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Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine
M Packer1, C M O'Connor, J K Ghali
1College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.
Insights
Amlodipine did not increase risks in severe heart failure patients. However, it showed survival benefits in those with nonischemic cardiomyopathy, warranting further investigation for this specific group.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Calcium-channel blockers have been linked to increased morbidity and mortality in chronic heart failure.
- This study investigates amlodipine, a novel calcium-channel blocker, in severe chronic heart failure patients.
Purpose of the Study:
- To evaluate the safety and efficacy of amlodipine in patients with severe chronic heart failure.
- To determine amlodipine's effect on cardiovascular morbidity and mortality.
Main Methods:
- A randomized, double-blind trial involving 1153 patients with severe heart failure (ejection fraction <30%).
- Patients received either placebo or amlodipine for 6-33 months, alongside standard therapy.
- Stratification was based on ischemic or nonischemic heart failure causes; primary endpoint was death or major cardiovascular events.
Main Results:
- Amlodipine showed a non-significant 9% reduction in combined fatal and nonfatal events (P=0.31).
- Mortality risk was reduced by 16% with amlodipine (P=0.07), though not statistically significant.
- In nonischemic cardiomyopathy, amlodipine significantly reduced combined events by 31% (P=0.04) and mortality by 46% (P<0.001).
Conclusions:
- Amlodipine is safe and does not increase cardiovascular risks in severe heart failure patients.
- Amlodipine may prolong survival in patients with nonischemic dilated cardiomyopathy, meriting further research.
Background:
Previous studies have shown that calcium-channel blockers increase morbidity and mortality in patients with chronic heart failure. We studied the effect of a new calcium-channel blocker, amlodipine, in patients with severe chronic heart failure.
Methods:
We randomly assigned 1153 patients with severe chronic heart failure and ejection fractions of less than 30 percent to double-blind treatment with either placebo (582 patients) or amlodipine (571 patients) for 6 to 33 months, while their usual therapy was continued. The randomization was stratified on the basis of whether patients had ischemic or nonischemic causes of heart failure. The primary end point of the study was death from any cause and hospitalization for major cardiovascular events.
Results:
Primary end points were reached in 42 percent of the placebo group and 39 percent of the amlodipine group, representing a 9 percent reduction in the combined risk of fatal and nonfatal events with amlodipine (95 percent confidence interval, 24 percent reduction to 10 percent increase; P=0.31). A total of 38 percent of the patients in the placebo group died, as compared with 33 percent of those in the amlodipine group, representing a 16 percent reduction in the risk of death with amlodipine (95 percent confidence interval, 31 percent reduction to 2 percent increase; P=0.07). Among patients with ischemic heart disease, there was no difference between the amlodipine and placebo groups in the occurrence of either end point. In contrast, among patients with nonischemic cardiomyopathy, amlodipine reduced the combined risk of fatal and nonfatal events by 31 percent (P=0.04) and decreased the risk of death by 46 percent (P<0.001).
Conclusions:
Amlodipine did not increase cardiovascular morbidity or mortality in patients with severe heart failure. The possibility that amlodipine prolongs survival in patients with nonischemic dilated cardiomyopathy requires further study.