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新闻

新闻资源主要是让您在线获得与拜瑞妥相关的及时信息。在该部分中,您可找到当前和已经发表的有关拜瑞妥的新闻稿以及拜瑞妥的背景信息与图片资料集。


关于拜瑞妥

拜瑞妥被批准用于择期髋关节或膝关节置换术成年患者静脉血栓的预防。1

拜瑞妥属于抗凝药物。 通过阻断凝血因子Xa而发挥作用,从而降低血液发生凝固的倾向性。1

静脉血栓发生于把血流运回到心脏再到肺脏的血管中。静脉血栓栓塞症(VTE)可表现为深静脉血栓形成(DVT)-血凝块发生于深静脉中(通常是腿部);也可表现为肺栓塞-血凝块阻塞肺血管并可能致命。14
  • 深静脉血栓形成(DVT)是指发生于深静脉(通常是下肢)中的血凝块,可部分或完全阻塞血流。
  • 肺栓塞(PE)是指血凝块脱落后随血流流经全身,最终阻塞肺部血管。

进行择期骨科大手术(如全膝关节或全髋关节置换术)的健康患者由于有血管损伤以及活动减少,而面临着静脉血栓的风险。43 如果不采取预防措施,有40-60%的骨科手术患者会发生静脉血栓。61, 65

目前的指南推荐对那些进行择期髋关节或膝关节置换术的患者进行常规的抗凝剂治疗。6

快讯:

  • 拜瑞妥进行了大量的临床试验-包括急性适应症和慢性适应症,使得拜瑞妥成为迄今为止世界上被研究得最多的口服直接Xa因子抑制剂。总共有大约60,000例患者将被纳入到拜瑞妥的临床研究项目中。9
  • 欧洲每年死于静脉血栓的患者数量多于每年死于AIDS、乳腺癌、前列腺癌以及道路交通事故的总和。46, 47
  • 欧洲每年有超过500,000人死于VTE。46
  • 每年美国约有300,000人死于VTE。41
  • 几乎所有因PE导致的院内死亡都是可以预防的。59

背景资料

  • 1 - 拜瑞妥产品说明书
  • 14 - Turpie AG, Chin BS, Lip GY. Venous thromboembolism: pathophysiology, clinical features, and prevention. BMJ. 2002;325(7369):887-890.
  • 43 - Merli GJ. Pathophysiology of venous thrombosis, thrombophilia, and the diagnosis of deep vein thrombosis-pulmonary embolism in the elderly. Clin Geriatr Med. 2006;22(1):75-92.
  • 61 - Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 suppl):338S-400S.
  • 65 - White RH, Zhou H, Romano PS. Incidence of symptomatic venous thromboembolism after different elective or urgent surgical procedures. Thromb Haemost. 2003;90(3):446-455.
  • 6 - Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 suppl):381S-453S.
  • 9 - International Congress on Thrombosis: Rivaroxaban is first novel oral anticoagulant to significantly reduce the composite outcome of symptomatic VTE and death [press release]. Leverkusen, Germany: Bayer HealthCare AG; June 30, 2008.
  • 46 - Cohen AT, Agnelli G, Anderson FA, et al; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007;98(4):756-764.
  • 47 - Fitzmaurice DA, Murray E. Thromboprophylaxis for adults in hospital. BMJ. 2007;334(7602):1017-1018.
  • 41 - Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost. 2005;3(8):1611-1617.
  • 59 - House of Commons Health Committee. The prevention of venous thromboembolism in hospitalised patients. Available at http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/99/99.pdf

新闻稿

28th May 2009

髋、膝关节置换术后静脉血栓预防:

U.S. FDA Issues Complete Response Letter for Rivaroxaban

No new clinical or non-clinical studies to be conducted as a pre-requisite for approval

08. Dec 2008

髋、膝关节置换术后静脉血栓预防:

Xarelto® Reduces Symptomatic VTE and Death Following Knee or Hip Replacement Surgery by More Than 50% Compared to Enoxaparin in Pooled Analysis of RECORD Clinical Trial Program

Pooled Analysis of RECORD1-4 Trials Confirms Significant Benefit in Clinical Outcomes for Patients Treated with Xarelto

RECORD4 Study Demonstrates Xarelto is the Only Oral Anticoagulant to Show Clinical Benefit in Head-to-Head Comparison Against U.S.-Approved Regimen of Enoxaparin

10. Nov 2008

急性冠脉综合征(ACS)的二级预防

Bayer’s Xarelto® Shows Encouraging Results in Patients with Acute Coronary Syndrome

Phase II Data Presented as Late-Breaker at American Heart Association Meeting

Phase III Study to be Initiated in December 2008

01. Oct 2008

择期髋或膝关节置换术后静脉血栓预防:

Bayer’s Novel Anticoagulant Xarelto® now also Approved in the EU

Bayer will start marketing the new oral, once-daily anticoagulant very soon

First-in-class product to demonstrate superior efficacy to current standard of care

16 Sept 2008

择期全髋和全膝关节置换术后静脉血栓预防:

Bayer’s Xarelto® Approved in Canada

First approval for Bayer's new oral, once-daily anticoagulant

Marketing to start immediately

First-in-class product to demonstrate superior efficacy to standard of care

Most studied oral, direct Factor Xa inhibitor in the world today

31 Aug 2008

急性冠脉综合征 (ACS)的二级预防

Rivaroxaban Phase II Data in ACS to be Presented at AHA Congress in November 2008

First data presentation from large dose-finding trial involving about 3,500 patients

Acceleration of clinical development in acute coronary syndrome planned

30 Jul 2008

髋或膝关节置换术后静脉血栓预防:

Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S.

Rivaroxaban is first oral anticoagulant to achieve superior efficacy over the twice-daily

No evidence of safety issues attributable to rivaroxaban after long-term exposure

25 Jul 2008

择期髋或膝关节置换术后静脉血栓预防:

Bayer’s Novel Anticoagulant Rivaroxaban Recommended for Approval in the EU

Final approval from the European Commission expected within the next few months

30 Jun 2008

髋、膝关节置换术后静脉血栓的预防:

Rivaroxaban is First Novel Oral Anticoagulant to Significantly Reduce the Composite Outcome of Symptomatic VTE and Death

Rivaroxaban shows superior efficacy to enoxaparin for this clinical outcome with a

Pre-specified analysis of pooled data from RECORD 1-3 studies involving nearly

26. Jun 2008

全髋关节和全膝关节置换术后静脉血栓预防:

New England Journal of Medicine Publishes Results from Two of the Landmark Phase III RECORD Studies with Rivaroxaban

Head-to-Head trials involving over 7000 patients after Major Orthopedic Surgery

Rivaroxaban superior to Enoxaparin in Preventing Venous Blood Clots

Bleeding rates were low and comparable between the treatment arms

25. Jun 2008

髋关节置换术后静脉血栓预防:

The Lancet Publishes Results from the Landmark Phase III Rivaroxaban Study RECORD2

Trial involving over 2.500 patients after hip replacement surgery

Five weeks of Rivaroxaban compared to two weeks enoxaparin

Extended Rivaroxaban treatment regimen significantly more effective with comparable low bleeding rates

30. May 2008

膝关节置换术后静脉血栓栓塞症预防:

Rivaroxaban One Tablet/Once-Daily Superior to Twice-Daily Injectable Enoxaparin in Preventing Venous Blood Clots after Total Knee Replacement Surgery in Pivotal Phase III Trial

Rivaroxaban is First Oral Anticoagulant to Achieve Superior Efficacy over the Twice- Daily Injection of Enoxaparin while Maintaining Low Major Bleeding Rates

RECORD4 Confirms Results of RECORD1, 2 and 3

U.S. Submission Planned for mid 2008

Prof. Turpie: “Rivaroxaban has the potential to revolutionize the way we prevent the formation of dangerous blood clots”

10. Dec 2007

骨科大手术后VTE预防:

Three Pivotal Phase III Trials Show Superior Efficacy of Rivaroxaban over Standard of Care with Enoxaparin

Consistent results across three RECORD trials involving nearly 10,000 patients

Venous thromboembolism considered the most frequent and potentially fatal complication following major orthopaedic surgery

No evidence of liver signal attributable to rivaroxaban has been seen

2007.12.8

髋关节置换术后VTE预防:

Pivotal Phase III Data Show Superior Efficacy of Rivaroxaban over Enoxaparin

Head-to-Head Study Demonstrates Similar and Low Rate of Bleeding for Both Drugs

9. Nov 2007
2007.10.31

骨科大手术后静脉血栓栓塞症预防:

Bayer HealthCare Submits Rivaroxaban for European Approval

Data Package for Rivaroxaban Involves Nearly 10,000 Patients in Three Phase III Trials


图片

结合在Xa因子中的拜瑞妥

图片显示了一个拜瑞妥分子阻断了Xa因子蛋白的活性部位(X射线晶体衍射)

www.xarelto.com.cn
©2008, 拜耳医药保健有限公司



放大反应

活化的X因子(Xa因子),作为活化的血小板表面的凝血酶原酶复合物的一部分,可将大量凝血酶原转化为凝血酶-称之为“凝血酶爆发式生成”。




血栓形成

血栓碎片可脱落,游移,成为可能致命的肺动脉栓子。




肺栓子

整个肺的肺动脉被新鲜(红色)血栓(圈中)阻塞。




肺栓塞

下肢血栓引起肺栓塞(PE)的路径:下腔静脉-右心房-右心室-肺动脉,最终阻塞肺部血流。患有深静脉血栓形成(DVT)的患者具有患致死性肺栓塞(PE)的风险。

下肢的主要静脉

VTE最为常见的类型是深静脉血栓形成(DVT),发生于腿部和骨盆肌肉的深静脉中。











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整个拜瑞妥研究项目计划纳入60,000例患者。至今为止,利伐沙班是被研究得最多的直接Xa因子抑制剂。9

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