Datar Manasi, Crivera Concetta, Rozjabek Heather, Abbass Ibrahim M, Xu Yihua, Pasquale Margaret K, Schein Jeff R, Andrews George A
Comprehensive Health Insights, Humana Inc., Louisville, KY.
Janssen Scientific Affairs, Janssen Pharmaceuticals, Titusville, NJ.
Am J Health Syst Pharm. 2019 Feb 9;76(5):275-285. doi: 10.1093/ajhp/zxy032.
To compare patients with atrial fibrillation (AF) initiating direct oral anticoagulants (DOACs) versus warfarin on clinical outcomes including stroke, systemic embolism (SE), bleeding events, and cost of care.
This retrospective observational study used Medicare Advantage Prescription Drug and fully insured commercial claims from the Humana Research Database. Patients with AF who initiated a DOAC or warfarin from January 1, 2012, through September 30, 2015, were included. Date of the first prescription of DOAC or warfarin was the index date. Patients in the DOAC and warfarin groups were matched on propensity scores. Patients were censored at end of enrollment or study period, discontinuation, or switch of index medication. Clinical outcomes were compared in the matched groups using Cox proportional hazards models. Annualized costs and costs adjusted for censoring using Lin's interval method were also compared between the two cohorts.
Patients on DOACs had a significantly lower risk of ischemic stroke (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.79-0.98), hemorrhagic stroke (HR, 0.65; CI, 0.46-0.92), SE (HR, 0.53; 95% CI, 0.43-0.65), and composite outcome of stroke or SE (HR, 0.78; 95% CI, 0.71-0.86) compared with patients on warfarin. Bleeding risk was not statistically significant (HR, 0.85; 95% CI, 0.71-1.01). While annualized pharmacy costs were higher, annualized medical and total costs were lower in the DOAC group compared with the warfarin group.
The results of the study indicated that patients on DOACs had lower rates of ischemic stroke, hemorrhagic stroke, SE, and composite outcome of stroke or SE compared with patients on warfarin. No significant differences in bleeding rates between the DOAC and warfarin groups were observed, while total cost of care was lower in the DOAC group.
比较起始使用直接口服抗凝剂(DOACs)与华法林的房颤(AF)患者在包括中风、全身性栓塞(SE)、出血事件及护理费用等临床结局方面的差异。
这项回顾性观察性研究使用了来自Humana研究数据库的医疗保险优势处方药和全额保险商业索赔数据。纳入2012年1月1日至2015年9月30日期间起始使用DOAC或华法林的房颤患者。DOAC或华法林的首次处方日期为索引日期。DOAC组和华法林组患者按倾向得分进行匹配。患者在入组结束、研究期结束、停药或更换索引药物时进行截尾。使用Cox比例风险模型比较匹配组的临床结局。还比较了两组队列的年化成本以及使用林氏区间法调整截尾后的成本。
与使用华法林的患者相比,使用DOACs的患者发生缺血性中风(风险比[HR],0.88;95%置信区间[CI],0.79 - 0.98)、出血性中风(HR,0.65;CI,0.46 - 0.92)、SE(HR,0.53;95% CI,0.43 - 0.65)以及中风或SE复合结局(HR,0.78;95% CI,0.71 - 0.86)的风险显著更低。出血风险无统计学显著差异(HR,0.85;95% CI,0.71 - 1.01)。虽然DOAC组的年化药费较高,但与华法林组相比,其年化医疗费用和总费用更低。
研究结果表明,与使用华法林的患者相比,使用DOACs的患者发生缺血性中风、出血性中风、SE以及中风或SE复合结局的发生率更低。DOAC组和华法林组之间的出血率未观察到显著差异,而DOAC组的总护理费用更低。