Based on data of the CANVAS program and DECLARE-TIMI 58, the HR was 1.00 (95%0.87-1.16, P=0.98) for individuals without existing CVD, but with multiple risk factors.
No difference between treatment groups was seen in amputations and fractures.Ī meta-analysis of the three CV outcome trials with SGLT2i’s was also performed (EMPA-REG OUTCOME, CANVAS program, DECLARE-TIMI 58). Significant increases of treatment-emergent AEs leading to drug discontinuation (8.1 vs.
The first renal composite endpoint (40% reduction in eGFR, ESRD, renal or CV death) was reduced with dapagliflozin vs.The co-primary endpoints showed a reduction with dapagliflozin vs.Systolic BP was reduced with dapagliflozin (LSM difference: 2.7 mmHg, 95%CI: 2.4-3.0), as was diastolic BP (LSM difference: 0.7 mmHg, 95%CI: 0.6-0.9).placebo, which was maintained throughout the study (LSM difference: 1.8 kg, 95%CI: 1.7-2.0). Dapagliflozin showed a weight reduction of 1.8 kg vs.HbA1c showed a least square mean (LSM) difference of 0.42% (95%CI: 0.40-0.45), with lower values for dapagliflozin vs.Mean eGFR was 85 ml/min/1.73m², which is higher than in most other such trials, due to a mandate that patients should have eGFR ≥60 ml/min/1.73m². 17160 patients were randomized (1:1) at 882 centers in 33 countries. Participants also had established ASCVD (ischemic heart disease, cerebrovascular disease, peripheral artery disease: secondary prevention population), or multiple risk factors for ASCVD (men ≥55 years and woman ≥60 years with at least one additional risk factor: dyslipidemia, hypertension, current tobacco use: primary prevention population). To enroll, patients had to have a diagnosis of T2DM, with HbA1c 6.5-12% and CrCL ≥60 ml/min.
The primary safety endpoint was MACE (CVD/MI/ischemic stroke), and endpoints for both safety and efficacy were CVD or hospitalization for HF (HHF), and MACE. Follow-up visits were performed in person every 6 months, and by telephone every 3 months. The DECLARE TIMI-58 studied the effect of dapagliflozin 10 mg daily in both primary prevention (with multiple risk factors, n=10186) and secondary prevention patients (with established CVD, n=6974). Some safety questions with SGLT2i in these other trials have been raised in relation to amputation, stroke and diabetic ketoacidosis (DKA). Prior CV outcome trials with other SGLT2i’s have demonstrated reductions in CV and renal events, mostly in secondary prevention patients, with known atherosclerotic CVD (ASCVD). This results in a reduction of blood sugar, blood pressure and weight. Dapagliflozin is a selective SGLT2 inhibitor (SGLT2i) which blocks glucose and sodium resorption in the kidney.
Patients with diabetes type 2 (T2DM) are at high risk for development of and complications from atherosclerotic CV events and heart failure (HF). Presented at the AHA congress 2018 by: Stephen Wiviott (Boston, MA, USA) Introduction and methods
DECLARE TIMI 58 TRIAL
The Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Trial
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