Efficacy of SGLT2 inhibitors in patients recently hospitalized for heart failure: an exploratory prespecified pooled analysis of the DELIVER and EMPEROR-preserved trials
Abstract
Background: Hospitalization for heart failure identifies patients with preserved ejection fraction (HFpEF) at highest risk. However, precise efficacy estimates for sodium-glucose cotransporter 2 (SGLT2) inhibitors in this vulnerable subgroup-and whether they depend on the definition of "recent" hospitalization-are lacking.
Methods: This exploratory, hypothesis-generating analysis was a prespecified pooled analysis of the EMPEROR-Preserved and DELIVER trials in patients with HFpEF (LVEF >40%). High-risk subgroups were defined using data from each trial respectively: HF hospitalization within 30 days ("strict", from DELIVER, n = 654) or 12 months ("broad", from EMPEROR-Preserved, n = 1,369). The primary endpoint was the composite of cardiovascular death or HF hospitalization.
Results: Treatment with SGLT2 inhibitors reduced the risk of the primary endpoint by 22% in the strict group (HR: 0.78, 95% CI: 0.60-1.03, with a confidence interval that includes the null) and by 27% in the broad group (HR: 0.73, 95% CI: 0.59-0.90). There was no significant heterogeneity between these estimates (I² = 0%), and a similar direction of effect was observed across the two trials. The safety profile was consistent with the known class effect.
Conclusion: In patients with HFpEF and a recent HF hospitalization, these exploratory findings suggest that SGLT2 inhibitors may provide cardiovascular benefit. The similar direction of effect across two definitions of "recent" (≤30 days and ≤12 months)…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 1,369 participants or records.
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