Thiazolidinediones and Cardiovascular Events in Patients with Type 2 Diabetes Mellitus A Retrospective Cohort Study of over 473 000 Patients Using the National Health Insurance Database in Taiwan
Thiazolidinediones and Cardiovascular Events in Patients with Type 2 Diabetes Mellitus A Retrospective Cohort Study of over 473 000 Patients Using the National Health Insurance Database in Taiwan
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DOI：
10.2165/00002018-200932080-00006
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发表时间：
2009-01-01
期刊：
影响因子：
4.2
通讯作者：
Tsai, Yi-Wen
中科院分区：
文献类型：
--
作者：
Hsiao, Fei-Yuan;Huang, Weng-Foung;Tsai, Yi-Wen
背景和目的：罗格列酮和吡格列酮引起的心血管风险已引起关注。本研究探讨了口服抗高血压药（罗格列酮，吡格列酮，磺脲类药物和二甲双胍）与心肌梗死，充血性心力衰竭，心绞痛，中风和短暂性脑缺血attack.Methods：我们使用台湾的2000-5年国民健康保险数据库进行人口为基础的，回顾性队列研究或473483新诊断的2型糖尿病患者之间的关联。我们根据研究期间处方的药物将研究患者分为五个基本组：（i）罗格列酮单药治疗;（ii）吡格列酮单药治疗;（iii）磺脲类药物治疗;（iv）二甲双胍治疗;（v）磺脲类药物和二甲双胍治疗。采用考克斯比例风险模型评估罗格列酮或吡格列酮与心血管事件发生的关系。结果：接受罗格列酮单药治疗的患者发生任何心血管事件的风险均较高（风险比[HR] 1.89; 95% CI 1.57，2.28），心肌梗死（HR 2.09; 95% CI 1.36，3.24）、心绞痛（HR 1.79; 95% CI 1.39，2.30）和短暂性脑缺血发作（FIR 2.57; 95% CI 1.33，4.96）。总的来说，罗格列酮和吡格列酮添加治疗与心血管风险相当。基于我们的点估计。吡格列酮作为一个附加治疗被发现有一个有利的，但nonsignificant，效果outcome.Conclusions：我们的研究结果从目前的文献证据扩展到现实世界的设置和支持数据从临床试验中的缺点或伤害所造成的噻唑烷二酮类，特别是罗格列酮，可能超过他们的好处在2型糖尿病患者。
Background and objective: Concern has been expressed over the cardiovascular risks associated with rosiglitazone and pioglitazone. This Study investigates the association between oral antihyperglycaemics (rosiglitazone, pioglitazone, sulfonylureas and metformin) with myocardial infarction, congestive heart failure, angina pectoris, stroke and transient ischaemic attack.Methods: We used Taiwan's 2000-5 National Health Insurance database to conduct a population-based, retrospective cohort Study or 473483 newly diagnosed patients with type 2 diabetes mellitus. We classified study patients into five basic groups based on the agents they were prescribed during the study period: (i) rosiglitazone monotherapy; (ii) pioglitazone monotherapy; (iii) sulfonylurea-based therapy; (iv) metformin-based therapy; and (v) sulfonylurea and metformin-based therapy. Cox proportional hazards models were used to evaluate the association between the use of rosiglitazone or pioglitazone and the occurrence of cardiovascular events.Results: Patients receiving rosiglitazone monotherapy were at higher risk for any cardiovascular event (hazard ratio [HR] 1.89; 95% CI 1.57, 2.28), myocardial infarction (HR 2.09; 95% CI 1.36, 3.24), angina pectoris (HR 1.79; 95% CI 1.39, 2.30) and transient ischaemic attack (FIR 2.57; 95% CI 1.33, 4.96) than those receiving metformin monotherapy. Overall, add-on rosiglitazone and pioglitazone were associated with comparable cardiovascular risk. Based on our point estimates. pioglitazone as an add-on therapy was found to have a favourable, but nonsignificant, effect on outcome.Conclusions: Our findings extend the evidence from current literature to a real-world setting and support data from clinical trials that the disadvantages or harm caused by thiazolidinediones, especially rosiglitazone, may outweigh their benefits in patients with type 2 diabetes.