Combination antihypertensive therapy with valsartan and hydrochlorothiazide in Chinese patients with mild-to-moderate hypertension

ABSTRACT

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] ≥ 95 and < 110 mmHg) from 26 centers in China received VAL 80 mg o.d. for 4 weeks, 864 patients whose MSDBP remained ≥ 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 (≥ 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.

Trial registration: NCT00250562.

Key words: :

• Chinese population
• Combination therapy
• Hydrochlorothiazide
• Hypertension
• Valsartan

Acknowledgments

Declaration of interest: This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. The authors take full responsibility for the content of the paper and would like to thank Krutin Boloor and Dr. Thej Kumar Nallagangula (Novartis), for their assistance in the manuscript preparation.

Conflict of interest statements: Jun-ren Zhu and Nai-sheng Cai had participated in the VALUE trial sponsored by Novartis Pharmaceuticals Corporation. Yanxing Zhao and Ying-M. Tu are employees of Novartis Pharmaceuticals Corporation. None of the authors has any conflicts of interest with respect to the contents of this article.

The authors wish to acknowledge the following investigators who participated in the study.

Study Committee Co-chairs: Ning-Ling Sun and Jun-Ren Zhu.

Study Committee Members: Nai-Sheng Cai, Yu-Ming Hao, Kan Yang, Jan Hu, Lan Huang, Xin-Chun Yang, Yan Huang, Zheng Wan, Hai Su, Qing He, Zhan-Quan Li, Yu-Hua Liao, Hui Li, Hua-Shan Hong, Yingxin Peng, Hai-Chang Wang, Jian-Lin Ma, Peng Qu, Zhen-Wen Huang, Jin-Xiu Lin, Bo Yu, Yi-Nong Jiang, Wei-Min Li, Ya-Ling Han, and Guo-Qiang Zhong.

Trial investigators: Jun-Ren Zhu, Nai-Sheng Cai, Bin Tang (Shanghai); Ning-Ling Sun, Hong-Yi Wang (Beijing); Yu-Ming Hao, Bing-Chen Wang (Harbin); Kan Yang, Jian-Gang Wang (Changsha); Jan Hu, Zi-Xin Zhang (Shenyang); Lan Huang, Xue-Jun Yu (Chongqing); Xin-Chun Yang, Ming-Ming Gao (Beijing); Yan Huang, Qiang Li (Lanzhou); Zheng Wan, Yue-Min Sun (Tianjin); Hai Su, Jin-Song Xu (Nanchang); Qing He, Fang Wang (Beijing); Zhan-Quan Li, Hong Chen (Shenyang); Yu-Hua Liao, Zi-Hua Zhou (Wuhan); Hui Li, Li-Na Wang (Daqing); Hua-Shan Hong, Lin-Lin Zhang (Fuzhou); Yingxin Peng, Dong-Ping Cao (Shijiazhuang); Hai-Chang Wang, Zheng He (Xian); Jian-Lin Ma, Zhong Wu (Haikou); Peng Qu, Zhong-Yan Li (Dalian); Zhen-Wen Huang, Jing Dong (Zhenzhou); Jin-Xiu Lin, Feng Peng (Fuzhou); Bo Yu, Shuo Zhang (Harbin); Yi-Nong Jiang, Ying Zhang (Dalian); Wei-Min Li, Li-Hua Xu,(Harbin); Ya-Ling Han, Dong-Mei Wang (Shenyang); Guo-Qiang Zhong, Qi Bi (Nanning).