Efficacy and Safety of the Generic and Original Preparation of Atorvastatin:A Systematic Review
10.6039/j.issn.1001-0408.2016.24.25
- VernacularTitle:阿托伐他汀仿制药和原研药疗效与安全性的系统评价
- Author:
Xiaorong CAI
;
Hongmei WANG
;
Junwen ZHOU
;
Wei LIU
;
Suodi ZHAI
- Publication Type:Journal Article
- Keywords:
Atorvastatin;
Generic preparation;
Original preparation;
Meta-analysis;
Systematic review
- From:
China Pharmacy
2016;27(24):3393-3396
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To systematically review the efficacy and safety of the generic and original preparation of atorvas-tatin,and provide evidence-based reference for clinical treatment. METHODS:Retrieved from PubMed,EMBase,Cochrane Li-brary,CJFD,Wanfang Database,VIP and CBM,related randomized controlled trials(RCT)about generic preparation of atorvas-tatin(test group)versus original preparation of atorvastatin(control group)were collected. Meta-analysis was performed by using Rev Man 5.3 software after data extract and quality evaluation. RESULTS:Totally 16 RCTs were included,involving 2 077 pa-tients. Results of Meta-analysis showed,compared with control group,there were no significant differences in reducing total choles-terol (TC) [MD=-0.06,95%CI(-0.14,0.01),P=0.11],triglyceride (TG) [MD=-0.00,95%CI(-0.08,0.08),P=0.99], low-density lipoprotein cholesterol (LDL-C) [MD=-0.07,95%CI(-0.16,0.01),P=0.09],increasing high-density lipoprotein cholesterol(HDL-C)[MD=-0.00,95% CI(-0.03,0.03),P=0.96] and the incidence of major adverse cardiac events(MACE) [OR=1.18,95%CI(0.71,1.97),P=0.52] in test group;in terms of safety,compared with control group,there were no significant differences in the resulting in alanine aminotransferase (ALT) increased [OR=1.08,95%CI(0.51,2.30),P=0.83],the incidences of myalgia [OR=2.46,95%CI(0.70,8.65),P=0.16] and gastrointestinal adverse reactions [OR=1.11,95%CI(0.64,1.95),P=0.71]. CONCLUSIONS:Both the generic and original preparation of atorvastatin can effectively reduce blood lipid levels,with sim-ilar safety.
