Long-term oral administration of amrinone for congestive heart failure: lack of efficacy in a multicenter controlled trial.
Key result
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.
Why the study?
Does oral amrinone improve clinical response and exercise tolerance in patients with NYHA class 3 or 4 congestive heart failure?
Population
99 patients with NYHA functional class 3 or 4 congestive heart failure on digitalis and diuretics, of whom…
Comparison
Amrinone oral, beginning at 1.5 mg/kg tid and… vs Placebo
Design
RCT, Randomly assigned, Double-blind, placebo-controlled
Follow-up
12 weeks
Authors
Discussion
Loading...
Member takes
Implication
Avoid oral amrinone in NYHA III-IV HF; RCT confirms lack of benefit with substantial toxicity.
Key Points
- The trial aimed to evaluate the efficacy of amrinone in improving clinical response and exercise tolerance in patients with congestive heart failure.
- Multicenter, double-blind, placebo-controlled trial conducted over 12 weeks.
- Ninety-nine patients with NYHA functional class 3 or 4 congestive heart failure received amrinone or placebo.
- Patients underwent clinical assessments and measurements of left ventricular ejection fraction before and after treatment.
- No significant differences observed between amrinone and placebo in symptoms, exercise tolerance, or left ventricular ejection fraction.
- Exercise tolerance improved by 37% in the amrinone group and 35% in the placebo group, with no significant treatment difference.
- Adverse reactions were prevalent, occurring in 83% of patients on amrinone, leading to withdrawal in 34%.
Study Design
Type
RCT (n=99)
Blinding
Double-blind
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does oral amrinone improve clinical response and exercise tolerance in patients with NYHA class 3 or 4 congestive heart failure?
P
Population
99 patients with NYHA functional class 3 or 4 congestive heart failure on digitalis and diuretics, of whom 31 were also receiving captopril
I
Intervention
Amrinone oral, beginning at 1.5 mg/kg tid and increasing to a maximum dosage of 200 mg tid for 12 weeks
C
Comparator
Placebo
O
Outcome
Clinical response and change in exercise tolerance during 12 weekssurrogate
Main Result
Absolute Event Rate: 37% vs 35%
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.
Cite This Study
Massie et al. (1985) conducted an 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.