Sun Ning-L, Zhu Jun-R, Zhao Yanxing, Tu Ying-M
Department of Cardiology, People's hospital, Beijing University, Beijing, China.
Curr Med Res Opin. 2008 Oct;24(10):2863-71. doi: 10.1185/03007990802390647. Epub 2008 Aug 29.
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.
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.
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.
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.
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.
比较缬沙坦（VAL）/氢氯噻嗪（HCTZ）80/12.5mg与缬沙坦80mg对单用缬沙坦80mg血压控制不佳的中国轻至中度原发性高血压患者的疗效和安全性。
这是一项多中心、双盲、双模拟、随机、活性药物对照、平行组试验。来自中国26个中心的1175例轻至中度原发性高血压患者（平均坐位舒张压[MSDBP]≥95且<110mmHg）接受缬沙坦80mg每日一次，共4周，864例MSDBP仍≥90且<110mmHg的患者被随机（1:1）分为接受缬沙坦80/氢氯噻嗪12.5mg（n = 429）或缬沙坦80mg（n = 435）治疗8周。
疗效变量为谷值MSDBP从基线至终点的变化。次要疗效变量为平均坐位收缩压（MSSBP）的变化、有效率和控制率。
两组患者从基线至终点的MSDBP和MSSBP均显著降低。与缬沙坦80mg组相比，缬沙坦80/氢氯噻嗪12.5mg组在终点时MSDBP（8.4mmHg对6.2mmHg）和MSSBP（10.2mmHg对6.7mmHg）降低更显著，有效率（64.2%对52.5%）和控制率（53.9%对40.9%）更高（p<0.001）。缬沙坦80/氢氯噻嗪12.5mg在两个年龄亚组（≥65岁和<65岁）中疗效相当，耐受性良好。无死亡病例，报告的两例严重不良事件与研究用药无关。
对于单用缬沙坦80mg血压控制不佳的中国轻至中度原发性高血压患者，缬沙坦80/氢氯噻嗪12.5mg联合用药耐受性良好，且能进一步降低血压。本研究的局限性在于无法纳入氢氯噻嗪组作为对照组以及试验持续时间较短。
