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Efficacy and safety of pitavastatin versus simvastatin: a meta-analysis of randomized controlled trials.
Clin Drug Investig 2014; 34(9):599-608CD

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.

Authors+Show Affiliations

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

Pub Type(s)

Comparative Study
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

25022719

Citation

Jiang, Zhen, et al. "Efficacy and Safety of Pitavastatin Versus Simvastatin: a Meta-analysis of Randomized Controlled Trials." Clinical Drug Investigation, vol. 34, no. 9, 2014, pp. 599-608.
Jiang Z, Gong RR, Qiu L, et al. Efficacy and safety of pitavastatin versus simvastatin: a meta-analysis of randomized controlled trials. Clin Drug Investig. 2014;34(9):599-608.
Jiang, Z., Gong, R. R., Qiu, L., Wang, Q., Su, M., Liu, X. J., ... Fang, D. Z. (2014). Efficacy and safety of pitavastatin versus simvastatin: a meta-analysis of randomized controlled trials. Clinical Drug Investigation, 34(9), pp. 599-608. doi:10.1007/s40261-014-0215-0.
Jiang Z, et al. Efficacy and Safety of Pitavastatin Versus Simvastatin: a Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2014;34(9):599-608. PubMed PMID: 25022719.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of pitavastatin versus simvastatin: a meta-analysis of randomized controlled trials. AU - Jiang,Zhen, AU - Gong,Ren Rong, AU - Qiu,Li, AU - Wang,Qian, AU - Su,Mi, AU - Liu,Xiao Juan, AU - Hu,Min Shan, AU - Lin,Jia, AU - Fang,Ding Zhi, PY - 2014/7/16/entrez PY - 2014/7/16/pubmed PY - 2015/5/12/medline SP - 599 EP - 608 JF - Clinical drug investigation JO - Clin Drug Investig VL - 34 IS - 9 N2 - 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. SN - 1179-1918 UR - https://www.unboundmedicine.com/medline/citation/25022719/Efficacy_and_safety_of_pitavastatin_versus_simvastatin:_a_meta_analysis_of_randomized_controlled_trials_ L2 - https://dx.doi.org/10.1007/s40261-014-0215-0 DB - PRIME DP - Unbound Medicine ER -