Circulation, Vol 71, 963-971, Copyright © 1985 by American Heart Association
B Massie, M Bourassa, R DiBianco, M Hess, M Konstam, M Likoff and M Packer
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)
ARTICLES
Long-term oral administration of amrinone for congestive heart failure: lack of efficacy in a multicenter controlled trial
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