The Headline
Spironolactone saves lives in heart failure patients
The Facts
The Big Idea:
Spironolactone reduces mobidity and mortality among heart failure patients
Study Design:
Multicenter, double-blind, randomized, placebo-controlled trial (intention to treat)
Outcomes
Death from any cause, hospitalization for cardiac problems, and a change in NYHA heart failure class
Number of Patients
1663 randomized patients, 822 patients received sprionolactone 25 mg QD, 841 patients in placebo arm
Type of Patients
Patients who have severe heart failure (NYHA III-IV class) with a left ejection fraction less than 35 percent who were being treated with an angiotensin-converting–enzyme inhibitor (ACEI), a loop diuretic, and in most cases digoxin.
Important ExclusionsPatients were excluded if they had primary operable valvular heart disease (other than mitral or tricuspid regurgitation with clinical symptoms due to left ventricular systolic heart failure), congenital heart disease, unstable angina, primary hepatic failure, active cancer, or any life-threatening disease (other than heart failure). Patients who had undergone heart transplantation or were awaiting the procedure were also ineligible. Other criteria for exclusion were a serum creatinine concentration of more than 2.5 mg per deciliter (221 µmol per liter) and a serum potassium concentration of more than 5.0 mmol per liter
Interventions
Spironolactone 25 mg daily and my be increased to 50 mg, or placebo once daily
Duration
24 months, the trial was terminated early because an interim analysis determined that spironolactone was efficacious.
Statistics
Kaplan–Meier, log-rank test, Cox proportional-hazards regression models,
Funding
Supported by a grant from Searle, Skokie, Ill
Results
There were 386 deaths in the placebo group (46%) compared to 284 (35%) in the spironolactone group (CI 0.60-0.82, P < 0.001). The frequency of hospitalization for worsening heart failure (NYHA heart failure class) was 35% lower in the spironolactone group than in the placebo grou. Gynecomastia or breast pain was reported in 10% of men who were treated with spironolactone, as compared with 1% of men in the placebo group (P<0.001).
Spironolacotone 25-50 mg a day with an ACEI, and loop diuretic reduces mobidity and mortality among heart failure (NYHA III-IV class) patients
Reference
Pitt, B, Zannad, F et al. The Effect of Spironolactone on Morbidity and Mortality in Patients with Severe Heart Failure. N Eng J Med1999;341:709
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