11/13/2023 0 Comments Dapagliflozin declare trialThe sodium-glucose cotransporter 2 inhibitor dapagliflozin reduces the risk for hospitalization for heart failure (HHF) and kidney events in patients with type 2 diabetes mellitus. Cardiovascular outcomes trials in type 2 diabetes: where do we go from here? Reflections from a Diabetes Care Editors’ Expert Forum. Abstract Background: Patients with peripheral artery disease (PAD) are at heightened risk of cardiovascular complications. Strategy for mitigating DKA risk in patients with type 1 diabetes on adjunctive treatment with SGLT inhibitors: a STICH protocol. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. Wiviott SD, Raz I, Bonaca MP, Mosenzon O, et. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019 Diabetes Care. 2018 ACC expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. People with type 2 diabetes and either risk factors for or established atherosclerotic cardiovascular disease were randomly assigned (1:1) to receive oral dapagliflozin 10 mg or placebo once daily. Researchers added two efficacy outcomes after results of another SGLT2 inhibitor trial were released: MACE and a composite of CV death or hospitalization from heart failure (HF).(1) Secondary efficacy outcomes were death from any cause and a renal composite (≥ 40% decrease in estimated glomerular filtration rate to 400,000 patients: the CVD-REAL 2 study. The DECLARE-TIMI 58 trial was a double-blind, multicentre, randomised, placebo-controlled study. The primary safety outcome was a composite of major adverse CV events (MACE), defined as CV death, myocardial infarction or ischemic stroke. (2019) questioned the CV benefits of the third SGLT2 inhibitor, dapagliflozin, in the randomized, double-blinded, placebo-controlled trial, dapagliflozin (Farxiga) Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58 (DECLARE-TIMI 58).(9) We review the findings of DECLARE-TIMI 58 and its implications in clinical practice.ĭECLARE-TIMI 58 included 17,160 patients with T2D, of which, 10,186 (59.4%) were without established ASCVD.(9) Patients with T2D and a creatinine clearance (CrCl) of 60 mL or more per minute, who also had multiple risk factors for ASCVD or established ASCVD, were eligible and followed for a median of 4.2 years. (ADA) incorporating sodium–glucose cotransporter 2 (SGLT2) inhibitors into decision pathways for patients with T2D and atherosclerotic cardiovascular disease (ASCVD).(7,8) These pathways create a renewed focus on clinicians utilizing all available comprehensive CV risk reduction strategies. Results from multiple trials prompted the Food and Drug Administration’s (FDA) approval of empagliflozin (Jardiance) for reducing cardiovascular (CV) death and canagliflozin (Invokana) for reducing CV death and CV events, in patients with cardiovascular disease and type II diabetes (T2D).(1-6) The FDA’s expanded approval of empagliflozin and canagliflozin led to the American College of Cardiology (ACC) and the American Diabetes Association
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