New York University School of Medicine, New York, NY, USA.
Groupe d'analyse, Ltée, Québec, Canada.
Curr Med Res Opin. 2021 Jun;37(6):881-890. doi: 10.1080/03007995.2021.1901223. Epub 2021 Apr 10.
Current evidence indicates that the pharmacokinetic profile of rivaroxaban is not significantly impacted by body weight. However, real-world data are needed to better assess the potential clinical benefits and risks associated with rivaroxaban in non-valvular atrial fibrillation (NVAF) patients with obesity. Thus, our objectives were to assess the real-world effectiveness and safety of rivaroxaban versus warfarin among NVAF patients with obesity in the US nationally representative commercially-insured population.
Health insurance claims data from the IQVIA PharMetrics Plus database (January 2010-September 2019) were used to identify NVAF patients with obesity (based on diagnosis codes) initiated on rivaroxaban or warfarin. Inverse probability of treatment weighting (IPTW) was used to adjust for imbalances between groups. Study outcomes of interest were evaluated up to 36 months post-treatment initiation and included the composite of stroke or systemic embolism (stroke/SE) and major bleeding. Outcomes were compared using Cox proportional hazards regression models with hazard ratios (HR) and 95% confidence intervals (CIs).
A total of 10,555 patients were initiated on rivaroxaban and 5080 patients on warfarin. Following IPTW, the risk of stroke/SE was 26% lower among patients prescribed rivaroxaban relative to warfarin (HR: 0.74, 95% CI: 0.60, 0.91, = .004) at 36 months. Rivaroxaban-initiated patients had a risk of major bleeding similar to that of warfarin-initiated patients (HR: 0.85, 95% CI: 0.71, 1.02, = .085).
These results suggest that rivaroxaban is an effective and safe treatment option among NVAF patients with obesity in a commercially-insured US population.
现有证据表明，利伐沙班的药代动力学特征不受体重的显著影响。然而，需要真实世界的数据来更好地评估肥胖的非瓣膜性心房颤动（NVAF）患者使用利伐沙班的潜在临床获益和风险。因此，我们的目的是评估在美国全国代表性的商业保险人群中，肥胖 NVAF 患者使用利伐沙班与华法林的真实世界疗效和安全性。
使用 IQVIA PharMetrics Plus 数据库（2010 年 1 月至 2019 年 9 月）中的健康保险索赔数据，确定了根据诊断代码诊断为肥胖的 NVAF 患者，并开始使用利伐沙班或华法林。采用逆概率治疗加权（IPTW）来调整组间的不平衡。研究感兴趣的结果在治疗开始后 36 个月内进行评估，包括卒中或全身性栓塞（卒中/SE）和主要出血的复合结果。使用 Cox 比例风险回归模型比较结果，采用风险比（HR）和 95%置信区间（CI）。
共 10555 例患者开始使用利伐沙班，5080 例患者开始使用华法林。经过 IPTW，与华法林相比，利伐沙班组患者的卒中/SE 风险降低了 26%（HR：0.74，95%CI：0.60，0.91，P=0.004），在 36 个月时。利伐沙班组患者发生大出血的风险与华法林组相似（HR：0.85，95%CI：0.71，1.02，P=0.085）。
这些结果表明，在商业保险的美国人群中，利伐沙班是肥胖 NVAF 患者的一种有效且安全的治疗选择。
