Stockl Karen M, Le Lisa, Zhang Shaoang, Harada Ann S M
Clinical Analytics, Clinical Services Department, Prescription Solutions, 2300 Main Street, Mail Stop CA134-0404, Irvine, CA 92614, USA.
Pharmacoepidemiol Drug Saf. 2009 Feb;18(2):166-74. doi: 10.1002/pds.1700.
Controversy surrounds the question whether thiazolidinediones (TZDs) increase the risk of acute myocardial infarction (AMI). This study examined risk of AMI in patients with type 2 diabetes mellitus (T2DM) who were taking TZDs or other antidiabetic medications.
Using a nested case-control design, a cohort of patients aged 18-84 years with T2DM and use of an oral antidiabetic medication or exenatide between January 2002 and June 2006 was identified. Cases of AMI were matched with up to four controls based on age, gender, health plan, geography, and diabetes therapy regimen. Over the 1-year pre-index period, TZD exposure was compared with no TZD exposure, after adjustment for potential confounders.
Overall, 1681 cases were identified and matched with 6653 controls. Compared with no TZD exposure, an increased risk of AMI was not observed among TZD exposed patients (adjusted OR 1.01; 95%CI, 0.85-1.20; adjusted p = 0.98). When exposure proximity to the event was examined, the risk of AMI was significantly increased with recent rosiglitazone exposure between 1 and 60 days prior to the case date (adjusted OR 1.69; 95%CI, 1.18-2.44; adjusted p = 0.045) and was not significantly increased with current or remote rosiglitazone exposure or current, recent, or remote pioglitazone exposure.
TZD exposure did not increase the risk of AMI when exposure proximity was not considered. However, when evaluating exposure proximity to the event, the risk of AMI was increased with recent rosiglitazone exposure between 1 and 60 days prior to the case date.
噻唑烷二酮类药物(TZDs)是否会增加急性心肌梗死(AMI)风险这一问题存在争议。本研究调查了服用TZDs或其他抗糖尿病药物的2型糖尿病(T2DM)患者发生AMI的风险。
采用巢式病例对照设计,确定了一组年龄在18 - 84岁、患有T2DM且在2002年1月至2006年6月期间使用口服抗糖尿病药物或艾塞那肽的患者。根据年龄、性别、健康计划、地理位置和糖尿病治疗方案,将AMI病例与最多4名对照进行匹配。在索引前1年期间,在对潜在混杂因素进行调整后,比较了TZDs暴露组与非TZDs暴露组。
总体而言,共确定了1681例病例,并与6653名对照进行了匹配。与未暴露于TZDs的患者相比,暴露于TZDs的患者未观察到AMI风险增加(调整后的比值比为1.01;95%置信区间为0.85 - 1.20;调整后的p = 0.98)。当检查暴露与事件的接近程度时,在病例日期前1至60天近期暴露于罗格列酮的患者中,AMI风险显著增加(调整后的比值比为1.69;95%置信区间为1.18 - 2.44;调整后的p = 0.045),而当前或既往暴露于罗格列酮或当前、近期或既往暴露于吡格列酮的患者中,AMI风险未显著增加。
在不考虑暴露与事件接近程度时,TZDs暴露不会增加AMI风险。然而,在评估暴露与事件的接近程度时,在病例日期前1至60天近期暴露于罗格列酮会增加AMI风险。