Shuiping Zhao1, Fang Wang2, Yangyang Dai3, Ling Lin4, Qiguang Tong5, Yuhua Liao6, Yuehui Yin7, Guang Wang8, Yafei Yan9, Xiaodong Li10, Daowen Wang11, Ping Wei12, Xingbo Cheng13, Qiang Xie14, Yuemin Sun15, Guosheng Fu16, Hongman Huang17, Yugang Dong18, Jianxiong Liu19, Jianling Yan20, Li Yan21, Shiwei Cui22, Xuebo Liu23, Zhaoping Li24, Hong Chen25, Taohong Hu26, Hui Gong27. 1. Department of Cardiology, The Second Xiangya Hospital of Central South University, 139 Middle Renmin Road, Changsha 410011, China. Electronic address: Shuiping_Zhao@163.com. 2. Department of Cardiology, Beijing Hospital of the Ministry of Health, 1 Dahua Road, Dongdan, Beijing 100730, China. 3. Department of Cardiology, Wuhan Asia Heart Hospital, 753 Jinghan Road, Wuhan 430022, China. 4. Department of Cardiology, Hainan Province Nongken Sanya Hospital, 146 Jiefang Si Road, Sanya 572000, China. 5. Department of Cardiology, China Meitan General Hospital, 29 South Xibahe Road, Beijing 100028, China. 6. Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Road, Wuhan 430022, China. 7. Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Chongqing 400010, China. 8. Department of Endocrinology, Beijing Chao-Yang Hospital, 8 Gongren Tiyuchang Nanlu, Beijing 100020, China. 9. Department of Cardiology, Chengdu First People's Hospital, 18 North Wanxiang Road, Chengdu 610041, China. 10. Department of Endocrinology, Shenjing Hospital of China Medical University, 36 Sanhao Road, Shenyang 110004, China. 11. Department of Cardiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Road, Wuhan 430030, China. 12. Department of Cardiology, Southwest Hospital, 30 Street Gaotanyan, Chongqing 400038, China. 13. Department of Cardiology, The First Affiliated Hospital of Soochow University, 188 Shizi Road, Suzhou 215006, China. 14. Department of Cardiology, The First Affiliated Hospital of XiaMen University, 55 Zhenhai Road, Xiamen 361003, China. 15. Department of Cardiology, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjing 300050, China. 16. Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou 310016, China. 17. Department of Cardiology, Shidong Hospital of Yangpu District, 999 Shiguang Road, Shanghai 200438, China. 18. Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, 58 Zhongshan Er Road, Guangzhou 510080, China. 19. Department of Cardiology, Chengdu Second People's Hospital, 10 South Qingyun Road, Chengdu 610017, China. 20. Department of Cardiology, Peking Union Medical College Hospital, 1 Shuaifuyuan, Dongcheng District, Beijing 100010, China. 21. Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen Univeristy, 107 West Yan Jiang Road, Guangzhou 510235, China. 22. Department of Cardiology, Affiliated Hospital of Nantong University, 20 Xisi Road, Nantong 226001, China. 23. Department of Cardiology, Shanghai East Hospital, 150 Jimo Road, Shanghai 200120, China. 24. Department of Cardiology, Peking University Third Hospital, 49 North Huayuan Road, Beijing 100191, China. 25. Department of Cardiology, Peking University People's Hospital, 11 Xizhimen South Street, Xicheng District, Beijing 100044, China. 26. Department of Cardiology, The Second Artillery General Hospital of Chinese People's Liberation Army, 16 Xinjiekou Wai Street, Xicheng District, Beijing 100088, China. 27. Department of Cardiology, Jinshan Hospital Fudan University, 1508 Longhang Road, Shanghai 201508, China.
Abstract
BACKGROUND: Since the withdrawal of cerivastatin, statin-fibrate combination therapy has been questioned in China due to safety concern. The objective of this study was to evaluate the efficacy and safety profile of fenofibrate as an add-on in patients with dyslipidemia despite receiving statin therapy. METHODS: This was a prospective, multi-center, single-arm, open-label study conducted in Chinese dyslipidemia patients with high CV risk. Fenofibrate (200mg daily) was added to the existing statin treatment for 8weeks. Lipid profile and safety parameters were measured and compared between baseline and after the treatment. Five hundred and six subjects were enrolled from 28 sites from 14 cities nationwide across China. RESULTS: After 8weeks of fenofibrate treatment, the mean blood triglyceride level decreased to 1.77mmol/L (38.1% reduction vs. 3.00mmol/L at the baseline; p<0.01). Mean high-density lipoprotein cholesterol (high density lipoprotein cholesterol) was increased to 1.22mmol/L (by 17.4% from 1.07mmol/L at the baseline; p<0.01). No case of severe muscle damage (defined as elevated creatine kinase over 5 times of upper limit of normal (ULN) or rhabdomyolysis was observed. CONCLUSION: In statin-treated patients with high CV risk who had elevated triglyceride, adding fenofibrate could improve lipid profile with acceptable safety profiles.
BACKGROUND: Since the withdrawal of cerivastatin, statin-fibrate combination therapy has been questioned in China due to safety concern. The objective of this study was to evaluate the efficacy and safety profile of fenofibrate as an add-on in patients with dyslipidemia despite receiving statin therapy. METHODS: This was a prospective, multi-center, single-arm, open-label study conducted in Chinese dyslipidemiapatients with high CV risk. Fenofibrate (200mg daily) was added to the existing statin treatment for 8weeks. Lipid profile and safety parameters were measured and compared between baseline and after the treatment. Five hundred and six subjects were enrolled from 28 sites from 14 cities nationwide across China. RESULTS: After 8weeks of fenofibrate treatment, the mean blood triglyceride level decreased to 1.77mmol/L (38.1% reduction vs. 3.00mmol/L at the baseline; p<0.01). Mean high-density lipoprotein cholesterol (high density lipoprotein cholesterol) was increased to 1.22mmol/L (by 17.4% from 1.07mmol/L at the baseline; p<0.01). No case of severe muscle damage (defined as elevated creatine kinase over 5 times of upper limit of normal (ULN) or rhabdomyolysis was observed. CONCLUSION: In statin-treated patients with high CV risk who had elevated triglyceride, adding fenofibrate could improve lipid profile with acceptable safety profiles.