Dapagliflozin declare trial11/28/2023 11,12 In brief, 17 160 patients aged 40 years with a diagnosis of T2DM, a glycated hemoglobin between 6.5 and 12, and established atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors were randomly assigned to dapagliflozin 10 mg. The DECLARE-TIMI 58 trial is expected to provide conclusive data on the effect of treatment with dapagliflozin in addition to standard of care, on CV outcomes in a broad patient population with type 2 diabetes and CVD or MRF for CVD.ĬVOTs SGLT2 inhibitors cardiovascular outcomes dapagliflozin type 2 diabetes. The DECLARE-TIMI 58 trial design and overall results have been published previously. Patients with CVD compared with patients with MRF were younger (62.5 ± 8.1 vs 64.7 ± 5.6 years), more frequently male (72.1% vs 56.1%), less often used metformin (74.6% vs 81.2%), more often used insulin (44.2% vs 36.4%), and more frequently used statins, aspirin, clopidogrel and β-blockers (82.2%, 71.1%, 24.7% and 66.6% vs 63.7%, 39.1%, 1.5% and 32.3%, respectively). Randomization included 6971 (40.6%) patients with atherosclerotic CV disease (CVD), and 10 189 (59.4%) patients with multiple risk factors (MRF) for CVD (defined as men age ≥ 55 years or women ≥60 years, with at least one of dyslipidaemia, hypertension or smoking). DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular EventsThrombolysis in Myocardial Infarction 58) randomized 17 160 patients with type 2 diabetes mellitus and either established atherosclerotic cardiovascular disease (n6974) or multiple risk factors (n10 186) to dapagliflozin versus placebo. The participants' mean ± SD age was 63.8 ± 6.8 years, 62.6% were male, and their mean ± SD diabetes duration was 11.8 ± 7.8 years, glycated haemoglobin 8.3% ± 1.2% (67 mmol/mol ± 9.7 mmol/mol) and body mass index 32.1 ± 6.0 kg/m 2. We analysed their baseline characteristics. Efficacy and Safety of Dapagliflozin According to Background Use of Cardiovascular Medications in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial Diabetes JAMA Cardiology JAMA Network Figure 1. The DECLARE-TIMI 58 trial will analyse 17 160 patients with type 2 diabetes randomized to treatment with dapagliflozin (10 mg/d) or matching placebo. ![]() The eGFR dynamics in DECLARE-TIMI 58, including the early drop following dapagliflozin initiation, are not included in this analysis. To describe the baseline characteristics of participants randomized in the Dapagliflozin Effect on CardiovascuLAR Events (DECLARE-TIMI 58) trial, the pivotal study conducted to assess cardiovascular (CV) outcomes with dapagliflozin. Another limitation of our trial was that we tested UACR only as a single sample, rather than an average of two to three samples, and only 6 months from baseline and thereafter once yearly. Methods: DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58) studied the efficacy and safety of the SGLT2 inhibitor dapagliflozin versus placebo in 17 160 patients with type 2 diabetes mellitus and either multiple risk factors for atherosclerotic cardiovascular disease (n10 186) or known.
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