Objective.
—To assess the efficacy of pharmacologic therapy in improving survival in patients with congestive heart failure (CHF) in the context of recent investigational studies having mortality as an end point.
Data Sources.
—Data were obtained from English-language articles that reported both randomized and retrospective studies assessing the efficacy of pharmacologic therapy in the treatment of patients with CHF. The review included articles indexed under the terms congestive heart failure and drug therapy in the National Library of Medicine's MEDLINE database.
Study Selection.
—Studies selected for detailed review were those having mortality as a primary or secondary end point.
Data Extraction.
—Guidelines for assessing data quality and validity included study size, double-blind and randomized design, the number of end points, the sensitivity and specificity of objective measurements, and the validity of the statistical analysis.
Data Synthesis.
—Review of the existing literature demonstrates that pharmacologic agents that improve resting hemodynamics or exercise duration in patients with CHF may not necessarily prolong survival. However, recent studies demonstrate that angiotensin-converting enzyme inhibitors prolong survival in patients with symptomatic CHF, while at the same time improving exercise capacity and left ventricular performance. Although less well tolerated, the combination of hydralazine hydrochloride and isosorbide dinitrate therapy also improves survival, but to a lesser degree. New agents show promise, but definitive assessment requires the results of large, randomized and double-blind studies having mortality as an end point.
Conclusions.
—Mortality is an important end point in assessing the efficacy of drugs for the treatment of CHF.
(JAMA. 1992;267:1956-1961)
