title: Efficacy and safety of pitavastatin versus simvastatin: a meta-analysis of randomized controlled trials.
abstract: OBJECTIVE
  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.affiliation: Department of Biochemistry and Molecular Biology, West China School of Preclinical and Forensic Medicine, Sichuan University, 3-17 Renmin South Road, Chengdu, 610041, China.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Jiang
authors.forename: Ren Rong
authors.initials: RR
authors.lastname: Gong
authors.forename: Li
authors.initials: L
authors.lastname: Qiu
authors.forename: Qian
authors.initials: Q
authors.lastname: Wang
authors.forename: Mi
authors.initials: M
authors.lastname: Su
authors.forename: Xiao Juan
authors.initials: XJ
authors.lastname: Liu
authors.forename: Min Shan
authors.initials: MS
authors.lastname: Hu
authors.forename: Jia
authors.initials: J
authors.lastname: Lin
authors.forename: Ding Zhi
authors.initials: DZ
authors.lastname: Fang
mesh_terms: D050171:Dyslipidemias / Q000188:drug therapy; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000188:drug therapy; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D019821:Simvastatin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; D019821:Simvastatin; C108475:pitavastatin