德国殷格翰，2016 年 8 月 29 日- GLORIA™-AF 登记研究的首项结果显示，使用泰毕全 ®（达比加群酯）治疗，卒中、大出血和危及生命的出血发生率低。这项从约 3000 例非瓣膜性房颤（NVAF）患者中得出的研究结果在 2016 年意大利罗马召开的 ESC 大会最新科学进展专题部分公布。1 这些来自 GLORIATM-AF 的研究数据增加了支持泰毕全®减少卒中风险的安全性和有效性特征的广泛数据，并且与最近发表的评估抗凝剂在日常临床实践中使用的研究数据一致。2,4-19
上述数据为 GLORIA™-AF 登记研究 II 阶段的数据，描述了新诊断为 NVAF 的 2932 例患者的结局，对这些患者随访了两年。1结果显示：
• 在实际临床实践中，接受泰毕全 ®治疗的患者安全性结局发生率低：仅 1.12% 接受泰毕全 ®治疗的患者发生大出血，仅 0.54% 发生危及生命的出血
• 泰毕全 ®有效降低了 NVAF 患者的卒中风险：不足 1% 接受泰毕全 ®治疗的患者发生卒中（0.63%）
• 在常规临床治疗中的两年随访期间内，泰毕全 ®保持了安全性和有效性
「像 GLORIA™-AF 的真实世界研究补充了从随机对照临床试验中获得的知识，并提供了在各种临床情况下，从更大、更多样以及伴有共病的患者人群中获得的洞见」，英国伯明翰大学心血管科学中心心血管内科的 Gregory Lip 教授表示。「GLORIA™-AF 项目的研究结果再次表明，在关键 III 期 RE-LY®临床试验中确立的达比加群更佳的风险-获益特征在常规临床治疗中也观察到。这与之前的大型真实世界数据分析结果一致，这些真实世界数据分析包括美国 FDA 医保数据分析和最近公布的丹麦全国卫生数据库结果，两项分析均为独立进行的分析。」
GLORIA™-AF 是目前正在进行的、在常规临床治疗中观察抗栓药物的全球最大的登记研究之一。将入组多达 56000 例 NVAF 患者，结果将支持医生使用抗凝药预防卒中的决策。截止目前，逾 34500 例患者已纳入 GLORIATM-AF 项目。3, 21
勃林格殷格翰进行了多项其他研究，考察其产品在常规临床抗凝管理中的应用：RE-COVERY DVT/ PE™，一项关于腿部血栓（深静脉血栓形成，DVT）和肺部血栓（肺栓塞，PE）管理的全球观察性研究。22另外一项最近启动的研究为 RE-VECTO，为一项获取 Praxbind®（idarucizumab）在临床实践中使用数据的全球项目。23Praxbind®是首个也是唯一一个 NOAC 特异性逆转剂，被批准用于需要立即逆转泰毕全®抗凝作用的紧急情况，24, 25并在包括欧洲 2500 多家医院在内的全球逾 5500 家医院广泛应用和储备。21
关于 GLORIA™-AF（房颤患者长期口服抗凝药物治疗的全球登记研究）
GLORIA™-AF 是在常规临床背景中研究长期使用口服抗凝药物预防非瓣膜性房颤相关卒中的全球最大登记研究之一。3该登记研究观察医生在治疗 AF 中的处方行为，及其处方决策背后的影响因素。这项研究收集了一系列抗栓药物的长期安全性和有效性数据，包括华法林、ASA（阿司匹林）和用于 AF 卒中预防的 NOAC，以及患者转归。3, 26
该项目将从近 50 个国家多达 2200 家研究中心入组多达 56000 例新诊断为 AF 并伴有卒中风险的患者。3GLORIA™-AF II 阶段研究于首个 NOAC 泰毕全 ®2011 年 11 月在美国获批后开始。
参考文献
1. Huisman MV. et al. Low Stroke and Bleeding Rates Observed after 2 Years: Prospective Follow-Up of Patients Treated with Dabigatran Etexilate for Stroke Prevention in Atrial Fibrillation: The GLORIA-AF Registry. Registry Session #4208, presented on Monday 29 August at the ESC Congress 2016, 27-31 August 2016, Rome, Italy.
2. Connolly SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361: 1139–51.
3. Huisman MV. et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: A global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014; 167: 329–34.
4. Connolly SJ. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010; 363: 1875–6.
5. Connolly SJ. et al. The long term multi-center extension of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study. Circulation. 2013; 128: 237–43.
6. Al-Khalili F. et al. The safety and persistence of non-vitamin-Kantagonist oral anticoagulants in atrial fibrillation patients treated in a well structured atrial fibrillation clinic. Curr Med Res Opin. 2016; 32: 779–85.
7. Amin A. et al. Early Comparison of Major Bleeding, Stroke and Associated Medical Costs Among Treatment-Naive Non-Valvular Atrial Fibrillation Patients Initiating Apixaban, Dabigatran, Rivaroxaban or Warfarin. Abstract #745. 57th Annual Meeting & Exposition of the American Society of Hematology, 5-8 December 2015, Orlando, USA.
8. Chan Y-H. et al. Cardiovascular, Bleeding, and Mortality Risks of Dabigatran in Asians With Nonvalvular Atrial Fibrillation. Stroke. 2016; 47: 441–9.
9. Deitelzweig S. et al. An early evaluation of bleeding-related hospital readmissions among hospitalized patients with nonvalvular atrial fibrillation treated with direct oral anticoagulants. Curr Med Res Opin. 2016; 32: 573–82.
10. Gorst-Rasmussen A. et al. Rivaroxaban versus warfarin and dabigatran in atrial fibrillation: comparative effectiveness and safety in Danish routine care. Pharmacoepidemiol Drug Saf. doi: 10.1002/pds.4034.
11. Graham DJ. et al. Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated With Dabigatran or Warfarin for Nonvalvular Atrial Fibrillation. Circulation. 2015; 131: 157–64.
12. Larsen TB. et al. Bleeding Events Among New Starters and Switchers to Dabigatran Compared with Warfarin in Atrial Fibrillation. Am J Med. 2014; 127: 650–6.
13. Larsen TB. et al. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2016; 353: i3189.
14. Lin I. et al. Real-world bleeding risk among non valvular atrial fibrillation (NVAF) patients prescribed apixaban, dabigatran, rivaroxaban and warfarin: analysis of electronic health records. Abstract #P6215, presented at the ESC Congress 2015, 29 August-2 September 2015, London, UK.
15. Lip GYH. et al. Real world comparison of major bleeding risk among non-valvular atrial fibrillation patients newly initiated on apixaban, warfarin, dabigatran or rivaroxaban: A 1: 1 propensity-score matched analysis. Abstract #1268-349, presented at The 65th American College of Cardiology Annual Scientific Session, 2-4 April 2016, Chicago, USA.
16. Pan X. et al. What do real world data say about safety and resource use of oral antagonists? Early analysis of newly anticoagulated non-valvular atrial fibrillation patients using either apixaban, dabigatran, rivaroxaban or warfarin. Abstract #1268-361, presented at The 65th American College of Cardiology Annual Scientific Session, 2-4 April 2016, Chicago, USA.
17. Seeger JD. et al. Safety and effectiveness of dabigatran and warfarin in routine care of patients with atrial fibrillation. Thromb Haemost. 2015; 114: 1277–89.
18. Tepper P. et al. Real-world comparison of bleeding risks among non valvular atrial fibrillation patients on apixaban, dabigatran, rivaroxaban: cohorts comprising new initiators and/or switchers from warfarin. Abstract #1975, presented at the ESC Congress 2015, 29 August-2 September, London, UK.
19. Villines TC. et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost. 2015; 114: 1277–89.
20. Medi C. et al. Stroke Risk and Antithrombotic Strategies in Atrial Fibrillation. Stroke. 2010; 41: 2705-2713.
21. Boehringer Ingelheim Data on File.
22. ClinicalTrials.gov. RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism. https: //clinicaltrials.gov/ct2/show/NCT02596230?term = re-covery&rank = 1 Last accessed August 2016.
23. Boehringer Ingelheim Press release–15 August 2016. Boehringer Ingelheim launches RE-VECTO global program to capture data on Praxbind® usage in clinical practice. https: //www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-launches-re-vecto-global-program Last accessed August 2016.
24. Praxbind®European Summary of Product Characteristics, 2015.
25. Praxbind®U.S. Prescribing Information, 2015.
26. GLORIA-AF Registry website: Registry Design. https: //www.gloria-af.com/public/about-regDesign.html Last accessed August 2016.