Author + information
- Silvio E. Inzucchi,
- Bernard Zinman,
- Jennifer McGinniss,
- Janet Schnee,
- Jyothis George and
- David Fitchett
Background: In the EMPA-REG OUTCOME trial, empagliflozin (EMPA) given in addition to standard of care significantly reduced the risk of cardiovascular (CV) death by 38%, hospitalization for heart failure (HHF) by 35%, and the composite of HHF or CV death by 34% vs placebo in patients with type 2 diabetes (T2DM) and high CV risk. CV outcomes and deaths were prospectively adjudicated by clinical event committees. Post-hoc, we investigated composite outcomes of HHF and modes of CV death commonly observed in patients with heart failure (HF): sudden death, death due to HF (worsening of HF or cardiogenic shock), and presumed CV death (insufficient data for adjudication committees to definitively categorize the cause).
Methods: Patients were randomized to receive EMPA 10 mg, EMPA 25 mg, or placebo. Using a Cox proportional hazards model, we analyzed three additional composite outcomes in the pooled EMPA group vs placebo: a) HHF or death due to HF; b) HHF, death due to HF, or sudden death; c) HHF, death due to HF, sudden death, or presumed CV death.
Results: A total of 7,020 patients were treated. At baseline, mean age was 63.1 years, BMI was 30.6 kg/m2, HbA1c was 8.1%, 71.5% were male and 10.1% had investigator-reported HF. Risk reductions for the composite outcomes studied are shown in the figure.
Conclusions: Risk reductions in composite outcomes of HHF and modes of CV death commonly observed in patients with HF were comparable to the 34% reduction in the pre-specified composite of HHF or CV death in the EMPA-REG OUTCOME trial.
Room 147 A
Sunday, March 19, 2017, 9:04 a.m.-9:14 a.m.
Session Title: Highlighted Original Research: Prevention and the Year in Review
Abstract Category: 32. Prevention: Clinical
Presentation Number: 911-12
- 2017 American College of Cardiology Foundation