CONTROLLED MULTICENTER STUDY WITH QUINAPRIL, HYDROCHLOROTHIAZIDE, ANDCOMBINATION IN PATIENTS WITH MODERATE TO SEVERE HYPERTENSION

In an 8-week, double-blind, randomized, active-controlled, multicenter study with three parallel treatment groups, we compared the efficacy and safety of once-daily 20 mg quinapril plus 12.5 mg hydrochlorothiaz ide (HCTZ) with each drug as monotherapy in patients with moderate to severe hypertension. Hypertensive outpatients with supine diastolic bl ood pressure (DBP) greater than or equal to 105 and less than or equal to 120 mm Hg at the end of a 2- to 4-week placebo-baseline period wer e randomly assigned to one of the treatment groups. Of the 323 patient s who were randomized to double-blind medication, 297 completed the st udy, but 6 patients were excluded for violations of protocol; therefor e, statistical analysis was performed in 291 patients. Only 7 patients withdrew owing to lack of efficacy (2 receiving combination therapy). In ah three treatment groups, clinically significant reductions in DB P were achieved. Combination therapy was statistically more effective than each component in both evaluable data and intent-to-treat analyse s. The incidence of adverse events (AE) was 24% in the quinapril monot herapy group, 14% in the combination therapy group, and 11% in the HCT Z monotherapy group. Orthostatic hypotension with related symptoms was observed in 4 patients (2 receiving quinapril monotherapy, 1 receivin g HCTZ monotherapy, and 1 receiving combination therapy). Once-daily q uinapril plus HCTZ provided increased reduction of DBP as compared wit h the monotherapies and was well tolerated in patients with moderate t o severe hypertension.