Oral amrinone therapy for 12 weeks did not significantly improve exercise tolerance compared to placebo (37% vs 35% improvement) and caused adverse reactions in 83% of patients.
RCT (n=99)
Double-blind
Randomized
Yes
Does oral amrinone improve clinical response and exercise tolerance in patients with NYHA class 3 or 4 congestive heart failure?
Oral amrinone failed to show efficacy over placebo for improving exercise tolerance or clinical symptoms in severe heart failure and was associated with high rates of adverse events.
Absolute Event Rate: 37% vs 35%
A number of uncontrolled studies have indicated that oral administration of amrinone, a phosphodiesterase inhibitor with potent positive inotropic effects in experimental preparations, may be beneficial in patients with chronic congestive heart failure. The present multicenter trial was designed to prospectively evaluate clinical response and change in exercise tolerance during 12 weeks of amrinone therapy in a double-blind, placebo-controlled protocol. Ninety-nine patients with NYHA functional class 3 or 4 congestive heart failure on digitalis and diuretics, of whom 31 were also receiving captopril, were enrolled. After baseline clinical assessment and determination of exercise tolerance, radionuclide left ventricular ejection fraction, and roentgenographic cardiothoracic ratio, patients were randomly assigned to receive amrinone or placebo, beginning at 1.5 mg/kg tid and increasing to a maximum dosage of 200 mg tid. After 12 weeks of therapy or at the last blinded evaluation in patients who did not complete this protocol, there were no significant differences from baseline values between treatment with amrinone or placebo with regard to symptoms, NYHA functional class, left ventricular ejection fraction, cardiothoracic ratio, frequency and severity of ventricular ectopy, or mortality. Exercise tolerance improved significantly from baseline by 37 +/- 10% (mean 163 sec) in patients on amrinone and 35 +/- 11% (mean 149 sec) in patients on placebo, but there was no significant difference between treatments. Adverse reactions were significantly more frequent and more severe on amrinone, occurring in 83% of patients and necessitating withdrawal in 34%.(ABSTRACT TRUNCATED AT 250 WORDS)
Massie et al. (Wed,) conducted a rct in congestive heart failure (n=99). amrinone vs. placebo was evaluated on clinical response and change in exercise tolerance. Oral amrinone therapy for 12 weeks did not significantly improve exercise tolerance compared to placebo (37% vs 35% improvement) and caused adverse reactions in 83% of patients.
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