Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA.
Center for Drug Evaluation and Safety, College of Pharmacy, University of Florida, Gainesville, FL, USA.
Ann Pharmacother. 2023 Dec;57(12):1349-1360. doi: 10.1177/10600280231155489. Epub 2023 Mar 31.
Little is known about anticoagulation medication nonadherence patterns impacting effectiveness and safety outcomes in clinical practice.
We identified adherence trajectories of extended therapy with direct-acting oral anticoagulants (DOACs) and warfarin after 6 months initial anticoagulant therapy among Medicare beneficiaries with venous thromboembolism (VTE). We further assessed the associated recurrent VTE and major bleeding risks.
Using group-based trajectory models, this retrospective cohort study identified distinct beneficiary subgroups with similar adherence patterns of extended-phase anticoagulant treatment (DOACs or warfarin) for patients with VTE who completed 6 months of initial anticoagulant treatment. We examined associations between adherence trajectories and risks of recurrent VTE and major bleeding using inverse probability treatment weighted Cox proportional hazards models.
Compared with no extended treatment, consistently high DOAC adherence was associated with decreased recurrent VTE risk (hazard ratio [HR] = 0.33, 95% confidence interval [CI] = 0.21-0.51) without increased major bleeding risk, and consistently high warfarin adherence was associated with decreased recurrent VTE risk (HR = 0.62, 95% CI = 0.40-0.95) and increased major bleeding risk (HR = 1.64, 95% CI = 1.12-2.41). Gradually declining adherence to DOACs (HR = 1.80, 95% CI = 1.07-3.03) or warfarin (HR = 2.34, 95% CI = 1.57-3.47) was associated with increased bleeding risk with no change in recurrent VTE risk.
This real-world evidence suggests persistently adhering to extended DOAC therapy is associated with lower recurrent VTE risk without increasing major bleeding among Medicare beneficiaries with VTE. Persistently adhering to extended warfarin therapy was associated with lower recurrent VTE risk but higher major bleeding risk.
在临床实践中,对于影响直接口服抗凝药物(DOACs)和华法林有效性和安全性结局的抗凝药物不依从模式知之甚少。
我们确定了医疗保险受益人群静脉血栓栓塞症(VTE)患者在接受 6 个月初始抗凝治疗后,延长 DOACs 和华法林治疗阶段的依从性轨迹。我们进一步评估了与复发 VTE 和大出血风险相关的因素。
本回顾性队列研究使用基于群组的轨迹模型,确定了 VTE 患者在完成 6 个月初始抗凝治疗后,在接受延长阶段抗凝治疗(DOACs 或华法林)方面具有相似依从模式的受益人群亚组。我们使用逆概率处理加权 Cox 比例风险模型,检验了依从性轨迹与复发 VTE 和大出血风险之间的关联。
与无延长治疗相比,持续高 DOAC 依从性与降低的复发 VTE 风险相关(风险比 [HR] = 0.33,95%置信区间 [CI] = 0.21-0.51),且不增加大出血风险;持续高华法林依从性与降低的复发 VTE 风险相关(HR = 0.62,95%CI = 0.40-0.95)和增加的大出血风险相关(HR = 1.64,95%CI = 1.12-2.41)。DOAC 或华法林依从性逐渐下降(HR = 1.80,95%CI = 1.07-3.03)与出血风险增加相关,且复发 VTE 风险无变化。
真实世界证据表明,在医疗保险受益人群 VTE 患者中,持续依从 DOAC 延长治疗与较低的复发 VTE 风险相关,且不增加大出血风险。持续依从华法林延长治疗与较低的复发 VTE 风险相关,但与较高的大出血风险相关。