EVALUATION BY 24-HOUR AMBULATORY BLOOD-PRESSURE MONITORING OF EFFICACY OF BENAZEPRIL 20-MG PLUS HYDROCHLOROTHIAZIDE 25-MG FIXED COMBINATION AS COMPARED TO CAPTOPRIL 25-MG PLUS HYDROCHLOROTHIAZIDE 25-MG FIXED COMBINATION IN TREATING MILD-TO-MODERATE HYPERTENSION - A DOUBLE-BLIND, WITHIN-PATIENT, PLACEBO-CONTROLLED STUDY

In a double-blind, placebo-controlled, three-period cross-over, randomized study we evaluated the efficacy and tolerability of a fixed combination of benazepril 20 mg and hydrochlorothiazide 25 mg (BN + HCT) as compared with the fixed combination of captopril 50 mg and hydrochlorothiazide 25 mg (CP + HCT) by ambulatory blood pressure monitoring (ABPM) in patients with mild to moderate hypertension. Eighteen outpatients, 16 men and 2 women aged 41-58 years, were randomized to receive BN + HCT, CP + HCT, or placebo, ah administered once daily for 4 weeks according to a three-period cross-over arranged in a 3 x 3 latin square design. Patients were checked after an initial 3-week washout period and every 4 weeks thereafter. At each visit, 24-h ABPM was performed by a noninvasive device (Spacelabs 5300); causal BP and heart rate (HR) were also measured. Both fixed combinations had a clear-cut antihypertensive effect in comparison with placebo. However, BN + HCT showed better antihypertensive activity as compared with CP + HCT, as demonstrated by (a) the behavior of 24-h ABPM diastolic BP (DBP), which was significantly lower than the corresponding DBP obtained with CP + HCT, (b) the percentage of 24-h ABPM DBP readings >90 mm Hg with BN + HCT, which was significantly inferior in respect to that obtained with CP + HCT, (c) the 24-h postdosing casual systolic BP (SBP) and DBP values with BN + HCT, which were lower than those obtained with CP + HCT, and (d) the patients' responder rate, which was higher with BN + HCT (61%) than with CP + HCT (28%).