| Backgroud Type 2 diabetes mellitus,one of the most common types of diabetes mellitus with complex etiologyhas thepathological manifestations of insulin resistance and lack of insulin secretion.Rosiglitazone(RSG),a TZDs(thiazolidinediones)drug,binds to and activates peroxisome proliferator activated receptor gamma(peroxisome proliferator-activated receptor,PPAR-?)to decrease the blood glucose.It is controversial about the cardiovascular safety of this drugsince it appeared on the market.The aims of this study were to evaluate the safety,efficacy and economics of rosiglitazone in patients with type 2 diabetes mellitus in order to provide evidence for the application of this drug in clinical practice.Objective To evaluate the safety,efficacy and economy of rosiglitazone in patients with type 2 diabetes,providing evidence for clinical rational application.Methods We searched EMbase,MEDLINE,The Cochrane library,VIP,CNKI and WAN FANG databases.After methodology quality evaluation and data extraction,we used the quality evaluation standard provided by Cochrane Handbook 5.1.0 to assessed the bias risks of included literatures.RevMan 5.3 was used to perform meta analysis or descriptive analysis.Results?Results of safety analysis is described as the following.There were 15667 articles searched,of which 46 articles published in English were screened out after Revman 5.3 automatic duplicate checking and artificial selection,including 17 RCTs,22 cohort studies,13 case controlled studies and 11 case reports.Safety analysis showed that the incidence of mortality,cardiovascular events and peripheral vascular events caused by rosiglitazone was slightly higher than that induced by metforminand sulfonylureas,with the differences of 0.1%to 1.5%.The total incidence of adverse reactions in rosiglitazone group compared with other oral drug groups had no significant differences,but the withdraw of patients in rosiglitazone group due to adverse effects is significantly increased than other groups(I2= 6%,RR =1.52,95%CI=1.28-1.84).At the same time,the research on the adverse reactions of individual results showed that rosiglitazone was more likely related with edema(RR =1.85,95%CI=1.57-2.17)and weight gain(RR = 3.03,95%CI =2.26,4.06),while the incidence of hypoglycemia is much lower than sulfonylurea group(P<0.000001),and there is no difference between metformin and Pioglitazone(RR = 0.25,95%CI = 0.63-1.39),which is also a TZDs drug,withdrawn due to adverse events was higher than that in the rosiglitazone group.Moreover,the proportion of weight gained patients,incidence of fractures,cardiovascular events and bladder cancer were significantly higher than those in the rosiglitazone group.? The results of efficiency analysis is as the following.We searched 8232 articles,of which 18 articles were screened out after Revman 5.3 automatic duplicate checking and artificial selection,which were all in English.By analysing the included RCTs,rosiglitazone monotherapy was inferior to metformin monotherapy for reducing HbA1c in patients with type 2 diabetes(I2 = 0%,mean =-0.10,CI = 95%,0.04-0.16).For FPG,there was no significant difference between rosiglitazone and metformin.In addition,compared with sulfonylureas and pioglitazone,there was no significant difference for rosiglitazone in reducing HbA1c and FPG.?The cost effectiveness analysis of rosiglitazone showed that the quality adjusted life year in rosiglitazone group was higher than that of sulfonylurea group,and the cost-effectiveness ratio was within the payment threshold.Compared with the DPP-4 inhibitors,rosiglitazone was equivalent to the clinical benefit of patients with type 2 diabetes mellitus with sitagliptin and saxagliptin.Compared with pioglitazone,the economy of rosiglitazone was slightly worse.Cost effectiveness analysis of domestic research showed that rosiglitazone showed no advantage compared with metformin,sulfonylureas or acarbose.Conclusions ?Compared with metformin,the first choice in type 2 diabetes,the effect of rosiglitazone on fasting blood glucose was not bad,while the effect of controlling HbA1c was poor.Taking into account the level of glycated hemoglobin reflecting up to two or three months of glycemic control,rosiglitazone can be used together with metformin as an insulin sensitizer if the blood glucose were unsatisfactory.? Safety analysis showed that rosiglitazone did not increase the total number of adverse reactions compared with other anti-diabetic drugs.?The results of pharmacoeconomic studies showed that the clinical benefit of rosiglitazone is non-inferiority compared with other oral drugs.It still requires further studies with long term and large sample of the domestic health care system to validate the cost-effectiveness of rosiglitazone in the treatment of patients with type 2 diabetes in china. |
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