Enalapril in the treatment of congestive heart failure: effects on signs, symptoms and mortality
Rucinska, E.J.
Acta Cardiologica 46(2): 231-246
1991
ISSN/ISBN: 0001-5385 PMID: 2048370 Document Number: 380619
This is a review of the effects of E on the symptoms of CHF which affect patients' (pts) quality of life and the signs associated with pts' prognosis. The review is based on clinical studies which were included in the New Drug Application for Vasotec (enalapril maleate, MSD) in the United States. There were 3 open-label (242 pts) and 4 double-blind, placebo (P)-controlled (661 pts) studies of at least 1 month and up to about 2 years duration. One of these, the CONSENSUS Trial evaluated mortality in 253 pts with class IV CHF. Dyspnea and fatigue are considered the most disabling symptoms causing pts' functional impairment and thus reducing the quality of life. Left ventricular gallop, pulmonary rales, cardiomegaly, and ejection fractions are known to adversely effect pts' prognosis. Evaluations of these signs, symptoms, and scores related to these symptoms were included in most, but not all, studies. The pts' NYHA cardiac status was evaluated in all studies. E alleviated the signs and symptoms of CHF and improved various scores in significant number of pts. Pts' quality of life improved as indicated by the number of pts "feeling better" after Rx with E (p less than 0.01 vs P) in a multinational study of 256 pts; reductions of cardiomegaly and increases in ejection fraction were significantly greater in E than in P treated pts; and in severe CHF (CONSENSUS Trial) the mortality was significantly reduced (p less than 0.003 vs P).