Efficacy, safety, and tolerability of valsartan/hydrochlorothiazide in Asian patients with essential hypertension.

Introduction: Previous studies have demonstrated that hypertensive patients need concomitant therapy with one or more drugs from different classes of antihypertensive agents to achieve their blood pressure control targets. We performed the first multinational observational study of valsartan/hydrochlorothiazide (HCTZ) single pill combination in Asia to determine the efficacy, safety, and tolerability in hypertensive patients. The objective of this multinational, multicenter, 24-week follow-up observational study is to evaluate the efficacy, safety, and tolerability of valsartan/hydrochlorothiazide single pill combination in the treatment of essential hypertension in the Asia-Pacific region.

Methods: A total of 7567 Asian patients who were diagnosed with stage 1 or stage 2 essential hypertension and who took at least one dose of valsartan/hydrochlorothiazide single pill combination were included in the statistical analyses. A total of 59% were taking antihypertensive medication at the time of the study. Eligible patients received valsartan/hydrochlorothiazide single pill combination 80/12.5 mg tablets orally once daily at visit 1. The investigator could decide the subsequent dose of valsartan/hydrochlorothiazide single pill combination for their patients, and efficacy, safety, and tolerability data were collected at week 4, 12, and 24.

Results: Basal blood pressure was 155.9±13.3 mmHg (systolic) and 96.3±10.1 mmHg (diastolic). Response rates and control rates increased continuously from baseline to the study endpoint at week 24, when they reached 94.6% and 73.2%, respectively. Systolic and diastolic blood pressure reductions were -25.4±15.2 mmHg and -14.9±13.5 mmHg, respectively (P<0.001). Using a four-point global assessment scale, 96.8% of the patients and physicians reported good, very good, or excellent for both their subjective efficacy and tolerability assessments.

Conclusion: In this multicenter, multicountry study including 7567 Asian patients with hypertension, valsartan/hydrochlorothiazide single pill combination was found efficacious, well tolerated, and devoid of any serious adverse effects.