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拜耳新型口服抗凝血剂Xarelto获EC批准

  1. Xarelto
  2. 急性冠脉综合征
  3. 拜瑞妥
  4. 拜耳

来源:生物谷 2013-05-28 12:04

2013年5月27日讯 /生物谷BIOON/ --拜耳(Bayer)上周五宣布,欧盟委员会(EC)已批准将拜瑞妥(Xarelto,rivaroxaban,利伐沙班)以2.5mg BID剂量(2.5mg,每日2次)联合标准抗血小板疗法,用于心脏生物标志物水平升高的成人患者急性冠脉综合征(ACS)发作后动脉粥样硬化事件(心血管死亡、心肌梗死或中风)的预防。

2013年5月27日讯 /生物谷BIOON/ --拜耳(Bayer)上周五宣布,欧盟委员会(EC)已批准将拜瑞妥(Xarelto,rivaroxaban,利伐沙班)以2.5mg BID剂量(2.5mg,每日2次)联合标准抗血小板疗法,用于心脏生物标志物水平升高的成人患者急性冠脉综合征(ACS)发作后动脉粥样硬化事件(心血管死亡、心肌梗死或中风)的预防。该批准,使Xarelto成为唯一获批用于心脏生物标志物水平升高患者ACS事件后保护心脏的新型口服抗凝血剂。

动脉血栓(arterial blood clots)通过血小板激活和凝血酶生成双重途径生成,可能会导致ACS事件的再次复发。标准抗血小板疗法,仅靶向于血栓形成中的血小板激活途径,Xarelto则靶向于凝血因子Xa,该蛋白是凝血酶生成的关键触发子。

Xarelto此次新适应症的获批,是基于关键性III期ATLAS ACS2-TIMI51试验的重要临床发现。该项试验在超过15500例患者中开展,研究结果表明,在那些近期经历过ACS事件的患者中,与接受标准抗血小板疗法[低剂量阿司匹林和/或噻吩吡啶类药物(氯吡格雷或噻氯匹定)]相比,将Xarelto 2.5mg BID添加至标准抗血小板疗法,能够显着降低患者心血管死亡、心肌梗死、卒中事件,达到了复合主要疗效终点。

研究中,与冠状动脉旁路移植(CABG)无相关性的心肌梗死溶栓(TIMI)大出血事件和颅内出血(ICH)事件发生率均较低,但重要的是,使用Xarelto时,未观察到致死性颅内出血(ICH)或致死性出血风险的升高。

基于ATLAS ACS 2-TIMI51的研究结果,2012年欧洲心脏病学会(ESC)指南推荐,对于正在接受阿司匹林+氯吡格雷抗血小板疗法且伴有低出血风险的ST段抬高型心肌梗死(STEMI)患者,应考虑使用Xarelto 2.5mg BID治疗。(生物谷bioon.com)

英文原文:Bayer’s Xarelto? Approved in the EU for Secondary Prevention after an Acute Coronary Syndrome

Following an ACS event, one in ten patients will have another major atherothrombotic event (cardiovascular death, myocardial infarction or stroke) within a year / Xarelto 2.5 mg BID in combination with antiplatelet therapy can help prevent athero-thrombotic events by providing more complete protection than antiplatelet therapy alone / Xarelto is approved to protect patients from blood clots across more venous and arterial thromboembolic conditions than any other novel oral anticoagulant

Berlin, Germany, May 24, 2013 – Bayer HealthCare’s novel oral anticoagulant Xarelto? (rivaroxaban) has been approved by the European Commission for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an Acute Coronary Syndrome (ACS) in adult patients with elevated cardiac biomarkers at a dose of 2.5 mg twice-daily (BID) in combination with standard antiplatelet therapy. This approval makes rivaroxaban the only novel oral anticoagulant approved to protect patients with elevated cardiac biomarkers following an ACS event.

Arterial blood clots, which may lead to a recurrence after an ACS event, are formed through the dual pathways of platelet activation and thrombin generation. Standard antiplatelet therapy only targets the platelet activation pathway of clot formation. Rivaroxaban targets Factor Xa, a key trigger of thrombin generation.

“We know that thrombin levels remain elevated long after an ACS event, leaving patients at risk. In the ATLAS ACS 2-TIMI 51 study, we’ve shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation providing more complete long-term protection, including significant reduction in mortality risk,” said C. Michael Gibson, M.S., M.D., Chairman of the PERFUSE Study Group, Harvard Medical School, and the Principal Investigator in the ATLAS ACS studies. “This approval marks an important shift in the way we deliver protection to patients who are at risk of a secondary atherothrombotic event.”

“Xarelto is already finding extensive use by cardiologists for stroke prevention in patients with atrial fibrillation. This approval re-enforces the compelling profile of the product, further extending its clinical value in preventing arterial blood clots,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

The approval of rivaroxaban in this indication is based on important clinical findings of the pivotal Phase III ATLAS ACS 2-TIMI 51 study of more than 15,500 patients. The study demonstrated that the addition of rivaroxaban 2.5 mg BID to standard antiplatelet therapy — low-dose aspirin with or without a thienopyridine (clopidogrel or ticlopidine) — significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction or stroke in patients after a recent ACS compared to those who received standard antiplatelet therapy alone.

Rates of TIMI (Thrombolysis In Myocardial Infarction) major bleeding events not associated with coronary artery bypass graft (CABG) surgery and of intracranial haemorrhage (ICH) were low overall, yet increased with the addition of rivaroxaban. But importantly, there was no increase observed with rivaroxaban in the risk of fatal intracranial haemorrhage (ICH) or fatal bleeding.

Based on the ATLAS ACS 2-TIMI 51 study findings, the 2012 European Society of Cardiology (ESC) Guidelines recommend that treatment with rivaroxaban 2.5 mg BID be considered for patients with ST-Segment Elevation Myocardial Infarction (STEMI) who are at low bleeding risk and are on antiplatelet therapy with aspirin and clopidogrel.

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