GLORIA??-AF 研究支持泰畢全減少卒中風險的安全性和有效性

德國殷格翰，2016 年 8 月 29 日- GLORIA?-AF 登記研究的首項結果顯示，使用泰畢全 ^?（達比加群酯）治療，卒中、大出血和危及生命的出血發生率低。這項從約 3000 例非瓣膜性房顫（NVAF）患者中得出的研究結果在 2016 年意大利羅馬召開的 ESC 大會最新科學進展專題部分公布。¹ 這些來自 GLORIA^TM-AF 的研究數據增加了支持泰畢全^?減少卒中風險的安全性和有效性特征的廣泛數據，并且與最近發表的評估抗凝劑在日常臨床實踐中使用的研究數據一致。^2,4-19

上述數據為 GLORIA?-AF 登記研究 II 階段的數據，描述了新診斷為 NVAF 的 2932 例患者的結局，對這些患者隨訪了兩年。¹結果顯示：

? 在實際臨床實踐中，接受泰畢全 ^?治療的患者安全性結局發生率低：僅 1.12% 接受泰畢全 ^?治療的患者發生大出血，僅 0.54% 發生危及生命的出血

? 泰畢全 ^?有效降低了 NVAF 患者的卒中風險：不足 1% 接受泰畢全 ^?治療的患者發生卒中（0.63%）

? 在常規臨床治療中的兩年隨訪期間內，泰畢全 ^?保持了安全性和有效性

「像 GLORIA?-AF 的真實世界研究補充了從隨機對照臨床試驗中獲得的知識，并提供了在各種臨床情況下，從更大、更多樣以及伴有共病的患者人群中獲得的洞見」，英國伯明翰大學心血管科學中心心血管內科的 Gregory Lip 教授表示。「GLORIA?-AF 項目的研究結果再次表明，在關鍵 III 期 RE-LY^?臨床試驗中確立的達比加群更佳的風險-獲益特征在常規臨床治療中也觀察到。這與之前的大型真實世界數據分析結果一致，這些真實世界數據分析包括美國 FDA 醫保數據分析和最近公布的丹麥全國衛生數據庫結果，兩項分析均為獨立進行的分析。」

GLORIA?-AF 是目前正在進行的、在常規臨床治療中觀察抗栓藥物的全球最大的登記研究之一。將入組多達 56000 例 NVAF 患者，結果將支持醫生使用抗凝藥預防卒中的決策。截止目前，逾 34500 例患者已納入 GLORIA^TM-AF 項目。^{3, 21?}

勃林格殷格翰進行了多項其他研究，考察其產品在常規臨床抗凝管理中的應用：RE-COVERY DVT/ PE?，一項關于腿部血栓（深靜脈血栓形成，DVT）和肺部血栓（肺栓塞，PE）管理的全球觀察性研究。²²另外一項最近啟動的研究為 RE-VECTO，為一項獲取 Praxbind?（idarucizumab）在臨床實踐中使用數據的全球項目。²³Praxbind?是首個也是唯一一個 NOAC 特異性逆轉劑，被批準用于需要立即逆轉泰畢全?抗凝作用的緊急情況，^{24, 25}并在包括歐洲 2500 多家醫院在內的全球逾 5500 家醫院廣泛應用和儲備。²¹

關于 GLORIA?-AF（房顫患者長期口服抗凝藥物治療的全球登記研究）

GLORIA?-AF 是在常規臨床背景中研究長期使用口服抗凝藥物預防非瓣膜性房顫相關卒中的全球最大登記研究之一。³該登記研究觀察醫生在治療 AF 中的處方行為，及其處方決策背后的影響因素。這項研究收集了一系列抗栓藥物的長期安全性和有效性數據，包括華法林、ASA（阿司匹林）和用于 AF 卒中預防的 NOAC，以及患者轉歸。^{3, 26}

該項目將從近 50 個國家多達 2200 家研究中心入組多達 56000 例新診斷為 AF 并伴有卒中風險的患者。³GLORIA?-AF II 階段研究于首個 NOAC 泰畢全 ^?2011 年 11 月在美國獲批后開始。

參考文獻

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21. Boehringer Ingelheim Data on File.

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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.?

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編輯： zhouwei    來源：丁香園