The anticoagulant response to warfarin, a narrow therapeutic index drug, increases with age, which may make older patients susceptible to adverse outcomes resulting from small differences in bioavailability between generic and brand products. Using US Medicare claims linked to electronic medical records from two large hospitals in Boston, we designed a cohort study of ≥ 65-year-old patients. Patients were followed for a composite effectiveness outcome of ischemic stroke or venous thromboembolism, a composite safety outcome, including major hemorrhage, and a 1-year all-cause mortality outcome. After propensity score fine-stratification and weighting to account for > 90 confounders, hazard ratios comparing brand vs. generic warfarin initiators (95% confidence intervals) for the effectiveness, safety, and all-cause mortality outcomes, were 0.97 (0.65-1.46), 0.94 (0.65-1.35), and 0.84 (0.62-1.13), respectively. Results from subgroup analyses of patients with atrial fibrillation, CHADS-VASc score ≥ 3, and HAS-BLED score ≥ 3 were consistent with the primary analysis.

中文翻译：

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老年患者使用品牌药与普通华法林开始治疗的比较结果。

对华法林（一种狭窄的治疗指数药物）的抗凝反应会随着年龄的增长而增加，这可能会使老年患者易受不良影响，这是由于仿制药与品牌产品之间生物利用度的微小差异所致。利用与波士顿两家大型医院的电子病历相关的美国医疗保险索赔，我们设计了一项针对≥65岁患者的队列研究。对患者进行缺血性卒中或静脉血栓栓塞综合疗效结局，包括重大出血在内的综合安全结局和1年全因死亡率结局的随访。在倾向得分精细分层和加权后得出> 90个混杂因素后，比较品牌与一般华法林引发剂（95％置信区间）的有效性，安全性和全因死亡率结果的危险比为0.97（0。65-1.46），0.94（0.65-1.35）和0.84（0.62-1.13）。心房颤动，CHADS-VASc分数≥3和HAS-BLED分数≥3的房颤患者的亚组分析结果与主要分析一致。