Spoendlin Julia, Gagne Joshua J, Lewey Jennifer J, Patorno Elisabetta, Schneeweiss Sebastian, Desai Rishi J
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Pharmacoepidemiol Drug Saf. 2018 Dec;27(12):1361-1370. doi: 10.1002/pds.4668. Epub 2018 Oct 31.
Comparative outcomes of treatment with antiplatelet drugs in patients with acute coronary syndrome (ACS) and co-morbid diabetes mellitus (DM) are not well studied.
We performed a cohort study using US commercial claims data (2009-2015) and conducted the following pairwise comparisons in ACS patients with DM: prasugrel vs clopidogrel, ticagrelor vs clopidogrel, and prasugrel vs ticagrelor. Outcomes of interest included (1) a composite effectiveness endpoint including myocardial infarction, ischemic stroke, or inpatient mortality; (2) a composite safety endpoint including major bleeding events requiring hospitalization; and (3) pneumonia hospitalizations as a negative control endpoint. We used calendar time-specific propensity score matching to account for confounding and applied Cox proportional hazard models to calculate hazard ratios (HR) with 95% confidence intervals (CI).
Comparative risk of the effectiveness endpoint was lower among prasugrel initiators compared to clopidogrel initiators (HR 0.82, 95% CI 0.68-0.99, N = 7011 matched pairs), but no different between ticagrelor and clopidogrel (HR 1.02, 95% CI 0.76-1.37, N = 3013 pairs) or prasugrel and ticagrelor (HR 0.83, 95% CI 0.58-1.18, N = 2207 pairs). Bleeding risk was higher among prasugrel initiators when compared to clopidogrel initiators within the first month of treatment (HR 1.85, 95% CI 1.03-3.35); no other comparison indicated any difference. No differences in the negative control outcomes were noted after PS matching for all comparisons, indicating adequate confounding control.
Prasugrel was associated with superior cardiovascular outcomes and a higher risk of short-term bleeding compared to clopidogrel in patients with ACS and DM. Comparative outcomes were similar between ticagrelor and clopidogrel or prasugrel and ticagrelor.
急性冠状动脉综合征（ACS）合并糖尿病（DM）患者使用抗血小板药物治疗的比较结果尚未得到充分研究。
我们使用美国商业索赔数据（2009 - 2015年）进行了一项队列研究，并在合并DM的ACS患者中进行了以下两两比较：普拉格雷与氯吡格雷、替格瑞洛与氯吡格雷、普拉格雷与替格瑞洛。感兴趣的结局包括：（1）一个综合有效性终点，包括心肌梗死、缺血性中风或住院死亡率；（2）一个综合安全性终点，包括需要住院治疗的大出血事件；（3）肺炎住院作为阴性对照终点。我们使用特定日历时间的倾向评分匹配来控制混杂因素，并应用Cox比例风险模型计算风险比（HR）及95%置信区间（CI）。
与氯吡格雷起始使用者相比，普拉格雷起始使用者的有效性终点比较风险较低（HR 0.82，95% CI 0.68 - 0.99，N = 7011对匹配对），但替格瑞洛与氯吡格雷之间无差异（HR 1.02，95% CI 0.76 - 1.37，N = 3013对），普拉格雷与替格瑞洛之间也无差异（HR 0.83，95% CI 0.58 - 1.18，N = 2207对）。在治疗的第一个月内，普拉格雷起始使用者的出血风险高于氯吡格雷起始使用者（HR 1.85，95% CI 1.03 - 3.35）；其他比较均未显示出差异。所有比较在倾向评分匹配后，阴性对照结局均无差异，表明混杂因素得到了充分控制。
在合并ACS和DM的患者中，与氯吡格雷相比，普拉格雷具有更好的心血管结局，但短期出血风险更高。替格瑞洛与氯吡格雷或普拉格雷与替格瑞洛的比较结局相似。
