurak , Iulia Jurca Simina , Vesna Juresa , Rudolf Kaaks , Felix O Kaducu , Anthony Kafatos , Eero O Kajantie , Zhanna Kalmatayeva , Ofra Kalter-Leibovici , Yves Kameli , Freja B Kampmann , Kodanda R Kanala , Srinivasan Kannan , Efthymios Kapantais , Argyro Karakosta , Line L Kårhus , Khem B Karki , Marzieh Katibeh , Joanne Katz , Peter T Katzmarzyk , Jussi Kauhanen , Prabhdeep Kaur , Maryam Kavousi , Gyulli M Kazakbaeva , Ulrich Keil , Lital Keinan Boker , Sirkka Keinänen-Kiukaanniemi , Roya Kelishadi , Cecily Kelleher , Han Cg Kemper , Andre P Kengne , Maryam Keramati , Alina Kerimkulova , Mathilde Kersting , Timothy Key , Yousef Saleh Khader , Davood Khalili , Kay-Tee Khaw , Bahareh Kheiri , Motahareh Kheradmand , Alireza Khosravi , Ilse Msl Khouw , Ursula Kiechl-Kohlendorfer , Stefan Kiechl , Japhet Killewo , Dong Wook Kim , Hyeon Chang Kim , Jeongseon Kim , Jenny M Kindblom , Heidi Klakk , Magdalena Klimek , Jeannette Klimont , Jurate Klumbiene , Michael Knoflach , Bhawesh Koirala , Elin Kolle , Patrick Kolsteren , Jürgen König , Raija Korpelainen , Paul Korrovits , Magdalena Korzycka , Jelena Kos , Seppo Koskinen , Katsuyasu Kouda , Viktoria A Kovacs , Sudhir Kowlessur , Slawomir Koziel , Jana Kratenova , Wolfgang Kratzer , Susi Kriemler , Peter Lund Kristensen , Steinar Krokstad , Daan Kromhout , Herculina S Kruger , Ruzena Kubinova , Renata Kuciene , Urho M Kujala , Enisa Kujundzic , Zbigniew Kulaga , R Krishna Kumar , Marie Kunešová , Pawel Kurjata , Yadlapalli S Kusuma , Kari Kuulasmaa , Catherine Kyobutungi , Quang Ngoc La , Fatima Zahra Laamiri , Tiina Laatikainen , Carl Lachat , Youcef Laid , Tai Hing Lam , Christina-Paulina Lambrinou , Edwige Landais , Vera Lanska , Georg Lappas , Bagher Larijani , Tint Swe Latt , Laura Lauria , Maria Lazo-Porras , Gwenaëlle Le Coroller , Khanh Le Nguyen Bao , Agnès Le Port , Tuyen D Le , Jeannette Lee , Jeonghee Lee , Paul H Lee , Nils Lehmann , Terho Lehtimäki , Daniel Lemogoum , Naomi S Levitt , Yanping Li , Merike Liivak , Christa L Lilly , Wei-Yen Lim , M Fernanda Lima-Costa , Hsien-Ho Lin , Xu Lin , Yi-Ting Lin , Lars Lind , Allan Linneberg , Lauren Lissner , Mieczyslaw Litwin , Lijuan Liu , Wei-Cheng Lo , Helle-Mai Loit , Khuong Quynh Long , Luis Lopes , Oscar Lopes , Esther Lopez-Garcia , Tania Lopez , Paulo A Lotufo , José Eugenio Lozano , Janice L Lukrafka , Dalia Luksiene , Annamari Lundqvist , Robert Lundqvist , Nuno Lunet , Charles Lunogelo , Michala Lustigová , Edyta Łuszczki , Guansheng Ma , Jun Ma , Xu Ma , George Ll Machado-Coelho , Aristides M Machado-Rodrigues , Luisa M Macieira , Ahmed A Madar , Stefania Maggi , Dianna J Magliano , Sara Magnacca , Emmanuella Magriplis , Gowri Mahasampath , Bernard Maire , Marjeta Majer , Marcia Makdisse , Päivi Mäki , Fatemeh Malekzadeh , Reza Malekzadeh , Rahul Malhotra , Kodavanti Mallikharjuna Rao , Sofia K Malyutina , Lynell V Maniego , Yannis Manios , Jim I Mann , Fariborz Mansour-Ghanaei , Enzo Manzato , Paula Margozzini , Anastasia Markaki , Oonagh Markey , Eliza Markidou Ioannidou , Pedro Marques-Vidal , Larissa Pruner Marques , Jaume Marrugat , Yves Martin-Prevel , Rosemarie Martin , Reynaldo Martorell , Eva Martos , Katharina Maruszczak , Stefano Marventano , Luis P Mascarenhas , Shariq R Masoodi , Ellisiv B Mathiesen , Prashant Mathur , Alicia Matijasevich , Tandi E Matsha , Christina Mavrogianni , Artur Mazur , Jean Claude N Mbanya , Shelly R McFarlane , Stephen T McGarvey , Martin McKee , Stela McLachlan , Rachael M McLean , Scott B McLean , Breige A McNulty , Sounnia Mediene Benchekor , Jurate Medzioniene , Parinaz Mehdipour , Kirsten Mehlig , Amir Houshang Mehrparvar , Aline Meirhaeghe , Jørgen Meisfjord , Christa Meisinger , Ana Maria B Menezes , Geetha R Menon , Gert Bm Mensink , Maria Teresa Menzano , Alibek Mereke , Indrapal I Meshram , Andres Metspalu , Haakon E Meyer , Jie Mi , Kim F Michaelsen , Nathalie Michels , Kairit Mikkel , Karolina Milkowska , Jody C Miller , Cláudia S Minderico , G K Mini , Juan Francisco Miquel , Mohammad Reza Mirjalili , Daphne Mirkopoulou , Erkin Mirrakhimov , Marjeta Mišigoj-Durakovic , Antonio Mistretta , Veronica Mocanu , Pietro A Modesti , Sahar Saeedi Moghaddam , Bahram Mohajer , Mostafa K Mohamed , Shukri F Mohamed , Kazem Mohammad , Zahra Mohammadi , Noushin Mohammadifard , Reza Mohammadpourhodki , Viswanathan Mohan , Salim Mohanna , Muhammad Fadhli Mohd Yusoff , Iraj Mohebbi , Farnam Mohebi , Marie Moitry , Drude Molbo , Line T Møllehave , Niels C Møller , Dénes Molnár , Amirabbas Momenan , Charles K Mondo , Michele Monroy-Valle , Eric Monterrubio-Flores , Kotsedi Daniel K Monyeki , Jin Soo Moon , Mahmood Moosazadeh , Leila B Moreira , Alain Morejon , Luis A Moreno , Karen Morgan , Suzanne N Morin , Erik Lykke Mortensen , George Moschonis , Malgorzata Mossakowska , Aya Mostafa , Anabela Mota-Pinto , Jorge Mota , Mohammad Esmaeel Motlagh , Jorge Motta , Marcos André Moura-Dos-Santos , Malay K Mridha , Kelias P Msyamboza , Thet Thet Mu , Magdalena Muc , Boban Mugoša , Maria L Muiesan , Parvina Mukhtorova , Martina Müller-Nurasyid , Neil Murphy , Jaakko Mursu , Elaine M Murtagh , Kamarul Imran Musa , Sanja Music Milanovic , Vera Musil , Norlaila Mustafa , Iraj Nabipour , Shohreh Naderimagham , Gabriele Nagel , Balkish M Naidu , Farid Najafi , Harunobu Nakamura , Jana Námešná , Ei Ei K Nang , Vinay B Nangia , Martin Nankap , Sameer Narake , Paola Nardone , Matthias Nauck , William A Neal , Azim Nejatizadeh , Chandini Nekkantti , Keiu Nelis , Liis Nelis , Ilona Nenko , Martin Neovius , Flavio Nervi , Chung T Nguyen , Nguyen D Nguyen , Quang Ngoc Nguyen , Ramfis E Nieto-Martínez , Yury P Nikitin , Guang Ning , Toshiharu Ninomiya , Sania Nishtar , Marianna Noale , Oscar A Noboa , Helena Nogueira , Teresa Norat , Maria Nordendahl , Børge G Nordestgaard , Davide Noto , Natalia Nowak-Szczepanska , Mohannad Al Nsour , Irfan Nuhoglu , Eha Nurk , Terence W O'Neill , Dermot O'Reilly , Galina Obreja , Caleb Ochimana , Angélica M Ochoa-Avilés , Eiji Oda , Kyungwon Oh , Kumiko Ohara , Claes Ohlsson , Ryutaro Ohtsuka , Örn Olafsson , Maria 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Siantar, Rosalynn, Sibai, Abla M, Silva, Antonio M, Silva, Diego Augusto Santo, Simon, Mary, Simons, Judith, Simons, Leon A, Sjöberg, Agneta, Sjöström, Michael, Skodje, Gry, Slowikowska-Hilczer, Jolanta, Slusarczyk, Przemyslaw, Smeeth, Liam, So, Hung-Kwan, Soares, Fernanda Cunha, Sobek, Grzegorz, Sobngwi, Eugène, Sodemann, Morten, Söderberg, Stefan, Soekatri, Moesijanti YE, Soemantri, Agustinu, Sofat, Reecha, Solfrizzi, Vincenzo, Somi, Mohammad Hossein, Sonestedt, Emily, Song, Yi, Sørensen, Thorkild IA, Sørgjerd, Elin P, Jérome, Charles Sossa, Soto-Rojas, Victoria E, Soumaré, Aïcha, Sovic, Slavica, Sparboe-Nilsen, Bente, Sparrenberger, Karen, Spinelli, Angela, Spiroski, Igor, Staessen, Jan A, Stamm, Hanspeter, Stathopoulou, Maria G, Staub, Kaspar, Stavreski, Bill, Steene-Johannessen, Jostein, Stehle, Peter, Stein, Aryeh D, Stergiou, George S, Stessman, Jochanan, Stevanovic, Ranko, Stieber, Jutta, Stöckl, Dori, Stocks, Tanja, Stokwiszewski, Jakub, Stoyanova, Ekaterina, Stratton, Gareth, Stronks, Karien, Strufaldi, Maria Wany, Sturua, Lela, Suárez-Medina, Ramón, Suka, Machi, Sun, Chien-An, Sundström, Johan, Sung, Yn-Tz, Sunyer, Jordi, Suriyawongpaisal, Paibul, Swinburn, Boyd A, Sy, Rody G, Syddall, Holly E, Sylva, René Charle, Szklo, Moyse, Szponar, Lucjan, Tai, E Shyong, Tammesoo, Mari-Lii, Tamosiunas, Abdona, Tan, Eng Joo, Tang, Xun, Tanrygulyyeva, Maya, Tanser, Frank, Tao, Yong, Tarawneh, Mohammed Rasoul, Tarp, Jakob, Tarqui-Mamani, Carolina B, Braunerová, Radka Taxová, Taylor, Anne, Taylor, Julie, Tchibindat, Félicité, Tebar, William R, Tell, Grethe S, Tello, Tania, Tham, Yih Chung, Thankappan, KR, Theobald, Holger, Theodoridis, Xenophon, Thijs, Lutgarde, Thomas, Nihal, Thuesen, Betina H, Tichá, Lubica, Timmermans, Erik J, Tjonneland, Anne, Tolonen, Hanna K, Tolstrup, Janne S, Topbas, Murat, Topór-Madry, Roman, Torheim, Liv Elin, Tormo, María José, Tornaritis, Michael J, Torrent, Matie, Torres-Collado, Laura, Toselli, Stefania, Touloumi, Giota, Traissac, Pierre, Tran, Thi Tuyet-Hanh, Trichopoulos, Dimitrio, Trichopoulou, Antonia, Trinh, Oanh TH, Trivedi, Atul, Tshepo, Lechaba, Tsigga, Maria, Tsugane, Shoichiro, Tuliakova, Azaliia M, Tulloch-Reid, Marshall K, Tullu, Fikru, Tuomainen, Tomi-Pekka, Tuomilehto, Jaakko, Turley, Maria L, Twig, Gilad, Tynelius, Per, Tzotzas, Themistokli, Tzourio, Christophe, Ueda, Peter, Ugel, Eunice, Ukoli, Flora AM, Ulmer, Hanno, Unal, Belgin, Usupova, Zhamyila, Uusitalo, Hannu MT, Uysal, Nalan, Vaitkeviciute, Justina, Valdivia, Gonzalo, Vale, Susana, Valvi, Damaskini, van Dam, Rob M, Van der Heyden, Johan, van der Schouw, Yvonne T, Van Herck, Koen, Van Minh, Hoang, Van Schoor, Natasja M, van Valkengoed, Irene GM, Vanderschueren, Dirk, Vanuzzo, Diego, Varbo, Anette, Varela-Moreiras, Gregorio, Varona-Pérez, Patricia, Vasan, Senthil K, Vega, Toma, Veidebaum, Tooma, Velasquez-Melendez, Gustavo, Velika, Biruta, Veronesi, Giovanni, Verschuren, WM Monique, Victora, Cesar G, Viegi, Giovanni, Viet, Lucie, Villalpando, Salvador, Vineis, Paolo, Vioque, Jesu, Virtanen, Jyrki K, Visser, Marjolein, Visvikis-Siest, Sophie, Viswanathan, Bharathi, Vladulescu, Mihaela, Vlasoff, Tiina, Vocanec, Dorja, Vollenweider, Peter, Völzke, Henry, Voutilainen, Ari, Voutilainen, Sari, Vrijheid, Martine, Vrijkotte, Tanja GM, Wade, Alisha N, Wagner, Aline, Waldhör, Thoma, Walton, Janette, Wambiya, Elvis OA, Bebakar, Wan Mohamad Wan, Mohamud, Wan Nazaimoon Wan, de Souza Wanderley Júnior, Rildo, Wang, Ming-Dong, Wang, Ningli, Wang, Qian, Wang, Xiangjun, Wang, Ya Xing, Wang, Ying-Wei, Wannamethee, S Goya, Wareham, Nichola, Weber, Adelheid, Wedderkopp, Niel, Weerasekera, Deepa, Weghuber, Daniel, Wei, Wenbin, Weres, Aneta, Werner, Bo, Whincup, Peter H, Widhalm, Kurt, Widyahening, Indah S, Wiecek, Andrzej, Wilks, Rainford J, Willeit, Johann, Willeit, Peter, Williams, Julianne, Wilsgaard, Tom, Wojtyniak, Bogdan, Wong-McClure, Roy A, Wong, Andrew, Wong, Jyh Eiin, Wong, Tien Yin, Woo, Jean, Woodward, Mark, Wu, Frederick C, Wu, Jianfeng, Wu, Li Juan, Wu, Shouling, Xu, Haiquan, Xu, Liang, Yaacob, Nor Azwany, Yamborisut, Uruwan, Yan, Weili, Yang, Ling, Yang, Xiaoguang, Yang, Yang, Yardim, Nazan, Yaseri, Mehdi, Yasuharu, Tabara, Ye, Xingwang, Yiallouros, Panayiotis K, Yoosefi, Moein, Yoshihara, Akihiro, You, Qi Sheng, You, San-Lin, Younger-Coleman, Novie O, Md Yusof, Safiah, Yusoff, Ahmad Faudzi, Zaccagni, Luciana, Zafiropulos, Vassili, Zainuddin, Ahmad A, Zakavi, Seyed Rasoul, Zamani, Farhad, Zambon, Sabina, Zampelas, Antoni, Zamrazilová, Hana, Zapata, Maria Elisa, Zargar, Abdul Hamid, Ko Zaw, Ko, Zdrojewski, Tomasz, Zejglicova, Kristyna, Vrkic, Tajana Zeljkovic, Zeng, Yi, Zhang, Luxia, Zhang, Zhen-Yu, Zhao, Dong, Zhao, Ming-Hui, Zhao, Wenhua, Zhen, Shiqi, Zheng, Wei, Zheng, Yingfeng, Zholdin, Bekbolat, Zhou, Maigeng, Zhu, Dan, Zins, Marie, Zitt, Emanuel, Zocalo, Yanina, Cisneros, Julio Zuñiga, Zuziak, Monika, Ezzati, Majid, Filippi, Sarah, Cohortes épidémiologiques en population (CONSTANCES), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université Paris Cité (UPCité), Université Paris Cité (UPCité), Centre International de Hautes Études Agronomiques Méditerranéennes (CIHEAM)-Centre International de Hautes Études Agronomiques Méditerranéennes (CIHEAM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut Agro - Montpellier SupAgro, and Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)

Subjects
Population -- Health aspects, Leanness, Baixo peso/Underweight, none, Double burden, alipainoisuus, tulotaso, global health, systematic analysis, Sedentary behaviors, RC1200, Prospective associations, 0302 clinical medicine, underweight, nälänhätä, Biology (General), skin and connective tissue diseases, Children, ComputingMilieux_MISCELLANEOUS, Body mass index, Human Nutrition & Health, education.field_of_study, Humane Voeding & Gezondheid, ylipaino, General Medicine, kansainvälinen vertailu, 3. Good health, World health, Medicine, A100 Pre-clinical Medicine, Population distribution, medicine.medical_specialty, QH301-705.5, Science, Socio-culturale, Nursing, Social sciences, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, Thinness, SDG 3 - Good Health and Well-being, BMI, epidemiology, obesity, None, Humans, Obesidade/Obesity, SDG 2 - Zero Hunger, education, VLAG, US adults, Omvårdnad, body mass index, malnutrition, obesity, underweight, nutritional and metabolic diseases, medicine.disease, terveellisyys, Obesity, Faculdade de Ciências Sociais, Body Mass Index, Prevalence, Risk Factors, General Biochemistry, WIAS, lihavuus, RA, Demography, N.A, double burden, Settore MED/09 - Medicina Interna, alueelliset erot, Nutrition and Disease, Animal Nutrition, [SDV]Life Sciences [q-bio], Medizin, 030204 cardiovascular system & hematology, 0601 Biochemistry and Cell Biology, Change distribution of body mass index, RA0421, Voeding en Ziekte, Epidemiology, Medicine and Health Sciences, Global health, Índice de massa corporal/Body Mass Index, 030212 general & internal medicine, Underweight, painoindeksi, 2. Zero hunger, General Neuroscience, aliravitsemus, elintarvikkeet, health, Public Health, Global Health, Social Medicine and Epidemiology, Diervoeding, 3142 Public health care science, environmental and occupational health, purl.org/pe-repo/ocde/ford#3.01.03 [https], Chinese adults, pooled analysis, medicine.symptom, Diet quality, B120 Physiology, Research Article, trends, purl.org/pe-repo/ocde/ford#1.06.03 [https], prevalence, Population, Mothers, Genetics and Molecular Biology, 3121 Internal medicine, medicine, Life Science, ddc:610, 3125 Otorhinolaryngology, ophthalmology, kehonkoostumus, Nutrition, Australian adults, General Immunology and Microbiology, purl.org/pe-repo/ocde/ford#3.01.04 [https], Ciências sociais, Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi, Malnutrition, Epidemiology and Global Health, sense organs, Estilos de Vida e Impacto na Saúde
Abstract

From 1985 to 2016, the prevalence of underweight decreased, and that of obesity and severe obesity increased, in most regions, with significant variation in the magnitude of these changes across regions. We investigated how much change in mean body mass index (BMI) explains changes in the prevalence of underweight, obesity, and severe obesity in different regions using data from 2896 population-based studies with 187 million participants. Changes in the prevalence of underweight and total obesity, and to a lesser extent severe obesity, are largely driven by shifts in the distribution of BMI, with smaller contributions from changes in the shape of the distribution. In East and Southeast Asia and sub-Saharan Africa, the underweight tail of the BMI distribution was left behind as the distribution shifted. There is a need for policies that address all forms of malnutrition by making healthy foods accessible and affordable, while restricting unhealthy foods through fiscal and regulatory restrictions., Wellcome Trust, Medical Research Council, peer-reviewed

Published
2021
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41. Safety of Antithymocyte Globulin Use in Kidney Graft Recipients During the COVID-19 Pandemic

Author

Andrzej Wiecek and Aureliusz Kolonko

Subjects
Graft Rejection, medicine.medical_specialty, Basiliximab, Lymphocyte, Kidney, Gastroenterology, Internal medicine, medicine, Humans, Dosing, Adverse effect, Pandemics, Kidney transplantation, Antilymphocyte Serum, Retrospective Studies, Original Paper, Transplantation, Thymoglobulin, business.industry, Graft Survival, COVID-19, Retrospective cohort study, General Medicine, medicine.disease, Kidney Transplantation, Treatment Outcome, medicine.anatomical_structure, business, Immunosuppressive Agents, medicine.drug
Abstract

BACKGROUND There are many safety concerns regarding the use of antithymocyte globulin (ATG) in kidney transplant recipients (KTRs) during the ongoing COVID-19 pandemic. Hereby, we present our recent experience with ATG administration both as induction therapy and as an anti-rejection treatment. MATERIAL AND METHODS We retrospectively analyzed all patients transplanted during the first 12 months of the COVID-19 pandemic who were treated with thymoglobulin. The ATG dosing, lymphocyte number and percentage in blood smear, adverse effects (thrombocytopenia and infectious complications), and kidney graft function up to 12 months and patients' outcomes were analyzed and compared to KTRs who received basiliximab induction. RESULTS During pandemic, a total of 31 patients were treated with ATG and 59 received basiliximab. The median cumulative ATG doses were 275 (175-325) mg in the induction subgroup and 263 (200-275) mg in the anti-rejection treatment subgroup. Mild thrombocytopenia was noted in 7 (22.6%) and 13 (29.5%) patients, respectively. There were more infectious complications among patients treated with ATG as compared with the basiliximab subgroup (32.3 vs 10.2%, P

Published
2021
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42. Causes of Anemia in Polish Older Population—Results from the PolSenior Study

Author

Alicja Klich-Rączka, Krzysztof Lewandowski, Arkadiusz Styszynski, Jerzy Chudek, Andrzej Wiecek, Monika Puzianowska-Kuźnicka, Katarzyna Wieczorowska-Tobis, and Małgorzata Mossakowska

Subjects
Male, Pediatrics, medicine.medical_specialty, Anemia, QH301-705.5, Population, iron deficiency, folate deficiency, vitamin B12 deficiency, anemia of inflammation, chronic kidney disease, aging, Folic Acid Deficiency, Article, hemic and lymphatic diseases, medicine, Humans, Vitamin B12, Biology (General), education, Inflammation, education.field_of_study, Anemia, Iron-Deficiency, medicine.diagnostic_test, biology, business.industry, Vitamin B 12 Deficiency, General Medicine, Iron deficiency, medicine.disease, Ferritin, Malnutrition, Serum iron, biology.protein, Female, Poland, business, Kidney disease
Abstract

Vitamin B12, folate, iron deficiency (IDA), chronic kidney disease (CKD), and anemia of inflammation (AI) are among the main causes of anemia in the elderly. WHO criteria of nutritional deficiencies neglect aging-related changes in absorption, metabolism, and utilization of nutrients. Age-specific criteria for the diagnosis of functional nutritional deficiency related to anemia are necessary. We examined the nationally representative sample of Polish seniors. Complete blood count, serum iron, ferritin, vitamin B12, folate, and renal parameters were assessed in 3452 (1632 women, 1820 men) participants aged above 64. Cut-off points for nutritional deficiencies were determined based on the WHO criteria (method-A), lower 2.5 percentile of the studied population (method-B), and receiver operating characteristic (ROC) analysis (method-C). Method-A leads to an overestimation of the prevalence of vitamin B12 and folate deficiency, while method-B to their underestimation with over 50% of unexplained anemia. Based on method-C, anemia was classified as nutritional in 55.9%. In 22.3% of cases, reasons for anemia remained unexplained, the other 21.8% were related to CKD or AI. Mild cases were less common in IDA, and more common in non-deficiency anemia. Serum folate had an insignificant impact on anemia. It is necessary to adopt the age-specific criteria for nutrient deficiency in an old population.

Published
2021

43. Beneficial Effect of Successful Simultaneous Pancreas-Kidney Transplantation on Plasma Profile of Metalloproteinases in Type 1 Diabetes Mellitus Patients

Author

Aleksander Owczarek, Dorota Kamińska, Mariusz Kusztal, Aureliusz Kolonko, Jerzy Chudek, A. Kowalik, Piotr Kuczera, Piotr Choręza, Agata Kujawa-Szewieczek, Tomasz Francuz, Robert Król, Joanna Kluz, Andrzej Wiecek, Jacek Ziaja, Lech Cierpka, Magdalena Krajewska, and D. Bożek-Pająk

Subjects
medicine.medical_specialty, simultaneous pancreas kidney transplantation, type 1 diabetes, medicine.medical_treatment, Urology, Pancreas transplantation, Article, medicine, cardiovascular diseases, intima-media thickness, Pulse wave velocity, Kidney transplantation, Type 1 diabetes, business.industry, matrix metalloproteinases, General Medicine, medicine.disease, Transplantation, arterial stiffness, Intima-media thickness, Arterial stiffness, cardiovascular system, Medicine, atherosclerosis, business, Calcification
Abstract

It is not fully elucidated whether the restoring of normal glucose metabolism after successful simultaneous pancreas-kidney transplantation (SPK) improves vascular wall morphology and function in type 1 diabetic (T1D) patients. Therefore, we compared arterial stiffness, assessed by pulse wave velocity (PWV), carotid intima-media thickness (IMT), and biomarkers of arterial wall calcification in T1D patients after SPK or kidney transplantation alone (KTA). In 39 SPK and 39 KTA adult patients of similar age, PWV, IMT, circulating matrix metalloproteinases (MMPs) and calcification biomarkers were assessed at median 83 months post transplantation. Additionally, carotid plaques were visualized and semi-qualitatively classified. Although PWV and IMT values were similar, the occurrence of atherosclerotic plaques (51.3 vs. 70.3%, p &lt, 0.01) and calcified lesions (35.9 vs. 64.9%, p &lt, 0.05) was lower in SPK patients. There were significantly lower concentrations of MMP-1, MMP-2, MMP-3, and osteocalcin in SPK subjects. Among the analyzed biomarkers, only logMMP-1, logMMP-2, and logMMP-3 concentrations were associated with log HbA1c. Multivariate stepwise backward regression analysis revealed that MMP-1 and MMP-3 variability were explained only by log HbA1c. Normal glucose metabolism achieved by SPK is followed by the favorable profile of circulating matrix metalloproteinases, which may reflect the vasoprotective effect of pancreas transplantation.

Published
2021

44. Inflammation is an amplifier of lung congestion by high lv filling pressure in hemodialysis patients: a longitudinal study

Author

Radovan Hojs, Claudia Torino, Eugenio Picano, Krzysztof Letachowicz, Sarah Seiler-Mußler, Fabio Lizzi, Giovanni Tripepi, Itzchak Slotki, Pantelis Sarafidis, Robert Ekart, Ziad A. Massy, Charalampos Loutradis, Alexandre Seidowsky, Rocco Tripepi, Dimitrie Siriopol, Marian Klinger, Patrick Rossignol, Enrico Fiaccadori, Danilo Fliser, Luna Gargani, Gérard M. London, Kostas C. Siamopoulos, Yuri Battaglia, Andrzej Wiecek, Nejra Prohic, Linda Shavit, Carmine Zoccali, Francesca Mallamaci, Thierry Hannedouche, Olga Balafa, Aristeidis Stavroulopoulos, Rosa Sicari, Thomas Bachelet, Marie-Jeanne Coudert-Krier, Adrian Covic, Giuseppe Regolisti, and Alberto Martínez-Castelao

Subjects
Nephrology, medicine.medical_specialty, medicine.medical_treatment, 030232 urology & nephrology, Inflammation, Vascular permeability, Infammation, 030204 cardiovascular system & hematology, Systemic inflammation, 03 medical and health sciences, 0302 clinical medicine, Renal Dialysis, Pulmonary edema, Internal medicine, medicine, Humans, Longitudinal Studies, Lung congestion, ESRD, Lung, Body surface area, business.industry, Cardiovascular risk, medicine.disease, medicine.anatomical_structure, Hemodialysis, Cardiology, medicine.symptom, business
Abstract

Introduction Since infammation alters vascular permeability, including vascular permeability in the lung, we hypothesized that it can be an amplifer of lung congestion in a category of patients at high risk for pulmonary oedema like end stage kidney disease (ESKD) patients. Objective and methods We investigated the efect modifcation by systemic infammation (serum CRP) on the relationship between a surrogate of the flling pressure of the LV [left atrial volume indexed to the body surface area (LAVI)] and lung water in a series of 220 ESKD patients. Lung water was quantifed by the number of ultrasound B lines (US-B) on lung US. Six-hundred and three recordings were performed during a 2-year follow up. Longitudinal data analysis was made by the Mixed Linear Model. Results At baseline, 88 had absent, 101 had mild to moderate lung congestion and 31 severe congestion. The number of US B lines associated with LAVI (r=0.23, P

Published
2020
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45. Integrative analysis of prognostic biomarkers derived from multiomics panels helps discrimination of chronic kidney disease trajectories in people with type 2 diabetes

Author

Gert Mayer, Andreas Heinzel, Maria F. Gomez, Paul Perco, Rainer Oberbauer, László Rosivall, Kevin L. Duffin, Mathias J. Gerl, Matthias Kretzler, Roman Reindl-Schwaighofer, Karin Hu, Mark I. McCarthy, Michael Kammer, Wenjun Ju, Patrick B. Mark, Andrzej Wiecek, Kai Simons, Hiddo J.L. Heerspink, Christian Klose, Jill A. Willency, Susanne Eder, Georg Heinze, Groningen Kidney Center (GKC), and Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)

Subjects
Male, 0301 basic medicine, Oncology, medicine.medical_specialty, FUNCTION DECLINE, 030232 urology & nephrology, Renal function, PROGRESSION, Type 2 diabetes, Disease, HIGH-THROUGHPUT, Logistic regression, LIPIDOMICS, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Natriuretic Peptide, Brain, Humans, Medicine, Hepatitis A Virus Cellular Receptor 1, INCIDENT CKD, Renal Insufficiency, Chronic, Prospective cohort study, Aged, OUTCOMES, Receiver operating characteristic, business.industry, Type 2 Diabetes Mellitus, Bayes Theorem, ASSOCIATION, Middle Aged, medicine.disease, Peptide Fragments, MODEL, 030104 developmental biology, Diabetes Mellitus, Type 2, Nephrology, Case-Control Studies, Female, prognosis, type 2 diabetes, business, chronic kidney disease, multiomics, Biomarkers, integrative analysis, Glomerular Filtration Rate, Kidney disease
Abstract

Clinical risk factors explain only a fraction of the variability of estimated glomerular filtration rate (eGFR) decline in people with type 2 diabetes. Cross-omics technologies by virtue of a wide spectrum screening of plasma samples have the potential to identify biomarkers for the refinement of prognosis in addition to clinical variables. Here we utilized proteomics, metabolomics and lipidomics panel assay measurements in baseline plasma samples from the multinational PROVALID study (PROspective cohort study in patients with type 2 diabetes mellitus for VALIDation of biomarkers) of patients with incident or early chronic kidney disease (median follow-up 35 months, median baseline eGFR 84 mL/min/1.73 m(2), urine albumin-to-creatinine ratio 8.1 mg/g). In an accelerated case-control study, 258 individuals with a stable eGFR course (median eGFR change 0.1 mL/min/year) were compared to 223 individuals with a rapid eGFR decline (median eGFR decline -6.75 mL/min/year) using Bayesian multivariable logistic regression models to assess the discrimination of eGFR trajectories. The analysis included 402 candidate predictors and showed two protein markers (KIM-1, NTproBNP) to be relevant predictors of the eGFR trajectory with baseline eGFR being an important clinical covariate. The inclusion of metabolomic and lipidomic platforms did not improve discrimination substantially. Predictions using all available variables were statistically indistinguishable from predictions using only KIM-1 and baseline eGFR (area under the receiver operating characteristic curve 0.63). Thus, the discrimination of eGFR trajectories in patients with incident or early diabetic kidney disease and maintained baseline eGFR was modest and the protein marker KIM-1 was the most important predictor.

Published
2019
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46. Influence of Sociodemographic, Behavioral and Other Health-Related Factors on Healthy Ageing Based on Three Operative Definitions

Author

Anna Skalska, Jean-Pierre Michel, Agnieszka Pac, Piotr Błędowski, Andrzej Wiecek, Beata Tobiasz-Adamczyk, Aleksandra Szybalska, Jerzy Chudek, Tomasz Grodzicki, and Tomasz Zdrojewski

Subjects
Male, Gerontology, Aging, lifestyle, 030309 nutrition & dietetics, Concordance, Medicine (miscellaneous), Disease, Article, Healthy Aging, older people, functioning, 03 medical and health sciences, 0302 clinical medicine, Physical functioning, Surveys and Questionnaires, Healthy ageing, Activities of Daily Living, Prevalence, Humans, Medicine, Cognitive Dysfunction, 030212 general & internal medicine, Cognitive impairment, Aged, Aged, 80 and over, 0303 health sciences, Nutrition and Dietetics, Marital Status, business.industry, Health related, PolSenior, Middle Aged, Cross-Sectional Studies, Socioeconomic Factors, Ageing, Chronic Disease, Income, Marital status, Female, Poland, Self Report, Geriatrics and Gerontology, business
Abstract

Objectives Healthy ageing (HA) is a key concept and highly desirable phenomenon in every ageing and already old societies. The aim of our study was to evaluate the influence of socio-economic conditions as well as life-style and other health-related factors on the WHO definition of HA. Design, Setting, Participants The study used cross-sectional data of the PolSenior Project — nationwide research evaluating different aspects of ageing in Poland — which included 4’653 respondents aged 65 years and over. Measurements Data were collected by trained interviewers in respondents’ homes. Three definitions of HA including or not the participants’ chronic conditions were analyzed. Results The prevalence of HA appeared as high as 17.6% if none or 1 chronic disease was present and 42.8% if no information about chronic diseases was taken into account. The association between known health predictors (age, marital status, education, income) and HA was observed. Moreover, HA appeared in relation with indicators of physical functioning and lifestyle. There was a strong concordance between HA and the fair self-rated health (OR = 1.87; 1.99, and 2.74 for the 1st, 2nd and 3rd definitions, respectively) and opposite relation with self-reported need for help (OR = 0.15; 0.15; and 0.13, respectively). Conclusions The HA definition based on no functional activity limitations, no cognitive impairment, no depressive symptoms, no more than one disease and being socially active seems to be a useful approach of HA.. Electronic Supplementary Material Supplementary material is available for this article at 10.1007/s12603-019-1243-5 and is accessible for authorized users.

Published
2019
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47. Neuropeptide Y as a risk factor for cardiorenal disease and cognitive dysfunction in chronic kidney disease: translational opportunities and challenges

Author

Carmine, Zoccali, Alberto, Ortiz, Inga Arune, Blumbyte, Sarina, Rudolf, Annette G, Beck-Sickinger, Jolanta, Malyszko, Goce, Spasovski, Sol, Carriazo, Davide, Viggiano, Justina, Kurganaite, Vaiva, Sarkeviciene, Daiva, Rastenyte, Andreja, Figurek, Merita, Rroji, Christopher, Mayer, Mustapha, Arici, Gianvito, Martino, Gioacchino, Tedeschi, Annette, Bruchfeld, Belinda, Spoto, Ivan, Rychlik, Andrzej, Wiecek, Mark, Okusa, Giuseppe, Remuzzi, Francesca, Mallamaci, George, Reusz, Zoccali, C., Ortiz, A., Blumbyte, I. A., Rudolf, S., Beck-Sickinger, A. G., Malyszko, J., Spasovski, G., Carriazo, S., Viggiano, D., Kurganaite, J., Sarkeviciene, V., Rastenyte, D., Figurek, A., Rroji, M., Mayer, C., Arici, M., Martino, G., Tedeschi, G., Bruchfeld, A., Spoto, B., Rychlik, I., Wiecek, A., Okusa, M., Remuzzi, G., and Mallamaci, F.

Subjects
dialysi, Hypertension, Renal, hypertension, medicine.medical_treatment, Population, Review, Bioinformatics, Renal Dialysis, Risk Factors, Renin–angiotensin system, mental disorders, medicine, CKD, Dementia, Humans, Cognitive Dysfunction, Neuropeptide Y, Renal Insufficiency, Chronic, education, Receptor, AcademicSubjects/MED00340, renin–angiotensin system, Dialysis, Rheumatology and Autoimmunity, Reumatologi och inflammation, Transplantation, education.field_of_study, Kidney, business.industry, cardiovascular, Neuropeptide Y receptor, medicine.disease, humanities, Receptors, Neuropeptide Y, medicine.anatomical_structure, Nephrology, Peptide YY, dialysis, business, renin-angiotensin system
Abstract

Neuropeptide Y (NPY) is a 36-amino-acid peptide member of a family also including peptide YY and pancreatic polypeptide, which are all ligands to Gi/Go coupled receptors. NPY regulates several fundamental biologic functions including appetite/satiety, sex and reproduction, learning and memory, cardiovascular and renal function and immune functions. The mesenteric circulation is a major source of NPY in the blood in man and this peptide is considered a key regulator of gut-brain cross talk. A progressive increase in circulating NPY accompanies the progression of chronic kidney disease (CKD) toward kidney failure and NPY robustly predicts cardiovascular events in this population. Furthermore, NPY is suspected as a possible player in accelerated cognitive function decline and dementia in patients with CKD and in dialysis patients. In theory, interfering with the NPY system has relevant potential for the treatment of diverse diseases from cardiovascular and renal diseases to diseases of the central nervous system. Pharmaceutical formulations for effective drug delivery and cost, as well as the complexity of diseases potentially addressable by NPY/NPY antagonists, have been a problem until now. This in part explains the slow progress of knowledge about the NPY system in the clinical arena. There is now renewed research interest in the NPY system in psychopharmacology and in pharmacology in general and new studies and a new breed of clinical trials may eventually bring the expected benefits in human health with drugs interfering with this system. Funding Agencies|COST Action CA19127-Cognitive Decline in Nephro-Neurology: European Cooperative Target (CONNECT)

Published
2021

48. A urinary peptidomic profile predicts outcome in SARS-CoV-2-infected patients

Author

Jan A. Staessen, Emmanuel Dudoignon, Barbara Neuhaus, Lutgarde Thijs, Joachim Beige, K Rothfuss, Beata Czerwieńska, Åsa Nilsson, Alexandre Mebazaa, Jochen Metzger, Christoph Lübbert, Justyna Siwy, Goce Spasovski, Andrzej Wiecek, Heiko von der Leyen, Mimoza Milenkova, Julia Raad, Aleksandra Canevska-Talevska, Björn Peters, Harald Mischak, Sven Kalbitz, Matthias Schwab, and Ralph Wendt

Subjects
medicine.medical_specialty, Urinary system, Logistic regression, 01 natural sciences, 03 medical and health sciences, 0302 clinical medicine, Urinary proteomics, Internal medicine, Medicine, 030212 general & internal medicine, 0101 mathematics, Disease severity, Framingham Risk Score, Receiver operating characteristic, business.industry, SARS-CoV-2, 010102 general mathematics, Area under the curve, COVID-19, General Medicine, Odds ratio, Biomarker (medicine), Risk score, business, Body mass index, Research Paper
Abstract

BACKGROUND: COVID-19 prediction models based on clinical characteristics, routine biochemistry and imaging, have been developed, but little is known on proteomic markers reflecting the molecular pathophysiology of disease progression. METHODS: The multicentre (six European study sites) Prospective Validation of a Proteomic Urine Test for Early and Accurate Prognosis of Critical Course Complications in Patients with SARS-CoV-2 Infection Study (Crit-COV-U) is recruiting consecutive patients (≥ 18 years) with PCR-confirmed SARS-CoV-2 infection. A urinary proteomic biomarker (COV50) developed by capillary-electrophoresis-mass spectrometry (CE-MS) technology, comprising 50 sequenced peptides and identifying the parental proteins, was evaluated in 228 patients (derivation cohort) with replication in 99 patients (validation cohort). Death and progression along the World Health Organization (WHO) Clinical Progression Scale were assessed up to 21 days after the initial PCR test. Statistical methods included logistic regression, receiver operating curve (ROC) analysis and comparison of the area under the curve (AUC). FINDINGS: In the derivation cohort, 23 patients died, and 48 developed worse WHO scores. The odds ratios (OR) for death per 1 standard deviation (SD) increment in COV50 were 3·52 (95% CI, 2·02-6·13, p

Published
2021

49. MO089HISTOMORPHOMETRIC ANALYSIS OF GLOMERULI AND CAPILLARIES DENSITY IN THE INTERSTITIUM IN PREIMPLANTATION NEEDLE BIOPSIES OF PAIRED KIDNEYS HARVESTED FROM ADULT CADAVERIC DONORS

Author

Henryk Karkoszka, Robert Król, Andrzej Wiecek, Marcin Adamczak, and Katarzyna Kwiecień

Subjects
Transplantation, Pathology, medicine.medical_specialty, urogenital system, Nephrology, business.industry, Intracranial Hemorrhages, Medicine, business, Cadaveric spasm, Craniocerebral trauma
Abstract

Background and Aims Preimplantation needle biopsy of kidney allows more precise interpretation of subsequent kidney biopsies performed after transplantation and potentially also may predict kidney graft survival. It is unknown, whether it is justified to perform the biopsy of one kidney only and then to transmit obtained results also to the second kidney or biopsies of both kidneys are mandatory. The aim of the study was to assess differences regarding glomerular volume, glomerular density and capillary density in the interstitium of both kidneys harvested from the same deceased donor. Method The study involved 40 pairs of kidneys (all together 80 kidneys) in which preimplantation kidney biopsies were performed. Kidneys were harvested from 40 deceased donors (17 females and 23 males; mean age 42.3 [37.6-47.0] years old) died because of intracranial haemorrhage (17 donors) or cerebral trauma due to accident (23 donors). Histomorphometric analysis was performed using “Olympus BX51” microscope (Olympus, Tokyo, Japan) coupled with “Olympus BX50” camera and the “cellSens Standard” software (Olympus, Tokyo, Japan). Weibel-Gomez formula was adapted to calculate glomerular volume. Results No significant differences were found between mean kidneys length [115.8 (112.4-119.1) vs.115.5 (112.5-118.5) mm], glomerular volume [2.59 (2.24-2.93) vs 2.49 (2.15-2.84) μm3 x106 ], glomerular density [3.43 (3.07-3.80) vs 3.24 (2.87-3.61) n/mm2] and interstitial capillaries density [233.58 (211.26) vs 217.80 (199.45-236.47) n/mm2] of both kidneys harvested from the same deceased donor. Conclusions 1. Both kidneys harvested from the same deceased donor did not differ significantly in kidney length, glomerular volume, glomerular density and capillary density. 2. Our results justify to preimplantation biopsy of only one kidney and the results from the histomorphometric analysis may be used in the future also for assessment of the second kidney.

Published
2021
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50. MO559ASCEND-ND: STUDY DESIGN AND BASELINE CHARACTERISTICS

Author

Christoph Wanner, Kirsten L. Johansen, Borut Cizman, Andrzej Wiecek, Tara L DiMino, David C. Wheeler, Richard Davies, Ajay K. Singh, Allison Blackorby, Lin Taft, Iain C. Macdougall, Kevin Carroll, Scott D. Solomon, John J.V. McMurray, Vlado Perkovic, Lata Kler, Gregorio T. Obrador, Sushrut S. Waikar, Amy Meadowcroft, Alexander R. Cobitz, Renato D. Lopes, and Vivekanand Jha

Subjects
Transplantation, medicine.medical_specialty, Randomization, Nephrology, business.industry, Internal medicine, Baseline characteristics, medicine, Procollagen-proline dioxygenase, business
Abstract

Background and Aims The Anemia Study in Chronic kidney disease (CKD): Erythropoiesis via a Novel prolyl hydroxylase inhibitor (PHI) Daprodustat-Non-Dialysis (ASCEND-ND; NCT02876835) trial is evaluating the efficacy and safety of daprodustat when compared with darbepoetin alfa in CKD patients with anaemia not requiring dialysis. We report the trial design as well as key baseline characteristics of participants. Method Eligible patients from 39 countries were adults with CKD stages 3–5 who were able to provide informed consent and demonstrated adherence to daprodustat placebo tablets and study procedures during the run-in period. Patients were eligible if (1) they were not using erythropoiesis stimulating agents (ESAs) and had a screening haemoglobin (Hb) 8 to 10 g/dL or if (2) they were receiving ESAs with screening Hb of 8 to 12 g/dL. Patients were required to be iron replete [transferrin saturation (TSAT) >20% and serum ferritin >100 ng/mL] at screening. Participants were randomised to daprodustat or darbepoetin alfa (1:1) in an open-label (sponsor-blind) trial design with blinded endpoint assessment. An IDMC conducts regular reviews of unblinded safety and efficacy data and makes recommendations for additions or adjustments. An external, independent and blinded Clinical Events Classification (CEC) group, led by the Duke Clinical Research Institute, in collaboration with George Clinical, adjudicate predefined events. During the study, both groups had randomised treatment adjusted using a protocol-defined algorithm targeting a Hb range of 10 to 11 g/dL. Participants also followed protocol-defined iron management criteria to ensure they remained iron replete. Additionally, an anaemia rescue algorithm was in place to minimise the risk of extended periods of inadequate Hb response and to ensure consistent application of rescue therapy across the study. The co-primary endpoints are mean change in Hb between baseline and Evaluation Period (EP; Weeks 28 to 52, inclusive) and time to first adjudicated major adverse cardiovascular event (MACE; composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke). The study has more than 99% power for the Hb non-inferiority (NI) test with an NI margin of -0.75 g/dL for the treatment difference of mean change in Hb between baseline and EP, and approximately 90% power to exclude the NI margin of 1.25 for time to first adjudicated MACE, for daprodustat compared with darbepoetin alfa. Conditional on both co-primary endpoints achieving NI at the one-sided 2.5% level, statistical testing will progress to evaluate MACE and the principal secondary endpoint of CKD progression for superiority. These tests will be multiplicity adjusted. Results A total of 3872 patients were randomised (median age 67 years, 56% female; 55% white, 28% Asian, and 10% black). The median baseline Hb was 9.8 g/dL, serum ferritin was 274 ng/mL, TSAT 30%, and eGFR 18 mL/min/1.73 m2. Among randomised patients, 54% were ESA non-users, 57% reported a history of diabetes mellitus and 36% a history of cardiovascular disease. Median blood pressure was 135/74 mmHg. Sixty percent of participants were taking angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, while 57% were taking lipid modifying agents at baseline. The trial is expected to complete during 2021. Conclusion ASCEND-ND will define the efficacy and safety of daprodustat compared with darbepoetin alfa in the treatment of patients with anaemia associated with CKD not requiring dialysis.

Published
2021
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