Hypertension in the elderly, especially systolic hypertension, has been recognized as a major cardiovascular risk factor. Several international studies, using primarily diuretics and/or beta-blockers, have shown the benefits of antihypertensive treatment in elderly patients in terms of cardiovascular morbidity and mortality reduction. However, because the risk of side-effects is a major concern when treating the elderly, the use of low-dose combination treatments may be of particular interest. A randomized, multicentre, double-blind, parallel group study was conducted to compare the efficacy and safety of bisoprolol 2.5 mg/hydrochlorothiazide 6.25 mg (biso 2.5/HCTZ 6.25) (n = 84) versus amlodipine 5 mg (n = 80) in subjects over 60years of age with isolated systolic hypertension. The effects of these two treatment strategies on patients' quality of life were also assessed. After a two- to four-week placebo washout period, both drugs were administered once daily and taken for 12 weeks. Blood pressure was measured 24 h after treatment administration. Systolic blood pressure/diastolic blood pressure changes from baseline to week 12 were similar for both biso 2.5/HCTZ6.25 and amlodipine (-20.0/-4.5 mmHg and -19.6/-2.4 mmHg, respectively). Overall adverse events for biso 2.5/HCTZ 6.25 and amlodipine were 39% and 40%, respectively. Both treatments improved quality of life scores in the same way. This study demonstrates comparable efficacy and tolerability of biso 2.5/HCTZ 6.25 and amlodipine. Low-dose combination of bisoprolol and hydrochlorothiazide may be an appropriate alternative for elderly patients with systolic hypertension.