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Silber, S, Vetter S, Regourd E, Lilienthal J, Ruf G. Safety Profile of Quinapril and Quinapril/Hydrochlorothiazide for the Treatment of Patients with arterial Hypertension and/or Congestive Heart Failure Results of a pooled analysis of 109.364 patients from 11 studies Perfusion, 16:437­444, 2003

Summary Aims: In a pooled analysis of several studies, the drug utilisation profile as well as the tolerability and efficacy of quinapril in monotherapy or in combination with hydrochlorothiazide (HCTZ), respectively, were investigated in outpatients (general practices) and inpatients (hospitals) with hypertension and/o chronic heart insufficiency (CHF). Methods: 11 observational studies performed in 1991­1996 including a total of 84,339 patients with hypertension and 25,025 patients with CHF, were pooled. Most patients had at least one concomitant disease or various concomitant medications, respectively. In the descriptive and exploratory analyses, the number and type of adverse events (AEs) were addressed in the following groups: (a) Quinapril monotherapy in outpatients, (b) quinapril monotherapy in inpatients, predominantly with CHF, and (c) quinapril/HCTZ combination therapy in outpatients. The blood pressure lowering efficacy was also addressed. Results: Mean treatment duration was 65 days in outpatients and 16 days in inpatients; the mean quinapril dosage was in (a) 8.9 mg/d, in (b) 7.0 mg/d, and in (c) 10.3 mg/d. Quinapril was very well tolerated, with the following rate of patients with AEs: (a) 4.2%, (b) 5.4 %, and (c) 2.6 %. The rate of SAEs (serious adverse events) was (a) 0.1 %, (b) 0.8 %, and (c) 0.2 %. Cough was reported in (a) 1.5 %, in (b) 0,5%, and in (c) 1,0 %, hypotension in (a) 0.3 %, in (b) 1.7%, and in (c) 0.1 %. Metabolic parameters were influenced favourably. Mean diastolic blood pressure was lowered by (a) 14.1 mmHg, (b) 15.8 mmHg, and (c) 14.8 mmHg, respectively. In conclusion, treatment of essential hypertension and/or CHF with quinapril in monotherapy and in combination with HCTZ was well tolerated and safe in a large unselected patient sample. Keywords: arterial hypertension, chronic heart failure, general physicians, metaanalysis, prospective trial, safety, tolerability

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