Post-marketing surveillance study of valsartan/amlodipine combination in Taiwanese hypertensive patients

AIMS: To assess safety and efficacy of valsartan/amlodipine combination in hypertensive Taiwanese patients. METHODS: This 12-week, multi-center, prospective, observational, post-marketing study enrolled 1029 patients to receive valsartan/amlodipine combination alone or as add-on to other antihypertensives. Efficacy was evaluated by blood pressure (BP) control rate (in mmHg; non-diabetics, < 140/90; diabetics, < 130/80) at Week 12 and BP-lowering ability at Weeks 4 and 12. Additionally, responder rate (sitting-SBP < 140 for baseline SBP ≥ 140 or sitting-DBP < 90 for baseline DBP ≥ 90, or SBP reduction > 20 or DBP reduction > 10 from baseline) was determined. MAJOR FINDINGS: Adverse events (AEs) were reported in 12.15% patients; dizziness, cough, and peripheral edema were the most commonly reported AEs. Overall BP control rate was 48.27%. Greater BP reduction was noted at Week 12 than at Week 4 between all groups and subgroups. Greater SBP/DBP reduction was observed in patients with stage 2 hypertension than stage 1 hypertension at baseline. The overall responder rate was 78.52%. Subgroup analysis showed greater BP reduction in non-diabetics than diabetics; only SBP reduction reached statistical significance (- 13.7 [18.3] vs. - 10.7 [17.4] mmHg; p < 0.0093). PRINCIPAL CONCLUSION: Valsartan/amlodipine combination was well tolerated, with no safety concerns identified and an effective treatment option for hypertensive Taiwanese patients.