• J. Diabetes Complicat. · Jul 2017

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

    • Mikhail Kosiborod, Ingrid Gause-Nilsson, John Xu, Christian Sonesson, and Eva Johnsson.
    • Department of Cardiology, Saint Luke's Mid America Heart Institute and University of Missouri, Kansas City, MO, USA. Electronic address: mkosiborod@saint-lukes.org.
    • J. Diabetes Complicat. 2017 Jul 1; 31 (7): 1215-1221.

    AimWe 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).MethodsData for patients randomized to dapagliflozin 10mg or placebo with a history of HF were pooled from five clinical trials. HbA1c, 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.ResultsPatients (mean age 64years, T2DM duration ~14years, HbA1c 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 HbA1c (-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.ConclusionsDapagliflozin produced clinically meaningful reductions in HbA1c, weight, and SBP in patients with T2DM and HF, and was well tolerated.Copyright © 2017 Elsevier Inc. All rights reserved.

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