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J Am Coll Cardiol. 2014 Feb 18;63(6):528-36. doi: 10.1016/j.jacc.2013.09.056. Epub 2013 Oct 30.

Spironolactone reduces cardiovascular and cerebrovascular morbidity and mortality in hemodialysis patients.

Author information

1
Department of Nephrology and Dialysis, Shizuoka City Hospital, Shizuoka, Japan. Electronic address: matsumoto16@aol.com.
2
Shibukawa Clinic, Shizuoka, Japan.
3
Kageyama Urological Clinic, Shizuoka, Japan.
4
Ohtemachi Clinic, Shizuoka, Japan.
5
Sugiyama Clinic, Shizuoka, Japan.
6
Sugawara Clinic, Shizuoka, Japan.
7
Department of Nephrology and Dialysis, Shizuoka City Hospital, Shizuoka, Japan.

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

PMID:
24184249
DOI:
10.1016/j.jacc.2013.09.056
[Indexed for MEDLINE]
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