title: Efficacy and safety of fenofibrate as an add-on in patients with elevated triglyceride despite receiving statin treatment.
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.
  
  
  CONCLUSIONS
  In statin-treated patients with high CV risk who had elevated triglyceride, adding fenofibrate could improve lipid profile with acceptable safety profiles.
authors.affiliation: Department of Cardiology, The Second Xiangya Hospital of Central South University, 139 Middle Renmin Road, Changsha 410011, China. Electronic address: Shuiping_Zhao@163.com.
authors.forename: Shuiping
authors.initials: S
authors.lastname: Zhao
authors.affiliation: Department of Cardiology, Beijing Hospital of the Ministry of Health, 1 Dahua Road, Dongdan, Beijing 100730, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Wang
authors.affiliation: Department of Cardiology, Wuhan Asia Heart Hospital, 753 Jinghan Road, Wuhan 430022, China.
authors.forename: Yangyang
authors.initials: Y
authors.lastname: Dai
authors.affiliation: Department of Cardiology, Hainan Province Nongken Sanya Hospital, 146 Jiefang Si Road, Sanya 572000, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Lin
authors.affiliation: Department of Cardiology, China Meitan General Hospital, 29 South Xibahe Road, Beijing 100028, China.
authors.forename: Qiguang
authors.initials: Q
authors.lastname: Tong
authors.affiliation: Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Road, Wuhan 430022, China.
authors.forename: Yuhua
authors.initials: Y
authors.lastname: Liao
authors.affiliation: Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Chongqing 400010, China.
authors.forename: Yuehui
authors.initials: Y
authors.lastname: Yin
authors.affiliation: Department of Endocrinology, Beijing Chao-Yang Hospital, 8 Gongren Tiyuchang Nanlu, Beijing 100020, China.
authors.forename: Guang
authors.initials: G
authors.lastname: Wang
authors.affiliation: Department of Cardiology, Chengdu First People's Hospital, 18 North Wanxiang Road, Chengdu 610041, China.
authors.forename: Yafei
authors.initials: Y
authors.lastname: Yan
authors.affiliation: Department of Endocrinology, Shenjing Hospital of China Medical University, 36 Sanhao Road, Shenyang 110004, China.
authors.forename: Xiaodong
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Cardiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Road, Wuhan 430030, China.
authors.forename: Daowen
authors.initials: D
authors.lastname: Wang
authors.affiliation: Department of Cardiology, Southwest Hospital, 30 Street Gaotanyan, Chongqing 400038, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Wei
authors.affiliation: Department of Cardiology, The First Affiliated Hospital of Soochow University, 188 Shizi Road, Suzhou 215006, China.
authors.forename: Xingbo
authors.initials: X
authors.lastname: Cheng
authors.affiliation: Department of Cardiology, The First Affiliated Hospital of XiaMen University, 55 Zhenhai Road, Xiamen 361003, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Xie
authors.affiliation: Department of Cardiology, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjing 300050, China.
authors.forename: Yuemin
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou 310016, China.
authors.forename: Guosheng
authors.initials: G
authors.lastname: Fu
authors.affiliation: Department of Cardiology, Shidong Hospital of Yangpu District, 999 Shiguang Road, Shanghai 200438, China.
authors.forename: Hongman
authors.initials: H
authors.lastname: Huang
authors.affiliation: Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, 58 Zhongshan Er Road, Guangzhou 510080, China.
authors.forename: Yugang
authors.initials: Y
authors.lastname: Dong
authors.affiliation: Department of Cardiology, Chengdu Second People's Hospital, 10 South Qingyun Road, Chengdu 610017, China.
authors.forename: Jianxiong
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Cardiology, Peking Union Medical College Hospital, 1 Shuaifuyuan, Dongcheng District, Beijing 100010, China.
authors.forename: Jianling
authors.initials: J
authors.lastname: Yan
authors.affiliation: Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen Univeristy, 107 West Yan Jiang Road, Guangzhou 510235, China.
authors.forename: Li
authors.initials: L
authors.lastname: Yan
authors.affiliation: Department of Cardiology, Affiliated Hospital of Nantong University, 20 Xisi Road, Nantong 226001, China.
authors.forename: Shiwei
authors.initials: S
authors.lastname: Cui
authors.affiliation: Department of Cardiology, Shanghai East Hospital, 150 Jimo Road, Shanghai 200120, China.
authors.forename: Xuebo
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of Cardiology, Peking University Third Hospital, 49 North Huayuan Road, Beijing 100191, China.
authors.forename: Zhaoping
authors.initials: Z
authors.lastname: Li
authors.affiliation: Department of Cardiology, Peking University People's Hospital, 11 Xizhimen South Street, Xicheng District, Beijing 100044, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Chen
authors.affiliation: Department of Cardiology, The Second Artillery General Hospital of Chinese People's Liberation Army, 16 Xinjiekou Wai Street, Xicheng District, Beijing 100088, China.
authors.forename: Taohong
authors.initials: T
authors.lastname: Hu
authors.affiliation: Department of Cardiology, Jinshan Hospital Fudan University, 1508 Longhang Road, Shanghai 201508, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Gong
mesh_terms: D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis / Q000453:epidemiology; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000097:blood* / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D011345:Fenofibrate / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D000960:Hypolipidemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood*
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D014280:Triglycerides; D011345:Fenofibrate
keywords: Dyslipidemia; Fenofibrate; Statin; Triglyceride