ANTIHYPERTENSIVE ACTIVITY AND PREDICTIVE FACTORS OF THE EFFICACY OF BENAZEPRIL IN MILD-TO-MODERATE HYPERTENSION - GENERAL-PRACTICE CLINICAL-TRIAL IN 16,981 PATIENTS

The aim of the study was to evaluate in general practice, in a large a nd unselected population of patients, the efficacy and safety of benaz epril associated or not with hydrochlorothiazide (HCTZ) and to identif y clinical and demographic predictive factors of antihypertensive effi cacy. In this open uncontrolled study, 16,987 patients with mild to mo derate hypertension were included by 5350 GPs. They received benazepri l (BNZ) 10 mg once daily for 8 weeks. If silting DBP remained > 90 mmH g after 4 weeks, HCTZ 12.5 mg once a day was then added for the last 4 weeks. Results: In the intent to treat analysis, 54.5 % of patients, after 4 weeks, and 80.6 % of patients after 8 weeks, were controlled ( DBP < 90 mmHg). Mean sitting DBP decreased from 100.5 +/- 5.5 mmHg (ba seline) to 86.7 +/- 7.5 mmHg after 4 weeks and to 82.5 +/- 6.5 mmHg af ter 8 weeks. Mean SEP decreased from 169.5 +/- 13.1 mmHg to 150.5 +/- 12.5 mmHg after 4 weeks and to 145.0 +/- 10.9 mmHg after 8 weeks. Of t he 16,900 patients included in the safety analysis, 853 (5.0 %) droppe d out of the study, 504 (3.0 %) for adverse events (AE). The most freq uent AE were: cough (3.5 %), headache (0.9 %), dizziness (0.8 %), asth enia (0.6 %) and nausea (0.5 %). 13 deaths were observed during the st udy, mainly due to stroke or cancer. Six cases of raised serum creatin ine level, 3 cases of angio-oedema and 2 cases of hepatitis were also reported. After 8 weeks of treatment, the main predictors of therapeut ic response (DBP) were: recently discovered hypertension (86.3 % of co ntrolled DBP), regular exercise (85.5 %) and age < 50 years (84.6 %). Conversely: obesity, diabetes mellitus (77.9 %), previously treated wi th several drugs (75.2 %) and initial DBP greater than or equal to 105 mmHg (74.5 %) were not predictive. Predictive factors emerging from l ogistic regression were: baseline DBP (< 105 mmHg), history of hyperte nsion, body mass index, initial treatment of hypertension (no treatmen t - one drug - several drugs) and age. Conclusion:this large-scale stu dy confirms, the antihypertensive efficacy and good tolerability of be nazepril alone or associated with hydrochlorothiazide in general pract ice.