Department of Pharmacy Practice, University of Connecticut School of Pharmacy, Storrs, Connecticut.
Evidence-Based Practice Center, Hartford Hospital, Hartford, Connecticut.
Diabetes Obes Metab. 2019 Sep;21(9):2107-2114. doi: 10.1111/dom.13787. Epub 2019 Jun 11.
To assess the effectiveness and safety of rivaroxaban versus warfarin for the prevention of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with type 2 diabetes (T2D) and non-valvular atrial fibrillation (NVAF).
Using MarketScan data from January 2012 to December 2017, we identified oral anticoagulant-naïve patients with NVAF and comorbid T2D and ≥12 months of insurance coverage prior to rivaroxaban or warfarin initiation. Differences in baseline covariates between cohorts were adjusted for using inverse probability of treatment weights based on propensity scores (absolute standardized differences <0.1 achieved for all covariates after adjustment). Patients were followed until a MACE, MALE or major bleeding event, oral anticoagulant discontinuation/switch, insurance disenrolment or end of data availability. Hazard ratios (HRs) and 95% confidence intervals (CIs) comparing the cohorts were calculated using Cox regression.
We identified 10 700 rivaroxaban users (24.1% received a reduced dose) and 13 946 warfarin users. The median (25%, 75% range) age was 70 (62, 79) years, CHA2DS2-VASc score was 4 (3, 5) and duration of available follow-up was 1.4 (0.6, 2.7) years. Eleven percent of patients had peripheral artery disease, 5.1% had coronary artery disease, and 5.1% had a prior MALE, at baseline. Rivaroxaban was associated with a 25% (95% CI 4-41) reduced risk of MACE and a 63% (95% CI 35-79) reduced risk of MALE compared to warfarin. Major bleeding risk did not significantly differ between cohorts (HR 0.95).
Among patients with NVAF and T2D treated in routine practice, rivaroxaban was associated with lower risks of both MACE and MALE versus warfarin, with no significant difference in major bleeding.
评估利伐沙班与华法林预防 2 型糖尿病（T2D）合并非瓣膜性心房颤动（NVAF）患者主要不良心血管事件（MACE）和主要不良肢体事件（MALE）的有效性和安全性。
使用 2012 年 1 月至 2017 年 12 月 MarketScan 数据，我们确定了 NVAF 合并 T2D 的口服抗凝剂初治患者，且在开始利伐沙班或华法林之前有≥12 个月的保险覆盖。使用基于倾向评分的逆概率治疗权重（调整后所有协变量的绝对标准化差异均<0.1）调整队列之间的基线协变量差异。患者随访至 MACE、MALE 或大出血事件、口服抗凝剂停药/转换、保险退保或数据可用结束。使用 Cox 回归计算比较队列的风险比（HR）和 95%置信区间（CI）。
我们确定了 10700 名利伐沙班组（24.1%接受了减量治疗）和 13946 名华法林组患者。中位（25%，75%范围）年龄为 70（62，79）岁，CHA2DS2-VASc 评分为 4（3，5），可随访的中位时间为 1.4（0.6，2.7）年。11%的患者有外周动脉疾病，5.1%的患者有冠心病，5.1%的患者有既往 MALE，基线时。与华法林相比，利伐沙班可降低 25%（95%CI 4-41）的 MACE 风险，降低 63%（95%CI 35-79）的 MALE 风险。主要出血风险在两组间无显著差异（HR 0.95）。
在常规实践中治疗 NVAF 和 T2D 的患者中，与华法林相比，利伐沙班可降低 MACE 和 MALE 的风险，且大出血风险无显著差异。
