Overall Tolerance and Safety of Quinapril in Clinical Trials

Abstract

A comprehensive analysis of the reporting of adverse events, withdrawals due to adverse events, and serious adverse events has been conducted on 2,010 patients treated with quinapril hydrochloride. An analysis of all events (from both double-blind and open label studies combined) showed no increase in the incidence of events reported in congestive heart failure (CHF) patients compared to hypertensive patients. When the data for all studies were combined, an age analysis showed no increase in the total reporting of adverse events in the 379 elderly patients studied. The incidence of events was lower in those patients who did not take concomitant diuretic therapy. A comparison of the double-blind phases showed quinapril to have a lower incidence of adverse events than captopril, enalapril, or chlorthalidone. An analysis of the onset of events, or withdrawals, did not show an increase with time on quinapril therapy, and no dose-relationship. A review of serious adverse events did not reveal an unexpected occurrence or a high incidence of serious events considered to be related to quinapril therapy. The proportion of patients who experienced "first-dose" hypotension, or symptomatic hypotension was similar to captopril or enalapril. Quinapril, a nonsulfhydryl ACE inhibitor, has been extensively studied and is equally well tolerated in the young and elderly for the treatment of hypertension and CHF.