Abstract | OBJECTIVES: BACKGROUND: A pre-specified subgroup analysis in an earlier, large-scale, placebo-controlled study suggested that amlodipine might reduce the risk for death in patients with heart failure due to a nonischemic cardiomyopathy. METHODS: RESULTS: There were 278 deaths in the amlodipine group and 262 deaths in the placebo group (hazard ratio: 1.09; 95% confidence interval [CI]: 0.92 to 1.29; p = 0.33). The differences between the 2 groups in the risks for cardiovascular death and hospitalization were also not significant. When the results from patients with a nonischemic cardiomyopathy in both the earlier trial and in the current study were combined, there was no evidence of a favorable or unfavorable effect of amlodipine on mortality (hazard ratio: 0.97; 95% CI: 0.83 to 1.13; p = 0.66). Both trials, however, observed higher frequencies of peripheral edema and pulmonary edema and lower frequencies of uncontrolled hypertension and chest pain in patients treated with amlodipine. CONCLUSIONS: These results of the current trial, viewed together with the results from the earlier study, indicate that amlodipine does not exert favorable effects on the clinical course of patients with heart failure, regardless of the presence or absence of underlying coronary artery disease. These findings indicate the need for great caution when striking benefits are observed in subgroups of patients or in trials not primarily designed to assess such effects.
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Authors | Milton Packer, Peter Carson, Uri Elkayam, Marvin A Konstam, Gordon Moe, Christopher O'Connor, Jean-Lucien Rouleau, Douglas Schocken, Susan A Anderson, David L DeMets, PRAISE-2 Study Group |
Journal | JACC. Heart failure
(JACC Heart Fail)
Vol. 1
Issue 4
Pg. 308-314
(Aug 2013)
ISSN: 2213-1787 [Electronic] United States |
PMID | 24621933
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Calcium Channel Blockers
- Amlodipine
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Topics |
- Amlodipine
(therapeutic use)
- Calcium Channel Blockers
(therapeutic use)
- Cardiomyopathies
(complications)
- Chronic Disease
- Double-Blind Method
- Female
- Heart Failure
(drug therapy, etiology, mortality)
- Humans
- Male
- Middle Aged
- Prospective Studies
- Severity of Illness Index
- Survival Rate
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