Abstract | BACKGROUND: OBJECTIVES: This study sought to study the mutual influence of empagliflozin and MRAs in EMPEROR-Reduced ( Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction). METHODS: Secondary analysis that compared the effects of empagliflozin versus placebo in 3,730 patients with heart failure and a reduced ejection fraction, of whom 71% used MRAs at randomization. RESULTS: The effects of empagliflozin on the primary endpoint, on most efficacy endpoints, and on safety were similar in patients receiving or not receiving an MRA (interaction p > 0.20). For cardiovascular death, the hazard ratios for the effect of empagliflozin versus placebo were 0.82 (95% confidence interval [CI]: 0.65 to 1.05) in MRA users and 1.19 (95% CI: 0.82 to 1.71) in MRA nonusers (interaction p = 0.10); a similar pattern was seen for all-cause mortality (interaction p = 0.098). Among MRA nonusers at baseline, patients in the empagliflozin group were 35% less likely than those in the placebo group to initiate treatment with an MRA following randomization (hazard ratio: 0.65; 95% CI: 0.49 to 0.85). Among MRA users at baseline, patients in the empagliflozin group were 22% less likely than those in the placebo group to discontinue treatment with an MRA following randomization (hazard ratio: 0.78; 95% CI: 0.64 to 0.96). Severe hyperkalemia was less common in the empagliflozin group. CONCLUSIONS: In EMPEROR-Reduced, the use of MRAs did not influence the effect of empagliflozin to reduce adverse heart failure and renal outcomes. Treatment with empagliflozin was associated with less discontinuation of MRAs. ( Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction [EMPEROR-Reduced]; NCT03057977).
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Authors | João Pedro Ferreira, Faiez Zannad, Stuart J Pocock, Stefan D Anker, Javed Butler, Gerasimos Filippatos, Martina Brueckmann, Waheed Jamal, Dominik Steubl, Elke Schueler, Milton Packer |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 77
Issue 11
Pg. 1397-1407
(03 23 2021)
ISSN: 1558-3597 [Electronic] United States |
PMID | 33736821
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Benzhydryl Compounds
- Glucosides
- Mineralocorticoid Receptor Antagonists
- Sodium-Glucose Transporter 2 Inhibitors
- empagliflozin
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Topics |
- Aged
- Benzhydryl Compounds
(administration & dosage, adverse effects)
- Drug Interactions
- Drug Monitoring
(methods, statistics & numerical data)
- Drug Therapy, Combination
(methods)
- Female
- Glucosides
(administration & dosage, adverse effects)
- Heart Failure
(drug therapy, mortality, physiopathology)
- Humans
- Hyperkalemia
(chemically induced, diagnosis, prevention & control)
- Kidney Function Tests
(methods)
- Male
- Mineralocorticoid Receptor Antagonists
(administration & dosage, adverse effects)
- Outcome and Process Assessment, Health Care
- Sodium-Glucose Transporter 2 Inhibitors
(administration & dosage, adverse effects)
- Stroke Volume
(drug effects)
- Withholding Treatment
(statistics & numerical data)
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