Objectives: To compare the efficacy and safety of valsartan (VAL)/HCTZ 80/12.5 mg with VAL 80 mg in Chinese patients with mild-to-moderate essential hypertension not adequately controlled with VAL 80 mg alone.
Research design and methods: This was a multicenter, double-blind, double-dummy, randomized, active-controlled, parallel-group trial. Patients (1175) with mild-to-moderate essential hypertension (mean sitting diastolic blood pressure [MSDBP] > or = 95 and < 110 mmHg) from 26 centers in China received VAL 80 mg o.d. for 4 weeks, 864 patients whose MSDBP remained > or = 90 and < 110 mmHg were randomized (1:1) to receive VAL80/HCTZ12.5 mg (n = 429) or VAL80 mg (n = 435) for 8 weeks.
Main outcome measures: The efficacy variable was changed from baseline to endpoint in trough MSDBP. The secondary efficacy variables were changed in mean sitting systolic blood pressure (MSSBP), response rate, and control rate.
Results: Significant reductions in MSDBP and MSSBP from baseline to endpoint were observed in both groups. There were significantly greater reductions in MSDBP (8.4 mmHg vs. 6.2 mmHg) and MSSBP (10.2 mmHg vs. 6.7 mmHg), higher response (64.2% vs. 52.5%) and control rates (53.9% vs. 40.9%) in the VAL80/HCTZ12.5 group as compared with the VAL80 group at endpoint (p < 0.001). VAL80/HCTZ12.5 was equally effective in both age subgroups (> or = 65 and < 65 years) and was well tolerated. There were no deaths and the two serious adverse events reported were unrelated to study medication.
Conclusion: In Chinese patients with mild-to-moderate essential hypertension not adequately controlled by VAL 80 mg alone, VAL80/HCTZ12.5 mg combination was well tolerated and showed additional BP reduction. The limitations of this study were the inability to include an HCTZ arm as a control group and the short trial duration.