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

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.