Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
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DOI：
10.1056/nejmoa072761
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发表时间：
2007-06-14
影响因子：
158.5
通讯作者：
Wolski, Kathy
中科院分区：
文献类型：
--
作者：
Nissen, Steven E.;Wolski, Kathy
背景：罗格列酮被广泛用于治疗2型糖尿病患者，但其对心血管发病率和死亡率的影响尚未确定。方法：我们对已发表的文献、美国食品和药物管理局网站以及药物制造商（葛兰素史克）维护的临床试验登记处进行了检索。纳入我们荟萃分析的标准包括研究持续时间超过24周，使用不接受罗格列酮的随机对照组，以及心肌梗死和心血管原因死亡的结局数据的可用性。在116项潜在相关研究中，42项试验符合纳入标准。我们将所有心肌梗死和心血管原因死亡的发生率制成表格。在42项试验中，受试者的平均年龄约为56岁，平均基线糖化血红蛋白水平约为8.2%。罗格列酮组与对照组相比，心肌梗死的优势比为1.43（95%可信区间[CI]，1.03 - 1.98; P=0.03），心血管原因死亡的优势比为1.64（95% CI，0.98至2.74; P=0.06）。罗格列酮与心肌梗死风险的显著增加以及临界心血管疾病死亡风险的增加相关。意义我们的研究受到缺乏原始源数据的限制，这将使时间到事件的分析成为可能。尽管有这些局限性，患者和供应商应考虑罗格列酮治疗2型糖尿病的严重心血管不良反应的可能性。
BACKGROUND:Rosiglitazone is widely used to treat patients with type 2 diabetes mellitus, but its effect on cardiovascular morbidity and mortality has not been determined.METHODS:We conducted searches of the published literature, the Web site of the Food and Drug Administration, and a clinical-trials registry maintained by the drug manufacturer (GlaxoSmithKline). Criteria for inclusion in our meta-analysis included a study duration of more than 24 weeks, the use of a randomized control group not receiving rosiglitazone, and the availability of outcome data for myocardial infarction and death from cardiovascular causes. Of 116 potentially relevant studies, 42 trials met the inclusion criteria. We tabulated all occurrences of myocardial infarction and death from cardiovascular causes.RESULTS:Data were combined by means of a fixed-effects model. In the 42 trials, the mean age of the subjects was approximately 56 years, and the mean baseline glycated hemoglobin level was approximately 8.2%. In the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P=0.03), and the odds ratio for death from cardiovascular causes was 1.64 (95% CI, 0.98 to 2.74; P=0.06).CONCLUSIONS:Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance. Our study was limited by a lack of access to original source data, which would have enabled time-to-event analysis. Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes.