Johannes Catherine B, Koro Carol E, Quinn Sherry G, Cutone Jennifer A, Seeger John D
i3 Drug Safety, Auburndale, MA, USA.
Pharmacoepidemiol Drug Saf. 2007 May;16(5):504-12. doi: 10.1002/pds.1356.
To evaluate whether the risk of coronary heart disease (CHD) differs among adult diabetic patients treated with thiazolidinediones (TZDs) and similar patients treated with combined oral metformin and sulfonylurea (M + S) therapy.
We conducted a retrospective cohort study involving 25 140 diabetic patients aged 18 and older who had at least one pharmacy claim for a TZD or combined M + S therapy between 1 January 1999 and 30 June 2002. We used propensity score matching to adjust for observable differences between initiators of combined M + S therapy and TZD initiators. The data were analyzed in two ways: first based on the original matched groups, 'as balanced', without accounting for switching to another medication during follow-up, and second based on actual antidiabetic drug use during follow-up, 'as treated'. Cox proportional hazards regression and multivariable Poisson regression were performed to compare the risk of CHD events.
In the 'as balanced' analysis, the risk for CHD among TZD users relative to combination drug users was close to the null value (adjusted hazard ratio: 1.02, 95% confidence intervals (CI): 0.87-1.20). In the 'as treated' analysis, the risk of CHD was similar for periods of current use of TZDs compared to periods of non-use (incidence rate ratio: 1.10, 95%CI: 0.96-1.25).
These results do not suggest a cardioprotective or deleterious effects of TZDs compared with combined M + S oral therapy on the short-term CHD event risk in persons with type 2 diabetes after accounting for the greater baseline CHD risk in TZD initiators.
评估在成年糖尿病患者中,使用噻唑烷二酮类药物(TZDs)治疗的患者与使用二甲双胍和磺脲类药物联合治疗(M + S)的类似患者相比,冠心病(CHD)风险是否存在差异。
我们进行了一项回顾性队列研究,纳入了25140名18岁及以上的糖尿病患者,这些患者在1999年1月1日至2002年6月30日期间至少有一次关于TZDs或M + S联合治疗的药房配药记录。我们使用倾向评分匹配来调整M + S联合治疗起始者与TZDs起始者之间的可观察差异。数据以两种方式进行分析:首先基于最初匹配的组,即“平衡状态”,不考虑随访期间改用其他药物的情况;其次基于随访期间实际使用的抗糖尿病药物,即“治疗状态”。采用Cox比例风险回归和多变量泊松回归来比较冠心病事件的风险。
在“平衡状态”分析中,与联合用药者相比,TZDs使用者患冠心病的风险接近零值(调整后的风险比:1.02,95%置信区间(CI):0.87 - 1.20)。在“治疗状态”分析中,与未使用TZDs的时期相比,当前使用TZDs时期患冠心病的风险相似(发病率比:1.10,95%CI:0.96 - 1.25)。
在考虑到TZDs起始者更高的基线冠心病风险后,这些结果并未表明与M + S口服联合治疗相比,TZDs对2型糖尿病患者短期冠心病事件风险具有心脏保护作用或有害影响。