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M M Rieger

Publications and source records attributed to M M Rieger.

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Overview of quinapril, a new ACE inhibitor.

Quinapril has been extensively studied for efficacy and safety in patients with hypertension or congestive heart failure (CHF) in the United States and Europe. Thirty-nine clinical pharmacology studies involving 383 patients have been completed. Moreover, 12 controlled, multicenter clinical studies and 3 single-center studies involving 1,793 patients have been conducted in hypertension. Three hemodynamic trials, two of which included both acute and long-term phases, and one placebo-controlled, dose-response study have been conducted in 333 patients with CHF. An additional 519 patients who completed studies on comparative agents were started on quinapril at the initiation of six long-term, open-label trials, which extended for up to 3 years. Twelve of 15 hypertension trials evaluated quinapril as first-line monotherapy in 1,452 patients with hypertension. Comparative agents included placebo in five trials (524 patients), enalapril in three trials (339 patients), captopril in four trials (335 patients), and chlorthalidone in one trial (74 patients). A total of 510 patients received quinapril in addition to a diuretic in double-blind trials: 341 patients with moderate to severe hypertension participated in three trials, and 169 patients with CHF participated in one trial. Quinapril administered once daily (o.d.) was evaluated in four placebo-controlled studies and in two studies of o.d. vs. twice-daily doses. The safety of quinapril has been evaluated in almost 2,700 patients in controlled, double-blind studies or in open-label extensions, for a total of more than 1,600 patient-years of exposure to quinapril. More than one-half of all patients participated in long-term trials: 980 patients were studied for 1 year and 315 patients were studied for 2 years at the time of data analysis. Safety data are available for 451 older patients (aged greater than or equal to 65 years), and comparative safety data from other compounds in the controlled studies are available for 1,058 patients. Quinapril's efficacy is comparable to that of other angiotensin-converting enzyme (ACE) inhibitors, and it has a lower incidence of adverse events or withdrawals due to adverse events than has been associated with captopril or enalapril.

Angiotensin-Converting Enzyme Inhibitors

The safety and tolerability of quinapril.

Quinapril, a new angiotensin-converting enzyme (ACE) inhibitor with an intermediate duration of action, has been extensively studied in patients with hypertension and congestive heart failure (CHF) during a worldwide clinical development program. A comprehensive safety data base was established to allow appropriate analyses of the extensive patient safety data. The safety of quinapril has been evaluated in 2,697 patients with hypertension and CHF, including 451 elderly patients (greater than or equal to 65 years), and has been compared with safety data from a total of 1,058 patients receiving a comparative therapy. A comparison of the double-blind studies demonstrated that quinapril has a lower incidence of adverse events and/or withdrawals than reported for captopril or enalapril. An analysis of the onset of adverse events did not show either an increase with time on quinapril therapy or a dose relationship. The proportion of patients who experienced orthostatic hypotension or hypotension was less than that of patients who were treated with captopril or enalapril. An analysis of all events (from both double-blind and long-term, open-label studies) showed no increase in the incidence of events reported in patients with CHF compared with hypertensive patients. When the data for all studies were combined, an age analysis showed no increase in the total reporting of adverse events in elderly patients compared with the younger patients studied. The incidence of adverse events was lower in those patients not receiving concomitant diuretic therapy. An overall analysis of clinical laboratory data indicated that quinapril did not have significant adverse effects on clinical laboratory parameters when compared with captopril, enalapril, or placebo.(ABSTRACT TRUNCATED AT 250 WORDS)

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