Safety of spironolactone use in ambulatory heart failure patients.
BACKGROUND
Since the Randomized Aldactone Evaluation Study (RALES), the use of spironolactone is recommended in systolic heart failure (HF) patients that have been in New York Heart Association (NYHA) class III or IV. There is limited information on the use, side effects, and withdrawal rate of spironolactone in routine clinical practice.


OBJECTIVE
Side effects related to spironolactone use are more common than reported in clinical trials.


METHODS
Patients who had moderate to severe left ventricular systolic dysfunction (LVSD) under optimized medical therapy were included. We introduced spironolactone in those with serum potassium (K+) < or = 5 meq/L, and serum creatinine (Cr) < or = 2.5 mg/dL. Spironolactone was withdrawn if serum K + > or = 5.5 meq/L, serum Cr increased more than 30%- 50% of the baseline value, and/or if the patient had gynecomastia.


RESULTS
We selected 134 patients followed in an HF clinic. In our sample, 56.7% of the patients (76 out of 134) were currently or had formerly been on spironolactone therapy. The rate of spironolactone withdrawal was 25% (19 out of 76). Reasons for suspension were hyperkalemia (17.1%), renal function deterioration (14.5%), gynecomastia (5.3% of males), and other reasons (1.3%).


CONCLUSIONS
Spironolactone side effects are common and are mostly related to effects on the angiotensin-aldosterone axis. Our results reinforce the need to closely monitor serum K+ and Cr levels in patients treated with spironolactone, as its side effects are more common than reported in clinical trials.
Lopes
Ricardo J
RJ
Department of Cardiology, Hospital São João 4200-319 Porto, Portugal. rjlclopes@hotmail.com
Lourenço
Ana Patricia
AP
Mascarenhas
Joana
J
Azevedo
Ana
A
Bettencourt
Paulo
P
D000368:Aged; D000553:Ambulatory Care; D015415:Biomarkers / Q000097:blood; D015331:Cohort Studies; D003404:Creatinine / Q000097:blood; D018450:Disease Progression; D004232:Diuretics / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006333:Heart Failure / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D006947:Hyperkalemia / Q000097:blood / Q000139:chemically induced*; D007668:Kidney / Q000473:pathology*; D008297:Male; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects*; D012084:Renin-Angiotensin System / Q000187:drug effects; D012189:Retrospective Studies; D013148:Spironolactone / Q000008:administration & dosage / Q000009:adverse effects*
D015415:Biomarkers; D004232:Diuretics; D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone; D003404:Creatinine