A POSTMARKETING SURVEILLANCE EVALUATION OF QUINAPRIL IN 3742 CANADIANHYPERTENSIVE PATIENTS - THE ACCEPT STUDY

The Accupril Canadian Clinical Evaluation and Patient Teaching (ACCEPT ) study was a multicenter, 6-month, open-label, postmarketing surveill ance study where the efficacy and safety of quinapril, an angiotensin- converting enzyme (ACE) inhibitor, was evaluated in a general populati on of patients with essential hypertension. Participating physicians f ollowed their normal office procedures for the initiation of quinapril therapy (a dose of 10 mg QD in the majority of cases). The dose was t itrated to blood pressure response, generally at 2-week intervals, for a maintenance dose of 10 mg QD to 20 mg QD in most cases (86% at 6 mo nths) and not to exceed 40 mg QD. The use of concomitant antihypertens ive medications was left to the discretion of the physician. By random assignment, physicians obtained patient informed consent on either a detailed form that listed possible quinapril side effects or a less sp ecific form, which did not list particular side effects. The purpose o f using two different forms was to assess any potential association be tween the frequency of adverse-event reporting and patients' awareness of quinapril side effects. The patients also received an educational package that provided general information on hypertension and lifestyl e modifications known to reduce cardiovascular risk factors. An intent -to-treat analysis included data from 3742 patients in whom the median age was 56 years and the median duration of hypertension was 5 years. The demographic characteristics of these patients were similar to tho se identified in Canadian hypertensive patients in a recent population -based survey. Nearly 80% of the ACCEPT study patients had more than o ne cardiovascular risk factor, in addition to hypertension. Among 2979 patients receiving quinapril at 3 months, 77% were stabilized. Among 2517 patients continuing to receive quinapril at 6 months, 84% were st abilized. Greater declines in both diastolic and systolic blood pressu res were evident among patients who continued to receive quinapril as part of an antihypertensive regimen than among those who discontinued quinapril treatment. Blood pressure responses to quinapril were simila r in newly diagnosed patients and those with a history of hypertension . A total of 980 patients (26.2%) reported one or more adverse events. Cough was most frequently reported and was deemed as definitely relat ed to quinapril therapy by the treating physician in 3.6% of cases. Se rious adverse events occurred in 55 patients (1.5%) and were assessed as possibly related to quinapril in only three patients. Adverse event s were reported significantly more often by patients who received the detailed consent form than those who received the abbreviated one (P = 0.004). This study confirmed previous observations that the frequency of adverse-event reporting depends on the method of data collection. The rate of quinapril discontinuation was unaffected by type of patien t consent form. The results of this study demonstrate that quinapril i s safe and effective for the management of patients with essential hyp ertension under conditions of actual use in clinical practice.