Clinical Research
Cardiometabolic Risk
Spironolactone Reduces Cardiovascular and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients

https://doi.org/10.1016/j.jacc.2013.09.056Get rights and content
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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)

Key Words

cardiovascular and cerebrovascular event
hemodialysis
spironolactone

Abbreviations and Acronyms

ACEI
angiotensin-converting enzyme inhibitor
ARB
angiotensin receptor blocker
CCV
cardiovascular and cerebrovascular
CI
confidence interval
CT
computed tomography
CTR
cardiothoracic ratio
ESRD
end-stage renal disease
HD
hemodialysis
HR
hazard ratio
MRI
magnetic resonance imaging
RAAS
renin-angiotensin-aldosterone system
SCD
sudden cardiac death
TIA
transient ischemic attack

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The authors have reported that they have no relationships relevant to the contents of this paper to disclose.