PMID- 28284707 OWN - NLM STAT- MEDLINE DCOM- 20180402 LR - 20221207 IS - 1873-460X (Electronic) IS - 1056-8727 (Linking) VI - 31 IP - 7 DP - 2017 Jul TI - Efficacy and safety of dapagliflozin in patients with type 2 diabetes and concomitant heart failure. PG - 1215-1221 LID - S1056-8727(16)30861-3 [pii] LID - 10.1016/j.jdiacomp.2017.02.001 [doi] AB - 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. CI - Copyright (c) 2017 Elsevier Inc. All rights reserved. FAU - Kosiborod, Mikhail AU - Kosiborod M AD - Department of Cardiology, Saint Luke's Mid America Heart Institute and University of Missouri, Kansas City, MO, USA. Electronic address: mkosiborod@saint-lukes.org. FAU - Gause-Nilsson, Ingrid AU - Gause-Nilsson I AD - AstraZeneca, Gothenburg, Molndal, Sweden. FAU - Xu, John AU - Xu J AD - AstraZeneca, Gaithersburg, MD, USA. FAU - Sonesson, Christian AU - Sonesson C AD - AstraZeneca, Gothenburg, Molndal, Sweden. FAU - Johnsson, Eva AU - Johnsson E AD - AstraZeneca, Gothenburg, Molndal, Sweden. LA - eng PT - Journal Article DEP - 20170210 PL - United States TA - J Diabetes Complications JT - Journal of diabetes and its complications JID - 9204583 RN - 0 (Benzhydryl Compounds) RN - 0 (Diuretics, Osmotic) RN - 0 (Glucosides) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Membrane Transport Modulators) RN - 0 (Sodium-Glucose Transport Proteins) RN - 0 (hemoglobin A1c protein, human) RN - 1ULL0QJ8UC (dapagliflozin) SB - IM CIN - J Diabetes Complications. 2017 Jul;31(7):1075-1076. PMID: 28479154 MH - Adult MH - Aged MH - Aged, 80 and over MH - Benzhydryl Compounds/adverse effects/*therapeutic use MH - Diabetes Mellitus, Type 2/blood/complications/*drug therapy MH - Diabetic Cardiomyopathies/epidemiology/*prevention & control MH - Diuretics, Osmotic/adverse effects/*therapeutic use MH - Female MH - Glucosides/adverse effects/*therapeutic use MH - Glycated Hemoglobin/analysis MH - Heart Failure/complications/epidemiology/*prevention & control MH - Humans MH - Hyperglycemia/prevention & control MH - Hypoglycemia/chemically induced/prevention & control MH - Hypoglycemic Agents/adverse effects/therapeutic use MH - Longitudinal Studies MH - Male MH - Membrane Transport Modulators/adverse effects/*therapeutic use MH - Middle Aged MH - Randomized Controlled Trials as Topic MH - Risk Factors MH - Secondary Prevention MH - Sodium-Glucose Transport Proteins/*antagonists & inhibitors/metabolism OTO - NOTNLM OT - Cardiovascular safety OT - Dapagliflozin OT - Efficacy OT - Heart failure OT - Pooled analysis OT - Type 2 diabetes mellitus EDAT- 2017/03/13 06:00 MHDA- 2018/04/03 06:00 CRDT- 2017/03/13 06:00 PHST- 2016/11/16 00:00 [received] PHST- 2017/01/24 00:00 [revised] PHST- 2017/02/07 00:00 [accepted] PHST- 2017/03/13 06:00 [pubmed] PHST- 2018/04/03 06:00 [medline] PHST- 2017/03/13 06:00 [entrez] AID - S1056-8727(16)30861-3 [pii] AID - 10.1016/j.jdiacomp.2017.02.001 [doi] PST - ppublish SO - J Diabetes Complications. 2017 Jul;31(7):1215-1221. doi: 10.1016/j.jdiacomp.2017.02.001. Epub 2017 Feb 10.