Effect of Amlodipine on Morbidity and Mortality in Severe Chronic Heart Failure
Key result
Amlodipine did not significantly reduce the combined risk of death or major cardiovascular hospitalization compared to placebo in patients with severe heart failure (39% vs 42%; P=0.31).
Why the study?
Does amlodipine reduce morbidity and mortality in patients with severe chronic heart failure?
Population
1153 patients with severe chronic heart failure and ejection fractions of less than 30 percent, stratified…
Comparison
Amlodipine added to usual therapy for 6 to 33… vs Placebo added to usual therapy
Design
RCT, Stratified on the basis of whether patients had ischemic or nonischemic…
Follow-up
6 to 33 months
Authors
Discussion
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Implication
Amlodipine is safe without increasing events in severe heart failure; confirms neutral primary effect and leaves nonischemic subgroup signals open.
Study Design
Type
RCT (n=1,153)
Blinding
Double-blind
Randomization
Stratified
Structured PICO
Does amlodipine reduce morbidity and mortality in patients with severe chronic heart failure?
P
Population
1153 patients with severe chronic heart failure and ejection fractions of less than 30 percent, stratified by ischemic or nonischemic causes
I
Intervention
Amlodipine added to usual therapy for 6 to 33 months
C
Comparator
Placebo added to usual therapy
O
Outcome
Composite of death from any cause and hospitalization for major cardiovascular eventscomposite
Main Result
Effect estimate: 9% risk reduction (95% CI 24% reduction to 10% increase)
Absolute Event Rate: 39% vs 42%
p-value: p=0.31
Amlodipine does not increase cardiovascular morbidity or mortality in patients with severe heart failure, and it may prolong survival in those with nonischemic dilated cardiomyopathy.
Cite This Study
Packer et al. (1996) conducted an RCT in Severe chronic heart failure (n=1,153). Amlodipine vs. Placebo was evaluated on Death from any cause and hospitalization for major cardiovascular events (9% risk reduction, 95% CI 24% reduction to 10% increase, p=0.31). Amlodipine did not significantly reduce the combined risk of death or major cardiovascular hospitalization compared to placebo in patients with severe heart failure (39% vs 42%; P=0.31).