Systematic Review on Efficacy and Safety of Generic and Original Statins
OBJECTIVE:To systematically evaluate the real-world efficacy and safety of generic and original statins,so as to provide evidence-based reference for clinical drug selection.METHODS:The Cochrane Library,MEDLINE,Embase,CNKI,SinoMed,VIP,and Wanfang Data were retrieved to collect observational studies on generic and original statins(the exposed group were treated with generic statins or replaced with generic drugs,the non-exposed group received original statins)from the establishment of the database to Jul.2023.And references attached to the obtained studies were consulted.After data extraction for studies that met the inclusion criteria,quality was evaluated by using the Newcastle-Ottawa scale.RevMan 5.4 statistical software was used for Meta-analysis and descriptive analysis.RESULTS:A total of 14 studies were enrolled,including 3 historical control studies and 11 cohort studies.Meta-analysis showed that there was no significant difference in the overall incidence of major adverse cardiovascular events(MACE)between the generic and original drugs(HR=1.07,95%CI=0.98-1.18,P=0.14),yet the fluvastatin subgroup showed that the overall incidence of MACE of generic drugs was significantly higher than that of the original drugs.Overall all-cause mortality was significantly higher in the generic drug group than in the original drug group,yet the difference was not statistically significant in subgroups with a follow-up period of 12 months(P>0.05).There were no significant differences in stroke hospitalization rate and incidence of adverse drug reactions between two groups(P>0.05).Qualitative description of"drug replacement"study design showed that in two retrospective cohort studies,there was no statistical significance in reduction of total cholesterol,triacylglycerol and low-density lipoprotein cholesterol in the group of patients who changed from original drugs to generic drugs compared with the group who did not change drugs(P>0.05).In three historical controlled studies,changing the original drugs to generic drugs did not decrease efficacy,yet the original drugs were more effective than the generic drugs in raising HDL cholesterol.CONCLUSIONS:There is no significant difference in clinical efficacy and safety between generic statins and original statins.
万方数据
维普
