Empagliflozin reduced cardiovascular death or HF hospitalization consistently across predicted HFpEF (HR 0.60), HFmrEF/HFrEF (HR 0.79), and no HF (HR 0.63) subgroups (P interaction=0.62).
RCT (n=7,001)
Does empagliflozin reduce cardiovascular death or heart failure hospitalization in patients with predicted HFpEF, HFmrEF/HFrEF, and no HF?
Empagliflozin consistently reduces cardiovascular death and heart failure hospitalizations regardless of predicted ejection fraction in patients from the EMPA-REG OUTCOME trial.
Estimación del efecto: HR 0.60, 0.79, 0.63 (95% CI 0.31-1.17, 0.51-1.23, 0.50-0.78)
valor p: p=0.62
BACKGROUND: In the EMPA-REG OUTCOME trial, ejection fraction (EF) data were not collected. In the subpopulation with heart failure (HF), we applied a new predictive model for EF to determine the effects of empagliflozin in HF with predicted reduced (HFrEF) vs preserved (HFpEF) EF vs no HF. METHODS AND RESULTS: We applied a validated EF predictive model based on patient baseline characteristics and treatments to categorize patients with HF as being likely to have HF with mid-range EF (HFmrEF)/HFrEF (EF <50%) or HFpEF (EF ≥50%). Cox regression was used to assess the effect of empagliflozin vs placebo on cardiovascular death/HF hospitalization (HHF), cardiovascular and all-cause mortality, and HHF in patients with predicted HFpEF, HFmrEF/HFrEF and no HF. Of 7001 EMPA-REG OUTCOME patients with data available for this analysis, 6314 (90%) had no history of HF. Of the 687 with history of HF, 479 (69.7%) were predicted to have HFmrEF/HFrEF and 208 (30.3%) to have HFpEF. Empagliflozin's treatment effect was consistent in predicted HFpEF, HFmrEF/HFrEF and no-HF for each outcome (HR 95% CI for the primary outcome 0.60 0.31-1.17, 0.79 0.51-1.23, and 0.63 0.50-0.78, respectively; P interaction = 0.62). CONCLUSIONS: In EMPA-REG OUTCOME, one-third of the patients with HF had predicted HFpEF. The benefits of empagliflozin on HF and mortality outcomes were consistent in nonHF, predicted HFpEF and HFmrEF/HFrEF.
Savarese et al. (Sun,) conducted a rct in Heart failure (predicted HFpEF, HFmrEF/HFrEF, and no HF) (n=7,001). Empagliflozin vs. Placebo was evaluated on Cardiovascular death or heart failure hospitalization (HR 0.60, 0.79, 0.63, 95% CI 0.31-1.17, 0.51-1.23, 0.50-0.78, p=0.62). Empagliflozin reduced cardiovascular death or HF hospitalization consistently across predicted HFpEF (HR 0.60), HFmrEF/HFrEF (HR 0.79), and no HF (HR 0.63) subgroups (P interaction=0.62).