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Eplerenone: A Review of Its Use in Patients with Chronic Systolic Heart Failure and Mild Symptoms

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Abstract

Eplerenone (Inspra®) is a selective mineralocorticoid receptor antagonist (MRA). In the EU, it is approved for use (in addition to standard optimal therapy) to reduce the risk of cardiovascular (CV) mortality and morbidity in adult patients with chronic systolic heart failure (HF) and mild symptoms. This article reviews the efficacy and tolerability of eplerenone in this indication and briefly summarizes its pharmacology. In the EMPHASIS-HF study, relative to placebo, the addition of eplerenone to optimal background therapy significantly reduced the risk of death from CV causes or hospitalization for HF in patients with chronic systolic HF and mild symptoms. Benefits of eplerenone therapy over placebo were also observed in several secondary outcomes, including: death from any cause or hospitalization for HF; death from any cause; hospitalization for any reason; or hospitalization for HF. Eplerenone was generally well tolerated in this study, with the most frequent adverse event being hyperkalaemia, which is a known adverse event of the drug class. Sexual adverse events (e.g. gynecomastia) occurred in <1 % of eplerenone recipients, reflecting the selectivity of eplerenone for mineralocorticoid receptors. Based on these results, European guidelines have been updated and recommend the use of an MRA to reduce the risk of HF hospitalization and premature death in all patients with persisting symptoms (New York Heart Association class II–IV) and a left-ventricular ejection fraction of ≤35 %, despite treatment with ACE inhibitor (or an angiotensin receptor blocker if an ACE inhibitor is not tolerated) and a β-blocker.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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    Sohita Dhillon

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The manuscript was reviewed by: D.R. Abernethy, Office of Clinical Pharmacology, US Food and Drug Administration, Annapolis, MD, USA; R. Desai, Department of Cardiovascular Medicine, Lehigh Valley Hospital and Health Network, Allentown, PA, USA; S.K. Maulik, Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India; B. Pitt, University of Michigan School of Medicine, Ann Arbor, MI, USA

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Dhillon, S. Eplerenone: A Review of Its Use in Patients with Chronic Systolic Heart Failure and Mild Symptoms. Drugs 73, 1451–1462 (2013). https://doi.org/10.1007/s40265-013-0098-z

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