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201. Dapagliflozin in Patients with Chronic Kidney Disease

Author

Heerspink, Hiddo J.L., Stefánsson, Bergur V., Correa-Rotter, Ricardo, Chertow, Glenn M., Greene, Tom, Hou, Fan-Fan, Mann, Johannes F.E., McMurray, John J.V., Lindberg, Magnus, Rossing, Peter, Sjöström, C. David, Toto, Roberto D., Langkilde, Anna-Maria, Wheeler, David C., Cruzado, Josep Ma., Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), and Groningen Kidney Center (GKC)

Subjects
Male, Kidney Failure, Chronic/mortality, Benzhydryl Compounds/adverse effects, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Glomerular Filtration Rate/drug effects, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Glucosides, law, Diabetic Nephropathies, 030212 general & internal medicine, Dapagliflozin, Kidney, Diabetis, Kidney diseases, Diabetes, EMPAGLIFLOZIN, General Medicine, Middle Aged, medicine.anatomical_structure, Cardiovascular Diseases, Regression Analysis, Female, Glomerular Filtration Rate, medicine.medical_specialty, Finerenone, Renal Insufficiency, Chronic/complications, CARDIOVASCULAR OUTCOMES, Glucosides/adverse effects, 03 medical and health sciences, Internal medicine, Diabetes mellitus, Empagliflozin, medicine, Humans, Benzhydryl compounds, Cardiovascular Diseases/etiology, Benzhydryl Compounds, Renal Insufficiency, Chronic, Sodium-Glucose Transporter 2 Inhibitors, Aged, urogenital system, business.industry, Diabetes Mellitus, Type 2/complications, Glucòsids, Sodium-Glucose Transporter 2 Inhibitors/adverse effects, medicine.disease, Diabetes Mellitus, Type 2, chemistry, Diabetic Nephropathies/drug therapy, Kidney Failure, Chronic, Malalties del ronyó, business, Kidney disease
Abstract

Background: \ud Patients with chronic kidney disease have a high risk of adverse kidney and cardiovascular outcomes. The effect of dapagliflozin in patients with chronic kidney disease, with or without type 2 diabetes, is not known.\ud Methods: \ud We randomly assigned 4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m2 of body-surface area and a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin (10 mg once daily) or placebo. The primary outcome was a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.\ud Results:\ud The independent data monitoring committee recommended stopping the trial because of efficacy. Over a median of 2.4 years, a primary outcome event occurred in 197 of 2152 participants (9.2%) in the dapagliflozin group and 312 of 2152 participants (14.5%) in the placebo group (hazard ratio, 0.61; 95% confidence interval [CI], 0.51 to 0.72; P

Published
2020

202. Executive summary of the 2020 KDIGO Diabetes Management in CKD Guideline:evidence-based advances in monitoring and treatment

Author

de Boer, Ian H., Caramori, M. Luiza, Chan, Juliana C.N., Heerspink, Hiddo J.L., Hurst, Clint, Khunti, Kamlesh, Liew, Adrian, Michos, Erin D., Navaneethan, Sankar D., Olowu, Wasiu A., Sadusky, Tami, Tandon, Nikhil, Tuttle, Katherine R., Wanner, Christoph, Wilkens, Katy G., Zoungas, Sophia, Lytvyn, Lyubov, Craig, Jonathan C., Tunnicliffe, David J., Howell, Martin, Tonelli, Marcello, Cheung, Michael, Earley, Amy, Rossing, Peter, de Boer, Ian H., Caramori, M. Luiza, Chan, Juliana C.N., Heerspink, Hiddo J.L., Hurst, Clint, Khunti, Kamlesh, Liew, Adrian, Michos, Erin D., Navaneethan, Sankar D., Olowu, Wasiu A., Sadusky, Tami, Tandon, Nikhil, Tuttle, Katherine R., Wanner, Christoph, Wilkens, Katy G., Zoungas, Sophia, Lytvyn, Lyubov, Craig, Jonathan C., Tunnicliffe, David J., Howell, Martin, Tonelli, Marcello, Cheung, Michael, Earley, Amy, and Rossing, Peter

Abstract

The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease represents the first KDIGO guideline on this subject. The guideline comes at a time when advances in diabetes technology and therapeutics offer new options to manage the large population of patients with diabetes and chronic kidney disease (CKD) at high risk of poor health outcomes. An enlarging base of high-quality evidence from randomized clinical trials is available to evaluate important new treatments offering organ protection, such as sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists. The goal of the new guideline is to provide evidence-based recommendations to optimize the clinical care of people with diabetes and CKD by integrating new options with existing management strategies. In addition, the guideline contains practice points to facilitate implementation when insufficient data are available to make well-justified recommendations or when additional guidance may be useful for clinical application. The guideline covers comprehensive care of patients with diabetes and CKD, glycemic monitoring and targets, lifestyle interventions, antihyperglycemic therapies, and self-management and health systems approaches to management of patients with diabetes and CKD.

Published
2020

203. Early detection of diabetic kidney disease by urinary proteomics and subsequent intervention with spironolactone to delay progression (PRIORITY):a prospective observational study and embedded randomised placebo-controlled trial

Author

Tofte, Nete, Lindhardt, Morten, Adamova, Katarina, Bakker, Stephan J.L., Beige, Joachim, Beulens, Joline W.J., Birkenfeld, Andreas L., Currie, Gemma, Delles, Christian, Dimos, Ingo, Francová, Lidmila, Frimodt-Møller, Marie, Girman, Peter, Göke, Rüdiger, Havrdova, Tereza, Heerspink, Hiddo J.L., Kooy, Adriaan, Laverman, Gozewijn D., Mischak, Harald, Navis, Gerjan, Nijpels, Giel, Noutsou, Marina, Ortiz, Alberto, Parvanova, Aneliya, Persson, Frederik, Petrie, John R., Ruggenenti, Piero L., Rutters, Femke, Rychlík, Ivan, Siwy, Justyna, Spasovski, Goce, Speeckaert, Marijn, Trillini, Matias, Zürbig, Petra, von der Leyen, Heiko, Rossing, Peter, Zimmermann, Silke, Rädisch, Brit, Hävemeier, Anika, Busmann, Annette, Wittkop, Ulrike, Curovic, Viktor R., Tougaard, Ninna H., Hansen, Tine W., Hansen, Christian S., Zobel, Emilie H., Laursen, Jens C., Juhl, Tina R., Lundgaard, Anne G., Lajer, Maria, Tofte, Nete, Lindhardt, Morten, Adamova, Katarina, Bakker, Stephan J.L., Beige, Joachim, Beulens, Joline W.J., Birkenfeld, Andreas L., Currie, Gemma, Delles, Christian, Dimos, Ingo, Francová, Lidmila, Frimodt-Møller, Marie, Girman, Peter, Göke, Rüdiger, Havrdova, Tereza, Heerspink, Hiddo J.L., Kooy, Adriaan, Laverman, Gozewijn D., Mischak, Harald, Navis, Gerjan, Nijpels, Giel, Noutsou, Marina, Ortiz, Alberto, Parvanova, Aneliya, Persson, Frederik, Petrie, John R., Ruggenenti, Piero L., Rutters, Femke, Rychlík, Ivan, Siwy, Justyna, Spasovski, Goce, Speeckaert, Marijn, Trillini, Matias, Zürbig, Petra, von der Leyen, Heiko, Rossing, Peter, Zimmermann, Silke, Rädisch, Brit, Hävemeier, Anika, Busmann, Annette, Wittkop, Ulrike, Curovic, Viktor R., Tougaard, Ninna H., Hansen, Tine W., Hansen, Christian S., Zobel, Emilie H., Laursen, Jens C., Juhl, Tina R., Lundgaard, Anne G., and Lajer, Maria

Abstract

Background: Microalbuminuria is an early sign of kidney disease in people with diabetes and indicates increased risk of cardiovascular disease. We tested whether a urinary proteomic risk classifier (CKD273) score was associated with development of microalbuminuria and whether progression to microalbuminuria could be prevented with the mineralocorticoid receptor antagonist spironolactone. Methods: In this multicentre, prospective, observational study with embedded randomised controlled trial (PRIORITY), we recruited people with type 2 diabetes, normal urinary albumin excretion, and preserved renal function from 15 specialist centres in ten European countries. All participants (observational cohort) were tested with the CKD273 classifier and classified as high risk (CKD273 classifier score >0·154) or low risk (≤0·154). Participants who were classified as high risk were entered into a randomised controlled trial and randomly assigned (1:1), by use of an interactive web-response system, to receive spironolactone 25 mg once daily or matched placebo (trial cohort). The primary endpoint was development of confirmed microalbuminuria in all individuals with available data (observational cohort). Secondary endpoints included reduction in incidence of microalbuminuria with spironolactone (trial cohort, intention-to-treat population) and association between CKD273 risk score and measures of impaired renal function based on estimated glomerular filtration rate (eGFR; observational cohort). Adverse events (particularly gynaecomastia and hyperkalaemia) and serious adverse events were recorded for the intention-to-treat population (trial cohort). This study is registered with the EU Clinical Trials Register (EudraCT 20120-004523-4) and ClinicalTrials.gov (NCT02040441) and is completed. Findings: Between March 25, 2014, and Sept 30, 2018, we enrolled and followed-up 1775 participants (observational cohort), 1559 (88%) of 1775 participants had a low-risk urinary proteomic patte

Published
2020

204. Cardiovascular and renal outcomes by baseline albuminuria status and renal function:Results from the LEADER randomized trial

Author

Mosenzon, Ofri, Bain, Stephen C., Heerspink, Hiddo J.L., Idorn, Thomas, Mann, Johannes F.E., Persson, Frederik, Pratley, Richard E., Rasmussen, Søren, Rossing, Peter, von Scholten, Bernt Johan, Raz, Itamar, Mosenzon, Ofri, Bain, Stephen C., Heerspink, Hiddo J.L., Idorn, Thomas, Mann, Johannes F.E., Persson, Frederik, Pratley, Richard E., Rasmussen, Søren, Rossing, Peter, von Scholten, Bernt Johan, and Raz, Itamar

Abstract

Aim: To assess cardiorenal outcomes by baseline urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) in the contemporary LEADER cohort. Materials and methods: LEADER was a multinational, double-blind trial. Patients with type 2 diabetes and high cardiovascular (CV) risk were randomized 1:1 to the glucagon-like peptide-1 analogue liraglutide (≤1.8 mg daily; n = 4668) or placebo (n = 4672) plus standard care and followed for 3.5 to 5 years. Primary composite outcomes were time to first non-fatal myocardial infarction, non-fatal stroke or CV death. Post hoc Cox regression analyses of outcomes by baseline UACR and eGFR subgroups were conducted with adjustment for baseline variables. Results: In the LEADER population, 1598 (17.5%), 2917 (31.9%), 1200 (13.1%), 1611 (17.6%), 845 (9.2%) and 966 (10.6%) had UACR = 0, >0 to <15, 15 to <30, 30 to <100, 100 to <300 and ≥300 mg/g, respectively. Increasing UACR and decreasing eGFR were linked with higher risks of the primary outcome, heart failure hospitalization, a composite renal outcome and death (P-values for the Cochran-Armitage test for trends were all <.0001). Across UACR and eGFR subgroups, risks of cardiorenal events and death were generally lower or similar with liraglutide versus placebo. Conclusions: In a contemporary type 2 diabetes population, increasing baseline UACR and declining eGFR were linked with higher risks of cardiorenal events and death.

Published
2020

205. The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial:baseline characteristics

Author

Wheeler, David C., Stefansson, Bergur V., Batiushin, Mikhail, Bilchenko, Oleksandr, Cherney, David Z.I., Chertow, Glenn M., Douthat, Walter, Dwyer, Jamie P., Escudero, Elizabeth, Pecoits-Filho, Roberto, Furuland, Hans, Górriz, José Luis, Greene, Tom, Haller, Hermann, Hou, Fan Fan, Kang, Shin Wook, Isidto, Rey, Khullar, Dinesh, Mark, Patrick B., McMurray, John J.V., Kashihara, Naoki, Nowicki, Michal, Persson, Frederik, Correa-Rotter, Ricardo, Rossing, Peter, Toto, Robert D., Umanath, Kausik, Van Bui, Pham, Wittmann, István, Lindberg, Magnus, Sjöström, C. David, Langkilde, Anna Maria, Heerspink, Hiddo J.L., Wheeler, David C., Stefansson, Bergur V., Batiushin, Mikhail, Bilchenko, Oleksandr, Cherney, David Z.I., Chertow, Glenn M., Douthat, Walter, Dwyer, Jamie P., Escudero, Elizabeth, Pecoits-Filho, Roberto, Furuland, Hans, Górriz, José Luis, Greene, Tom, Haller, Hermann, Hou, Fan Fan, Kang, Shin Wook, Isidto, Rey, Khullar, Dinesh, Mark, Patrick B., McMurray, John J.V., Kashihara, Naoki, Nowicki, Michal, Persson, Frederik, Correa-Rotter, Ricardo, Rossing, Peter, Toto, Robert D., Umanath, Kausik, Van Bui, Pham, Wittmann, István, Lindberg, Magnus, Sjöström, C. David, Langkilde, Anna Maria, and Heerspink, Hiddo J.L.

Abstract

BACKGROUND: The Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD; NCT03036150) trial was designed to assess the effect of the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin on kidney and cardiovascular events in participants with CKD with and without type 2 diabetes (T2D). This analysis reports the baseline characteristics of those recruited, comparing them with those enrolled in other trials. METHODS: In DAPA-CKD, 4304 participants with a urinary albumin:creatinine ratio (UACR) ≥200 mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75 mL/min/1.73 m2 were randomized to dapagliflozin 10 mg once daily or placebo. Mean eGFR was 43.1 mL/min/1.73 m2 and median UACR was 949 mg/g (108 mg/mmol). RESULTS: Overall, 2906 participants (68%) had a diagnosis of T2D and of these, 396 had CKD ascribed to a cause other than diabetes. The most common causes of CKD after diabetes (n = 2510) were ischaemic/hypertensive nephropathy (n = 687) and chronic glomerulonephritis (n = 695), of which immunoglobulin A nephropathy (n = 270) was the most common. A total of 4174 participants (97%) were receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, 1882 (43.7%) diuretics, 229 (5.3%) mineralocorticoid receptor antagonists and 122 (2.8%) glucagon-like peptide 1 receptor agonists. In contrast to the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), the DAPA-CKD trial enrolled participants with CKD due to diabetes and to causes other than diabetes. The mean eGFR of participants in the DAPA-CKD trial was 13.1 mL/min/1.73 m2 lower than in CREDENCE, similar to that in the Finerenone in Reducing Kidney Failure and Disease Progression in DKD (FIDELIO-DKD) trial and the Study Of diabetic Nephropathy with AtRasentan (SONAR). CONCLUSIONS: Participants with a wide range of underlying kidney diseases receiving renin-angiotensin system blocking thera

Published
2020

206. Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial

Author

Persson, Frederik, primary, Bain, Stephen C, primary, Mosenzon, Ofri, primary, Heerspink, Hiddo J.L., primary, Mann, Johannes F. E., primary, Pratley, Richard, primary, Raz, Itamar, primary, Idorn, Thomas, primary, Rasmussen, Søren, primary, Scholten, Bernt Johan von, primary, Rossing, Peter, primary, and Investigators, the LEADER Trial, primary

Published
2021
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207. Efficacy of Dapagliflozin on Renal Function and Outcomes in Patients With Heart Failure With Reduced Ejection Fraction

Author

Jhund, Pardeep S., primary, Solomon, Scott D., additional, Docherty, Kieran F., additional, Heerspink, Hiddo J.L., additional, Anand, Inder S., additional, Böhm, Michael, additional, Chopra, Vijay, additional, de Boer, Rudolf A., additional, Desai, Akshay S., additional, Ge, Junbo, additional, Kitakaze, Masafumi, additional, Merkley, Bela, additional, O'Meara, Eileen, additional, Shou, Morten, additional, Tereshchenko, Sergey, additional, Verma, Subodh, additional, Vinh, Pham Nguyen, additional, Inzucchi, Silvio E., additional, Køber, Lars, additional, Kosiborod, Mikhail N., additional, Martinez, Felipe A., additional, Ponikowski, Piotr, additional, Sabatine, Marc S., additional, Bengtsson, Olof, additional, Langkilde, Anna Maria, additional, Sjöstrand, Mikaela, additional, and McMurray, John J.V., additional

Published
2021
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208. SGLT2 Inhibition for CKD and Cardiovascular Disease in Type 2 Diabetes: Report of a Scientific Workshop Sponsored by the National Kidney Foundation

Author

Tuttle, Katherine R., primary, Brosius, Frank C., additional, Cavender, Matthew A., additional, Fioretto, Paola, additional, Fowler, Kevin J., additional, Heerspink, Hiddo J.L., additional, Manley, Tom, additional, McGuire, Darren K., additional, Molitch, Mark E., additional, Mottl, Amy K., additional, Perreault, Leigh, additional, Rosas, Sylvia E., additional, Rossing, Peter, additional, Sola, Laura, additional, Vallon, Volker, additional, Wanner, Christoph, additional, and Perkovic, Vlado, additional

Published
2021
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210. Natriuretic Effect of Two Weeks of Dapagliflozin Treatment in Patients With Type 2 Diabetes and Preserved Kidney Function During Standardized Sodium Intake: Results of the DAPASALT Trial

Author

Scholtes, Rosalie A., primary, Muskiet, Marcel H.A., additional, van Baar, Michiel J.B., additional, Hesp, Anne C., additional, Greasley, Peter J., additional, Karlsson, Cecilia, additional, Hammarstedt, Ann, additional, Arya, Niki, additional, van Raalte, Daniël H., additional, and Heerspink, Hiddo J.L., additional

Published
2020
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212. Effects of Canagliflozin in Patients with Baseline eGFR <30 ml/min per 1.73 m2

Author

Bakris, George, primary, Oshima, Megumi, additional, Mahaffey, Kenneth W., additional, Agarwal, Rajiv, additional, Cannon, Christopher P., additional, Capuano, George, additional, Charytan, David M., additional, de Zeeuw, Dick, additional, Edwards, Robert, additional, Greene, Tom, additional, Heerspink, Hiddo J.L., additional, Levin, Adeera, additional, Neal, Bruce, additional, Oh, Richard, additional, Pollock, Carol, additional, Rosenthal, Norman, additional, Wheeler, David C., additional, Zhang, Hong, additional, Zinman, Bernard, additional, Jardine, Meg J., additional, and Perkovic, Vlado, additional

Published
2020
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213. The effects of combination canagliflozin and glucagon-like peptide-1 receptor agonist therapy on intermediate markers of cardiovascular risk in the CANVAS program

Author

Arnott, Clare, primary, Neuen, Brendon L., additional, Heerspink, Hiddo J.L., additional, Figtree, Gemma A., additional, Kosiborod, Mikhail, additional, Lam, Carolyn S., additional, Cannon, Christopher P., additional, Rosenthal, Norman, additional, Shaw, Wayne, additional, Mahaffey, Kenneth W., additional, Jardine, Meg J., additional, Perkovic, Vlado, additional, and Neal, Bruce, additional

Published
2020
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214. Initial Decline (Dip) in Estimated Glomerular Filtration Rate After Initiation of Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction: Insights From DAPA-HF

Author

Adamson, Carly, Docherty, Kieran F., Heerspink, Hiddo J.L., de Boer, Rudolf A., Damman, Kevin, Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Martinez, Felipe A., Petrie, Mark C., Ponikowski, Piotr, Sabatine, Marc S., Schou, Morten, Solomon, Scott D., Verma, Subodh, Bengtsson, Olof, Langkilde, Anna Maria, Sjöstrand, Mikaela, Vaduganathan, Muthiah, Jhund, Pardeep S., and McMurray, John J.V.

Published
2022
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215. Albuminuria-Lowering Effect of Dapagliflozin, Eplerenone, and Their Combination in Patients with Chronic Kidney Disease: A Randomized Crossover Clinical Trial

Author

Provenzano, Michele, Puchades, Maria Jes?s, Garofalo, Carlo, Jongs, Niels, D?Marco, Luis, Andreucci, Michele, De Nicola, Luca, Gorriz, Jose Luis, Heerspink, Hiddo J.L., Pennino, Luigi, De Gregorio, Ilaria, Polese, Lucio, Caturano, Alfredo, Minutolo, Roberto, Sasso, Ferdinando, Gagliardi, Ida, Zicarelli, Mariateresa, Crugliano, Giuseppina, Civera, Elena Gimenez, Panizo, Nayara, Sen, Taha, and Xie, Di

Abstract

In this randomized crossover clinical trial in patients with CKD with and without type 2 diabetes, we assessed the albuminuria-lowering effect of the sodium glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin and mineralocorticoid receptor antagonist (MRA) eplerenone individually and in combination. We demonstrated that the albuminuria-lowering effects of dapagliflozin and eplerenone alone are additive when they are used in combination, resulting in a clinically relevant albuminuria reduction of 53% after 4 weeks of dapagliflozin-eplerenone treatment. The incidence of hyperkalemia was significantly less with combination treatment compared with eplerenone alone. These data support future clinical trials to confirm long-term efficacy and safety of combined SGLT2 inhibitor and MRA treatment.

Published
2022
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216. SGLT2 Inhibition for CKD and Cardiovascular Disease in Type 2 Diabetes: Report of a Scientific Workshop Sponsored by the National Kidney Foundation

Author

Tuttle, Katherine R., primary, Brosius, Frank C., additional, Cavender, Matthew A., additional, Fioretto, Paola, additional, Fowler, Kevin J., additional, Heerspink, Hiddo J.L., additional, Manley, Tom, additional, McGuire, Darren K., additional, Molitch, Mark E., additional, Mottl, Amy K., additional, Perreault, Leigh, additional, Rosas, Sylvia E., additional, Rossing, Peter, additional, Sola, Laura, additional, Vallon, Volker, additional, Wanner, Christoph, additional, and Perkovic, Vlado, additional

Published
2020
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217. KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease

Author

de Boer, Ian H., primary, Caramori, M. Luiza, additional, Chan, Juliana C.N., additional, Heerspink, Hiddo J.L., additional, Hurst, Clint, additional, Khunti, Kamlesh, additional, Liew, Adrian, additional, Michos, Erin D., additional, Navaneethan, Sankar D., additional, Olowu, Wasiu A., additional, Sadusky, Tami, additional, Tandon, Nikhil, additional, Tuttle, Katherine R., additional, Wanner, Christoph, additional, Wilkens, Katy G., additional, Zoungas, Sophia, additional, and Rossing, Peter, additional

Published
2020
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218. Executive summary of the 2020 KDIGO Diabetes Management in CKD Guideline: evidence-based advances in monitoring and treatment

Author

de Boer, Ian H., primary, Caramori, M. Luiza, additional, Chan, Juliana C.N., additional, Heerspink, Hiddo J.L., additional, Hurst, Clint, additional, Khunti, Kamlesh, additional, Liew, Adrian, additional, Michos, Erin D., additional, Navaneethan, Sankar D., additional, Olowu, Wasiu A., additional, Sadusky, Tami, additional, Tandon, Nikhil, additional, Tuttle, Katherine R., additional, Wanner, Christoph, additional, Wilkens, Katy G., additional, Zoungas, Sophia, additional, Lytvyn, Lyubov, additional, Craig, Jonathan C., additional, Tunnicliffe, David J., additional, Howell, Martin, additional, Tonelli, Marcello, additional, Cheung, Michael, additional, Earley, Amy, additional, and Rossing, Peter, additional

Published
2020
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219. Early Change in Albuminuria with Canagliflozin Predicts Kidney and Cardiovascular Outcomes: A Post Hoc Analysis from the CREDENCE Trial

Author

Oshima, Megumi, primary, Neuen, Brendon L., additional, Li, JingWei, additional, Perkovic, Vlado, additional, Charytan, David M., additional, de Zeeuw, Dick, additional, Edwards, Robert, additional, Greene, Tom, additional, Levin, Adeera, additional, Mahaffey, Kenneth W., additional, De Nicola, Luca, additional, Pollock, Carol, additional, Rosenthal, Norman, additional, Wheeler, David C., additional, Jardine, Meg J., additional, and Heerspink, Hiddo J.L., additional

Published
2020
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220. Conversion of Urine Protein–Creatinine Ratio or Urine Dipstick Protein to Urine Albumin–Creatinine Ratio for Use in Chronic Kidney Disease Screening and Prognosis

Author

Sumida, Keiichi, primary, Nadkarni, Girish N., additional, Grams, Morgan E., additional, Sang, Yingying, additional, Ballew, Shoshana H., additional, Coresh, Josef, additional, Matsushita, Kunihiro, additional, Surapaneni, Aditya, additional, Brunskill, Nigel, additional, Chadban, Steve J., additional, Chang, Alex R., additional, Cirillo, Massimo, additional, Daratha, Kenn B., additional, Gansevoort, Ron T., additional, Garg, Amit X., additional, Iacoviello, Licia, additional, Kayama, Takamasa, additional, Konta, Tsuneo, additional, Kovesdy, Csaba P., additional, Lash, James, additional, Lee, Brian J., additional, Major, Rupert W., additional, Metzger, Marie, additional, Miura, Katsuyuki, additional, Naimark, David M.J., additional, Nelson, Robert G., additional, Sawhney, Simon, additional, Stempniewicz, Nikita, additional, Tang, Mila, additional, Townsend, Raymond R., additional, Traynor, Jamie P., additional, Valdivielso, José M., additional, Wetzels, Jack, additional, Polkinghorne, Kevan R., additional, and Heerspink, Hiddo J.L., additional

Published
2020
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224. Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program

Author

Oshima, Megumi, primary, Neal, Bruce, additional, Toyama, Tadashi, additional, Ohkuma, Toshiaki, additional, Li, Qiang, additional, de Zeeuw, Dick, additional, Heerspink, Hiddo J.L., additional, Mahaffey, Kenneth W., additional, Fulcher, Gregory, additional, Canovatchel, William, additional, Matthews, David R., additional, and Perkovic, Vlado, additional

Published
2020
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226. Exenatide once weekly decreases urinary albumin excretion in patients with type 2 diabetes and elevated albuminuria: Pooled analysis of randomized active controlled clinical trials

Author

Aart ‐ van der Beek, Annemarie B., primary, Raalte, Daniel H., additional, Guja, Cristian, additional, Hoogenberg, Klaas, additional, Suchower, Lisa J., additional, Hardy, Elise, additional, Sjöström, C. David, additional, and Heerspink, Hiddo J.L., additional

Published
2020
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228. Reply

Author

Heerspink, Hiddo J.L., primary, Li, JingWei, additional, Neal, Bruce, additional, and de Zeeuw, Dick, additional

Published
2020
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229. Discontinuation of RAAS Inhibition in Children with Advanced CKD

Author

van den Belt, Sophie M., primary, Heerspink, Hiddo J.L., additional, Kirchner, Marietta, additional, Gracchi, Valentina, additional, Thurn-Valsassina, Daniela, additional, Bayazit, Aysun K., additional, Niemirska, Anna, additional, Canpolat, Nur, additional, Kaplan Bulut, Ipek, additional, Azukaitis, Karolis, additional, Duzova, Ali, additional, Bacchetta, Justine, additional, Shroff, Rukshana, additional, Paripovic, Dusan, additional, Özçakar, Zeynep Birsin, additional, Fidan, Kibriya, additional, Erdogan, Hakan, additional, Gellermann, Jutta, additional, Wühl, Elke, additional, de Zeeuw, Dick, additional, Melk, Anette, additional, Querfeld, Uwe, additional, and Schaefer, Franz, additional

Published
2020
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230. High-Density Lipoprotein Particles and Their Relationship to Posttransplantation Diabetes Mellitus in Renal Transplant Recipients

Author

Sokooti, Sara, primary, Szili-Torok, Tamas, additional, Flores-Guerrero, Jose L., additional, Osté, Maryse C. J., additional, Gomes-Neto, António W., additional, Kootstra-Ros, Jenny E., additional, Heerspink, Hiddo J.L., additional, Connelly, Margery A., additional, Bakker, Stephan J. L., additional, and Dullaart, Robin P. F., additional

Published
2020
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231. CANAGLIFLOZIN (CANA) REDUCES CARDIOVASCULAR (CV) AND RENAL EVENTS INDEPENDENT OF BASELINE HEART FAILURE (HF): A CREDENCE SECONDARY ANALYSIS

Author

Sarraju, Ashish, primary, Li, JingWei, additional, Cannon, Christopher P., additional, Chang, Tara I., additional, Agarwal, Rajiv, additional, Bakris, George L., additional, Charytan, David M., additional, de Zeeuw, Dick, additional, Greene, Tom, additional, Heerspink, Hiddo J.L., additional, Levin, Adeera, additional, Neal, Bruce, additional, Pollock, Carol, additional, Wheeler, David C., additional, Yavin, Yshai, additional, Zhang, Hong, additional, Zinman, Bernard, additional, Perkovic, Vlado, additional, Jardine, Meg, additional, and Mahaffey, Kenneth W., additional

Published
2020
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232. Evaluating the Effects of Canagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease According to Baseline HbA1c, Including Those With HbA1c <7%

Author

Cannon, Christopher P., primary, Perkovic, Vlado, additional, Agarwal, Rajiv, additional, Baldassarre, James, additional, Bakris, George, additional, Charytan, David M., additional, de Zeeuw, Dick, additional, Edwards, Robert, additional, Greene, Tom, additional, Heerspink, Hiddo J.L., additional, Jardine, Meg J., additional, Levin, Adeera, additional, Li, Jing-Wei, additional, Neal, Bruce, additional, Pollock, Carol, additional, Wheeler, David C., additional, Zhang, Hong, additional, Zinman, Bernard, additional, and Mahaffey, Kenneth W., additional

Published
2020
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233. Randomized, double‐blind, placebo‐controlled, multicentre pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure (EMPA‐RESPONSE‐AHF)

Author

Damman, Kevin, primary, Beusekamp, Joost C., additional, Boorsma, Eva M., additional, Swart, Henk P., additional, Smilde, Tom D.J., additional, Elvan, Arif, additional, Eck, J.W. Martijn, additional, Heerspink, Hiddo J.L., additional, and Voors, Adriaan A., additional

Published
2020
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237. Increase in BNP in Response to Endothelin-Receptor Antagonist Atrasentan Is Associated With Incident Heart Failure

Author

Smeijer, J. David, Koomen, Jeroen, Kohan, Donald E., McMurray, John J.V., Bakris, George L., Correa-Rotter, Ricardo, Hou, Fan-Fan, Januzzi, James L., Kitzman, Dalane W., Kolansky, Daniel M., Makino, Hirofumi, Perkovic, Vlado, Tobe, Sheldon, Parving, Hans-Henrik, de Zeeuw, Dick, and Heerspink, Hiddo J.L.

Abstract

The endothelin receptor antagonist atrasentan reduced the risk of kidney failure in patients with type 2 diabetes mellitus and chronic kidney disease (CKD) in the SONAR (Study of Diabetic Nephropathy with Atrasentan) trial, although with a numerically higher incidence of heart failure (HF) hospitalization.

Published
2022
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239. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy

Author

Perkovic, Vlado, Jardine, Meg J., Neal, Bruce, Bompoint, Severine, Heerspink, Hiddo J.l., Charytan, David M., Edwards, Robert, Agarwal, Rajiv, Bakris, George, Bull, Scott, Cannon, Christopher P., Capuano, George, Chu, Pei-ling, De Zeeuw, Dick, Greene, Tom, Levin, Adeera, Pollock, Carol, Wheeler, David C., Yavin, Yshai, Zhang, Hong, Zinman, Bernard, Meininger, Gary, Brenner, Barry M., Mahaffey, Kenneth W., Bellary, Srikanth, Perkovic, Vlado, Jardine, Meg J., Neal, Bruce, Bompoint, Severine, Heerspink, Hiddo J.l., Charytan, David M., Edwards, Robert, Agarwal, Rajiv, Bakris, George, Bull, Scott, Cannon, Christopher P., Capuano, George, Chu, Pei-ling, De Zeeuw, Dick, Greene, Tom, Levin, Adeera, Pollock, Carol, Wheeler, David C., Yavin, Yshai, Zhang, Hong, Zinman, Bernard, Meininger, Gary, Brenner, Barry M., Mahaffey, Kenneth W., and Bellary, Srikanth

Abstract

BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m 2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m 2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular d

Published
2019

240. When drug treatments bias genetic studies: Mediation and interaction

Author

Researchbureau DHL, UMC Utrecht, Onderzoek Precision medicine, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, JC onderzoeksprogramma Methodologie, Schmidt, Amand F., Heerspink, Hiddo J.L., Denig, Petra, Finan, Chris, Groenwold, Rolf H.H., Researchbureau DHL, UMC Utrecht, Onderzoek Precision medicine, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, JC onderzoeksprogramma Methodologie, Schmidt, Amand F., Heerspink, Hiddo J.L., Denig, Petra, Finan, Chris, and Groenwold, Rolf H.H.

Published
2019

241. Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR):a double-blind, randomised, placebo-controlled trial

Author

Heerspink, Hiddo J.L., Parving, Hans Henrik, Andress, Dennis L., Bakris, George, Correa-Rotter, Ricardo, Hou, Fan Fan, Kitzman, Dalane W., Kohan, Donald, Makino, Hirofumi, McMurray, John J.V., Melnick, Joel Z., Miller, Michael G., Pergola, Pablo E., Perkovic, Vlado, Tobe, Sheldon, Yi, Tingting, Wigderson, Melissa, de Zeeuw, Dick, Elbert, Alicia, Vallejos, Augusto, Alvarisqueta, Andres, Maffei, Laura, Juncos, Luis, de Arteaga, Javier, Greloni, Gustavo, Farias, Eduardo, Zucchini, Alfredo, Vogel, Daniel, Cusumano, Ana, Santos, Juan, Fraenkel, Margaret, Gallagher, Martin, Davis, Tim, Acharya, Shamasunder, Cooke, Duncan, Suranyi, Michael, Roger, Simon, Toussaint, Nigel, Pollock, Carol, Chan, Doris, Stranks, Stephen, MacIsaac, Richard, Endre, Zoltan, Schmidt, Alice, Prager, Rudolf, Mayer, Gert, Warling, Xavier, Jadoul, Michel, Egstrup, Kenneth, Oczachowska-Kulik, Anna Ewa, Rossing, Peter, Ono, Yasuhirov, Yalcin, Murat, Karim, Shahana, Heerspink, Hiddo J.L., Parving, Hans Henrik, Andress, Dennis L., Bakris, George, Correa-Rotter, Ricardo, Hou, Fan Fan, Kitzman, Dalane W., Kohan, Donald, Makino, Hirofumi, McMurray, John J.V., Melnick, Joel Z., Miller, Michael G., Pergola, Pablo E., Perkovic, Vlado, Tobe, Sheldon, Yi, Tingting, Wigderson, Melissa, de Zeeuw, Dick, Elbert, Alicia, Vallejos, Augusto, Alvarisqueta, Andres, Maffei, Laura, Juncos, Luis, de Arteaga, Javier, Greloni, Gustavo, Farias, Eduardo, Zucchini, Alfredo, Vogel, Daniel, Cusumano, Ana, Santos, Juan, Fraenkel, Margaret, Gallagher, Martin, Davis, Tim, Acharya, Shamasunder, Cooke, Duncan, Suranyi, Michael, Roger, Simon, Toussaint, Nigel, Pollock, Carol, Chan, Doris, Stranks, Stephen, MacIsaac, Richard, Endre, Zoltan, Schmidt, Alice, Prager, Rudolf, Mayer, Gert, Warling, Xavier, Jadoul, Michel, Egstrup, Kenneth, Oczachowska-Kulik, Anna Ewa, Rossing, Peter, Ono, Yasuhirov, Yalcin, Murat, and Karim, Shahana

Abstract

Background: Short-term treatment for people with type 2 diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes. Methods: We did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18–85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR)25–75 mL/min per 1·73 m2 of body surface area, and a urine albumin-to-creatinine ratio (UACR)of 300–5000 mg/g who had received maximum labelled or tolerated renin–angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0·75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30% with no substantial fluid retention during the enrichment period (responders)were included in the double-blind treatment period. Responders were randomly assigned to receive either atrasentan 0·75 mg orally daily or placebo. All patients and investigators were masked to treatment assignment. The primary endpoint was a composite of doubling of serum creatinine (sustained for ≥30 days)or end-stage kidney disease (eGFR <15 mL/min per 1·73 m2 sustained for ≥90 days, chronic dialysis for ≥90 days, kidney transplantation, or death from kidney failure)in the intention-to-treat population of all responders. Safety was assessed in all patients who received at least one dose of their assigned study treatment. The study is registered with ClinicalTrials.gov, number NCT01858532. Findings: Between May 17, 2013, and July 13, 2017, 11 087 patients were screened; 5117 entered the enrichment period, and 4711 completed the enrichment period. Of these, 2648 patients were responders and were randomly assigned to the atrasentan group (n=1325)or placebo group (n=1323). Median follow-up was 2·2 years (IQR

Published
2019

242. Albuminuria-lowering effect of dapagliflozin alone and in combination with saxagliptin and effect of dapagliflozin and saxagliptin on glycaemic control in patients with type 2 diabetes and chronic kidney disease (DELIGHT):a randomised, double-blind, placebo-controlled trial

Author

Pollock, Carol, Stefánsson, Bergur, Reyner, Daniel, Rossing, Peter, Sjöström, C. David, Wheeler, David C., Langkilde, Anna Maria, Heerspink, Hiddo J.L., Pollock, Carol, Stefánsson, Bergur, Reyner, Daniel, Rossing, Peter, Sjöström, C. David, Wheeler, David C., Langkilde, Anna Maria, and Heerspink, Hiddo J.L.

Abstract

Background: In patients with type 2 diabetes, intensive glucose control can be renoprotective and albuminuria-lowering treatments can slow the deterioration of kidney function. We assessed the albuminuria-lowering effect of the sodium-glucose co-transporter-2 inhibitor dapagliflozin with and without the dipeptidyl peptidase-4 inhibitor saxagliptin, and the effect of dapagliflozin–saxagliptin on glycaemic control in patients with type 2 diabetes and moderate-to-severe chronic kidney disease. Methods: In this double-blind, placebo-controlled trial (DELIGHT), we enrolled patients at 116 research centres in Australia, Canada, Japan, South Korea, Mexico, South Africa, Spain, Taiwan, and the USA. We included patients with a known history of type 2 diabetes, increased albuminuria (urine albumin-to-creatinine ratio [UACR] 30–3500 mg/g), an estimated glomerular filtration rate of 25–75 mL/min per 1·73 m2, and an HbA1c of 7·0–11·0% (53–97 mmol/mol), who had been receiving stable doses of angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker therapy and glucose-lowering treatment for at least 12 weeks. After a 4-week, single-blind placebo run-in period, participants were randomly assigned (1:1:1; via an interactive voice–web response system) to receive dapagliflozin (10 mg) only, dapagliflozin (10 mg) and saxagliptin (2·5 mg), or placebo once-daily for 24 weeks. Primary endpoints were change from baseline in UACR (dapagliflozin and dapagliflozin–saxagliptin groups) and HbA1c (dapagliflozin–saxagliptin group) at week 24 in all randomly allocated patients with available data (full analysis set). This study is registered with ClinicalTrials.gov, number NCT02547935 and is completed. Findings: The study took place between July 14, 2015, and May 18, 2018. 1187 patients were screened, of whom 461 were randomly assigned: 145 to the dapagliflozin group, 155 to the dapagliflozin–saxagliptin group, and 148 to the placebo group (13

Published
2019

243. Acute Treatment Effects on GFR in Randomized Clinical Trials of Kidney Disease Progression

Author

Neuen, Brendon L., Tighiouart, Hocine, Heerspink, Hiddo J.L., Vonesh, Edward F., Chaudhari, Juhi, Miao, Shiyuan, Chan, Tak Mao, Fervenza, Fernando C., Floege, J?rgen, Goicoechea, Marian, Herrington, William G., Imai, Enyu, Jafar, Tazeen H., Lewis, Julia B., Li, Philip Kam-Tao, Locatelli, Francesco, Maes, Bart D., Perrone, Ronald D., Praga, Manuel, Perna, Annalisa, Schena, Francesco P., Wanner, Christoph, Wetzels, Jack F.M., Woodward, Mark, Xie, Di, Greene, Tom, and Inker, Lesley A.

Abstract

GFR slope has been proposed as a surrogate endpoint for progression to kidney failure in clinical trials studying patients with CKD. Acute or immediate effects on GFR after treatment initiation may complicate the interpretation of long-term treatment effects. In this large meta-analysis of 53 randomized clinical studies of CKD progression, the authors found the magnitude and nature of acute effects are variable across different interventions and may be larger at a higher baseline GFR. Negative acute effects (such as an acute reduction in GFR) were observed in trials of renin-angiotensin system blockade and BP lowering, whereas positive acute effects were more common in trials of immunosuppressive therapies. Such information can inform the optimal design and analysis plan for randomized clinical trials in CKD.

Published
2022
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244. The authors reply

Author

Chan, Juliana C.N., Heerspink, Hiddo J.L., Hurst, Clint, Khunti, Kamlesh, Liew, Adrian, Michos, Erin D., Navaneethan, Sankar D., Olowu, Wasiu A., Sadusky, Tami, Wanner, Christoph, Wilkens, Katy G., Zoungas, Sophia, Lytvyn, Lyubov, Craig, Jonathan C., Howell, Martin, Tonelli, Marcello, Cheung, Michael, Earley, Amy, Caramori, M. Luiza, Tuttle, Katherine R., Tandon, Nikhil, Tunnicliffe, David J., de Boer, Ian H., and Rossing, Peter

Published
2022
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245. Response to Comment on Curovic et al. Optimization of Albuminuria-Lowering Treatment in Diabetes by Crossover Rotation to Four Different Drug Classes: A Randomized Crossover Trial. Diabetes Care 2023;46:593–601.

Author

Curovic, Viktor Rotbain, Persson, Frederik, Jongs, Niels, and Heerspink, Hiddo J.L.

Subjects
CROSSOVER trials, DIABETES, ROTATIONAL motion, DRUGS
Abstract

The article focuses on concerns raised about the methodology of a trial optimizing albuminuria-lowering treatment in diabetes, particularly regarding drug selection and exposure. It mentiions despite limitations in reexposing patients to certain drugs, the results demonstrate patient-specific and reproducible responses to treatment, aligning with clinical practice guidelines and supporting the concept of personalized medicine.

Published
2024
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246. Effect of bardoxolone methyl on the urine albumin-to-creatinine ratio in patients with type 2 diabetes and stage 4 chronic kidney disease

Author

Rossing, Peter, primary, Block, Geoffrey A., additional, Chin, Melanie P., additional, Goldsberry, Angie, additional, Heerspink, Hiddo J.L., additional, McCullough, Peter A., additional, Meyer, Colin J., additional, Packham, David, additional, Pergola, Pablo E., additional, Spinowitz, Bruce, additional, Sprague, Stuart M., additional, Warnock, David G., additional, and Chertow, Glenn M., additional

Published
2019
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248. Performance of GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Statistical Simulation

Author

Greene, Tom, primary, Ying, Jian, additional, Vonesh, Edward F., additional, Tighiouart, Hocine, additional, Levey, Andrew S., additional, Coresh, Josef, additional, Herrick, Jennifer S., additional, Imai, Enyu, additional, Jafar, Tazeen H., additional, Maes, Bart D., additional, Perrone, Ronald D., additional, del Vecchio, Lucia, additional, Wetzels, Jack F.M., additional, Heerspink, Hiddo J.L., additional, and Inker, Lesley A., additional

Published
2019
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250. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy

Author

Perkovic, Vlado, primary, Jardine, Meg J., additional, Neal, Bruce, additional, Bompoint, Severine, additional, Heerspink, Hiddo J.L., additional, Charytan, David M., additional, Edwards, Robert, additional, Agarwal, Rajiv, additional, Bakris, George, additional, Bull, Scott, additional, Cannon, Christopher P., additional, Capuano, George, additional, Chu, Pei-Ling, additional, de Zeeuw, Dick, additional, Greene, Tom, additional, Levin, Adeera, additional, Pollock, Carol, additional, Wheeler, David C., additional, Yavin, Yshai, additional, Zhang, Hong, additional, Zinman, Bernard, additional, Meininger, Gary, additional, Brenner, Barry M., additional, and Mahaffey, Kenneth W., additional

Published
2019
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