欢迎访问文传商讯!

全部新闻

Updated Phase III Results Reinforce Safety and Efficacy of Praxbind® (idarucizumab) in Urgent Situations

发布时间:2016-11-16 17:18


  • Idarucizumab immediately reversed the anticoagulant effect of dabigatran in 100 percent of patients1
  • Updated results of 494 patients from largest study investigating a reversal agent for a novel oral anticoagulant in real-world emergency settings1,2
  • Data presented at AHA Scientific Sessions 20161

INGELHEIM, Germany--()--Boehringer Ingelheim announced updated results from data for 494 patients participating in the ongoing phase III RE-VERSE AD™ study, which showed that administration of 5g of idarucizumab immediately reversed the anticoagulant effect of dabigatran, the active ingredient in Pradaxa® (dabigatran etexilate).1 Idarucizumab, marketed as Praxbind®, is the first and only approved specific reversal agent for a non vitamin K antagonist oral anticoagulant (NOAC) and RE-VERSE AD™ is the largest patient study investigating a reversal agent for a NOAC.2-4 The updated results were presented at the American Heart Association (AHA) Scientific Sessions 2016 in New Orleans, Louisiana.1

RE-VERSE AD™ includes the types of patients healthcare professionals may treat in real-world emergency settings.2 The study enrolled patients treated with dabigatran who had uncontrolled or life-threatening bleeding (Group A, n=298, 60 percent) or required emergency surgery or an invasive procedure (Group B, n=196, 40 percent).1 This includes severely ill or injured patients (e.g. patients in an automobile accident with multiple injuries, patients with aortic aneurysm or patients receiving an organ transplant) who as such require urgent reversal of dabigatran.2

The primary endpoint of reversal of the anticoagulant effect of dabigatran within four hours was 100 percent1,2, as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT) (95% CI, 100-100).1,2 Of note, reversal was evident immediately after administration of idarucizumab.1 For Group A patients with extracranial bleeding, median time to confirmation of haemostasis was 3.5 to 4.5 hours, depending on anatomical location.1 The source of bleeding was similar to the previous interim analysis (45 percent gastrointestinal, 33 percent intracranial haemorrhage).1,5 In Group B, 93 percent of patients experienced normal haemostasis during surgery, and the median time to the operating room was 1.6 hours after administration of idarucizumab.1

No safety signals attributed to idarucizumab were detected. All serious adverse events reported were considered to be related to the index event or comorbidities rather than to study treatment. Thrombotic events occurred in 6.3 percent (31/494) of patients within 90 days after idarucizumab administration. Approximately two-thirds of these patients received no anticoagulation prior to the event. Mortality rates were 12.3 percent (Group A) and 12.4 percent (Group B) at 30 days, and 18.7 percent (Group A) and 18.5 percent (Group B) at 90 days. 1

“The availability of idarucizumab as a reversal agent for dabigatran is an important development in anticoagulation care, and RE-VERSE AD™ is the most robust examination of its real-world use and impact,” said Dr. Charles Pollack, lead investigator of RE-VERSE AD™, Professor of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, US. “These results further support that, although idarucizumab is likely to be rarely used in light of the safety profile of dabigatran, a specific reversal agent provides an important therapeutic option for physicians and patients.”

“With these results, we have an unprecedented wealth of data on the use and effects of idarucizumab in urgent situations,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “These insights, together with the confirmed safety profile of dabigatran, can truly give physicians confidence in choosing a NOAC that provides a new level of care for their patients.”

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

~ENDS~

Please click on the link below for ‘Notes to Editors and References’:

http://www.boehringer-ingelheim.com/press-release/updated-phase-iii-results-reinforce-safety-and-efficacy-of-praxbind

 

Contacts

Boehringer Ingelheim GmbH
Friederike Middeke
Phone: +49 6132 – 77 141575
Fax: +49 6132 – 77 6601
E-mail: press@boehringer-ingelheim.com
Twitterhttp://twitter.com/Boehringer
or
More information
www.boehringer-ingelheim.com

金联创 xinhua08 cacs takungpao China.com 和讯 财讯 C114.net 看商界 畅享网 中国能源网 证券之星 金融界 中金在线 天和网 中国金融网 中汽传媒 国际财经日报 中国环保网 今日亚洲新闻网 百歌新闻专线 亚洲商机 新华网能源频道 IT资讯网 中国智能卡论坛 广西物流网 品牌世家 汽车点评网 中国电子标签网 360教育在线 21世纪保险网 中国能源投资网 中国电子商业联盟 中国汽车咨询中心网 煤炭供应链 美国证券网 百奥知 CTI论坛 中国测控网 北极星电力网 能源财经网 福建之窗 智库在线 eeworld 电脑商情在线 中国电池网 赢商网 湖南信息港 赢在中国网 比邻星环保网 中国制造业门户 中国涂料在线 渝网 - 了解重庆第一站,重庆城市生活门户网站 中国云计算第一门户网站—中云网 投资界 i美股 天和财富网 太阳能信息网 爱中国能源网 世纪新能源网 中国新能源网 PVMate.com 环球外汇 橡胶网-hc360慧聪网 百年企业在线 IT168 米内 汽车工业网 第一车市汽车网 股市资讯 中国西部网 中原汽配网 科技在线 煤炭网 51招生网 教育人生 驴皮网 物流北京 51电池搜索网 大众医学 岭南医药网 5联网 股城网 BIT CNELC XXTLW 外汇通 供应链中国网 中国粘合剂网 中国储能网 家具迷 家居装修网 中華检测网 中国食品招商网 华东化工网 新疆第一汽车网 中国汽车用品交易网 大娱网 中国汽配网 山东化工网 960化工网 妈咪爱 塑胶五金网 慧聪电子网 迈点酒店网 火爆网 emcsino eetrend 绿色节能网 赤浪绿色新能源网 中国商业网 生物无忧 全球医疗器械网 贷商网 手机在线 汽车轻量化在线 中国汽车材料网 科易网 中国电子顶级开发网 中国POS机网 乐康家居 必修 国易网