A CLINICAL-TRIAL EVALUATING THE 24-HOUR EFFECTS OF BISOPROLOL HYDROCHLOROTHIAZIDE 5 MG 6.25 MG COMBINATION IN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION/

This study used 24-h ambulatory blood pressure (BP) monitoring to inve stigate the effectiveness of a novel low-dose combination of bisoprolo l/hydrochlorothiazide in adult patients with mild to moderate essentia l hypertension. Thirty-six patients with stable mild to moderate hyper tension (sitting diastolic BP 95-114 mmHg) after a placebo run-in phas e received oral bisoprolol/hydrochlorothiazide 5 mg/6.25 mg once daily for 4 weeks in a single-blind regimen. At office visits, BP and pulse were measured with statistically significant reductions (p < 0.01) re corded after 2 and 4 weeks of treatment. Twenty-four-h ambulatory BP m onitoring at the completion of therapy revealed significant reductions (p < 0.01) in both systolic and diastolic 24-h, daytime, and nighttim e BP, compared with the end of the placebo treatment phase. Systolic a nd diastolic load were also reduced (p < 0.01). The combination was we ll tolerated, and overall quality-of-life questionnaire scores indicat ed an improvement after bisoprolol/hydrochlorothiazide therapy (p = 0. 02). No clinically significant changes from baseline in laboratory par ameters were observed; in particular, serum potassium was unchanged. T his is the first study to demonstrate the 24-h effectiveness of the bi soprolol/hydrochlorothiazide 5 mg/6.25 mg combination, using 24-h ambu latory BP monitoring. In addition, antihypertensive therapy with low d oses of bisoprolol/hydrochlorothiazide in combination may improve tole rability.