title: Safety of low-dose spironolactone administration in chronic haemodialysis patients.
abstract: BACKGROUND
  Prevention of cardiovascular diseases is essential in chronic haemodialysis patients. Recently, low-dose spironolactone has been shown to decrease cardiovascular mortality in patients with severe heart failure. However, since haemodialysis patients are prone to hyperkalaemia, a known side effect of spironolactone, this treatment is not used in this population. We performed a study to assess whether low-dose spironolactone (3 x 25 mg/week) could be administered without inducing hyperkalaemia in haemodialysis patients.
  
  
  METHODS
  The study design included a 2-week baseline period, followed by a 4-week treatment period in which doses of spironolactone were started at 12.5 mg three times/week for 2 weeks, then increased to 25 mg three times/week, and followed by a 2-week wash-out period. Fourteen patients receiving low-dose spironolactone after each dialysis were compared with 21 haemodialysis patients (control group).
  
  
  RESULTS
  Low-dose spironolactone did not change mean serum potassium (4.9 +/- 0.7 vs 4.9 +/- 0.3 mmol/l: control). The mean plasma canrenone level induced by administration of spironolactone 25 mg three times/week in the 14 treated patients was 13 +/- 5.3 ng/ml. Serum aldosterone was not significantly modified by the administration of spironolactone in these patients [before, median 0.35; interquartile range (IQR) 0.11-2.83 nmol/l vs after, median 0.22; IQR 0.12-0.60 nmol/l, NS]. Dietary potassium intake and the use of ion-exchange resin, angiotensin-converting enzyme inhibitors and beta-blockers were similar for the two groups throughout the study.
  
  
  CONCLUSIONS
  This non-randomized and non-blinded study shows that administration of 25 mg spironolactone thrice weekly is not associated with an increased frequency of hyperkalaemia in haemodialysis patients when they are carefully monitored. More studies are required, however, before concluding that spironolactone administration is safe in the chronic haemodialysis population.
authors.affiliation: Division of Nephrology, Department of Medicine, University Hospital, Geneva Medical School, Geneva, Switzerland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Saudan
authors.forename: Francois
authors.initials: F
authors.lastname: Mach
authors.forename: Thomas
authors.initials: T
authors.lastname: Perneger
authors.forename: Bruno
authors.initials: B
authors.lastname: Schnetzler
authors.forename: Catherine
authors.initials: C
authors.lastname: Stoermann
authors.forename: Zina
authors.initials: Z
authors.lastname: Fumeaux
authors.forename: Michel
authors.initials: M
authors.lastname: Rossier
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Martin
mesh_terms: D000328:Adult; D000368:Aged; D000450:Aldosterone / Q000097:blood; D002192:Canrenone / Q000097:blood; D006801:Humans; D006947:Hyperkalemia / Q000097:blood / Q000139:chemically induced*; D007676:Kidney Failure, Chronic / Q000097:blood / Q000628:therapy; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage* / Q000009:adverse effects*; D011188:Potassium / Q000097:blood; D006435:Renal Dialysis; D013148:Spironolactone / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone; D000450:Aldosterone; D002192:Canrenone; D011188:Potassium