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1. Outcomes of integrated management versus specialized care for patients with type 2 diabetes: An observational study

Author: Sabione, I., Cavalot, F., Paccotti, P., Massucco, P., and Vigna-Taglianti, F.D.
Published: 2018
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2. Sex differences in cardiovascular disease and cardiovascular risk estimation in patients with type 1 diabetes

Author: Dei Cas, A, Aldigeri, R, Mantovani, A, Masulli, M, Palmisano, L, Cavalot, F, Bonomo, K, Baroni, M, Cossu, E, Cavallo, G, Cimini, F, Buzzetti, R, Mignogna, C, Leonetti, F, Bacci, S, Trevisan, R, Morieri, M, Pollis, R, Targher, G, Vigili de Kreutzenberg, S, Dei Cas, Alessandra, Aldigeri, Raffaella, Mantovani, Alessandro, Masulli, Maria, Palmisano, Luisa, Cavalot, Franco, Bonomo, Katia, Baroni, Marco Giorgio, Cossu, Efisio, Cavallo, Gisella, Cimini, Flavia Agata, Buzzetti, Raffaella, Mignogna, Carmen, Leonetti, Frida, Bacci, Simonetta, Trevisan, Roberto, Morieri, Mario Luca, Pollis, Riccardo Maria, Targher, Giovanni, Vigili de Kreutzenberg, Saula, Dei Cas, A, Aldigeri, R, Mantovani, A, Masulli, M, Palmisano, L, Cavalot, F, Bonomo, K, Baroni, M, Cossu, E, Cavallo, G, Cimini, F, Buzzetti, R, Mignogna, C, Leonetti, F, Bacci, S, Trevisan, R, Morieri, M, Pollis, R, Targher, G, Vigili de Kreutzenberg, S, Dei Cas, Alessandra, Aldigeri, Raffaella, Mantovani, Alessandro, Masulli, Maria, Palmisano, Luisa, Cavalot, Franco, Bonomo, Katia, Baroni, Marco Giorgio, Cossu, Efisio, Cavallo, Gisella, Cimini, Flavia Agata, Buzzetti, Raffaella, Mignogna, Carmen, Leonetti, Frida, Bacci, Simonetta, Trevisan, Roberto, Morieri, Mario Luca, Pollis, Riccardo Maria, Targher, Giovanni, and Vigili de Kreutzenberg, Saula
Abstract: Aims: Patients with type 1 diabetes (T1D) have higher cardiovascular disease (CVD) risk compared to the general population. This observational study aims to evaluate sex-related differences in CVD prevalence and CVD risk estimates in a large cohort of T1D adults. Materials and methods: We conducted a multicenter, cross-sectional study involving 2,041 T1D patients (mean age 46 years; 44.9% women). In patients without pre-existing CVD (primary prevention), we calculated the Steno type 1 risk engine to estimate the 10-year risk of developing CVD events. Results: CVD prevalence (n=116) was higher in men than in women aged ≥55 years (19.2 vs 12.8%, p=0.036), but comparable between the two sexes in those aged <55 years (p=0.91). In patients without pre-existing CVD (n=1,925), mean 10-year estimated CVD risk was 15.4±0.4% without any significant sex difference. However, stratifying this patient group by age, the 10-year estimated CVD risk was significantly higher in men than in women until age 55 years (p<0.001), but this risk equalized after this age. Carotid-artery plaque burden was significantly associated with age ≥55 years and with a medium and high 10-year estimated CVD risk, without any significant sex difference. Diabetic retinopathy and sensory-motor neuropathy were also associated with higher 10-year CVD risk and female sex. Conclusions: Both men and women with T1D are at high CVD risk. The 10-year estimated CVD risk was higher in men aged <55 years than in women of similar age, but these sex differences disappeared at age ≥55 years, suggesting that female sex was no longer protective.
Published: 2023

3. Retinopathy as an independent predictor of all-cause mortality in individuals with type 2 diabetes

Author: Orsi, E, Solini, A, Bonora, E, Vitale, M, Garofolo, M, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Zerbini, G, Nicolucci, A, Pugliese, G, Orsi, Emanuela, Solini, Anna, Bonora, Enzo, Vitale, Martina, Garofolo, Monia, Fondelli, Cecilia, Trevisan, Roberto, Vedovato, Monica, Cavalot, Franco, Zerbini, Gianpaolo, Nicolucci, Antonio, Pugliese, Giuseppe, Orsi, E, Solini, A, Bonora, E, Vitale, M, Garofolo, M, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Zerbini, G, Nicolucci, A, Pugliese, G, Orsi, Emanuela, Solini, Anna, Bonora, Enzo, Vitale, Martina, Garofolo, Monia, Fondelli, Cecilia, Trevisan, Roberto, Vedovato, Monica, Cavalot, Franco, Zerbini, Gianpaolo, Nicolucci, Antonio, and Pugliese, Giuseppe
Abstract: Aims: To assess whether the presence and grade of diabetic retinopathy (DR) predict all-cause mortality, independent of risk factors for cardiovascular disease (CVD) and other complications, including diabetes-related kidney disease (DKD) and CVD, in individuals with type 2 diabetes mellitus. Methods: Prospective cohort study that enroled 15,773 patients in 19 Italian centers in 2006–2008. DR ascertained by fundoscopy, DKD by albuminuria and estimated glomerular filtration rate, and prior CVD by hospital discharge records. All-cause mortality retrieved for 15,656 patients on 31 October 2015. Results: The adjusted risk of death was increased in patients with any DR (hazard ratio, 1.136 [95% confidence interval, 1.054;1.224] P < 0.0001), advanced DR, including severe non-proliferative and proliferative DR and diabetic macula edema (1.213 [1.097;1.340] P < 0.0001), and especially proliferative DR alone (1.381 [1.207;1.580] P < 0.0001), compared with those without DR. The impact of DR was more evident in patients without than in those with DKD or CVD. Mortality risk was increased in participants with DR alone, though much less than in those with DKD or CVD alone and particularly in those with both DR and DKD or CVD. DR grade was related to mortality in individuals without DKD or CVD, whereas it conferred no additional risk to those with albuminuric or nonalbuminuric DKD or established CVD. Conclusions: In patients with type 2 diabetes mellitus, the excess mortality risk conferred by DR is relatively small and higher in those without DKD and CVD, suggesting that it may be mediated by the concurrent presence of these complications, even at a subclinical level.
Published: 2023

4. Reported muscle symptoms during statin treatment amongst Italian dyslipidaemic patients in the real‐life setting: the PROSISA Study

Author: Casula, M., Gazzotti, M., Bonaiti, F., Oimastroni, E., Arca, M., Averna, M., Zambon, A., Catapano, A. L., Montali, A., Giammanco, A., Biolo, G., Vinci, P., Borghi, C., D'Addato, S., Bossi, A. C., Meregalli, G., Branchi, A., Squiccimarro, G., Cavalot, F., Ramadori, L., Cipollone, F., Bucci, M., Del Ben, M., Angelico, F., Fiorenza, A. M., Colombo, E., Grigore, L., Zampoleri, V., Lupattelli, G., Gandolfo, V., Mandraffino, G., Savarino, F., Mombelli, G., Pavanello, C., Pisciotta, L., Pasta, A., Purrello, F., Scicali, R., Rubba, P., Fortunato, G., Sabba, C., Suppressa, P., Sarzani, R., Di Pentima, C., Vigna, G. B., Colangiulo, A., Werba, J. P., Vigo, L. M., Zambon, S., Previato, L., Zenti, M. G., Maneschi, C., Casula, M., Gazzotti, M., Bonaiti, F., Oimastroni, E., Arca, M., Averna, M., Zambon, A., Catapano, A. L., Montali, A., Giammanco, A., Biolo, G., Vinci, P., Borghi, C., D'Addato, S., Bossi, A. C., Meregalli, G., Branchi, A., Squiccimarro, G., Cavalot, F., Ramadori, L., Cipollone, F., Bucci, M., Del Ben, M., Angelico, F., Fiorenza, A. M., Colombo, E., Grigore, L., Zampoleri, V., Lupattelli, G., Gandolfo, V., Mandraffino, G., Savarino, F., Mombelli, G., Pavanello, C., Pisciotta, L., Pasta, A., Purrello, F., Scicali, R., Rubba, P., Fortunato, G., Sabba, C., Suppressa, P., Sarzani, R., Di Pentima, C., Vigna, G. B., Colangiulo, A., Werba, J. P., Vigo, L. M., Zambon, S., Previato, L., Zenti, M. G., Maneschi, C., Casula M, Gazzotti M, Bonaiti F, OImastroni E, Arca M, Averna M, Zambon A, Catapano AL, PROSISA Study Group, Borghi C, Casula M., Gazzotti M., Bonaiti F., OImastroni E., Arca M., Averna M., Zambon A., Catapano A.L., Montali A., Giammanco A., Biolo G., Vinci P., Borghi C., D'Addato S., Bossi A.C., Meregalli G., Branchi A., Squiccimarro G., Cavalot F., Ramadori L., Cipollone F., Bucci M., Del Ben M., Angelico F., Fiorenza A.M., Colombo E., Grigore L., Zampoleri V., Lupattelli G., Gandolfo V., Mandraffino G., Savarino F., Mombelli G., Pavanello C., Pisciotta L., Pasta A., Purrello F., Scicali R., Rubba P., Fortunato G., Sabba C., Suppressa P., Sarzani R., Di Pentima C., Vigna G.B., Colangiulo A., Werba J.P., Vigo L.M., Zambon S., Previato L., Zenti M.G., and Maneschi C.
Subjects: 0301 basic medicine, Male, medicine.medical_specialty, Settore MED/09 - Medicina Interna, adverse effects, myopathy, statin-associated muscle symptoms, statins, 030204 cardiovascular system & hematology, Medication Adherence, 03 medical and health sciences, 0302 clinical medicine, Muscular Diseases, Internal medicine, adverse effect, Internal Medicine, medicine, Prevalence, Humans, statin‐associated muscle symptoms, Adverse effect, Dechallenge, Creatine Kinase, Dyslipidemias, Female, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Italy, Middle Aged, Retrospective Studies, business.industry, Retrospective cohort study, Odds ratio, Original Articles, Confidence interval, Discontinuation, 030104 developmental biology, Concomitant, Cohort, Original Article, business, statin-associated muscle symptom
Abstract: Aim: Statin-associated muscle symptoms (SAMS) are a major determinant of poor treatment adherence and/or discontinuation, but a definitive diagnosis of SAMS is challenging. The PROSISA study was an observational retrospective study aimed to assess the prevalence of reported SAMS in a cohort of dyslipidaemic patients. Methods: Demographic/anamnestic data, biochemical values and occurrence of SAMS were collected by 23 Italian Lipid Clinics. Adjusted logistic regression was performed to estimate odds ratio (OR) and 95% confidence intervals for association between probability of reporting SAMS and several factors. Results: Analyses were carried out on 16717 statin-treated patients (mean±SD, age 60.5±12.0years; 52.1% men). During statin therapy, 9.6% (N=1599) of patients reported SAMS. Women and physically active subjects were more likely to report SAMS (OR 1.23 [1.10–1.37] and OR 1.35 [1.14–1.60], respectively), whist age≥65 (OR 0.79 [0.70–0.89]), presence of type 2 diabetes mellitus (OR 0.62 [0.51–0.74]), use of concomitant nonstatin lipid-lowering drugs (OR 0.87 [0.76–0.99]), use of high-intensity statins (OR 0.79 [0.69–0.90]) and use of potential interacting drugs (OR 0.63 [0.48–0.84]) were associated with lower probability of reporting SAMS. Amongst patients reporting SAMS, 82.2% underwent dechallenge (treatment interruption) and/or rechallenge (change or restart of statin therapy), with reappearance of muscular symptoms in 38.4% (3.01% of the whole cohort). Conclusions: The reported prevalence of SAMS was 9.6% of the whole PROSISA cohort, but only a third of patients still reported SAMS after dechallenge/rechallenge. These results emphasize the need for a better management of SAMS to implement a more accurate diagnosis and treatment re-evaluation.
Published: 2020

5. Short-term effectiveness of dapagliflozin versus DPP-4 inhibitors in elderly patients with type 2 diabetes: a multicentre retrospective study

Author: Morieri, M. L., Raz, I., Consoli, A., Rigato, M., Lapolla, A., Broglio, F., Bonora, E., Avogaro, A., Fadini, G. P., Ginestra, F., Formoso, G., Andreozzi, F., Sesti, G., Turco, S., Lucibelli, L., Gatti, A., Aldigeri, R., Dei Cas, A., Felace, G., Li Volsi, P., Sorice, G. P., Giaccari, A., Mignogna, C., Buzzetti, R., Filardi, T., Morano, S., Barchetta, I., Gisella Cavallo, M., Malandrucco, I., Frontoni, S., Carletti, S., D'Angelo, P., Leto, G., Leonetti, F., Silvia Morpurgo, P., Fiorina, P., Palmieri, E., Orsi, E., Mantovani, E., Franzetti, I., Querci, F., Bossi, A., Turchi, F., Manfrini, S., Guida, D., Placentino, G., Beccuti, G., Cavalot, F., Nuzzo, A., Aimaretti, G., Lamacchia, O., Cignarelli, A., Laviola, L., Giorgino, F., Devangelio, E., Cazzetta, G., Chianetta, R., Citarrella, R., Tumminia, A., Frittitta, L., Anzaldi, M., Buscema, M., Piro, S., Di Pino, A., Purrello, F., Di Benedetto, A., Russo, G., Anichini, R., Solini, A., Garofolo, M., Del Prato, S., Fattor, B., Paolo Fadini, G., Sartore, G., D'Ambrosio, M., Da Tos, V., Frison, V., Simioni, N., Cigolini, M., Brun, E., Strazzabosco, M., Poli, M., Paccagnella, A., and Vinci, C.
Subjects: Aging, Cardiovascular, Heart failure, Kidney disease, Observational
Published: 2023

6. Insulin resistance, diabetic kidney disease, and all-cause mortality in individuals with type 2 diabetes: a prospective cohort study

Author: Penno, G, Solini, A, Orsi, E, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Zerbini, G, Lamacchia, O, Nicolucci, A, Pugliese, G, Laviola, L, Penno G., Solini A., Orsi E., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Zerbini G., Lamacchia O., Nicolucci A., Pugliese G., Laviola L., Penno, G, Solini, A, Orsi, E, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Zerbini, G, Lamacchia, O, Nicolucci, A, Pugliese, G, Laviola, L, Penno G., Solini A., Orsi E., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Zerbini G., Lamacchia O., Nicolucci A., Pugliese G., and Laviola L.
Abstract: Background: It is unclear whether insulin resistance (IR) contributes to excess mortality in patients with type 2 diabetes independent of diabetic kidney disease (DKD), which is strongly associated with IR and is a major risk factor for cardiovascular disease (CVD), the main cause of death in these individuals. We tested this hypothesis in patients with type 2 diabetes from the Renal Insufficiency And Cardiovascular Events Italian Multicentre Study. Methods: This observational, prospective, cohort study enrolled 15,773 patients with type 2 diabetes attending 19 Italian Diabetes Clinics in 2006–2008. Insulin sensitivity was assessed as estimated glucose disposal rate (eGDR), which was validated against the euglycaemic-hyperinsulinemic clamp technique. Vital status on October 31, 2015, was retrieved for 15,656 patients (99.3%). Participants were stratified by eGDR tertiles from T1 (≥ 5.35 mg/kg/min) to T3 (≤ 4.14 mg/kg/min, highest IR). Results: CVD risk profile was worse in T2 and T3 vs T1. eGDR tertiles were independently associated with micro- and macroalbuminuria and the albuminuric DKD phenotypes (albuminuria with preserved or reduced estimated glomerular filtration rate [eGFR]) as well as with eGFR categories or the nonalbuminuric DKD phenotype. Over a 7.4-year follow-up, unadjusted death rates and mortality risks increased progressively across eGDR tertiles, but remained significantly elevated after adjustment only in T3 vs T1 (age- and gender- adjusted death rate, 22.35 vs 16.74 per 1000 person-years, p < 0.0001, and hazard ratio [HR] adjusted for multiple confounders including DKD, 1.140 [95% confidence interval [CI], 1.049–1.238], p = 0.002). However, eGDR was independently associated with mortality in participants with no DKD (adjusted HR, 1.214 [95% CI, 1.072–1.375], p = 0.002) and in those with nonalbuminuric DKD (1.276 [1.034–1.575], p = 0.023), but not in those with the albuminuric DKD phenotypes. Moreover, the association was stronger in males and i
Published: 2021

7. Independent association of atherogenic dyslipidaemia with all‐cause mortality in individuals with type 2 diabetes and modifying effect of gender: a prospective cohort study

Author: Orsi, E, Penno, G, Solini, A, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Morano, S, Baroni, M, Nicolucci, A, Pugliese, G, Orsi E., Penno G., Solini A., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Morano S., Baroni M. G., Nicolucci A., Pugliese G., Orsi, E, Penno, G, Solini, A, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Morano, S, Baroni, M, Nicolucci, A, Pugliese, G, Orsi E., Penno G., Solini A., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Morano S., Baroni M. G., Nicolucci A., and Pugliese G.
Abstract: Background: Atherogenic dyslipidaemia has been implicated in the residual risk for cardiovascular morbidity and mortality, which remains despite attainment of LDL cholesterol goals especially in individuals with type 2 diabetes. However, its relationship with all-cause death has not been sufficiently explored. This analysis evaluated the independent association of increased triglycerides and triglyceride:HDL cholesterol ratio (TG:HDL) and decreased HDL cholesterol with total mortality and the possible modifying effect of gender in a large cohort of patients with type 2 diabetes. Methods: This observational, prospective study enrolled 15,773 patients in 19 Diabetes Clinics throughout Italy in the years 2006–2008. Triglycerides and total and HDL cholesterol were measured by colorimetric enzymatic methods. Vital status was retrieved on 31 October 2015 for 15,656 patients (99.3%). Participants were stratified by quartiles of triglycerides, HDL cholesterol, and TG:HDL. Results: There were 3,602 deaths over a follow-up 7.42 ± 2.05 years (31.0 × 1000 person-years). In the unadjusted analyses, the highest TG:HDL (but not triglyceride) and the lowest HDL cholesterol quartile were associated with increased death rate and mortality risk. When sequentially adjusting for confounders, including total, LDL, or non-HDL cholesterol and lipid-lowering treatment, mortality risk was significantly higher in the highest triglyceride (hazard ratio 1.167 [95% confidence interval 1.055–1.291], p = 0.003) and TG:HDL (1.192 [1.082–1.314], p < 0.0001) and the lowest HDL cholesterol (1.232 [1.117–1.360], p < 0.0001) quartile, though the association of triglycerides and HDL cholesterol disappeared after further adjustment for each other. Interaction with gender was significant only for HDL cholesterol (p = 0.0009). The relationship with death was stronger for triglycerides in males and HDL cholesterol in females, with these associations remaining significant even after adjustment for
Published: 2021

8. Renal hyperfiltration is independently associated with increased all-cause mortality in individuals with type 2 diabetes: A prospective cohort study

Author: Penno, G, Orsi, E, Solini, A, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Gruden, G, Laviola, L, Nicolucci, A, Pugliese, G, Penno G., Orsi E., Solini A., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Gruden G., Laviola L., Nicolucci A., Pugliese G., Penno, G, Orsi, E, Solini, A, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Gruden, G, Laviola, L, Nicolucci, A, Pugliese, G, Penno G., Orsi E., Solini A., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Gruden G., Laviola L., Nicolucci A., and Pugliese G.
Abstract: Introduction In addition to favoring renal disease progression, renal hyperfiltration' has been associated with an increased risk of death, though it is unclear whether and how excess mortality is related to increased renal function. We investigated whether renal hyperfiltration is an independent predictor of death in patients with type 2 diabetes from the Renal Insufficiency And Cardiovascular Events Italian multicenter study. Research design and methods This observational, prospective cohort study enrolled 15 773 patients with type 2 diabetes consecutively attending 19 Italian diabetes clinics in 2006-2008. Serum creatinine, albuminuria, cardiovascular risk factors, and complications/comorbidities were assessed at baseline. Vital status on 31 October 2015 was retrieved for 15 656 patients (99.26%). Patients were stratified (A) by absolute estimated glomerular filtration rate (eGFR) values in eGFR deciles or Kidney Disease: Improving Global Outcomes (KDIGO) categories and (B) based on age-corrected thresholds or age and gender-specific 95th and 5th percentiles in hyperfiltration, hypofiltration, and normofiltration groups. Results The highest eGFR decile/category and the hyperfiltration group included (partly) different individuals with similar clinical features. Age and gender-adjusted death rates were significantly higher in deciles 1, 9, and 10 (≥103.9, 50.9-62.7, and <50.9 mL/min/1.73 m 2, respectively) versus the reference decile 3 (92.9-97.5 mL/min/1.73 m 2). Mortality risk, adjusted for multiple confounders, was also increased in deciles 1 (HR 1.461 (95% CI 1.175 to 1.818), p=0.001), 9 (1.312 (95% CI 1.107 to 1.555), p=0.002), and 10 (1.976 (95% CI 1.673 to 2.333), p<0.0001) versus decile 3. Similar results were obtained by stratifying patients by KDIGO categories. Death rates and adjusted mortality risks were significantly higher in hyperfiltering and particularly hypofiltering versus normofiltering individuals. Conclusions In type 2 diabetes, both hi
Published: 2020

9. Body mass index versus surrogate measures of central adiposity as independent predictors of mortality in type 2 diabetes

Author: Orsi, E, Solini, A, Penno, G, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Lamacchia, O, Haxhi, J, Nicolucci, A, Pugliese, G, Orsi, Emanuela, Solini, Anna, Penno, Giuseppe, Bonora, Enzo, Fondelli, Cecilia, Trevisan, Roberto, Vedovato, Monica, Cavalot, Franco, Lamacchia, Olga, Haxhi, Jonida, Nicolucci, Antonio, Pugliese, Giuseppe, Orsi, E, Solini, A, Penno, G, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Lamacchia, O, Haxhi, J, Nicolucci, A, Pugliese, G, Orsi, Emanuela, Solini, Anna, Penno, Giuseppe, Bonora, Enzo, Fondelli, Cecilia, Trevisan, Roberto, Vedovato, Monica, Cavalot, Franco, Lamacchia, Olga, Haxhi, Jonida, Nicolucci, Antonio, and Pugliese, Giuseppe
Abstract: Background: An “obesity paradox” for mortality has been shown in chronic disorders such as diabetes, and attributed to methodological bias, including the use of body mass index (BMI) for obesity definition. This analysis investigated the independent association of BMI versus surrogate measures of central adiposity with all-cause mortality in individuals with type 2 diabetes. Methods: The Renal Insufficiency And Cardiovascular Events Italian Multicentre Study is a prospective cohort study that enrolled 15,773 patients in 19 Italian centres in 2006–2008. Exposures were BMI and the surrogate measures of central adiposity waist circumference (WC), waist-to-height ratio (WHtR), and A Body Shape Index (ABSI). Vital status was retrieved on 31 October 2015 for 15,656 patients (99.3%), Results: Age- and sex-adjusted hazard ratios and 95% confidence intervals were significantly higher in BMI-based underweight (1.729 [1.193–2.505), P = 0.004), moderately obese (1.214 [1.058–1.392), P = 0.006) and severely obese (1.703 [1.402–2.068), P < 0.0001), lower in overweight (0.842 [0.775–0.915), P < 0.0001) and similar in mildly obese (0.950 [0.864–1.045), P = 0.292), compared to normal-weight individuals. When further adjusting for smoking, physical activity (PA), and comorbidities, risk was lower also in mildly obese versus normal-weight patients. The BMI-mortality relationship did not change after sequentially excluding ever smokers, individuals with comorbidities, and those died within two years from enrollment and when analyzing separately participants below and above the median age. Conversely, a paradox relationship was observed among inactive/moderately inactive, but not moderately/highly active patients. Mortality risk adjusted for age, gender, smoking, PA and comorbidities was significantly higher in the highest tertile of WC (1.279 [1.089–1.501], P = 0.003), WHtR (1.372 [1.165–1.615], P < 0.0001), and ABSI (1.263 [1.067–1.495], P = 0.007) versus the lowest tertile.
Published: 2022

10. Risk of all-cause mortality according to the European Society of Cardiology risk categories in individuals with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study

Author: Orsi, E, Solini, A, Bonora, E, Vitale, M, Garofolo, M, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Laviola, L, Morano, S, Pugliese, G, Orsi, Emanuela, Solini, Anna, Bonora, Enzo, Vitale, Martina, Garofolo, Monia, Fondelli, Cecilia, Trevisan, Roberto, Vedovato, Monica, Cavalot, Franco, Laviola, Luigi, Morano, Susanna, Pugliese, Giuseppe, Orsi, E, Solini, A, Bonora, E, Vitale, M, Garofolo, M, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Laviola, L, Morano, S, Pugliese, G, Orsi, Emanuela, Solini, Anna, Bonora, Enzo, Vitale, Martina, Garofolo, Monia, Fondelli, Cecilia, Trevisan, Roberto, Vedovato, Monica, Cavalot, Franco, Laviola, Luigi, Morano, Susanna, and Pugliese, Giuseppe
Abstract: Aims: The 2019 and 2021 European Society of Cardiology (ESC) classifications stratified patients with type 2 diabetes into three categories according to the 10-year risk of death from atherosclerotic cardiovascular disease (ASCVD). The very high-risk category included individuals with established ASCVD, target organ damage (TOD), and/or, in the 2019 classification only, ≥ 3 additional ASCVD risk factors. We assessed risk of all-cause mortality according to the two ESC classifications in the Renal Insufficiency And Cardiovascular Events cohort. Methods: Participants (n = 15,773) were stratified based on the presence of ASCVD, TOD, and ASCVD risk factors at baseline (2006–2008). Vital status was retrieved in 2015. Results: Less than 1% of participants fell in the moderate-risk category. According to the 2019 classification, ~ 1/3 fell in the high-risk and ~ 2/3 in the very high-risk category, whereas the opposite occurred with the 2021 classification. Mortality risk increased across categories according to both classifications. Among very high-risk patients, mortality was much lower in those with ≥ 3 additional ASCVD risk factors and almost equal in those with TOD and ASCVD ± TOD, using the 2019 classification, whereas it was much higher in those with ASCVD + TOD and, to a lesser extent, TOD only than in those with ASCVD only, using the 2021 classification. Conclusions: The negligible number of moderate-risk patients suggests that these classifications might overestimate risk of ASCVD death. Downgrading patients with ≥ 3 additional ASCVD risk factors to the high-risk category is consistent with mortality data. Risk of death is very high in the presence of TOD irrespective of established ASCVD. Trial registration: ClinicalTrials.gov, NCT00715481.
Published: 2022

11. Predictors of early discontinuation of dapagliflozin versus other glucose-lowering medications: a retrospective multicenter real-world study

Author: Fadini, G. P., Li Volsi, P., Devangelio, E., Poli, M., Cazzetta, G., Felace, G., Avogaro, A., Consoli, A., Formoso, G., Grossi, G., Pucci, A., Sesti, G., Andreozzi, F., Capobianco, G., Gatti, A., Bonadonna, R., Zavaroni, I., Cas, A. D., Buzzetti, R., Leto, G., Sorice, G. P., D'Angelo, P., Morano, S., Bossi, A. C., Duratorre, E., Franzetti, I., Morpurgo, P. S., Orsi, E., Querci, F., Boemi, M., D'Angelo, F., Petrelli, M., Aimaretti, G., Karamouzis, I., Cavalot, F., Saglietti, G., Cervone, S., Lamacchia, O., Arena, S., Di Benedetto, A., Frittitta, L., Giordano, C., Piro, S., Rizzo, M., Chianetta, R., Mannina, C., Anichini, R., Penno, G., Solini, A., Fattor, B., Bonora, E., Cigolini, M., Lapolla, A., Chilelli, N. C., Simioni, N., Frison, V., Vinci, C., Fadini G.P., Li Volsi P., Devangelio E., Poli M., Cazzetta G., Felace G., Avogaro A., Consoli A., Formoso G., Grossi G., Pucci A., Sesti G., Andreozzi F., Capobianco G., Gatti A., Bonadonna R., Zavaroni I., Cas A.D., Buzzetti R., Leto G., Sorice G.P., D'Angelo P., Morano S., Bossi A.C., Duratorre E., Franzetti I., Morpurgo P.S., Orsi E., Querci F., Boemi M., D'Angelo F., Petrelli M., Aimaretti G., Karamouzis I., Cavalot F., Saglietti G., Cervone S., Lamacchia O., Arena S., Di Benedetto A., Frittitta L., Giordano C., Piro S., Rizzo M., Chianetta R., Mannina C., Anichini R., Penno G., Solini A., Fattor B., Bonora E., Cigolini M., Lapolla A., Chilelli N.C., Simioni N., Frison V., and Vinci C.
Subjects: Blood Glucose, Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, Glucosides, Diabetes mellitus, Internal medicine, Adherence, Observational, Pharmacotherapy, Real-world, Aged, Benzhydryl Compounds, Diabetes Mellitus, Type 2, Dipeptidyl-Peptidase IV Inhibitors, Female, Humans, Hypoglycemic Agents, Middle Aged, Retrospective Studies, Withholding Treatment, Diabetes Mellitus, medicine, Outpatient clinic, Dapagliflozin, business.industry, Retrospective cohort study, medicine.disease, Metformin, Discontinuation, chemistry, Tolerability, 030220 oncology & carcinogenesis, business, Type 2, medicine.drug
Abstract: Background and aims: In routine clinical practice, early discontinuation of newly initiated glucose-lowering medications (GLM) is relatively common. We herein evaluated if the clinical characteristics associated with early discontinuation of dapagliflozin were different from those associated with early discontinuation of other GLM. Methods: The DARWIN-T2D was a multicenter retrospective study conducted at diabetes specialist outpatient clinics in Italy. We included 2484 patients who were initiated on dapagliflozin in 2015–2016 and 14,801 patients who were initiated on other GLM (DPP-4 inhibitors, GLP-1 receptor agonists, or gliclazide) in the same period. After excluding patients who had not (yet) returned to follow-up, we compared the characteristics of patients who persisted on drug versus those who were no longer on drug at the first available follow-up after at least 3months. Results: As compared to those who persisted on drug, patients who discontinued dapagliflozin (51.7%) were more often female, had higher baseline fasting plasma glucose (FPG), HbA1c, and eGFR, and less common use of metformin. Upon multiple regression, higher HbA1c, higher eGFR, and lower metformin use remained independently associated with early discontinuation. Among patients who had been initiated on other GLM, 41.7% discontinued. Variables independently associated with discontinuation were older age, longer diabetes duration, higher HbA1c, eGFR, and albumin excretion, more common use of insulin and less metformin. Conclusion: In routine clinical practice, all variables associated with dapagliflozin discontinuation were also associated with discontinuation of other GLM. Thus, despite a distinctive mechanism of action and a peculiar tolerability profile, no specific predictor of dapagliflozin discontinuation was detected.
Published: 2019

12. Insulin resistance, diabetic kidney disease, and all-cause mortality in individuals with type 2 diabetes: a prospective cohort study

Author: Penno G., Solini A., Orsi E., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Zerbini G., Lamacchia O., Nicolucci A., Pugliese G., Laviola L., Penno, G, Solini, A, Orsi, E, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Zerbini, G, Lamacchia, O, Nicolucci, A, Pugliese, G, and Laviola, L
Subjects: Male, medicine.medical_specialty, Mellitu, lcsh:Medicine, 030209 endocrinology & metabolism, Type 2 diabetes, 030204 cardiovascular system & hematology, Type 2 diabete, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Insulin resistance, Risk Factors, Diabetes mellitus, Internal medicine, Diabetes Mellitus, medicine, Humans, Albuminuria, Diabetic Nephropathies, Prospective Studies, Risk factor, Diabetic kidney disease, Prospective cohort study, albuminuria, all-cause mortality, diabetic kidney disease, estimated glucose disposal rate, glomerular filtration rate, mellitus, type 2 diabetes, Cause of death, Aged, Estimated glucose disposal rate, business.industry, Mortality rate, lcsh:R, General Medicine, medicine.disease, All-cause mortality, Survival Analysis, Glomerular filtration rate, Mellitus, Diabetes Mellitus, Type 2, Female, Insulin Resistance, medicine.symptom, business, Type 2, Research Article
Abstract: Background It is unclear whether insulin resistance (IR) contributes to excess mortality in patients with type 2 diabetes independent of diabetic kidney disease (DKD), which is strongly associated with IR and is a major risk factor for cardiovascular disease (CVD), the main cause of death in these individuals. We tested this hypothesis in patients with type 2 diabetes from the Renal Insufficiency And Cardiovascular Events Italian Multicentre Study. Methods This observational, prospective, cohort study enrolled 15,773 patients with type 2 diabetes attending 19 Italian Diabetes Clinics in 2006–2008. Insulin sensitivity was assessed as estimated glucose disposal rate (eGDR), which was validated against the euglycaemic-hyperinsulinemic clamp technique. Vital status on October 31, 2015, was retrieved for 15,656 patients (99.3%). Participants were stratified by eGDR tertiles from T1 (≥ 5.35 mg/kg/min) to T3 (≤ 4.14 mg/kg/min, highest IR). Results CVD risk profile was worse in T2 and T3 vs T1. eGDR tertiles were independently associated with micro- and macroalbuminuria and the albuminuric DKD phenotypes (albuminuria with preserved or reduced estimated glomerular filtration rate [eGFR]) as well as with eGFR categories or the nonalbuminuric DKD phenotype. Over a 7.4-year follow-up, unadjusted death rates and mortality risks increased progressively across eGDR tertiles, but remained significantly elevated after adjustment only in T3 vs T1 (age- and gender- adjusted death rate, 22.35 vs 16.74 per 1000 person-years, p p = 0.002). However, eGDR was independently associated with mortality in participants with no DKD (adjusted HR, 1.214 [95% CI, 1.072–1.375], p = 0.002) and in those with nonalbuminuric DKD (1.276 [1.034–1.575], p = 0.023), but not in those with the albuminuric DKD phenotypes. Moreover, the association was stronger in males and in younger individuals and was observed in those without but not with prior CVD, though interaction was significant only for age. Conclusions The proxy of insulin sensitivity eGDR predicts all-cause mortality in type 2 diabetes, independent of confounders including DKD. However, the impact of IR in individuals with albuminuric DKD may be mediated by its relationship with albuminuria. Trial registration ClinicalTrials.gov, NCT00715481, retrospectively registered 15 July 2008.
Published: 2021

13. Independent association of atherogenic dyslipidaemia with all‐cause mortality in individuals with type 2 diabetes and modifying effect of gender: a prospective cohort study

Author: Orsi, E., Penno, G., Solini, A., Bonora, E., Fondelli, C., Trevisan, R., Vedovato, M., Cavalot, F., Morano, S., Baroni, M. G., Nicolucci, A., Pugliese, G., Laviola, L., Orsi, E, Penno, G, Solini, A, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Morano, S, Baroni, M, Nicolucci, A, and Pugliese, G
Subjects: Male, lcsh:Diseases of the circulatory (Cardiovascular) system, Time Factors, Endocrinology, Diabetes and Metabolism, all-cause mortality, atherogenic dyslipidaemia, HDL cholesterol, triglyceride: HDL cholesterol ratio, triglycerides, type 2 diabetes, All-cause mortality, Atherogenic dyslipidaemia, Triglyceride:HDL cholesterol ratio, Triglycerides, Type 2 diabetes, Atherosclerosis, Biomarkers, Cause of Death, Cholesterol, HDL, Diabetes Mellitus, Type 2, Dyslipidemias, Female, Heart Disease Risk Factors, Humans, Italy, Prognosis, Prospective Studies, Risk Assessment, Sex Factors, Triglyceride, Type 2 diabete, chemistry.chemical_compound, Prospective cohort study, Original Investigation, Mortality rate, Hazard ratio, Cholesterol, Quartile, lipids (amino acids, peptides, and proteins), Cardiology and Cardiovascular Medicine, Type 2, medicine.medical_specialty, HDL, Diabetes mellitus, Internal medicine, Diabetes Mellitus, medicine, business.industry, nutritional and metabolic diseases, medicine.disease, Endocrinology, chemistry, lcsh:RC666-701, business
Abstract: Background Atherogenic dyslipidaemia has been implicated in the residual risk for cardiovascular morbidity and mortality, which remains despite attainment of LDL cholesterol goals especially in individuals with type 2 diabetes. However, its relationship with all-cause death has not been sufficiently explored. This analysis evaluated the independent association of increased triglycerides and triglyceride:HDL cholesterol ratio (TG:HDL) and decreased HDL cholesterol with total mortality and the possible modifying effect of gender in a large cohort of patients with type 2 diabetes. Methods This observational, prospective study enrolled 15,773 patients in 19 Diabetes Clinics throughout Italy in the years 2006–2008. Triglycerides and total and HDL cholesterol were measured by colorimetric enzymatic methods. Vital status was retrieved on 31 October 2015 for 15,656 patients (99.3%). Participants were stratified by quartiles of triglycerides, HDL cholesterol, and TG:HDL. Results There were 3,602 deaths over a follow-up 7.42 ± 2.05 years (31.0 × 1000 person-years). In the unadjusted analyses, the highest TG:HDL (but not triglyceride) and the lowest HDL cholesterol quartile were associated with increased death rate and mortality risk. When sequentially adjusting for confounders, including total, LDL, or non-HDL cholesterol and lipid-lowering treatment, mortality risk was significantly higher in the highest triglyceride (hazard ratio 1.167 [95% confidence interval 1.055–1.291], p = 0.003) and TG:HDL (1.192 [1.082–1.314], p p p = 0.0009). The relationship with death was stronger for triglycerides in males and HDL cholesterol in females, with these associations remaining significant even after adjustment for HDL cholesterol (1.161 [1.019–1.324], p = 0.025, for the highest vs the lowest triglyceride quartile) and triglycerides (1.366 [1.176–1.587], p Conclusions In patients with type 2 diabetes, higher triglycerides and TG:HDL and lower HDL cholesterol were independently associated with increased all-cause mortality, with a modifying effect of gender for triglycerides and HDL cholesterol. These data suggest that atherogenic dyslipidaemia, especially TG:HDL, may serve as predictor of all-cause death in these individuals. Trial registration ClinicalTrials.gov, NCT00715481, 15 July, 2008
Published: 2021

14. Is resistant hypertension an independent predictor of all-cause mortality in individuals with type 2 diabetes? A prospective cohort study

Author: Solini, A, Penno, G, Orsi, E, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Lamacchia, O, Baroni, M, Nicolucci, A, Pugliese, G, Bollanti, L, Alessi, E, Vitale, M, Cirrito, T, Cavallo-Perin, P, Gruden, G, Lorenzati, B, Trovati, M, Di Martino, L, Mazzaglia, F, Zerbini, G, Martina, V, Maestroni, S, Capuano, V, Palmieri, E, Lunati, E, Grancini, V, Resi, V, Pontiroli, A, Veronelli, A, Zecchini, B, Arosio, M, Montefusco, L, Rossi, A, Adda, G, Corsi, A, Albizzi, M, Zoppini, G, Avogaro, A, Pucci, L, Lucchesi, D, Russo, E, Garofolo, M, Dotta, F, Nigi, L, Morano, S, Filardi, T, Turinese, I, Rossetti, M, Buzzetti, R, Foffi, C, Cignarelli, M, Pinnelli, S, Monaco, L, Giorgino, F, Laviola, L, Natalicchio, A, Sesti, G, Andreozzi, F, Frau, G, Boi, A, Solini A., Penno G., Orsi E., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Lamacchia O., Baroni M. G., Nicolucci A., Pugliese G., Bollanti L., Alessi E., Vitale M., Cirrito T., Cavallo-Perin P., Gruden G., Lorenzati B., Trovati M., Di Martino L., Mazzaglia F., Zerbini G., Martina V., Maestroni S., Capuano V., Palmieri E., Lunati E., Grancini V., Resi V., Pontiroli A., Veronelli A., Zecchini B., Arosio M., Montefusco L., Rossi A., Adda G., Corsi A., Albizzi M., Zoppini G., Avogaro A., Pucci L., Lucchesi D., Russo E., Garofolo M., Dotta F., Nigi L., Morano S., Filardi T., Turinese I., Rossetti M., Buzzetti R., Foffi C., Cignarelli M., Pinnelli S., Monaco L., Giorgino F., Laviola L., Natalicchio A., Sesti G., Andreozzi F., Frau G., Boi A., Solini, A, Penno, G, Orsi, E, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Lamacchia, O, Baroni, M, Nicolucci, A, Pugliese, G, Bollanti, L, Alessi, E, Vitale, M, Cirrito, T, Cavallo-Perin, P, Gruden, G, Lorenzati, B, Trovati, M, Di Martino, L, Mazzaglia, F, Zerbini, G, Martina, V, Maestroni, S, Capuano, V, Palmieri, E, Lunati, E, Grancini, V, Resi, V, Pontiroli, A, Veronelli, A, Zecchini, B, Arosio, M, Montefusco, L, Rossi, A, Adda, G, Corsi, A, Albizzi, M, Zoppini, G, Avogaro, A, Pucci, L, Lucchesi, D, Russo, E, Garofolo, M, Dotta, F, Nigi, L, Morano, S, Filardi, T, Turinese, I, Rossetti, M, Buzzetti, R, Foffi, C, Cignarelli, M, Pinnelli, S, Monaco, L, Giorgino, F, Laviola, L, Natalicchio, A, Sesti, G, Andreozzi, F, Frau, G, Boi, A, Solini A., Penno G., Orsi E., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Lamacchia O., Baroni M. G., Nicolucci A., Pugliese G., Bollanti L., Alessi E., Vitale M., Cirrito T., Cavallo-Perin P., Gruden G., Lorenzati B., Trovati M., Di Martino L., Mazzaglia F., Zerbini G., Martina V., Maestroni S., Capuano V., Palmieri E., Lunati E., Grancini V., Resi V., Pontiroli A., Veronelli A., Zecchini B., Arosio M., Montefusco L., Rossi A., Adda G., Corsi A., Albizzi M., Zoppini G., Avogaro A., Pucci L., Lucchesi D., Russo E., Garofolo M., Dotta F., Nigi L., Morano S., Filardi T., Turinese I., Rossetti M., Buzzetti R., Foffi C., Cignarelli M., Pinnelli S., Monaco L., Giorgino F., Laviola L., Natalicchio A., Sesti G., Andreozzi F., Frau G., and Boi A.
Abstract: Background: Resistant hypertension is independently associated with an increased risk of death in the general hypertensive population. We assessed whether resistant hypertension is an independent predictor of all-cause mortality in individuals with type 2 diabetes from the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicentre Study. Methods: On 31 October 2015, vital status information was retrieved for 15,656 of the 15,773 participants enrolled in 2006-2008. Based on baseline blood pressure (BP) values and treatment, participants were categorized as normotensive, untreated hypertensive, controlled hypertensive (i.e., on-target with < 3 drugs), uncontrolled hypertensive (i.e., not on-target with 1-2 drugs), or resistant hypertensive (i.e., uncontrolled with > 3 drugs or controlled with > 4 drugs). Kaplan-Meier and Cox proportional hazards regression analyses were used to assess the association with all-cause mortality. Results: Using the 130/80 mmHg targets for categorization, crude mortality rates and Kaplan-Meier estimates were highest among resistant hypertension participants, especially those with controlled resistant hypertension. As compared with resistant hypertension, risk for all-cause mortality was significantly lower for all the other groups, including individuals with controlled hypertension (hazard ratio 0.81 [95% confidence interval 0.74-0.89], P < 0.0001), but became progressively similar between resistant and controlled hypertension after adjustment for cardiovascular risk factors and complications/comorbidities. Also when compared with controlled resistant hypertension, mortality risk was significantly lower for all the other groups, including controlled hypertension, even after adjusting for cardiovascular risk factors (0.77 [0.63-0.95], P = 0.012), but not for complications/comorbidities (0.88 [0.72-1.08], P = 0.216). BP was well below target in the controlled hypertensive groups (resistant and non-resistant) and values < 120/7
Published: 2019

15. Cardiovascular risk management in type 2 diabetes mellitus: a joint position paper of the Italian Cardiology (SIC) and Italian Diabetes (SID) Societies

Author: Avogaro, A, Barillà, F, Cavalot, F, Consoli, A, Federici, M, Mancone, M, Paolillo, S, Pedrinelli, R, Perseghin, G, Filardi, P, Scicali, R, Sinagra, G, Spaccarotella, C, Indolfi, C, Purrello, F, Avogaro, Angelo, Barillà, Francesco, Cavalot, Franco, Consoli, Agostino, Federici, Massimo, Mancone, Massimo, Paolillo, Stefania, Pedrinelli, Roberto, Perseghin, Gianluca, Filardi, Pasquale Perrone, Scicali, Roberto, Sinagra, Gianfranco, Spaccarotella, Carmen, Indolfi, Ciro, Purrello, Francesco, Avogaro, A, Barillà, F, Cavalot, F, Consoli, A, Federici, M, Mancone, M, Paolillo, S, Pedrinelli, R, Perseghin, G, Filardi, P, Scicali, R, Sinagra, G, Spaccarotella, C, Indolfi, C, Purrello, F, Avogaro, Angelo, Barillà, Francesco, Cavalot, Franco, Consoli, Agostino, Federici, Massimo, Mancone, Massimo, Paolillo, Stefania, Pedrinelli, Roberto, Perseghin, Gianluca, Filardi, Pasquale Perrone, Scicali, Roberto, Sinagra, Gianfranco, Spaccarotella, Carmen, Indolfi, Ciro, and Purrello, Francesco
Abstract: Aim: This review represents a joint effort of the Italian Societies of Cardiology (SIC) and Diabetes (SID) to define the state of the art in a field of great clinical and scientific interest which is experiencing a moment of major cultural advancements, the cardiovascular risk management in type 2 diabetes mellitus. Data synthesis: Consists of six chapters that examine various aspects of pathophysiology, diagnosis and therapy which in recent months have seen numerous scientific innovations and several clinical studies that require extensive sharing. Conclusions: The continuous evolution of our knowledge in this field confirms the great cultural vitality of these two cultural spheres, which requires, under the leadership of the scientific Societies, an ever greater and effective collaboration.
Published: 2021

16. The clinical reality of guidelines for primary prevention of cardiovascular disease in type 2 diabetes in Italy

Author: Vaccaro, O., Boemi, M., Cavalot, F., De Feo, P., Miccoli, R., Patti, L., Rivellese, A.A., Trovati, M., Ardigò, D., and Zavaroni, I.
Published: 2008
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17. Similar effectiveness of dapagliflozin and GLP-1 receptor agonists concerning combined endpoints in routine clinical practice: A multicentre retrospective study

Author: Fadini, G. P., Sciannameo, V., Franzetti, I., Bottigliengo, D., D'Angelo, P., Vinci, C., Berchialla, P., Arena, S., Buzzetti, R., Avogaro, A., Consoli, A., Formoso, G., Grossi, G., Pucci, A., Sesti, G., Andreozzi, F., Capobianco, G., Gatti, A., Bonadonna, R., Zavaroni, I., Cas, A. D., Felace, G., Volsi, P. L., Leto, G., Sorice, G. P., Morano, S., Bossi, A. C., Duratorre, E., Morpurgo, P. S., Orsi, E., Querci, F., Boemi, M., D'Angelo, F., Petrelli, M., Aimaretti, G., Karamouzis, I., Cavalot, F., Saglietti, G., Cazzetta, G., Cervone, S., Devangelio, E., Lamacchia, O., Di Benedetto, A., Frittitta, L., Giordano, C., Piro, S., Rizzo, M., Chianetta, R., Mannina, C., Anichini, R., Penno, G., Solini, A., Fattor, B., Bonora, E., Cigolini, M., Lapolla, A., Chilelli, N. C., Poli, M., Simioni, N., Frison, V., Fadini G.P., Sciannameo V., Franzetti I., Bottigliengo D., D'Angelo P., Vinci C., Berchialla P., Arena S., Buzzetti R., Avogaro A., Consoli A., Formoso G., Grossi G., Pucci A., Sesti G., Andreozzi F., Capobianco G., Gatti A., Bonadonna R., Zavaroni I., Cas A.D., Felace G., Volsi P.L., Leto G., Sorice G.P., Morano S., Bossi A.C., Duratorre E., Morpurgo P.S., Orsi E., Querci F., Boemi M., D'Angelo F., Petrelli M., Aimaretti G., Karamouzis I., Cavalot F., Saglietti G., Cazzetta G., Cervone S., Devangelio E., Lamacchia O., Di Benedetto A., Frittitta L., Giordano C., Piro S., Rizzo M., Chianetta R., Mannina C., Anichini R., Penno G., Solini A., Fattor B., Bonora E., Cigolini M., Lapolla A., Chilelli N.C., Poli M., Simioni N., and Frison V.
Subjects: Blood Glucose, Male, Glycated Hemoglobin A, Endocrinology, Diabetes and Metabolism, Blood Pressure, Type 2 diabetes, 030204 cardiovascular system & hematology, Settore MED/13 - Endocrinologia, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, Glucosides, Clinical endpoint, Medicine, Dapagliflozin, GLP-1 analogue, Middle Aged, Treatment Outcome, glycaemic control, antidiabetic drug, dapagliflozin, observational study, Combination, Original Article, Drug Therapy, Combination, Female, Type 2, medicine.drug, Adult, medicine.medical_specialty, 030209 endocrinology & metabolism, Glucagon-Like Peptide-1 Receptor, 03 medical and health sciences, Drug Therapy, GLP‐1 analogue, Internal medicine, Diabetes mellitus, Internal Medicine, Diabetes Mellitus, Humans, Hypoglycemic Agents, Benzhydryl Compounds, Aged, Retrospective Studies, Glycated Hemoglobin, Body Weight, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Exenatide, Liraglutide, business.industry, Retrospective cohort study, Original Articles, medicine.disease, Blood pressure, chemistry, Propensity score matching, business, Antidiabetic drug, dapagliflozin, GLP-1 analogue, glycaemic control, observational study
Abstract: Aims According to cardiovascular outcome trials, some sodium‐glucose contransporter‐2 inhibitors (SGLT2i) and glucagon‐like peptide‐1 receptor agonists (GLP‐1RA) are recommended for secondary cardiovascular prevention in type 2 diabetes (T2D). In this real‐world study, we compared the simultaneous reductions in HbA1c, body weight and systolic blood pressure after initiation of dapagliflozin or GLP‐1RA as second or a more advanced line of therapy. Materials and methods DARWIN‐T2D was a retrospective multi‐centre study conducted at diabetes specialist clinics in Italy that compared T2D patients who initiated dapagliflozin or GLP‐1RA (exenatide once weekly or liraglutide). Data were collected at baseline and at the first follow‐up visit after 3 to 12 months. The primary endpoint was the proportion of patients achieving a simultaneous reduction in HbA1c, body weight and systolic blood pressure. To reduce confounding, we used multivariable adjustment (MVA) or propensity score matching (PSM). Results Totals of 473 patients initiating dapagliflozin and 336 patients initiating GLP‐1RA were included. The two groups differed in age, diabetes duration, HbA1c, weight and concomitant medications. The median follow‐up was 6 months in both groups. Using MVA or PSM, the primary endpoint was observed in 30% to 32% of patients, with no difference between groups. Simultaneous reduction of HbA1c, BP and SBP by specific threshold, as well as achievement of final goals, did not differ between groups. GLP‐1RA reduced HbA1c by 0.3% more than the reduction achieved with dapagliflozin. Conclusion In routine specialist care, initiation of dapagliflozin can be as effective as initiation of a GLP‐1RA for attainment of combined risk factor goals.
Published: 2019

18. Dietary habits in type II diabetes mellitus: how is adherence to dietary recommendations?

Author: Rivellese, A A, Boemi, M, Cavalot, F, Costagliola, L, De Feo, P, Miccoli, R, Patti, L, Trovati, M, Vaccaro, O, and Zavaroni, I
Published: 2008
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19. Defining the contribution of chronic kidney disease to all-cause mortality in patients with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study

Author: Penno, G, Solini, A, Bonora, E, Orsi, E, Fondelli, C, Zerbini, G, Trevisan, R, Vedovato, M, Cavalot, F, Laviola, L, Nicolucci, A, Pugliese, G, Penno G., Solini A., Bonora E., Orsi E., Fondelli C., Zerbini G., Trevisan R., Vedovato M., Cavalot F., Laviola L., Nicolucci A., Pugliese G., Penno, G, Solini, A, Bonora, E, Orsi, E, Fondelli, C, Zerbini, G, Trevisan, R, Vedovato, M, Cavalot, F, Laviola, L, Nicolucci, A, Pugliese, G, Penno G., Solini A., Bonora E., Orsi E., Fondelli C., Zerbini G., Trevisan R., Vedovato M., Cavalot F., Laviola L., Nicolucci A., and Pugliese G.
Abstract: Aims: To define the contribution of chronic kidney disease (CKD) to excess mortality in patients with type 2 diabetes and identify the baseline variables associated with all-cause death in those with and without CKD using the RECursive Partitioning and Amalgamation (RECPAM) method. Methods: This observational, longitudinal, cohort study enrolled 15,773 consecutive non-dialytic patients with type 2 diabetes in 19 Diabetes Clinics throughout Italy in 2006–2008. Based on the presence of albuminuria ≥ 30 mg day−1 and/or estimated glomerular filtration rate (eGFR) < 60 mL min−1·1.73 m−2 at baseline, patients were classified as having or not CKD. Vital status was verified on October 31, 2015 for 99.26% of patients. Results: Mortality increased with increasing albuminuria and eGFR category. Excess risk versus the general population was maximal in patients aged < 55 years in the worse albuminuria or eGFR category. Conversely, in subjects aged ≥ 75 years with albuminuria < 10 mg day−1 or eGFR ≥ 75 mL min−1·1.73 m−2, excess mortality was no longer detectable. At RECPAM analysis, the main correlates of death in the whole cohort were albuminuria > 44 mg day−1, prevalent CVD, and eGFR < ~ 75 mL min−1·1.73 m−2; gender, prevalent CVD, and higher albuminuria in the normoalbuminuric range, in patients without CKD; and CVD, eGFR ~ < 50 mL min−1·1.73 m−2, and albuminuria > 53 mg day−1, in those with CKD. Conclusions: CKD is a major contributor to excess mortality in type 2 diabetes, conferring a very high risk in younger patients and fully accounting for excess risk in the older ones. Higher albuminuria and lower eGFR, even in the normal range, identify individuals with increased mortality risk. Trial registration ClinicalTrials.gov (NCT00715481; https://clinicaltrials.gov/ct2/show/NCT00715481).
Published: 2018

20. Haemoglobin A1c variability is a strong, independent predictor of all-cause mortality in patients with type 2 diabetes

Author: Orsi, E, Solini, A, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Gruden, G, Morano, S, Nicolucci, A, Penno, G, Pugliese, G, Orsi E., Solini A., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Gruden G., Morano S., Nicolucci A., Penno G., Pugliese G., Orsi, E, Solini, A, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Gruden, G, Morano, S, Nicolucci, A, Penno, G, Pugliese, G, Orsi E., Solini A., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Gruden G., Morano S., Nicolucci A., Penno G., and Pugliese G.
Abstract: Aims: To evaluate various measures of haemoglobin (Hb) A1c variability, compared with average HbA1c, as independent predictors of mortality. Materials and Methods: The Renal Insufficiency And Cardiovascular Events Italian multicentre study enroled 15 733 patients with type 2 diabetes from 19 diabetes clinics during 2006-2008. A total of 3 to 5 HbA1c measures, obtained during the 2-year period before enrolment, were available from 9 centres (8290 patients) and were used to calculate average HbA1c (HbA1c -MEAN) and HbA1c variability, measured as intra-individual standard deviation (HbA1c-SD), SD adjusted for the number of HbA1c assessments (HbA1c-AdjSD) and coefficient of variation (HbA1c-CV), that is, the HbA1c-SD to HbA1c-MEAN ratio. Vital status on October 31, 2015 was retrieved for 8252 patients (99.5%). Results: The measures of HbA1c variability increased according to quartiles of HbA1c-MEAN and vice versa. HbA1c-MEAN and measures of HbA1c variability were associated with all-cause mortality; however, the strength of association of HbA1c-MEAN was lower than that of HbA1c -SD, HbA1c-CV or HbA1c-AdjSD, and disappeared after adjusting for confounders and any of the measures of HbA1c variability. Mortality increased with quartiles of HbA1c-MEAN, HbA1c -SD, HbA1c-CV and HbA1c-AdjSD, but only the association with HbA1c variability measures remained after adjustment for confounders and/or each other measure. In the fully adjusted model, mortality risk was lower for HbA1c-SD below the median and higher for HbA1c-SD above the median, regardless of whether HbA1c-MEAN was below or above the median. Conclusions HbA1c variability is a strong, independent predictor of all-cause mortality in type 2 diabetes and appears to be even more powerful than average HbA1c in predicting mortality.
Published: 2018

21. Non-albuminuric renal impairment is a strong predictor of mortality in individuals with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian multicentre study

Author: Penno, G, Solini, A, Orsi, E, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Lamacchia, O, Scardapane, M, Nicolucci, A, Pugliese, G, Penno G., Solini A., Orsi E., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Lamacchia O., Scardapane M., Nicolucci A., Pugliese G., Penno, G, Solini, A, Orsi, E, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Lamacchia, O, Scardapane, M, Nicolucci, A, Pugliese, G, Penno G., Solini A., Orsi E., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Lamacchia O., Scardapane M., Nicolucci A., and Pugliese G.
Abstract: Aims/hypothesis: Non-albuminuric renal impairment has become the prevailing diabetic kidney disease (DKD) phenotype in individuals with type 2 diabetes and an estimated GFR (eGFR) <60 ml min−1 1.73 m−2. In the present study, we compared the rate and determinants of all-cause death in individuals with this phenotype with those in individuals with albuminuric phenotypes. Methods: This observational prospective cohort study enrolled 15,773 individuals with type 2 diabetes in 2006–2008. Based on baseline albuminuria and eGFR, individuals were classified as having: no DKD (Alb−/eGFR−), albuminuria alone (Alb+/eGFR−), reduced eGFR alone (Alb−/eGFR+), or both albuminuria and reduced eGFR (Alb+/eGFR+). Vital status on 31 October 2015 was retrieved for 15,656 individuals (99.26%). Results: Mortality risk adjusted for confounders was lowest for Alb−/eGFR− (reference category) and highest for Alb+/eGFR+ (HR 2.08 [95% CI 1.88, 2.30]), with similar values for Alb+/eGFR− (1.45 [1.33, 1.58]) and Alb−/eGFR+ (1.58 [1.43, 1.75]). Similar results were obtained when individuals were stratified by sex, age (except in the lowest age category) and prior cardiovascular disease. In normoalbuminuric individuals with eGFR <45 ml min−1 1.73 m−2, especially with low albuminuria (10–29 mg/day), risk was higher than in microalbuminuric and similar to macroalbuminuric individuals with preserved eGFR. Using recursive partitioning and amalgamation analysis, prevalent cardiovascular disease and lower HDL-cholesterol were the most relevant correlates of mortality in all phenotypes. Higher albuminuria within the normoalbuminuric range was associated with death in non-albuminuric DKD, whereas the classic ‘microvascular signatures’, such as glycaemic exposure and retinopathy, were correlates of mortality only in individuals with albuminuric phenotypes. Conclusions/interpretation: Non-albuminuric renal impairment is a strong predictor of mortality, thus supporting
Published: 2018

22. Association between On-Treatment Haemoglobin A1c and All-Cause Mortality in Individuals with Type 2 Diabetes: Importance of Personalized Goals and Type of Anti-Hyperglycaemic Treatment

Author: Orsi, E, Bonora, E, Solini, A, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Zerbini, G, Morano, S, Nicolucci, A, Penno, G, Pugliese, G, Orsi, Emanuela, Bonora, Enzo, Solini, Anna, Fondelli, Cecilia, Trevisan, Roberto, Vedovato, Monica, Cavalot, Franco, Zerbini, Gianpaolo, Morano, Susanna, Nicolucci, Antonio, Penno, Giuseppe, Pugliese, Giuseppe, Orsi, E, Bonora, E, Solini, A, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Zerbini, G, Morano, S, Nicolucci, A, Penno, G, Pugliese, G, Orsi, Emanuela, Bonora, Enzo, Solini, Anna, Fondelli, Cecilia, Trevisan, Roberto, Vedovato, Monica, Cavalot, Franco, Zerbini, Gianpaolo, Morano, Susanna, Nicolucci, Antonio, Penno, Giuseppe, and Pugliese, Giuseppe
Abstract: The increased mortality reported with intensive glycaemic control has been attributed to an increased risk of treatment-related hypoglycaemia. This study investigated the relationships of haemoglobin (Hb) A(1c), anti-hyperglycaemic treatment, and potential risks of adverse effects with all-cause mortality in patients with type 2 diabetes. Patients (n = 15,773) were stratified into four categories according to baseline HbA(1c) and then assigned to three target categories, based on whether HbA(1c) was <= 0.5% below or above (on-target), >0.5% below (below-target) or >0.5% above (above-target) their HbA(1c) goal, personalized according to the number of potential risks among age > 70 years, diabetes duration > 10 years, advanced complication(s), and severe comorbidity (ies). The vital status was retrieved for 15,656 patients (99.26%). Over a 7.4-year follow-up, mortality risk was increased among patients in the highest HbA(1c) category (>= 8.5%) (adjusted hazard ratio, 1.34 (95% confidence interval, 1.22-1.47), p < 0.001) and those above-target (1.42 (1.29-1.57), p < 0.001). Risk was increased among individuals in the lowest HbA(1c) category (<6.5%) and those below-target only if treated with agents causing hypoglycaemia (1.16 (1.03-1.29), p = 0.01 and 1.10 (1.01-1.22), p = 0.04, respectively). These data suggest the importance of setting both upper and lower personalized HbA(1c) goals to avoid overtreatment in high-risk individuals with type 2 diabetes treated with agents causing hypoglycaemia.
Published: 2020

23. How can we monitor glycaemic variability in the clinical setting?

Author: Inchiostro, S., Candido, R., and Cavalot, F.
Published: 2013
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24. Do data in the literature indicate that glycaemic variability is a clinical problem? Glycaemic variability and vascular complications of diabetes

Author: Cavalot, F.
Published: 2013
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25. Daily glycaemic variability: benefits of optimal control

Author: Cavalot, F.
Published: 2013
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26. Human vascular smooth muscle cells express a constitutive nitric oxide synthase that insulin rapidly activates, thus increasing guanosine 3′ : 5′-cyclic monophosphate and adenosine 3′ : 5′-cyclic monophosphate concentrations

Author: Trovati, M., Massucco, P., Mattiello, L., Costamagna, C., Aldieri, E., Cavalot, F., Anfossi, G., Bosia, A., and Ghigo, D.
Published: 1999
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27. Clinical application of best practice guidelines for the genetic diagnosis of MODY2 and MODY3

Author: Incani, M., Cambuli, V. M., Cavalot, F., Congiu, T., Paderi, M., Sentinelli, F., Romeo, S., Poy, P., Soro, M., Pilia, S., Loche, S., Cossu, E., Trovati, M., Mariotti, S., and Baroni, M. G.
Published: 2010
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28. Comparative Effectiveness of DPP-4 Inhibitors Versus Sulfonylurea for the Treatment of Type 2 Diabetes in Routine Clinical Practice: A Retrospective Multicenter Real-World Study

Author: Fadini, Gian Paolo, Bottigliengo, Daniele, D'Angelo, Federica, Cavalot, Franco, Bossi, Antonio Carlo, Zatti, Giancarlo, Baldi, Ileana, Avogaro, A, Consoli, A, Formoso, G, Grossi, G, Pucci, A, Sesti, G, Andreozzi, F, Capobianco, G, Gatti, A, Bonadonna, R, Zavaroni, I, Cas, Ad, Felace, G, Volsi, Pl, Buzzetti, R, Leto, G, Sorice, Gp, D'Angelo, P, Morano, S, Bossi, Ac, Duratorre, E, Franzetti, I, Morpurgo, Ps, Orsi, E, Querci, F, Boemi, M, D'Angelo, F, Petrelli, M, Aimaretti, G, Karamouzis, I, Cavalot, F, Saglietti, G, Cazzetta, G, Cervone, S, Devangelio, E, Lamacchia, O, Arena, S, Benedetto, Di, A, Frittitta, L, Giordano, C, Piro, S, Rizzo, M, Chianetta, R, Mannina, C, Anichini, R, Penno, G, Solini, A, Fattor, B, Bonora, E, Cigolini, M, Lapolla, A, Chilelli, Nc, Poli, M, Simioni, N, Frison, V, Vinci, C, Fadini G.P., Bottigliengo D., D'Angelo F., Cavalot F., Bossi A.C., Zatti G., Baldi I., Avogaro A., Consoli A., Formoso G., Grossi G., Pucci A., Sesti G., Andreozzi F., Capobianco G., Gatti A., Bonadonna R., Zavaroni I., Cas A.D., Felace G., Volsi P.L., Buzzetti R., Leto G., Sorice G.P., D'Angelo P., Morano S., Duratorre E., Franzetti I., Morpurgo P.S., Orsi E., Querci F., Boemi M., Petrelli M., Aimaretti G., Karamouzis I., Saglietti G., Cazzetta G., Cervone S., Devangelio E., Lamacchia O., Arena S., Di Benedetto A., Frittitta L., Giordano C., Piro S., Rizzo M., Chianetta R., Mannina C., Anichini R., Penno G., Solini A., Fattor B., Bonora E., Cigolini M., Lapolla A., Chilelli N.C., Poli M., Simioni N., Frison V., and Vinci C.
Subjects: endocrine system, medicine.medical_specialty, Epidemiology, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, 030204 cardiovascular system & hematology, Database, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Diabetes mellitus, Internal medicine, medicine, Clinical endpoint, Pharmacotherapy, Internal Medicine, Outpatient clinic, Gliclazide, Original Research, Glycemic, business.industry, nutritional and metabolic diseases, Retrospective cohort study, medicine.disease, Metformin, Diabetes and Metabolism, business, medicine.drug
Abstract: Introduction DPP-4 inhibitors (DPP4i) and sulfonylureas are popular second-line therapies for type 2 diabetes (T2D), but there is a paucity of real-world studies comparing their effectiveness in routine clinical practice. Methods This was a multicenter retrospective study on diabetes outpatient clinics comparing the effectiveness of DPP4i versus gliclazide extended release. The primary endpoint was change from baseline in HbA1c. Secondary endpoints were changes in fasting plasma glucose, body weight, and systolic blood pressure. Automated software extracted data from the same clinical electronic chart system at all centers. Propensity score matching (PSM) was used to generate comparable cohorts to perform outcome analysis. Results We included data on 2410 patients starting DPP4i and 1590 patients starting gliclazide (mainly 30–60 mg/day). At baseline, the two groups differed in disease duration, body weight, blood pressure, HbA1c, fasting glucose, HDL cholesterol, triglycerides, liver enzymes, eGFR, prevalence of microangiopathy, and use of metformin. Among DPP4i molecules, no difference in glycemic effectiveness was detected. In matched cohorts (n = 1316/group), patients starting DPP4i, as compared with patients starting gliclazide, experienced greater reductions in HbA1c (− 0.6% versus − 0.4%; p
Published: 2018

29. Influence of protamine on adhesion, chemotaxis and proliferation of human vascular smooth muscle cells

Author: Cavalot, F., Russo, I., Mattiello, L., Anfossi, G., Massucco, P., Mularoni, E., Hahn, A. W., and Trovati, M.
Published: 1997
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30. Studies on the influence of insulin on cyclic adenosine monophosphate in human vascular smooth muscle cells: dependence on cyclic guanosine monophosphate and modulation of catecholamine effects

Author: Trovati, M., Massucco, P., Mattiello, L., Cavalot, F., Mularoni, E. M., Hahn, A. W., and Anfossi, G.
Published: 1996
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31. Insulin increases cyclic nucleotide content in human vascular smooth muscle cells: a mechanism potentially involved in insulin-induced modulation of vascular tone

Author: Trovati, M., Massucco, P., Mattiello, L., Cavalot, F., Mularoni, E., Hahn, A., and Anfossi, G.
Published: 1995
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32. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes

Author: Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR, Josse RG, Califf RM, Goldstein BJ, Shapiro DR, Silverman R, Bethel A, Green J, Hayden S, Hannan K, Quintero K, Rorick T, Berdan L, Leloudis D, Califf S, Wilson M, McFarron D, Trollinger K, Pesarchick J, Eskenazi L, Campbell C, Townes O, Tolsma D, Keenan J, Milton J, Athwal R, Darbyshire J, Doran Z, Kennedy I, Gregory V, Lokhnygina Y, Prather K, Wolfley A, Usman M, Tajjar A, Gray R, Pfeffer MA, Gerstein HC, Groop L, McMurray JJ, Pocock SJ, Clayton T, Sinay I, Brieger D, Stranks S, Scheen A, Lopes R, Tankova T, Hramiak I, Grado CR, Wenying Y, Ge J, Aschner P, Skrha J, Ambos A, Strandberg T, Travert F, Hanefeld M, Riefflin A, Chan JC, Ofner P, Reddy NK, Christopher J, Mathur A, Arambam P, Mittal S, Manchanda M, Wainstein J, Ambrosio G, Pirags V, Jakuboniene N, Mohamed M, Scott R, White H, Cornel J, Halvorsen S, Tykarski A, Veresiu IA, Dreval AV, Misinkova I, Tai E, Krahulec B, Distiller L, Park Y, Rovira A, Alversson M, Chuang LM, Delibasi T, Adler A, Rodbard HW, Marre M, Goff D, Chacra A, DeVore A, Beaven A, Shah B, Hirsch B, Batch B, Bushnell C, Patel C, Melloni C, Henshaw C, Kong D, Bernecki G, Tillman H, Kang HJ, Hawes J, Strickler J, Piccini J, Wilder J, Alexander K, Mahaffey K, Patel K, Hyland K, Newby K, Jackson L, Cooper L, Armaganijan L, Szczeh L, Koshizaka M, Roe M, Morse M, Guimaraes P, Hess P, Tricoci P, Mehta R, Mathews R, Kociol R, Harrison R, Mentz R, Pokorney S, Leblanc T, Lazzarini V, Eapen Z, Truffa A, Fosbol E, Brito F, Katz M, Bahit M, Santos M, Barros P, Bernardez S, Alvarisqueta AF, Arias P, Cagide AL, Calella PR, Cantero MC, Canella JP, Cipullo MA, de Loredo L, Gelersztein ES, Gorban de Lapertosa SB, Klyver MI, Maffei LE, Maldonado N, Oviedo AI, Piskorz DL, Ridruejo MC, Saavedra SS, Sessa HA, Sinay IR, Sposetti GD, Ulla MR, Vico 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Alexandru C, Crisan C, Dumitrescu A, Ferariu IE, Lupusoru DA, Munteanu M, Negru D, Nicolau A, Pintiliei E, Popescu A, Serban G, Veresiu IA, Voitec M, Babenko A, Barbarash O, Bondar I, Chizhov P, Demin A, Dora S, Dreval A, Ershova O, Gratsiansky N, Ketova G, Kotelnikov M, Levashov S, Morugova T, Mustafina S, Pekarskiy S, Raskina T, Rechkova E, Samoylova Y, Sazonova O, Sherenkov A, Shilkina N, Stetsyuk O, Tretyakova T, Turova E, Valeeva F, Zadionchenko V, Dalan R, Tan RS, Tay L, Buganova I, Fabry J, Jan C, Krahulec B, Toserova E, Zak R, Zimanova J, Badat A, Bester F, Burgess L, De Jong D, Distiller L, Ellis G, Fouche L, Govender P, Govind U, Naidoo V, Nieuwoudt G, Nortje H, Rheeder P, Robertson L, Siddique N, Stapelberg AM, Trinder Y, Van Der Merwe A, Van Zyl L, Viljoen M, Wilhase A, Botella M, Civeira Murillo F, de Teresa L, Del Cañizo FJ, Extremera BG, Gimeno EJ, Martin-Hidalgo A, Morales C, Nubiola A, Rovira A, Tinahones Madueño F, Tranche S, Trescolí Serrano C, Alvarsson M, Eizyk E, Gillblad A, Johansson P, Löndahl M, Ohlsson-Önerud Å, Rautio A, Sundström U, Torstensson I, Chen JF, Chou CW, Chuang LM, Ho LT, Hsieh IC, Huang BH, Huang CL, Huang CN, Lai WT, Lo PH, Pei D, Sheu WH, Wang SY, Araz M, Bakiner O, Comlekci A, Delibasi T, Guler S, Sahin I, Sarac F, Tarkun I, Ukinc K, Yilmaz M, Abdulhakim E, Abraham P, Adamson K, Adler A, Blagden M, Bundy C, Daly M, Davies M, Deshpande M, Gillings S, Harvey P, Horvathova V, Horvathova V, Hristova D, Jaap A, Johnson A, Jones H, Kerrane J, Kilvert A, Ko T, Kumar J, Lindsay R, Litchfield J, McCrimmon R, McKnight J, Millward B, Oyesile B, Purewal T, Ravikumar C, Robinson A, Sathyapalan T, Simpson H, Thomas H, Turner W, Weaver J, Wilding J, Wiles P, Adkins K, Akpunonu B, Albu J, Anagnostis G, Anastasi L, Argoud G, Aroda V, Azizad M, Banerji MA, Bartkowiak A Jr, Bays H, Behn P, Bergenstal R, Bhargava A, Bias D, Bolster E, Buchanan P, Busch R, Chadha C, Chang M, Cheng C, Cohen A, Cohen J, Cole B, Connery L, Cooperman M, Cushman W, DAgostino R, Davies M, Dayamani P, De Lemos J, De Meireles M, Dean J, DeHart D, Detweiler R, Donovan D, Dugano-Daphnis P, Dulin M, Dunn F, Eaton C, Erickson B, Estevez R, Feinglos M, Fonseca V, Force R, Forker A, Fox D, Gabriel J, Garcia R, Garvey T, Gaudiani L, Getaneh A, Goff D, Goldberg A, Goldman S, Hairston K, Harris R, Haught W, Hidalgo H Jr, Higgins A, Houchin V, Ison R, Jacobs G, Jaffrani N, Jafry B, Kapsner P, Kaye W, Labroo A, Levinson L, Lewis S, Lillestol M, Luttrell L, Madu I, McNeill R, Merrick B, Metzger F, Nadar V, Nagelberg S, Nash S, Oparil S, Osei K, Papademetriou V, Patel N, Pedley C, Prentiss A, Radbill M, Raisinghani A, Rassouli N, Reddy R, Rees P, Rendell M, Robbins D, Rodbard H, Rohlf J, Roseman H, Rudolph L, Sadler L, Schnall A, Schramm R, Schubart U, Seneviratne T, Shanik M, Snyder H, Sorli C, Stich M, Sweeney ME, Tsao J, Ukwade P, Viswanath D, Vo A, Vogel C, Voyce S, Weintraub H, White J, Wood M, Wu P, Wysham C, Zimmerman R
Subjects: Oral, medicine.medical_specialty, Heart diseases, Glycosylated, Administration, Oral, heart failure, Type 2 diabetes, Dipeptidyl peptidase-4 inhibitor, Kaplan-Meier Estimate, Placebo, Sitagliptin Phosphate, Sitagliptin, Cardiovascular Outcomes, chemistry.chemical_compound, Drug Therapy, Double-Blind Method, Internal medicine, Diabetes Mellitus, medicine, Humans, Hypoglycemic Agents, Glycated Hemoglobin, Hemoglobin A, Glycosylated, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Follow-Up Studies, Heart Diseases, Heart Failure, Hospitalization, Pyrazines, Triazoles, Medicine (all), business.industry, Semaglutide, Hemoglobin A, General Medicine, ta3121, medicine.disease, Surgery, Cardiovascular diseases, chemistry, Sitagliptin, Administration, Combination, Glycated hemoglobin, business, Type 2, Alogliptin, medicine.drug
Abstract: BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to-0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P
Published: 2015

33. Postprandial Blood Glucose Is a Stronger Predictor of Cardiovascular Events Than Fasting Blood Glucose in Type 2 Diabetes Mellitus, Particularly in Women: Lessons from the San Luigi Gonzaga Diabetes Study

Author: Cavalot, F, Petrelli, A, Traversa, M, Bonomo, K, Fiora, E, Conti, M, Anfossi, G, Costa, G, and Trovati, M
Published: 2006

34. Occurrence of low blood glucose concentrations during the afternoon in Type 2 (non-insulin-dependent) diabetic patients on oral hypoglycaemic agents: importance of blood glucose monitoring

Author: Trovati, M., Burzacca, S., Mularoni, E., Massucco, P., Cavalot, F., Mattiello, L., and Anfossi, G.
Published: 1991
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35. Clinical significance of nonalbuminuric renal impairment in type 2 diabetes

Author: Penno, G., Solini, A., Bonora, E., Fondelli, C., Orsi, E., Zerbini, G., Trevisan, R., Vedovato, M., Gruden, G., Cavalot, F., Cignarelli, M., Laviola, L., Morano, S., Nicolucci, A., Pugliese, G., RIACE Study Group, Pugliese, G, Penno, G, Solini, A, Bonora, E, Orsi, E, Trevisan, R, Laviola, L, Nicolucci, A, De Cosmo, S, Gruden, G, Morano, S, Pugliese, F, Zerbini, G, Simonelli, P, Negro, A, Salvi, L, Bazuro, A, Frasheri, A, Cavallo Perin, P, Lorenzati, B, Trovati, M, Anfossi, G, Cavalot, F, Chirio, M, Martina, V, Dolci, A, Pontiroli, A, Laneri, M, Arosio, M, Rossi, A, Montefusco, L, Corsi, A, Zoppini, G, Avogaro, A, Vedovato, M, Pagnin, E, Pucci, L, Lucchesi, D, Storti, E, Dotta, Francesco, Fondelli, C, Nigi, L, Gatti, A, Mandosi, E, Fallarino, M, Buzzetti, R, Leto, G, Cignarelli, M, Lamacchia, O, Pinnelli, S, Giorgino, F, Perrini, S, Sesti, G, Andreozzi, F, Baroni, Mg, Frau, G., Penno, G, Solini, A, Bonora, E, Fondelli, C, Orsi, E, Zerbini, G, Trevisan, R, Vedovato, M, Gruden, G, Cavalot, F, Cignarelli, M, Laviola, L, Morano, S, Nicolucci, A, and Pugliese, G
Subjects: Male, albuminuria, cardiovascular disease, gfr, type 2 diabetes, medicine.medical_specialty, Physiology, Cardiovascular risk factors, MEDLINE, Renal function, Type 2 diabetes, GFR, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Humans, Clinical significance, albuminuria, cardiovascular disease, GFR, type 2 diabetes, type 2 diabete, business.industry, medicine.disease, chronic kidney disease, Diabetes Mellitus, Type 2, Albuminuria, Female, Kidney Diseases, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Glomerular Filtration Rate
Abstract: Objective: In type 2 diabetes, prevalence of nonalbuminuric renal impairment is increasing worldwide, though its clinical significance remains unclear. This large-cohort study aimed at evaluating the association of this phenotype with cardiovascular risk factors and other complications. Methods: Type 2 diabetic patients from the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study (n=15773), visiting consecutively 19 hospital-based Diabetes Clinics in years 2007-2008, were examined. Serum creatinine was assessed by the Jaffe method; albuminuria was measured by immunonephelometry or immunoturbidimetry. Results: Of patients with renal impairment, as identified by an estimated glomerular filtration rate (eGFR) less than 60ml/min per 1.73m, 56.6% were normoalbuminuric, 30.8% were microalbuminuric, and 12.6% were macroalbuminuric. Percentages were similar when GFR was estimated using the more accurate Chronic Kidney Disease Epidemiology Collaboration equation instead of the simplified Modification of Diet in Renal Disease formula, and were independent of age, thus indicating that the increasing prevalence of this phenotype does not reflects misclassification of elderly patients. Nonalbuminuric renal impairment was not associated with HbA1c and correlated less strongly with retinopathy and hypertension than albuminuria, either alone or associated with reduced eGFR. It was associated with a higher prevalence of cardiovascular disease (CVD) than albuminuria alone, but lower than albuminuric renal impairment. Female sex correlated with nonalbuminuric renal impairment and male sex with the albuminuric forms. Conclusion:S: These data show that type 2 diabetic patients with nonalbuminuric renal impairment exhibit distinct clinical features, suggesting predominance of macroangiopathy as underlying renal pathology, and that this phenotype is associated with significant CVD burden.
Published: 2011

36. Blood glucose pre-prandial baseline decreases from morning to evening in type 2 diabetes: role of fasting blood glucose and influence on post-prandial excursions

Author: Trovati, M, Ponziani, M. C, Massucco, P, Anfossi, G, Mularoni, E. M, Burzacca, S, Tassone, F, Perna, P, Traversa, M, and Cavalot, F
Published: 2002

37. Impaired Platelet Sensitivity to the Anti-Aggregating Effects of Adenosine in Obesity and Obese Non-Insulin-Dependent Diabetes mellitus

Author: Anfossi, G., primary, Mularoni, E., additional, Burzacca, S., additional, Ponziani, M.C., additional, Massucco, P., additional, Mattiello, L., additional, Perna, P., additional, Cavalot, F., additional, and Trovati, M., additional
Published: 1998
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38. N-acetyl-l-cysteine exerts direct anti-aggregating effect on human platelets

Author: Anfossi, G., Russo, I., Massucco, P., Mattiello, L., Cavalot, F., and Trovati, M.
Published: 2001

39. Na+/H+ antiporter properties in peripheral blood lymphocytes from normotensive obese and type 2 diabetic patients do not differ significantly from controls

Author: Ghigo, D., Alessio, P., Burzacca, S., Costamagna, C., Anfossi, G., Cavalot, F., Bosia, A., and Trovati, M.
Published: 1992
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40. Independent correlates of urinary albumin excretion within the normoalbuminuric range in patients with type 2 diabetes: The Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicentre Study

Author: Penno, G, Solini, A, Zoppini, G, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Gruden, G, Lamacchia, O, Laviola, L, Orsi, E, Pugliese, G, Penno G, Solini A, Zoppini G, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Gruden G, Lamacchia O, Laviola L, Orsi E, Pugliese G, Penno, G, Solini, A, Zoppini, G, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Gruden, G, Lamacchia, O, Laviola, L, Orsi, E, Pugliese, G, Penno G, Solini A, Zoppini G, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Gruden G, Lamacchia O, Laviola L, Orsi E, and Pugliese G
Abstract: Aims Within the normoalbuminuric range, low albuminuria (LA, 10-29 mg/24 h) is associated with higher adverse cardiovascular and renal outcomes than normal albuminuria (NA, < 10 mg/24 h). This cross-sectional analysis of the cohort from the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicentre Study was aimed at assessing the independent correlates of LA versus NA in patients with type 2 diabetes. Methods This analysis involved 11,538 normoalbuminuric patients (73.2 % of the entire RIACE cohort): 6023 (52.2 %) with NA and 5515 (47.8 %) with LA. Binary logistic regression analysis with backward conditional variable selection was applied to assess the independent correlates of LA versus NA. Results Compared with NA subjects, LA patients were more frequently males, older and with family history of hypertension, had longer diabetes duration, lower HDL cholesterol, and higher haemoglobin (Hb) A(1c), triglycerides, and blood pressure (BP), use of anti-hyperglycaemic and anti-hypertensive drugs, and prevalence of metabolic syndrome, retinopathy, chronic kidney disease, any cardiovascular disease, myocardial infarction, and coronary and peripheral events. Men with LA were also more frequently current or former smokers and had higher body mass index, waist circumference, and non-HDL cholesterol. Independent correlates of LA were age (OR 1.018), family history of hypertension (OR 1.321), smoking status (former, OR 1.158; current, OR 1.237), HbA(1c) (OR 1.062), waist circumference (OR 1.050), triglycerides (OR 1.001), and diastolic BP (OR 1.014), together with use of anti-hyperglycaemic and anti-hypertensive agents. Conclusions Several risk factors are associated with increased albuminuria within the normoalbuminuric range. As most of these factors are potentially modifiable, treating them aggressively might reduce the excess risk associated with LA.
Published: 2015

41. Rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes): A multicenter retrospective nationwide Italian study and crowdsourcing opportunity

Author: Fadini, G. P., Zatti, G., Consoli, A., Bonora, E., Sesti, G., Avogaro, Consoli A, A. DARWIN-T2D. Network., Formoso, G, Antenucci, D, Grossi, G, Pucci, A, Sesti, G, Andreozzi, F, Indrieri, L, Capobianco, G, Gatti, A, Bonadonna, R, Zavaroni, I, Dei Cas, A, Felace, G, Li Volsi, P, Buzzetti, R, Leto, G, D'Angelo, F, Morano, S, Giaccari, A, Sorice, G, Orsi, E, Carlo Bossi, A, Querci, F, Duratorre, E, Malagola, C, Franzetti, I, Silvia Morpurgo, P, Boemi, M, Petrelli, M, Aimaretti, G, Karamouzis, I, Cavalot, F, Saglietti, G, Gruden, G, Devangelio, E, Cazzetta, G, Lamacchia, O, Cervone, S, Frittitta, L, Arena, S, Di Benedetto, A, Piro, S, Giordano, C, Rizzo, M, Chianetta, R, Mannina, C, Solini, A, Natali, A, Anichini, R, Dotta, F, Fattor, B, Avogaro, A, Fadini, Gp, Bonora, E, Cigolini, M, Simioni, N, Frison, V, Poli, M, Lapolla, A, Cristiano Chilelli, N, Author information, Vinci C., Fadini, G, Zatti, G, Consoli, A, Bonora, E, Sesti, G, Avogaro, A, and Giordano, C
Subjects: randomized controlled trial, real-life, retrospective study, sodium glucose co-transporter-2 inhibitor, medicine (miscellaneous), endocrinology, diabetes and metabolism, nutrition and dietetics, cardiology and cardiovascular medicine, Blood Glucose, Time Factors, Glucoside, Glycated Hemoglobin A, Time Factor, Medicine (miscellaneous), Settore MED/13 - Endocrinologia, Endocrinology, Glucosides, Sodium-Glucose Transporter 2, Retrospective Studie, Diabetes Mellitus, Humans, Hypoglycemic Agents, Data Mining, Benzhydryl Compounds, Randomized controlled trial, Real-life, Retrospective study, Sodium glucose co-transporter-2 inhibitor, Biomarkers, Diabetes Mellitus, Type 2, Italy, Research Design, Retrospective Studies, Sodium-Glucose Transporter 2 Inhibitors, Treatment Outcome, Crowdsourcing, Evidence-Based Medicine, Endocrinology, Diabetes and Metabolism, Nutrition and Dietetics, Cardiology and Cardiovascular Medicine, Glycated Hemoglobin, Benzhydryl Compound, Hypoglycemic Agent, Sodium-Glucose Transporter 2 Inhibitor, Biomarker, Diabetes and Metabolism, Type 2, Human
Abstract: Background Randomized controlled trials (RCTs) in the field of diabetes have limitations inherent to the fact that design, setting, and patient characteristics may be poorly transferrable to clinical practice. Thus, evidence from studies using routinely accumulated clinical data are increasingly valued. Aims We herein describe rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes), a multicenter retrospective nationwide study conducted at 50 specialist outpatient clinics in Italy and promoted by the Italian Diabetes Society. Data synthesis The primary objective of the study is to describe the baseline clinical characteristics (particularly HbA1c) of patients initiated on dapagliflozin from marketing authorization approval to the end of 2016. Secondary and exploratory objectives will evaluate the changes in glycaemic and extraglycaemic efficacy parameters after initiation of dapagliflozin or after initiation of comparator glucose lowering medications (DPP-4 inhibitors, gliclazide extended release, and long-acting GLP-1 receptor agonists). An automated software will extract relevant data from the same electronic chart system at all centres, thereby minimizing data treatment and human intervention. Conclusion The study is expected to collect an enormous dataset of information on dapagliflozin- and comparator-using patients. After study completion, the Italian Diabetes Society will launch an open crowdsourcing call on the DARWIN-T2D database, challenging diabetes researchers to apply their ideas and approaches to address new unmet needs and knowledge gaps in diabetes. We believe this will move DARWIN-T2D to the next generation of real world studies.
Published: 2017

42. Chronic kidney disease in type 2 diabetes: Lessons from the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicentre Study

Author: Pugliese, G, Solini, A, Bonora, E, Fondelli, C, Orsi, E, Nicolucci, A, Penno, G, RIACE Study Group, Trevisan, R, Laviola, L, De Cosmo, S, Gruden, G, Morano, S, Pugliese, F, Zerbini, G, Salvi, L, Bollanti, L, Bazuro, A, Cavallo Perin, P, Lorenzati, B, Trovati, M, Anfossi, G, Cavalot, F, Chirio, M, Martina, V, Maestroni, S, Montefusco, L, Zimbalatti, D, Pontiroli, A, Veronelli, A, Zecchini, B, Arosio, M, Dolci, A, Corsi, A, Zoppini, G, Avogaro, A, Vedovato, M, Pagnin, E, Pucci, L, Lucchesi, D, Russo, E, Garofolo, M, Dotta, Francesco, Nigi, L, Gatti, A, Buzzetti, R, Foffi, C, Cignarelli, M, Lamacchia, O, Pinnelli, S, Monaco, L, Giorgino, F, Perrini, S, Sesti, G, Andreozzi, F, Baroni, Mg, and Frau, G.
Subjects: Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Medicine (miscellaneous), Renal function, Type 2 diabetes, urologic and male genital diseases, End stage renal disease, Coronary artery disease, Sex Factors, Albuminuria, cardiovascular disease, Chronic kidney disease, Diabetic retinopathy, eGFR, Risk Factors, Internal medicine, Prevalence, medicine, Humans, Hypoglycemic Agents, Multicenter Studies as Topic, Renal Insufficiency, Chronic, Intensive care medicine, Glycated Hemoglobin, Nutrition and Dietetics, business.industry, riace, medicine.disease, Metformin, Observational Studies as Topic, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, Italy, Cardiovascular Diseases, Cohort, Female, type 2 diabetes, medicine.symptom, Cardiovascular disease, EGFR, Cardiology and Cardiovascular Medicine, business, Glomerular Filtration Rate, Kidney disease
Abstract: The Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicentre Study is an ongoing observational survey that examines the role of estimated glomerular filtration rate (eGFR) as an independent predictor of cardiovascular and renal outcomes in 15,773 Italian subjects with type 2 diabetes. The analysis of data collected at the enrollment visit provided a picture of chronic kidney disease (CKD) and its association with other complications, risk factors for cardiovascular disease (CVD) and treatments in a large contemporary cohort. Main results of this analysis were that (a) non-albuminuric renal impairment is the predominant clinical phenotype in patients, particularly women, with reduced eGFR; (b) concordance between CKD and diabetic retinopathy is low, with only a minority of patients with renal dysfunction presenting with any or advanced retinal lesions; (c) the non-albuminuric form is associated with a significant prevalence of CVD, especially at the level of the coronary vascular bed; (d) CKD is associated with hemoglobin (Hb) A1c variability more than with average HbA1c, whereas retinopathy and CVD are not; (e) in elderly individuals with moderate-to-severe eGFR reduction, use of agents which are not recommended, such as sulphonylureas and metformin, is still frequent; and (f) though complications are generally more prevalent in men (except non-albuminuric renal impairment) women show a less favorable CVD risk profile and achieve therapeutic targets to a lesser extent than men, despite the fact that treatment intensity is not lower. These data update existing information on the natural history of CKD in patients with type 2 diabetes.
Published: 2014

43. Human platelets exert cardioprotective effects via Sphingosine-1 phosphate receptor activation

Author: Femminò, S., primary, Russo, I., additional, Barale, C., additional, Cavalot, F., additional, Pagliaro, P., additional, and Penna, C., additional
Published: 2018
Full Text: View/download PDF

44. Rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes)

Author: Fadini, G.P., primary, Zatti, G., additional, Consoli, A., additional, Bonora, E., additional, Sesti, G., additional, Avogaro, A., additional, Formoso, G., additional, Antenucci, D., additional, Grossi, G., additional, Pucci, A., additional, Andreozzi, F., additional, Indrieri, L., additional, Capobianco, G., additional, Gatti, A., additional, Bonadonna, R., additional, Zavaroni, I., additional, Dei Cas, A., additional, Felace, G., additional, Li Volsi, P., additional, Buzzetti, R., additional, Leto, G., additional, D'Angelo, F., additional, Morano, S., additional, Giaccari, A., additional, Sorice, G., additional, Orsi, E., additional, Carlo Bossi, A., additional, Querci, F., additional, Duratorre, E., additional, Malagola, C., additional, Franzetti, I., additional, Silvia Morpurgo, P., additional, Boemi, M., additional, Petrelli, M., additional, Aimaretti, G., additional, Karamouzis, I., additional, Cavalot, F., additional, Saglietti, G., additional, Gruden, G., additional, Devangelio, E., additional, Cazzetta, G., additional, Lamacchia, O., additional, Cervone, S., additional, Frittitta, L., additional, Arena, S., additional, Di Benedetto, A., additional, Piro, S., additional, Giordano, C., additional, Rizzo, M., additional, Chianetta, R., additional, Mannina, C., additional, Solini, A., additional, Natali, A., additional, Anichini, R., additional, Dotta, F., additional, Fattor, B., additional, Fadini, G.P., additional, Cigolini, M., additional, Simioni, N., additional, Frison, V., additional, Poli, M., additional, Lapolla, A., additional, Cristiano Chilelli, N., additional, and Vinci, C., additional
Published: 2017
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45. Distribution of cardiovascular disease and retinopathy in patients with type 2 diabetes according to different classification systems for chronic kidney disease: a cross-sectional analysis of the renal insufficiency and cardiovascular events (RIACE) Italian multicenter study

Author: Pugliese, G, Solini, A, Bonora, E, Orsi, E, Zerbini, G, Fondelli, C, Gruden, G, Cavalot, F, Lamacchia, O, Trevisan, R, Vedovato, M, Penno, G, Pugliese G, Solini A, Bonora E, Orsi E, Zerbini G, Fondelli C, Gruden G, Cavalot F, Lamacchia O, Trevisan R, Vedovato M, Penno G, Pugliese, G, Solini, A, Bonora, E, Orsi, E, Zerbini, G, Fondelli, C, Gruden, G, Cavalot, F, Lamacchia, O, Trevisan, R, Vedovato, M, Penno, G, Pugliese G, Solini A, Bonora E, Orsi E, Zerbini G, Fondelli C, Gruden G, Cavalot F, Lamacchia O, Trevisan R, Vedovato M, and Penno G
Abstract: Background: The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF's KDOQI) staging system for chronic kidney disease (CKD) is based primarily on estimated GFR (eGFR). This study aimed at assessing whether reclassification of subjects with type 2 diabetes using two recent classifications based on both eGFR and albuminuria, the Alberta Kidney Disease Network (AKDN) and the Kidney Disease: Improving Global Outcomes (KDIGO), provides a better definition of burden from cardiovascular disease (CVD) and diabetic retinopathy (DR) than the NKF's KDOQI classification.Methods: This is a cross-sectional analysis of patients with type 2 diabetes (n = 15,773) from the Renal Insufficiency And Cardiovascular Events Italian Multicenter Study, consecutively visiting 19 Diabetes Clinics throughout Italy in years 2007-2008. Exclusion criteria were dialysis or renal transplantation. CKD was defined based on eGFR, as calculated from serum creatinine by the simplified Modification of Diet in Renal Disease Study equation, and albuminuria, as measured by immunonephelometry or immunoturbidimetry. DR was assessed by dilated fundoscopy. Prevalent CVD, total and by vascular bed, was assessed from medical history by recording previous documented major acute events.Results: Though prevalence of complications increased with increasing CKD severity with all three classifications, it differed significantly between NKF's KDOQI stages and AKDN or KDIGO risk categories. The AKDN and KDIGO systems resulted in appropriate reclassification of uncomplicated patients in the lowest risk categories and a more graded independent association with CVD and DR than the NKF's KDOQI classification. However, CVD, but not DR prevalence was higher in the lowest risk categories of the new classifications than in the lowest stages of the NKF's KDOQI, due to the inclusion of subjects with reduced eGFR without albuminuria. CVD prevalence differed also among eGFR and albuminuria categories grouped
Published: 2014

46. Resistant hypertension in patients with type 2 diabetes: clinical correlates and association with complications

Author: Solini, A, Zoppini, G, Orsi, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Lamacchia, O, Arosio, M, Baroni, M, Penno, G, Pugliese, G, Solini A, Zoppini G, Orsi E, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Lamacchia O, Arosio M, Baroni MG, Penno G, Pugliese G, Solini, A, Zoppini, G, Orsi, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Lamacchia, O, Arosio, M, Baroni, M, Penno, G, Pugliese, G, Solini A, Zoppini G, Orsi E, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Lamacchia O, Arosio M, Baroni MG, Penno G, and Pugliese G
Abstract: Objective: The phenotype of resistant hypertension in patients with type 2 diabetes has been poorly characterized. This cross-sectional analysis of the large cohort from the Renal Insufficiency and Cardiovascular Events (RIACE) study was aimed at assessing the clinical correlates and association with complications of resistant hypertension in patients with type 2 diabetes. Methods: The RIACE study enrolled 15 773 patients consecutively visiting 19 diabetes clinics during the years 2007-2008. Resistant hypertension, defined as BP values not on target (i.e. >130/80 mmHg, respectively) with three antihypertensive agents, was detected in 2363 individuals (15% of the whole RIACE cohort, 17.4% of hypertensive individuals, and 21.2% of treated hypertensive patients). Patients without resistant hypertension [nonresistant hypertension (NRH)], that is on target with one (n = 1569), two (n = 1369), and three (n = 803) drugs, and individuals with uncontrolled hypertension, that is untreated or not on target with less than three drugs (n = 7440), served as controls. Results: As compared with NRH and uncontrolled hypertension patients, patients with resistant hypertension were older and more frequently women and had significantly higher waist circumference, albuminuria, and serum creatinine, and lower glomerular filtration rate. Prevalence values of chronic kidney disease and advanced retinopathy were significantly higher in resistant hypertension than in both nonresistant hypertension and uncontrolled hypertension individuals, whereas cardiovascular disease was more frequent in resistant hypertension versus uncontrolled hypertension, but not nonresistant hypertension patients, especially those on 2-3 drugs. Conclusions: Resistant hypertension is relatively common in patients with type 2 diabetes. In these individuals, age, female sex and waist circumference are independent correlates of resistant hypertension, which is strongly associated with microvascular (especially renal)
Published: 2014

47. Platelets poorly controlled type 2 diabetes subjects show an impaired ability to protect against the cardiac ischaemia/reperfusion injury

Author: Russo, Isabella, Femminò, Saveria, Barale, Cristina, Cavalot, F, Tullio, Francesca, Penna, Claudia, and Pagliaro, Pasquale
Subjects: diabetes, platelets, ischaemia/reperfusion, platelets, diabetes, heart, ischaemia/reperfusion, heart
Published: 2016

48. Resistenza agli effetti del GLP-1 sulla risposta pastrinica nel diabete di tipo 2

Author: Barale, Cristina, Cavalot, F, Frascaroli, Chiara, Guerrasio, Angelo, and Russo, Isabella
Subjects: diabete, GLP-1, piastrine, diabete, GLP-1, piastrine
Published: 2016

49. Il modello di disease management 'Gestione Integrata': l’esperienza di una popolazione afferente all’Ambulatorio di Malattie del Metabolismo e Diabetologia dell’AOU San Luigi Gonzaga nel periodo 2008-2014

Author: Sabione, I, Massucco, P, Paccotti, P, Vigna-Taglianti, F, and Cavalot, F
Published: 2016

50. Metabolic syndrome in subjects at high risk for type 2 diabetes: The genetic, physiopathology and evolution of type 2 diabetes (GENFIEV) study

Author: Bianchi, C, Miccoli, R, Bonadonna, Riccardo, Giorgino, F, Frontoni, S, Faloia, E, Marchesini, G, Dolci, Ma, Alviggi, L, Gnasso, A, Consoli, A, Cavalot, F, Cavallo, Mg, Leonetti, F, Giaccari, A, Del Prato, S, Cignarelli, A, Cerrelli, F, Moscatiello, S, Irace, C, Taraborelli, M, Formoso, G, Mori, M, Baccetti, F, Trovati, Am, Bonomo, K, Penno, G, Agostini, A, De Bellis, A, Anichini, R, Bracaglia, D, Perna, D, Calabria, M, Zappaterreno, A, Barchetta, I, Taverni, G, Antonelli, A, Trombetta, Maddalena, Calì, A., C. Bianchi, R. Miccoli, R.C. Bonadonna, F. Giorgino, S. Frontoni, E. Faloia, G. Marchesini Reggiani, M.A. Dolci, L. Alviggi, A. Gnasso, A. Consoli, F. Cavalot, M.G. Cavallo, F. Leonetti, A. Giaccari, S. Del Prato, and GENFIEV Investigators
Subjects: Blood Glucose, Male, insulin secretion, endocrine system diseases, Endocrinology, Diabetes and Metabolism, Medicine (miscellaneous), prediabetes, Type 2 diabetes, Impaired glucose tolerance, Risk Factors, insulin resistance, Prevalence, Prediabetes, Glucose tolerance test, Nutrition and Dietetics, C-Peptide, medicine.diagnostic_test, type 2 diabetes, metabolic syndrome, impaired glucose regulation, GENFIEV study, Metabolic Syndrome X, Middle Aged, Italy, Hypertension, Female, Cardiology and Cardiovascular Medicine, Type 2, Adult, medicine.medical_specialty, Prediabetic State, Insulin resistance, Diabetes mellitus, Internal medicine, Glucose Intolerance, Diabetes Mellitus, medicine, Humans, business.industry, nutritional and metabolic diseases, Settore MED/13 - ENDOCRINOLOGIA, Glucose Tolerance Test, medicine.disease, Impaired fasting glucose, Logistic Models, Endocrinology, Diabetes Mellitus, Type 2, Hyperglycemia, Metabolic syndrome, business
Abstract: Background and Aim: We evaluated the relationship between insulin resistance (IR) and insulin secretion with the metabolic syndrome (MS) in 885 subjects (377 men/508 women, age 49 11 years, BMI 29 5.2 kgm2) at risk of diabetes enrolled in the genetics, pathophysiology and evolution of type 2 diabetes (GENFIEV) study. Methods and Results: All subjects underwent a 75-g oral glucose tolerance test (OGTT) for the estimation of plasma levels of glucose and C-peptide, as well as fasting insulin and lipid profile. IR was arbitrarily defined as HOMA-IR value above the 75th centile of normal glucose tolerance (NGT) subjects. Overall MS prevalence (National Cholesterol Treatment Panel-Adult Treatment Panel (NCEP-ATPIII) criteria) was 33%, 19% in subjects with NGT, 42% in impaired fasting glucose (IFG), 34% in impaired glucose tolerance (IGT), 74% in IFG + IGT subjects, and 56% in newly diagnosed diabetic patients. Prevalence was slightly higher with IDF criteria. MS prevalence was >50% in subjects with 2 h glucose >7.8 mmol l-1, independently of fasting plasma glucose. IR prevalence was higher in subjects with MS than in those without (63% vs. 23%; p < 0.0001) and increased from 54% to 73% and 88% in the presence of three, four or five traits, respectively. IR occurred in 42% of subjects with non-diabetic alterations of glucose homeostasis, being the highest in those with IFG + IGT (IFG + IGT 53%, IFG 45%, IGT 38%; p < 0.0001). Individuals with MS were more IR irrespective of glucose tolerance (p < 0.0001) with no difference in insulinogenic index. Hypertriglyceridaemia (OR: 3.38; Confidence Interval, CI: 2.294.99), abdominal obesity (3.26; CI: 2.18-4.89), hyperglycaemia (3.02; CI: 1.80-5.07) and hypertension (1.69; CI: 1.12-2.55) were all associated with IR. Conclusions: These results show that in subjects with altered glucose tolerance (in particular IFG + IGT) MS prevalence is high and is generally associated to IR. Some combinations of traits of MS may significantly contribute to identify subjects with IR.
Published: 2011

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