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Eur Heart J. 2016 May 14;37(19):1526-34. doi: 10.1093/eurheartj/ehv728. Epub 2016 Jan 26.

Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME® trial.

Author information

1
St Michael's Hospital, Division of Cardiology, University of Toronto, Toronto, Canada fitchettd@smh.ca.
2
Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada Division of Endocrinology, University of Toronto, Toronto, Canada.
3
Comprehensive Heart Failure Center and Renal Division, University of Wuerzburg and Hospital, Wuerzburg, Germany.
4
The Biostatistics Center, The George Washington University, Rockville, MD, USA.
5
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
6
Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA.
7
Boehringer Ingelheim Norway KS, Asker, Norway.
8
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
9
Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.

Abstract

AIMS:

We previously reported that in the EMPA-REG OUTCOME(®) trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular events, cardiovascular and all-cause death, and hospitalization for heart failure in patients with type 2 diabetes and high cardiovascular risk. We have now further investigated heart failure outcomes in all patients and in subgroups, including patients with or without baseline heart failure.

METHODS AND RESULTS:

Patients were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo. Seven thousand and twenty patients were treated; 706 (10.1%) had heart failure at baseline. Heart failure hospitalization or cardiovascular death occurred in a significantly lower percentage of patients treated with empagliflozin [265/4687 patients (5.7%)] than with placebo [198/2333 patients (8.5%)] [hazard ratio, HR: 0.66 (95% confidence interval: 0.55-0.79); P < 0.001], corresponding to a number needed to treat to prevent one heart failure hospitalization or cardiovascular death of 35 over 3 years. Consistent effects of empagliflozin were observed across subgroups defined by baseline characteristics, including patients with vs. without heart failure, and across categories of medications to treat diabetes and/or heart failure. Empagliflozin improved other heart failure outcomes, including hospitalization for or death from heart failure [2.8 vs. 4.5%; HR: 0.61 (0.47-0.79); P < 0.001] and was associated with a reduction in all-cause hospitalization [36.8 vs. 39.6%; HR: 0.89 (0.82-0.96); P = 0.003]. Serious adverse events and adverse events leading to discontinuation were reported by a higher proportion of patients with vs. without heart failure at baseline in both treatment groups, but were no more common with empagliflozin than with placebo.

CONCLUSION:

In patients with type 2 diabetes and high cardiovascular risk, empagliflozin reduced heart failure hospitalization and cardiovascular death, with a consistent benefit in patients with and without baseline heart failure.

KEYWORDS:

Cardiovascular disease; Hospitalization; Mortality

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