title: High-risk patients treated with enalapril maleate: safety considerations.
abstract: The safety of 738 high-risk patients treated with enalapril under various clinical programs was evaluated. High risk was defined as the presence of a collagen vascular disease; a renal disease, including renovascular hypertension; or either hypertension or refractory cardiac failure with serum creatinine greater than or equal to 1.7 mg/dl at baseline. Essential hypertension was the primary diagnosis in most of these patients. Treatment with enalapril in these patients usually continued without interruption for the length of the particular protocol. The incidence of adverse reactions resulting in discontinuation of treatment was comparable to that observed with other standard antihypertensive therapies in patients with milder forms of disease. No enalapril-related neutropenia, proteinuria, dysgeusia or ageusia were reported in these high-risk patients. The incidence of discontinuation due to rash was less than 0.5%. Resolution and/or improvement of captopril-related adverse effects was observed in many patients crossed over to treatment with enalapril. In patients with collagen vascular diseases and those with severe impairment of renal function (serum creatinine greater than or equal to 3.0 mg/dl), the incidence of discontinuation due to adverse experiences or death as well as the profile of reported adverse experiences was similar to those for the total group of high-risk patients. The data suggest that enalapril is efficacious and well tolerated by the high-risk patients.
authors.affiliation: Merck Sharp & Dohme Research Laboratories, Merck & Co., Inc., West Point, Pennsylvania 19486.
authors.forename: E J
authors.initials: EJ
authors.lastname: Rucinska
authors.forename: R
authors.initials: R
authors.lastname: Small
authors.forename: J
authors.initials: J
authors.lastname: Irvin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001806:Blood Urea Nitrogen; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003095:Collagen Diseases / Q000150:complications; D003404:Creatinine / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004656:Enalapril / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D006978:Hypertension, Renovascular / Q000188:drug therapy; D007674:Kidney Diseases / Q000150:complications; D008297:Male; D008875:Middle Aged; D012307:Risk Factors
chemical_list: D004656:Enalapril; D003404:Creatinine