Objective: To assess the efficacy and safety of valsartan/hydrochlorothiazide (HCTZ) 80/12.5 mg once daily (o.d.) in Chinese patients with mild to moderate essential hypertension who was not adequately controlled by valsartan 80 mg o.d. monotherapy.
Methods: In this multi-center, double-blind, randomized, active controlled, parallel group trial, 1051 out of 1175 Chinese patients with mild to moderate essential hypertension [DBP >or= 95 mm Hg and < 110 mm Hg (1 mm Hg = 0.133 kPa)] completed single-blind run-in period (valsartan 80 mg o.d. therapy for 4 weeks) after 2 week's wash-out period. At the end of the single-blind run-in period, those patients with DBP >or= 95 mm Hg (n = 864) were randomized in 1:1 ratio to Valsartan and Valsartan 80 mg (n = 429)/HCTZ80/12.5 mg (n = 435) treatment o.d. for 8 weeks. Safety and efficacy was assessed every 4 weeks during double blind phase.
Results: At the end of study, valsartan/HCTZ 80/12.5 mg combination treatment further reduced systolic (-3.5 mm Hg) and diastolic (-2.2 mm Hg) pressures and increased the rate of patients reaching goal BP level (53.9% vs. 40.9%) compared to valsartan 80 mg o.d. monotherapy. Incidence of side effects was similar between the combination therapy and monotherapy groups (8.9% vs. 5.1%, P > 0.05).
Conclusion: Efficacy of Valsartan 80 mg/HCTZ 12.5 mg compound was superior to valsartan 80 mg on BP reduction and goal BP control rate in Chinese patients with mild to moderate essential hypertension. The combination of Valsartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg provides a suitable treatment for Chinese patients who are not adequately controlled by valsartan 80 mg o.d. monotherapy.