title: Spironolactone reduces cardiovascular and cerebrovascular morbidity and mortality in hemodialysis patients.
abstract: OBJECTIVE
  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).
authors.affiliation: Department of Nephrology and Dialysis, Shizuoka City Hospital, Shizuoka, Japan. Electronic address: matsumoto16@aol.com.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Matsumoto
authors.affiliation: Shibukawa Clinic, Shizuoka, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Mori
authors.affiliation: Kageyama Urological Clinic, Shizuoka, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Kageyama
authors.affiliation: Ohtemachi Clinic, Shizuoka, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Arihara
authors.affiliation: Sugiyama Clinic, Shizuoka, Japan.
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Sugiyama
authors.affiliation: Sugawara Clinic, Shizuoka, Japan.
authors.forename: Hiromichi
authors.initials: H
authors.lastname: Ohmura
authors.affiliation: Shibukawa Clinic, Shizuoka, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Yakushigawa
authors.affiliation: Sugiyama Clinic, Shizuoka, Japan.
authors.forename: Hatsumi
authors.initials: H
authors.lastname: Sugiyama
authors.affiliation: Department of Nephrology and Dialysis, Shizuoka City Hospital, Shizuoka, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Shimada
authors.affiliation: Department of Nephrology and Dialysis, Shizuoka City Hospital, Shizuoka, Japan.
authors.forename: Youichi
authors.initials: Y
authors.lastname: Nojima
authors.affiliation: Kageyama Urological Clinic, Shizuoka, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shio
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000150:complications / Q000401:mortality / Q000517:prevention & control*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007564:Japan / Q000453:epidemiology; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000401:mortality / Q000628:therapy; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use*; D011446:Prospective Studies; D006435:Renal Dialysis; D013148:Spironolactone / Q000627:therapeutic use*
chemical_list: D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone
keywords: cardiovascular and cerebrovascular event; hemodialysis; spironolactone