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Adverse events associated with early initiation of Eplerenone in patients hospitalized for acute heart failure.
Kobayashi, Masatake; Yamashina, Akira; Satomi, Kazuhiro; Tezuka, Ayako; Ito, Shin; Asakura, Masanori; Kitakaze, Masafumi; Ferreira, João Pedro.
Afiliación
  • Kobayashi M; Department of Cardiology, Tokyo Medical University, Tokyo, Japan. Electronic address: mkoba12@me.com.
  • Yamashina A; Department of Nursing, Kiryu University, Gunma, Japan.
  • Satomi K; Department of Cardiology, Tokyo Medical University, Tokyo, Japan.
  • Tezuka A; Department of Cardiology, Tokyo Medical University, Tokyo, Japan.
  • Ito S; Department of Clinical Research and Development, National Cerebral and Cardiovascular Center, Osaka, Japan.
  • Asakura M; Department of Cardiovascular and Renal Medicine, Hyogo Medical University, Hyogo, Japan.
  • Kitakaze M; Department of Clinical Research and Development, National Cerebral and Cardiovascular Center, Osaka, Japan; Hanwa Memorial Hospital, Osaka, Japan.
  • Ferreira JP; Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal; Heart Failure Clinic, Internal Medicine Department, Centro Hospitalar de Vila Nova de Gaia/Espinho, Gaia, Portugal; Université de Lorraine, INSERM, C
Int J Cardiol ; 415: 132477, 2024 Nov 15.
Article en En | MEDLINE | ID: mdl-39181408
ABSTRACT

BACKGROUND:

The guidelines recommend the initiation or up-titration of heart failure (HF) treatments following an HF hospitalization; however, concerns about adverse events may limit the use of mineralocorticoid receptor antagonists (MRAs). Patient profiles or disease severity might impact adverse events associated with MRA therapy in acute HF.

METHODS:

The EARLIER trial included patients with acute HF who were randomized to eplerenone or placebo over 6 months. Adverse events (i.e., worsening renal function [WRF], hyperkalemia, hypotension, and volume depletion/dehydration) were assessed. HF-related outcome included a composite of all-cause mortality, HF re-hospitalization, investigator-reported worsening HF and out-of-hospital diuretic intensification.

RESULTS:

In 297 patients (mean age 67 ± 13 years; 73% males), adverse events were observed 44.4% experienced WRF (>20% drop in estimated glomerular filtration rate[eGFR] and/or investigator-reported WRF), 8.4% had hyperkalemia (potassium >5.5 mmol/L and/or investigator-reported hyperkalemia), 27.9% experienced hypotension (systolic blood pressure[SBP] <90 mmHg and/or investigator-reported hypotension), and 16.8% had investigator-reported volume depletion/dehydration. Eplerenone vs. placebo did not elevate the incidence of these events (all-p-values>0.0 5). Multivariable analyses revealed that, irrespective of treatment allocation, older age (>7 5 years), prevalent diabetes, symptomatic congestion, and microalbuminuria were associated with increased risk of WRF. Baseline eGFR<60 ml/min/1.73m2 and SBP < 90 mmHg predicted hyperkalemia and hypotension, respectively, while older patients were more likely to experience volume depletion/dehydration. However, these patient profiles did not alter the benefit of eplerenone on outcomes (HR [9 5%CI] = 0.53 [0.29 to 0.97], P = 0.04; all-p-for-interaction>0.10).

CONCLUSION:

Eplerenone did not increase adverse events compared with placebo in acute HF. Importantly, disease severity and comorbidity burden greatly influence adverse events, but not benefit from eplerenone.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antagonistas de Receptores de Mineralocorticoides / Eplerenona / Insuficiencia Cardíaca / Hospitalización Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Int J Cardiol Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antagonistas de Receptores de Mineralocorticoides / Eplerenona / Insuficiencia Cardíaca / Hospitalización Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Int J Cardiol Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos