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Tolerability of Ramipril 10 mg/day in High-Risk Cardiovascular Chinese Patients

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Abstract

Objective

The aim of this study was to investigate the tolerability of ramipril 10 mg/day in high-risk cardiovascular Chinese patients, following similar criteria to those used for patient selection in the Heart Outcomes Prevention Evaluation (HOPE) study and through the collection of adverse event data by Chinese cardiologists.

Design and subjects

This was a non-comparative study with single-group non-blind assessment carried out in 76 nationwide investigational sites. The target population was around 1000 patients. Men and women aged ≥55 years were eligible for the study if they had one of the following risk factors for developing major cardiovascular events: a history of coronary artery disease, stroke, peripheral vascular disease or diabetes plus at least one other cardiovascular risk factor. Patients initially received ramipril 2.5mg tablets orally once daily, and were then titrated up to 5 mg/day and 10 mg/day at 2-week intervals. The maintenance dosage was 10 mg/day for 1 month. For patients with stable heart failure, the starting dosage was 1.25 mg/day, titrating up to the same maintenance dosage (10 mg/day). Adverse events were closely followed up and recorded. 981 patients were eligible for the intention-to-treat (ITT) analysis. Twenty-three patients dropped out at their own request or because of protocol violation. 958 patients (97.7%) completed the study per protocol.

Main results

880 of 958 (91.8%) patients reached and remained at the 10 mg/day dosage level; 78 of 958 (8.1%) stayed at 5mg/day or 2.5 mg/day. 168 patients (17.5%) had at least one adverse event. Fifty-eight patients (6.0%) stopped the treatment because of an adverse event; 110 (11.5%) completed the study in spite of adverse events. Altogether, 185 instances of adverse events were observed, mainly consisting of cough, dizziness, hypotension, rash and serum creatinine elevation. Most adverse events were possibly or probably related to ramipril. Three patients experienced serious adverse events, including one death, but investigation failed to show any evidence of a relationship to ramipril treatment.

Conclusion

Ramipril was well tolerated in Chinese patients with high-risk cardiovascular diseases. Patients were able to tolerate the full effective dosage level of 10 mg/day.

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Notes

  1. 1The use of tradenames is for product identification only and does not imply endorsement.

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Acknowledgement

The following nationwide hospitals participated in this trial: Guo Jing Xuan, Beijing University 3rd Hospital, Yu Jing De Guo Ji Zhen, Shanghai Ruijing Hospital, He Qing, Beijing Hospital, Cai Nai Sheng, Shanghai Zhongshan Hospital, Liu Guo Shu, Beijing 301 Hospital, Wu Zong Gui, Shanghai Chang Zheng Hospital, Long Jie, Beijing Tian Tan Hospital, Wu Shi Yao, Shanghai No. 9 People’s Hospital, Bian Yan Tao, Beijing Tong Ren Hospital, Zhao Mei Hua, Shanghai Xing Hua Hospital, Wu Ning, Peking Union Hospital, Jing Li Ren, Shanghai No. 6 People’s Hospital, Gao Wei, Beijing University Hospital, Sun Bao Gui, Shanghai No.1 People’s Hospital, Sheng Yi Fu, Beijing Sino-Nippon Friendship Hospital, Zheng Bai Sheng, Shanghai Hua Dong Hospital, Hong Zhao Guang, Beijing An Zhen Hospital, Wang Bing Yao, Shanghai Ren Ji Hospital, Hu Da Yi, Beijing Chao Yao Hospital, Huang Ping, Guangdong Province People’s Hospital, Liu Guo Zhang, Beijing Fu Wai Hospital, Zeng Qun Ying, Zhongshang Medical University No. 1 Hospital, Jia San Qing, Beijing Friendship Hospital, Wu Wei, Zhongshang Medical University No. 2 Hospital, Xu Cheng Bing, Beijing University People’s Hospital, Chen Ling, Zhongshang Medical University No. 3 Hospital, Zend Ding Ying, Chinese Medical University No. 1 Hospital, Lu Dfong Feng, Guangzhou Medical University No. 1 Hospital, Wu Ke Guang, Wang Li Jun, Chinese Medical University No. 2 Hospital, Mei ke Zhi, Guangzhou Hong Hui Hospital, Li Zhan Quan, Liaoning Province People’s Hospital, Jia Man Ying, Guangzhou Nag Fang Hospital, Fang Wei Yi, Dalian Medical University No. 1 Hospital, Fu Xiang Yang, Guangzhou Zhu Jiang Hospital, Qu Peng, Dalian Medical University No. 2 Hospital, Zhu Zhi Hui, Guangzhou Hua Qiao Hospital, Chen Shu Ming, Dalian Central Hospital, Chen Ci Bing, Guangzhou No. 2 People’s Hospital, Wan Zheng, Tianjing Medical University Hospital, Li Guang Liang, Guangzhou No. 1 People’s Hospital, Wang Lin, Tianjing Medical University No. 2 Hospital, Jiang Wen Ping, Suzhou Medical University No. 1 Hospital, Chen Dong Sheng, Tianjing Central Hospital, Xia Xie Qiu, Suzhou No. 4 People’s Hospital, Shao Jian Hua, Shangdong Province Hospital, Zhu Jian Qiu, Wuxi No. 1 Hospital, Dong Guo Xiong, Qingdao Medical University Hospital, Zheng Yi Tong, Wixi No. 2 Hospital, Wang Lou Sheng, Anhui Medical University Hospital, Xie Hai Bao, Zhejiang Hospital, Wang Jia Sheng, Anhui Province Hospital, Chen Jun Zhu, Zhejiang Medical University No. 1 Hospital, Huang Jun, Jiangsu Province People’s Hospital, Shan Jiang, Zhejiang Medical University No. 2 Hospital, Shi Guang Fei, Nanjing Gu Lou Hospital, Zhang Ji Ye, Zhejiang Province People’s Hospital, Duan Bao Xiang, Nanjing No. 1 Hospital, Li Pei Zhang, Hangzhou No. 1 People’s Hospital, Liu Cheng Hui, Hubei Province People’s Hospital, He Bing Xian, Xingjiang Medical University No. 1 Hospital, Yu Shu, Wquhan Tongji Hospital, Chen Yun Zhen, Chongqin Medical University No. 1 Hospital, Zhang Ying Huang, Wuhan Union Hospital, Luo Kai Liang, Chongqin Medical University No. 2 Hospital, Zhao Shui Ping, Hunan Medical University No. 2 Hospital, Li Long Gui, The 3rd Military Medical University Xing Qiao Hospital, Tian Wen Hua, Shanxi Province People’s Hospital, Yang Lie Yuan, Chengdou No. 3 People’s Hospital, Ma Ai Qun, Xi’An Medical University Hospital, Zhou Xiao Fang, Sichuan Province People’s Hospital, Jia Guo Liang, Xijing Hospital, Chen Xiao Ping, Huaxi Medical University No. 1 Hospital, Wei Jing Han, Henan Medical University No. 1 Hospital, Yan Ya Fei, Chengdou No. 1 People’s Hospital, Li Na Fang, Xingjiang Province People’s Hospital.

Acknowledgements

The statistical work in this study was done by Prof. Han Shao-Mei of the Department of Statistics, Chinese Academy of Medical Sciences and China Union Medical University, Beijing, China. The study was supported by Aventis Pharma, China.

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Authors and Affiliations

  1. No. 1, Shuai Fu Yuan Hu Tong, Cardiovascular Department of Peking Union Hospital, Beijing, China

    Ning Wu, Jun Ren Zhu & Kan An Chen

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  1. Ning Wu
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  2. Jun Ren Zhu
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Correspondence to Ning Wu.

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Wu, N., Zhu, J.R. & Chen, K.A. Tolerability of Ramipril 10 mg/day in High-Risk Cardiovascular Chinese Patients. Clin. Drug Investig. 22, 771–781 (2002). https://doi.org/10.2165/00044011-200222110-00005

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