Heart failure & cardiomyopathies

Efficacy and Safety of Empagliflozin According to Background Diuretic Use in Heart Failure with Reduced Ejection Fraction (HFrEF): Post-Hoc Analysis of EMPEROR-Reduced

JACC Heart FailPublished Secondary analysis of the EMPEROR-Reduced randomised trial

Authors' conclusion

Empagliflozin exhibits a consistent effect on time to CV death or HF hospitalization and an unaltered safety profile regardless of baseline diuretic therapy.

Study context

Population
Patients with HFrEF in the EMPEROR-Reduced trial3,656 analysed
Participants
3,730 patients
Comparison
Empagliflozin 10 mg vs placebo, by background diuretic dose
  • No diureticn = 482
  • <40 mgn = 731
  • 40 mgn = 1,411
  • >40 mgn = 1,032
Primary endpoint
Time to first event of hospitalization for heart failure (HF) or CV death
Methodological detailsdouble-blind, placebo-controlled, subgroup analysis by baseline diuretic dose
  • Double-blind
  • Placebo-controlled
  • Subgroup analysis by baseline diuretic dose

Primary result

As reported in the abstract

Hospitalization for HF or CV death, by baseline diuretic dose
Empagliflozin vs PlaceboHazard ratio (95% CI)
>40 mg
0.88(0.71–1.10)
40 mg
0.65(0.51–0.82)
<40 mg
0.65(0.46–0.92)
No diuretic
0.78(0.47–1.29)
Effect consistent regardless of background diuretic therapy
Ptrend test = 0.192

Further findings

Body weight, SBP, NT-proBNP, hematocrit · 52 weeks

Baseline diuretic dose did not influence empagliflozin's effect

Safety

Safety profile / adverse events

Safety profile of empagliflozin vs placebo unaffected by baseline diuretic dose
Total AE rates higher with higher baseline diuretic doses, independent of treatment allocation

Original publication

Efficacy and Safety of Empagliflozin According to Background Diuretic Use in HFrEF: Post-Hoc Analysis of EMPEROR-Reduced. JACC Heart Fail. Published 13 September 2023. doi:10.1016/j.jchf.2023.06.036

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