Efficacy and safety of dapagliflozin in patients with type 2 diabetes and concomitant heart failure

Abstract Aim We investigated the efficacy and safety of dapagliflozin, a sodium–glucose cotransporter 2 inhibitor, in patients with type 2 diabetes mellitus (T2DM) and heart failure (HF). Methods Data for patients randomized to dapagliflozin 10mg or placebo with a history of HF were pooled from five clinical trials. HbA 1c , weight and systolic blood pressure (SBP; two studies) were examined up to 52weeks using longitudinal repeated-measures models. Composite cardiovascular outcomes, hospitalizations for HF (HHF), and adverse events (AEs) were also assessed. Results Patients (mean age 64years, T2DM duration ~14years, HbA 1c 8.2%, ~50% with New York Heart Association Class ≥II) received dapagliflozin (N=171) or placebo (N=149). Dapagliflozin produced clinically meaningful placebo-adjusted reductions in HbA 1c (−0.55%; 95% confidence interval [CI]: −0.80, −0.30), weight (−2.67kg; 95% CI: −3.88, −1.47), and SBP (−2.05mmHg; 95% CI: −5.68, 1.57) over 52weeks. HHF was rare, but numerically lower with dapagliflozin (n=1 [0.6%]) vs placebo (n=7 [4.7%]). Point estimates for hazard ratios of composite cardiovascular outcomes favored dapagliflozin vs placebo, although 95% CIs crossed unity. Conclusions Dapagliflozin produced clinically meaningful reductions in HbA 1c , weight, and SBP in patients with T2DM and HF, and was well tolerated.