Efficacy and safety of coenzyme A versus fenofibrate in patients with hyperlipidemia: a multicenter, double-blind, double-mimic, randomized clinical trial

Abstract

Background

We investigated the lipid-lowering efficacy and safety of coenzyme A (CoA) versus fenofibrate in Chinese patients with moderate dyslipidemia.

Methods

A total of 417 subjects (aged 18–75 years) diagnosed with moderate dyslipidemia (triglyceride 2.3–6.5 mmol/L) from 13 large cardiovascular centers in China were recruited and randomly divided into a fenofibrate group (n = 207), which received 200 mg of fenofibrate orally once daily, and a CoA group (n = 210), which received 400 mg of CoA orally once a day. Blood lipoproteins, liver and renal function, creatine kinase, and blood glucose were measured at baseline, and after 4 and 8 weeks of treatment.

Results

The baseline triglyceride (TG) level in the fenofibrate group and the CoA group was 3.39 ± 0.99 mmol/L and 3.60 ± 1.11 mmol/L, respectively. After treatment for 4 and 8 weeks with fenofibrate, TG was reduced by 31.62% and 33.13%. In the CoA group, TG was reduced by 17.29% and 23.80%. Compared with baseline, total cholesterol (TC) was significantly decreased in both groups after either 4 or 8 weeks of treatment (p < .05). CoA increased high-density lipoprotein cholesterol (HDL-C) after 4 weeks of treatment, whereas it had no significant effect on HDL-C after 8 weeks of treatment. Low-density lipoprotein cholesterol (LDL-C) was not modified in either group. The incidence of side effects was significantly lower in the CoA group compared with the fenofibrate group (p < .05).

Conclusions

Compared with fenofibrate, CoA has less effect on reducing plasma TG levels in subjects with moderate dyslipidemia. However, it has fewer adverse effects.

Keywords:

• Dyslipidemia
• fibrates
• coenzyme A
• statins
• coronary vascular disease

Transparency

Declaration of funding

This work was supported by grants from the National Nature Sciences Foundation, China [Grant Number: 81500359] and the Nature Sciences Foundation of Hunan Province [Grant Number: 2016JJ4100].

Declaration of financial/other relationships

No potential conflict of interest was reported by the authors. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

S.P.Z. designed the study; H.J.Y. and Y.Q.C. controlled the clinical studies. All authors evaluated the results. Y.Q.C. drafted the manuscript, and S.P.Z. and H.J.Y. critically revised the paper. All authors approved the final version of the manuscript. All authors have participated in the work and have reviewed and agree with the content of the article.

Data availability statement

The datasets used or analyzed during the current study are available upon reasonable request. Please address requests to the corresponding authors, Shui-ping Zhao (email: [email protected]) or Hui-Jun Ye (email: [email protected]).

Ethics approval and patient consent

All subjects signed fully informed written consent before they were enrolled in the study. All protocols were approved by the Zhejiang University Ethical Review Board.

Acknowledgements

We gratefully thank the cardiology departments of the First Affiliated Hospital of Zhejiang Medical University; the First Affiliated Hospital of Anhui Medical University; West China Hospital of Sichuan University; the Third Affiliated Military Medical University, Daping Hospital; Qilu Hospital of Shangdong University; the Sixth Affiliated People’s Hospital of Shanghai, Jiaotong University; the Third Xiangya Hospital of Central South University; Wuxi People’s Hospital; Armed Police Corps Hospital of Guangxi; Northern Jiangsu People’s Hospital; Haikou People’s Hospital; and Xuchang Central Hospital for assistance in collecting the clinical data.