Randomized, double-blinded trial evaluation of valsartan/hydrochlorothiazide combination therapy in mild to moderate essential hypertension in north-east China.

In this randomized, double-blind study, 126 mild to moderate essential hypertensive patients from northern China were studied to determine the efficacy and safety of a combination therapy of valsartan and hydrochlorothiazide. Patients were randomized to the V80/H12.5 (80 mg valsartan/12.5 mg hydrochlorothiazide) group or the V80 (80 mg valsartan) group. Six weeks after treatment, the mean decrease from baseline in mean sitting systolic blood pressure (MSSBP) was significantly higher in the V80/H12.5 group than the V80 group, but there was no difference in the change of mean sitting diastolic blood pressure (MSDBP) in the two groups. Overall, 80.33% and 70.97% had a controlled response (normalized MSDBP), and 85.25% and 77.42% had a diastolic response (normalized MSDBP or > 10 mmHg reduction in MSDBP) in the V80/H12.5 and V80 groups, respectively (not significantly different). The incidence of adverse events was also similar between the two groups. The combination of 80 mg valsartan/12.5 mg hydrochlorothiazide was efficacious and well tolerated in mild and moderate essential hypertensive patients.

RCT Entities:   Population Interventions Outcomes