Department of Cardiology, Copenhagen University Hospital Gentofte, Hellerup, Denmark.
BMJ Open. 2013 May 3;3(5):e002758. doi: 10.1136/bmjopen-2013-002758.
Dabigatran was recently approved for anticoagulation in patients with atrial fibrillation (AF); data regarding real-world use, comparative effectiveness and safety are sparse.
Pharmacoepidemiological cohort study. METHODS/SETTINGS: From nationwide registers, we identified patients with an in-hospital or outpatient-clinic AF diagnosis who claimed a prescription of dabigatran 110 or 150 mg, or vitamin K antagonist (VKA), between 22 August and 31 December 2011. HRs of thromboembolic events (ischaemic stroke, transitory ischaemic attack and peripheral artery embolism) and bleedings were estimated using Cox regression analyses in all patients and stratified by previous VKA use.
Overall, 1612 (3.1%) and 1114 (2.1%) patients claimed a prescription of dabigatran 110 and 150 mg, and 49640 (94.8%) of VKA. Patients treated with dabigatran 150 mg were younger with less comorbidity than those treated with dabigatran 110 mg and VKA, as were VKA naïve patients compared with previous VKA users. Recommendations set by the European Medicine Agency (EMA) for dabigatran were met in 90.3% and 55.5% of patients treated with 110 and 150 mg. Patients treated with 150 mg dabigatran, who did not fulfil the recommendations by EMA, were >80 years, patients with liver or kidney disease, patients with previous bleeding. Compared with VKA, the thromboembolic risk associated with dabigatran 110 and 150 mg was HR 3.52 (1.40 to 8.84) and 5.79 (1.81 to 18.56) in previous VKA users, and HR 0.95(0.47 to 1.91) and 1.14(0.60 to 2.16) in VKA naïve patients. Bleeding risk was increased in previous VKA users receiving dabigatran 110 mg, but not in patients with 150 mg dabigatran, nor in the VKA naïve users.
Deviations from the recommended use of dabigatran were frequent among patients treated with 150 mg. With cautious interpretation, dabigatran use in VKA naïve patients seems safe. Increased risk of thromboembolism and bleeding with dabigatran among previous VKA users was unexpected and may reflect patient selection and 'drug switching' practices.
达比加群最近被批准用于房颤（AF）患者的抗凝治疗；关于真实世界使用、比较疗效和安全性的数据很少。
药物流行病学队列研究。
方法/设置：我们从全国登记处确定了 2011 年 8 月 22 日至 12 月 31 日期间因住院或门诊 AF 诊断而获得达比加群 110 或 150mg 或维生素 K 拮抗剂（VKA）处方的患者。使用 Cox 回归分析在所有患者和根据先前 VKA 使用分层的情况下估计血栓栓塞事件（缺血性中风、短暂性脑缺血发作和外周动脉栓塞）和出血的风险比（HR）。
总体而言，1612（3.1%）和 1114（2.1%）名患者分别接受了达比加群 110 和 150mg 的处方，49640（94.8%）名患者接受了 VKA 的处方。与接受达比加群 110mg 和 VKA 治疗的患者相比，接受达比加群 150mg 治疗的患者年龄较小，合并症较少，与 VKA 初治患者相比也是如此。欧洲药品管理局（EMA）对达比加群的建议在 90.3%和 55.5%的 110mg 和 150mg 患者中得到满足。不符合 EMA 建议的接受 150mg 达比加群治疗的患者年龄在 80 岁以上，患有肝脏或肾脏疾病，有出血史。与 VKA 相比，先前使用 VKA 的患者中达比加群 110 和 150mg 与血栓栓塞风险相关的 HR 为 3.52（1.40 至 8.84）和 5.79（1.81 至 18.56），VKA 初治患者的 HR 为 0.95（0.47 至 1.91）和 1.14（0.60 至 2.16）。先前使用 VKA 的患者中，接受达比加群 110mg 治疗的患者出血风险增加，但接受达比加群 150mg 治疗的患者以及 VKA 初治患者的出血风险并未增加。
在接受 150mg 达比加群治疗的患者中，经常出现不符合推荐使用的情况。谨慎解释后，VKA 初治患者使用达比加群似乎是安全的。先前使用 VKA 的患者中达比加群的血栓栓塞和出血风险增加是出乎意料的，可能反映了患者选择和“药物转换”做法。
