The efficacy and safety of fixed-dose combination of amlodipine/benazepril in Chinese essential hypertensive patients not adequately controlled with benazepril monotherapy: a multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial

Abstract

This double-blind, double-dummy clinical trial evaluated the efficacy and safety of two strengths of fixed-dose combination of amlodipine/benazepril in Chinese hypertensive patients not adequately controlled with benazepril. Of 442 patients who received treatment with benazepril 10 mg for 4 weeks, 341 patients failed to achieve to diastolic blood pressure (DBP) <90 mmHg. These non-responders were randomized to receive amlodipine/benazepril 2.5/10 mg, or amlodipine/benazepril 5/10 mg, or benazepril 10 mg for 8 weeks. BP reductions with amodipinel/benazepril 2.5/10 mg (15.2/11.8 mmHg) or amlodipine/benazepril 5/10 mg (15.4/12.4 mmHg) were significantly greater than that with benazepril 10 mg (9.88/9.46 mmHg) at study end (p < 0.01, combination versus benazepril). BP control rate was 83.8% with amlodipine/benazepril 2.5/10 mg, 80.2% with amlodipine/benazepril 5/10 mg, 64.9% with benazepril 10 mg at study end (p < 0.01, combination versus benazepril). Three groups were generally well tolerated. Our study indicated that amlodipine/benazepril fixed-dose combination offered significant additional BP reductions and BP control rate compared with the continuation of benazepril monotherapy. No significant differences were observed in both BP reductions and BP control rate between amlodipine/benazepril 2.5/10 mg and amlodipine/benazepril 5/10 mg.

• Amlodipine
• benazepril
• efficacy
• fixed-dose combination therapy
• hypertension

Acknowledgements

This clinical trial was sponsored by Suzhou Dongrui Pharmaceutical Company Limited. The authors thank the following individuals for their contributions to this research: Qingshan Zheng, Yingchun He for statistical analysis; and co-investigators: Weilin Qi, Shanghai Huashan Hospital Fudan university; Zonggui Wu, Yehua Tang, Shanghai Changzheng Hospital; Xiaosu Hong, Yang Jiao, The Second Affiliated Hospital of Soochow University; Xiaoqing Wu, Xianghong Gu, Wuxi People’s Hospital; Hehe Gong, Nanjing First Hospital; Xinhua Tang, Xiaoling Xu Wei Yu, Zhejiang Hospital; Jianan Wang, Shuqin Ying, The Second Affiliated Hospital of Zhejiang University School of Medicine; Guosheng Fu, He Huang, Huiqin Feng, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Xiang Gu, Li Hong, Houtian Zhou, North Jiangsu People’s Hospital; Yuexi Wang, Tuoya Yuan, Rong A, Baojun Ren, Saihua Yu, Yingming Ji, Xiaoyu Liu, The Affiliated Hospital of Inner Mongolia Medical University; Lina Wang, Shuo Yang, Hua Xu, The Daqing Oilfield General Hospital; Xiuli Zhao, Hui Zhou, Jie Xiao, Jiajing Li, Jianqi wang, Shumin Wang, Beijing Tongren Hospital of Capital Medical University; Heng Cao, Yongsheng Ke, Shibao Rui, Wenjie Liu, Hao Yang, Chaohong Xia, Jingfeng Wang, Youquan Wei, Guohua Yu, Yijishan Hospital of Wannan Medical Hospital. All locations are in the People’s Republic of China.