Clinical Research Papers:
Efficacy and safety of Zhibitai in combination with atorvastatin for lipid lowering in patients with coronary heart disease
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Danyan Xu1,*, Jiahui Hu1,*, Qinghua Wu2, Zhiming Du3, Yusheng Xue4, Xu Zhang5, Yi Li6, Yushan Chen7, Xiaoping Chen8, Hong Zhang9 and Shuiping Zhao10
1 Department of Cardiology, the Second Xiangya Hospital of Central South University, Changsha, P.R. China
2 Department of Cardiology, the Second Affiliated Hospital of Nanchang University, Nanchang, P.R. China
3 Department of Cardiology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, P.R. China
4 Department of Cardiology, Tangdu Hospital, Xi’an, P.R. China
5 Department of Chinese Medicine, Huadong Hospital Affiliated to Fudan University, Shanghai, P.R. China
6 Department of Chinese Medicine, Beijing Hospital, Beijing, P.R. China
7 Center of Cardiology, the First Affiliated Hospital of Henan University of TCM, Zhengzhou, P.R. China
8 Department of Cardiology, West China Hospital of Sichuan University, Chengdu, P.R. China
9 Department of Cardiology, the First People’s Hospital of Yunnan, Kunming, P.R. China
10 Department of Cardiology, the Second Xiangya Hospital of Central South University, Changsha, P.R. China
* These authors were the joint first authors and have contributed equally to this work
Shuiping Zhao, email:
Keywords: Zhibitai; atorvastatin; combination therapy; dyslipidemia; atherosclerosis
Received: December 29, 2016 Accepted: May 10, 2017 Published: June 01, 2017
Background: Zhibitai, a natural lipid-lowering Chinese medicine, is well tolerated in patients and has low incidence of adverse events. In this study, we evaluated the efficacy, safety, and side effects of Zhibitai in combination with low dose Atorvastatin compared to high dose Atorvastatin in patients with coronary heart disease or at high risk of coronary heart disease.
Methods: This was a randomized, double-blind, multi-center clinical trial on 720 patients with coronary heart disease or at high risk of coronary heart disease. The patients were randomly assigned to a Zhibitai-Atorvastatin group (480 mg Zhibitai twice daily plus 10 mg atorvastatin once daily) or Monotherapy group (40 mg Atorvastatin once daily). Blood samples were obtained at baseline, week 4, and week 8 after a minimum 8-hour fast. Efficacy was evaluated in terms of the changes in the following parameters: lipoprotein profiles [total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C)]. Safety was assessed throughout the study by clinical laboratory tests including liver function [alanine transaminase, aspartate transaminase] and renal function [blood urea nitrogen], and creatine kinase; physical examination; and adverse events monitoring.
Results: TC, TG, LDL-C levels were significantly decreased andHDL-C levels were significantly increased at week 4 and week 8 (all P < 0.05) in both groups but had no significant differences between the two groups (P > 0.05). In subgroup analyses, Zhibitai-Atorvastatin Group produced significantly greater reduction in TG compared with Monotherapy Group at week 8 in patients with TG > 203.72mg/dL (P < 0.01). Among patients with LDL-C levels > 131.48 mg/dL, Zhibitai-Atorvastatin Group produced a greater reduction of LDL-C levels compared with the Monotherapy Group at week 4 (P < 0.05). The incidence of liver dysfunction, headache, or gastrointestinal intolerance was significantly lower in the Zhibitai-Atorvastatin Group compared with Monotherapy Group during the 8-week study peroid (P < 0.001). There were no significant differences in renal function, myopathy, and other adverse events between the groups.
Conclusion: Overall the two groups have similar lipid regulation efficacy. Zhibitai plus low dose Atorvastatin is more efficacious in lowering TG in patients with TG > 203.72 mg/dL at week 8. There are fewer side effects in Zhibitai plus low dose Atorvastatin group. Long term follow up is required to evaluate cardiovascular outcomes.
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