Effect of Amlodipine on Morbidity and Mortality in Severe Chronic Heart Failure
Milton Packer, M.D., Christopher M. O'Connor, M.D., Jalal K. Ghali, M.D., Milton L. Pressler, M.D., Peter E. Carson, M.D., Robert N. Belkin, M.D., Alan B. Miller, M.D., Gerald W. Neuberg, M.D., David Frid, M.D., John H. Wertheimer, M.D., Anne B. Cropp, Pharm.D., David L. DeMets, Ph.D., for The Prospective Randomized Amlodipine Survival Evaluation Study Group
Background Previous studies have shown that calcium-channelblockers increase morbidity and mortality in patients with chronicheart failure. We studied the effect of a new calcium-channelblocker, amlodipine, in patients with severe chronic heart failure.
Methods We randomly assigned 1153 patients with severe chronicheart failure and ejection fractions of less than 30 percentto double-blind treatment with either placebo (582 patients)or amlodipine (571 patients) for 6 to 33 months, while theirusual therapy was continued. The randomization was stratifiedon the basis of whether patients had ischemic or nonischemiccauses of heart failure. The primary end point of the studywas death from any cause and hospitalization for major cardiovascularevents.
Results Primary end points were reached in 42 percent of theplacebo group and 39 percent of the amlodipine group, representinga 9 percent reduction in the combined risk of fatal and nonfatalevents with amlodipine (95 percent confidence interval, 24 percentreduction to 10 percent increase; P = 0.31). A total of 38 percentof the patients in the placebo group died, as compared with33 percent of those in the amlodipine group, representing a16 percent reduction in the risk of death with amlodipine (95percent confidence interval, 31 percent reduction to 2 percentincrease; P = 0.07). Among patients with ischemic heart disease,there was no difference between the amlodipine and placebo groupsin the occurrence of either end point. In contrast, among patientswith nonischemic cardiomyopathy, amlodipine reduced the combinedrisk of fatal and nonfatal events by 31 percent (P = 0.04) anddecreased the risk of death by 46 percent (P<0.001).
Conclusions Amlodipine did not increase cardiovascular morbidityor mortality in patients with severe heart failure. The possibilitythat amlodipine prolongs survival in patients with nonischemicdilated cardiomyopathy requires further study.
Source Information
From the College of Physicians and Surgeons, Columbia University, New York (M.P., G.W.N.); Duke University Medical Center, Durham, N.C. (C.M.O., D.F.); Louisiana State University, Shreveport (J.K.G.); Krannert Institute of Cardiology, Indianapolis (M.L.P.); Washington Veterans Affairs Medical Center, Washington, D.C. (P.E.C.); New York Medical College, Valhalla (R.N.B.); University of Florida College of Medicine, Jacksonville (A.B.M.); Albert Einstein Medical Center, Philadelphia (J.H.W.); Pfizer Central Research, Groton, Conn. (A.B.C.); and the University of Wisconsin, Madison (D.L.D.).
Address reprint requests to Dr. Packer at the Division of Circulatory Physiology, Columbia University College of Physicians and Surgeons, 630 W. 168th St., New York, NY 10032.
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