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:
背景资料
- About Xarelto (10 Nov 2008)
- About RECORD Studies (10 Nov 2008)
- About Xarelto Clinical Studies (10 Nov 2008)
- Glossary of Terms (10 Nov 2008)
- The History of Anticoagulants (10 Nov 2008)
- Unterstanding Venous Blood Clots (10 Nov 2008)
- ATLAS Backgrounder (10 Nov 2008)
- Understanding Acute Coronary Syndrome (10 Nov 2008)
- 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
髋、膝关节置换术后静脉血栓预防:
U.S. FDA Issues Complete Response Letter for RivaroxabanNo new clinical or non-clinical studies to be conducted as a pre-requisite for approval
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 ProgramPooled 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
急性冠脉综合征(ACS)的二级预防
Bayer’s Xarelto® Shows Encouraging Results in Patients with Acute Coronary SyndromePhase II Data Presented as Late-Breaker at American Heart Association Meeting
Phase III Study to be Initiated in December 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 EUBayer will start marketing the new oral, once-daily anticoagulant very soon
First-in-class product to demonstrate superior efficacy to current standard of care
择期全髋和全膝关节置换术后静脉血栓预防:
Bayer’s Xarelto® Approved in CanadaFirst 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
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 2008First data presentation from large dose-finding trial involving about 3,500 patients
Acceleration of clinical development in acute coronary syndrome planned
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
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 EUFinal approval from the European Commission expected within the next few months
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 DeathRivaroxaban shows superior efficacy to enoxaparin for this clinical outcome with a
Pre-specified analysis of pooled data from RECORD 1-3 studies involving nearly
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 RivaroxabanHead-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
髋关节置换术后静脉血栓预防:
The Lancet Publishes Results from the Landmark Phase III Rivaroxaban Study RECORD2Trial 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
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 TrialRivaroxaban 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”
骨科大手术后VTE预防:
Three Pivotal Phase III Trials Show Superior Efficacy of Rivaroxaban over Standard of Care with EnoxaparinConsistent 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
髋关节置换术后VTE预防:
Pivotal Phase III Data Show Superior Efficacy of Rivaroxaban over EnoxaparinHead-to-Head Study Demonstrates Similar and Low Rate of Bleeding for Both Drugs
New Phase III Trial Results for Rivaroxaban to be Presented at the 49th Annual Meeting of the American Society of Hematology
Endpoints Met for RECORD1 and RECORD2 Trials in Total Hip Replacement Surgery
骨科大手术后静脉血栓栓塞症预防:
Bayer HealthCare Submits Rivaroxaban for European ApprovalData Package for Rivaroxaban Involves Nearly 10,000 Patients in Three Phase III Trials

