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Efficacy and Safety of Pitavastatin Versus Simvastatin: A Meta-Analysis of Randomized Controlled Trials

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Abstract

Background and Objectives

Pitavastatin is the latest statin to be approved and has shown beneficial effects on plasma lipid profiles. The aim of the present meta-analysis was to assess both the efficacy and safety of pitavastatin versus simvastatin, one of the most commonly used statins.

Methods

A search of the MEDLINE, EMBASE, OVID and Cochrane Central Register of Controlled Trials (CENTRAL) databases was undertaken. Clinical trials evaluating the efficacy and safety of simvastatin versus pitavastatin, published up to February 2014, were identified. Trials were included if they (1) were randomized controlled trials (RCTs) of at least 12 weeks’ duration; (2) included patients with primary hypercholesterolaemia or mixed dyslipidaemia; (3) studied outcomes included low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), triglyceride (TG) and high-density lipoprotein cholesterol (HDL-C); and (4) were published in the English language. A fixed-effects model was used for data analysis if no significant heterogeneity was present; otherwise a random-effects model was used. Efficacy is reflected by the mean difference in the percentage change of plasma lipid profiles. Treatment-emergent adverse events (TEAEs) are presented as risk ratio (RR).

Results

A total of 1,468 patients were included in the meta-analysis. The results indicated similar efficacy of pitavastatin (versus simvastatin) in lowering LDL-C. Pitavastatin also had similar effects to simvastatin on other major aspects of plasma lipids, including TC, TG and HDL-C. Somewhat in contrast to common belief (based on distinct metabolism by P450 subtypes), the two statins did not differ in the incidence of TEAE.

Conclusions

In clinical trials, pitavastatin was comparable to simvastatin in both efficacy and safety profile. Large-scale, high-quality observational studies are required to determine whether the advantage of pitavastatin in metabolism profiles could be translated into noticeable benefits.

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Acknowledgments

This study was supported by a grant from the National Natural Science Foundation of China (Grant number 81370375 to Ding Zhi Fang).

Conflict of interest

There are no conflicts of interest to disclose.

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Authors and Affiliations

  1. Department of Biochemistry and Molecular Biology, West China School of Preclinical and Forensic Medicine, Sichuan University, 3-17 Renmin South Road, Chengdu, 610041, China

    Zhen Jiang, Li Qiu, Qian Wang, Mi Su, Xiao Juan Liu, Min Shan Hu, Jia Lin & Ding Zhi Fang

  2. Institute of Molecular Biology, North Sichuan Medical College, Nanchong, 637000, China

    Zhen Jiang

  3. Department of Cardiothoracic Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China

    Ren Rong Gong

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  1. Zhen Jiang
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Correspondence to Ding Zhi Fang.

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Jiang, Z., Gong, R.R., Qiu, L. et al. Efficacy and Safety of Pitavastatin Versus Simvastatin: A Meta-Analysis of Randomized Controlled Trials. Clin Drug Investig 34, 599–608 (2014). https://doi.org/10.1007/s40261-014-0215-0

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