Congestive Heart FailureEffect of amlodipine on mode of death among patients with advanced heart failure in the praise trial☆
Section snippets
Patient population
The PRAISE trial was a randomized, double-blind, placebo-controlled study of amlodipine versus placebo treatment of 1,153 patients with severe chronic heart failure despite treatment with angiotensin-converting enzyme inhibitors, digitalis, and diuretics. The details of the study design and patient population have been described previously.6
End points
The primary end point of the PRAISE trial was the combined incidence of death (categorized as cardiovascular or noncardiovascular) or severe cardiovascular
Patient population
The PRAISE trial was conducted over a 34-month period ending December 31, 1994. At the time of termination, 1,153 patients had been enrolled. Of the 732 patients enrolled with ischemic heart disease, 370 were assigned to treatment with placebo and 362 to treatment with amlodipine. Of the 421 patients enrolled with nonischemic dilated cardiomyopathy, 212 were assigned to treatment with placebo and 209 to treatment with amlodipine. The 2 treatment groups were similar with respect to baseline
Discussion
When added to digitalis, diuretics, and angiotensin-converting enzyme inhibitors, amlodipine resulted in a 16% reduction in the hazard of mortality in the 1,153 patients with advanced heart failure enrolled in the PRAISE trial,6 with a 6% reduction in pump failure deaths and a 21% reduction in sudden cardiac deaths. Whereas the relative reduction in overall mortality was modest, the absolute benefit was more striking because of the high event rates in congestive heart failure.
The overall
Acknowledgements
We would like to thank Milton Packer, MD, Robert Califf, MD, Wendy Gattis, PharmD, and Alan Kraska, PhD, for critically reviewing the manuscript. We also thank the PRAISE trial team: Lynn Vesey, Karen Soileau, Jean Glaze, Helene Minor, LeeAnn Robinson, Kathy Miller, Laura Sears, Dorothy Gardiner, Samantha Wolfe, and Dave Rendall. Finally, our thanks to Pat Williams for editorial support and Crystal Crawford, Sue Ann Gentry, and Renee Story for manuscript preparation.
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This work was supported by Pfizer, Groton, Connecticut. Manuscript received February 24, 1998; revised manuscript received and accepted May 15, 1998.