Lankenau Institute for Medical Research, 100 Lancaster Ave, Suite G36, Wynnewood, PA 19096, USA.
Circulation. 2010 Nov 30;122(22):2246-53. doi: 10.1161/CIRCULATIONAHA.110.973735.
The comparison of anticoagulants dabigatran and warfarin might be most equitable in vitamin K antagonist (VKA)-naive patients.
Warfarin and 2 doses of dabigatran-110 mg BID (D110) and 150 mg BID (D150)-were compared in a balanced population of VKA-naive (≤62 days of lifetime VKA exposure, with 33% never prescribed a VKA) and VKA-experienced patients with atrial fibrillation (n=18 113). For VKA-naive and -experienced patients assigned warfarin, the time in therapeutic range (international normalized ratio 2.0 to 3.0) was 62% and 67%, respectively, and 61% and 66% for those never and ever prescribed a VKA. In VKA-naive patients, stroke and systemic embolism rates were 1.57%, 1.07%, and 1.69% per year for D110, D150, and warfarin, respectively. D110 was similar to warfarin (P=0.65); D150 was superior (P=0.005). Major bleeding rates were 3.11%, 3.34%, and 3.57% per year, respectively. D110 and D150 were similar to warfarin (P=0.19 and P=0.55). Intracranial bleeding rates were 0.19%, 0.33%, and 0.73% per year, respectively. D110 and D150 were lower than warfarin (P<0.001 and P=0.005). In VKA-experienced patients, stroke and systemic embolism rates were 1.51%, 1.15%, and 1.74% per year for D110, D150, and warfarin, respectively. D110 was similar to warfarin (P=0.32); D150 was superior (P=0.007). Major bleeding rates were 2.66%, 3.30%, and 3.57% per year, respectively. D110 was lower than warfarin (P=0.003); D150 was similar (P=0.41). Intracranial bleeding rates were 0.26%, 0.32%, and 0.79% per year, respectively. D110 and D150 were lower than warfarin (P<0.001 for both). Results were similar for patients never on a VKA.
Previous VKA exposure does not influence the benefits of dabigatran at either dose compared with warfarin.
http://www.clinicaltrials.gov. Unique identifier: NCT00262600.
在华法林抗凝剂（VKA）初治患者中，达比加群与华法林的比较可能最为均衡。
在华法林初治（≤62 天的 VKA 暴露史，其中 33%从未开处 VKA）和 VKA 经验性房颤患者（n=18113）的均衡人群中，比较了华法林与两种剂量的达比加群-110mg bid（D110）和 150mg bid（D150）。对于华法林初治和经验性患者，治疗范围内的时间（国际标准化比值 2.0 至 3.0）分别为 62%和 67%，从未和曾经服用 VKA 的患者分别为 61%和 66%。在华法林初治患者中，D110、D150 和华法林的年卒中与全身性栓塞发生率分别为 1.57%、1.07%和 1.69%。D110 与华法林相似（P=0.65）；D150 优于华法林（P=0.005）。大出血发生率分别为 3.11%、3.34%和 3.57%/年。D110 和 D150 与华法林相似（P=0.19 和 P=0.55）。颅内出血发生率分别为 0.19%、0.33%和 0.73%/年。D110 和 D150 均低于华法林（P<0.001 和 P=0.005）。在 VKA 经验性患者中，D110、D150 和华法林的年卒中与全身性栓塞发生率分别为 1.51%、1.15%和 1.74%。D110 与华法林相似（P=0.32）；D150 优于华法林（P=0.007）。大出血发生率分别为 2.66%、3.30%和 3.57%/年。D110 低于华法林（P=0.003）；D150 相似（P=0.41）。颅内出血发生率分别为 0.26%、0.32%和 0.79%/年。D110 和 D150 均低于华法林（P<0.001）。对于从未服用过 VKA 的患者，结果相似。
与华法林相比，VKA 暴露史并不影响达比加群在任一剂量下的获益。
