Wilding: Astellas Pharma Europe Ltd., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, NAPP Pharmaceuticals Limited, Novo Nordisk A/S, Sanofi, Novo Nordisk A/S, WebMD. Jude Medical, XOMA Corporation, Amgen Inc., Arena Pharmaceuticals, Sanofi-Aventis. Wiviott: Aegerion Pharmaceuticals, Allergan, Angel Medical Systems, Inc., Arena Pharmaceuticals, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Boston Clinical Research Institute, Bristol-Myers Squibb Company, Daiichi Sankyo Company, Limited, Eisai Inc., Eli Lilly and Company, Icon Clinical, Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Servier, St. CBOL, Bristol-Myers Squibb Company, CameraEyes Ltd, DarioHealth, Diabot, Exscopia, GlucoMe Ltd., Insuline Medical, Medial EarlySign, Orgenesis Ltd. Raz: AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. Dapagliflozin had a good overall safety profile acute kidney injury and major hypoglycemia were less frequent vs.There were higher rates of improvement in the urine albumin/creatinine ratio vs.Patients were less likely to develop adverse renal outcomes, and had a significant reduction in a composite cardiorenal outcome (HR 0.76 95% CI 0.67-0.87 P
#DECLARE TIMI 58 TRIAL#
This event-driven trial continued until at least 1,390 subjects have a MACE outcome, thereby providing >99% power to test for the primary outcome of safety of dapagliflozin.Participants with multiple risk factors were men 55 years of age or older or women 60 years of age or older who had one or more traditional risk factors, including hypertension, dyslipidemia or use of lipid-lowering therapies, or use of tobacco.Eligible patients were ≥40 years and had type 2 diabetes, HbA 1c 6.5-12.0%, CrCl of ≥60 ml/min, and multiple risk factors for ASCVD or established ASCVD.17,160 patients with type 2 diabetes and established CV disease (n=6,974) or multiple risk factors (n=10,186) were enrolled.Randomized, double-blind, placebo-controlled trial.Type of study, patients, and inclusion criteria