Efficacy, safety, and effects on quality of life of bisoprolol/hydrochlorothiazide versus amlodipine in elderly patients with systolic hypertension.

ABSTRACT

BACKGROUND: Several studies have shown the benefits of antihypertensive treatment in elderly patients in terms of cardiovascular morbidity and mortality rate reduction. Low-dose drug combinations may be of interest in treating older subjects. A randomized, multicenter, double-blind, parallel group study was conducted to compare the efficacy and safety of bisoprolol 2.5 mg/hydrochlorothiazide 6.25 mg (n = 84) to amlodipine 5 mg (n = 80) in isolated systolic hypertension in patients older than 60 years. METHODS: After a 2- to 4-week placebo washout period, both drugs were administered once daily and taken for 12 weeks. Blood pressure was measured 24 hours after treatment administration. RESULTS: Systolic and diastolic blood pressure changes from baseline to week 12 were similar for both the bisoprolol and amlodipine groups (-20. 0/-4.5 mm Hg and -19.6/-2.4 mm Hg, respectively). Overall adverse events for bisoprolol and amlodipine were 39% and 40%, respectively. Changes in quality of life scores were +2.5 for bisoprolol and +3.2 for amlodipine, with a positive change indicating improvement. CONCLUSIONS: This study demonstrates comparable efficacy and tolerability of bisoprolol 2.5 mg/hydrochlorothiazide 6.25 mg and amlodipine 5 mg. The low-dose combination of bisoprolol and hydrochlorothiazide may be an appropriate alternative for elderly patients with systolic hypertension.