RALES trial: spironlactone for heart failure

ProfJameson Landmark Decisions 1

headline

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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