WASHINGTON, DC—Risk reductions in composite outcomes of hospitalization for heart failure (HHF) and modes of cardiovascular (CV) death observed with empagliflozin were comparable to the reduction in the pre-specified composite of HHF or CV death in the EMPAG-REG OUTCOME trial, reported Silvio E. Inzucchi, MD, from Boehringer Ingelheim & Eli Lilly Diabetes Alliance, Ingelheim, Germany. The full findings were were presented at the ACC.17 Scientific Session.
Empagliflozin, when given as an add-on to standard of care in patients with type 2 diabetes and high CV risk, significantly reduced the risk of CV death by 38% and HHF by 35% (composite of HHF or CV death by 34%) in the EMPAG-REG OUTCOME trial. For this post hoc analysis, Dr. Inzucchi and coauthors of the study analyzed composite outcomes of HHF and modes of CV death commonly seen in patients with heart failure: 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).
Study patients were randomized to receive empagliflozin 10mg, empagliflozin 25mg, or placebo. “Using a Cox proportional hazards model, we analyzed 3 additional composite outcomes in the pooled empagliflozin group vs. placebo,” explained Dr. Inzucchi. These composite outcomes included: HHF or death due to HF; HHF, death due to HF, or sudden death; and HHF, death due to HF, sudden death, or presumed CV death.
Baseline characteristics of the study sample (n=7,020) included: mean age 63.1 years, body mass index (BMI) 30.6kg/m2, HbA1c 8.1%, and 10.1% had investigator-reported HF.
Data from the analysis showed greater risk reductions (% event) with empagliflozin vs. placebo for the following outcomes:
- HHF: 2.7% vs. 4.1%; HR 0.65 (95% CI: 0.50, 0.85)
- Death due to HF: 0.3% vs. 0.9%; HR 0.32 (95% CI: 0.16, 0.62)
- Sudden death: 1.1% vs. 1.6%; HR 0.69 (95% CI: 0.45, 1.04)
- Presumed CV death: 1.5% vs. 2.3%; HR 0.66 (95% CI: 0.46, 0.94)
- HHF or CV death: 5.7% vs. 8.5%; HR 0.66 (95% CI: 0.55, 0.79)
- HHF or death due to HF: 2.8% vs. 4.5%; HR 0.62 (95% CI: 0.48, 0.80)
- HHF, death due to HF, or sudden death: 3.9% vs. 6.0%; HR 0.63 (95% CI: 0.51, 0.79)
- HHF, death due to HF, sudden death, or presumed CV death: 5.3% vs. 8.1%; HR 0.65 (95% CI: 0.53, 0.78)
The reductions seen with the composite outcomes of HHF and modes of CV death seen in patients with HF were similar to the 34% reduction in the pre-specified composite of HHF or CV death in the EMPAG-REG OUTCOME trial, concluded study authors.