Spironolactone reduces cardiovascular and cerebrovascular morbidity and mortality in hemodialysis patients
Yoshihiro Matsumoto, Yasuo Mori, Shinji Kageyama, Kazuo Arihara, Toshikazu Sugiyama, Hiromichi Ohmura, Toru Yakushigawa, Hatsumi Sugiyama, Yasushi Shimada, Youichi Nojima, Nobuo Shio, Yoshihiro Matsumoto, Yasuo Mori, Shinji Kageyama, Kazuo Arihara, Toshikazu Sugiyama, Hiromichi Ohmura, Toru Yakushigawa, Hatsumi Sugiyama, Yasushi Shimada, Youichi Nojima, Nobuo Shio
Abstract
Objectives: This study sought to assess whether spironolactone treatment reduces the high incidence of cardiovascular and cerebrovascular (CCV) morbidity and mortality in hemodialysis (HD) patients.
Background: Aldosterone receptor blockers reduce cardiac-related events, but the efficacy of the agents in HD patients is unclear.
Methods: A 3-year randomized trial involving 5 clinics was performed. Of the 309 oligoanuric HD patients enrolled in the study, 157 patients were randomly assigned to receive 25 mg/day of spironolactone without any restriction on dietary potassium intake (treatment group), and 152 patients were assigned to a control group. The primary outcome was a composite of death from CCV events or hospitalization for CCV events, and the secondary outcome was death from all causes.
Results: During the 3-year follow-up, the primary outcome occurred in 5.7% of patients in the treatment group and in 12.5% of patients in the control group. Hazard ratios (HRs) for the primary outcome for treatment were 0.404 (95% confidence interval [CI]: 0.202 to 0.809; p = 0.017) and 0.379 (95% CI: 0.173 to 0.832; p = 0.016) before and after adjustment, respectively. The secondary outcome was significantly reduced in the treatment group compared with the control group (6.4% vs. 19.7%; HRs: 0.355 [95% CI: 0.191 to 0.662; p = 0.002] and 0.335 [95% CI: 0.162 to 0.693; p = 0.003] before and after adjustment, respectively). Gynecomastia or breast pain was reported in 16 patients (10.2%) in the treatment group. Serious hyperkalemia led to treatment discontinuation in 3 patients (1.9%).
Conclusions: Aldosterone receptor blockade using spironolactone may substantially reduce the risk of both CCV morbidity and death among HD patients; however, larger-scale studies are recommended to further confirm its efficacy. (Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients; NCT01687699).
Keywords: cardiovascular and cerebrovascular event; hemodialysis; spironolactone.
Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed