2020年11月6日07:00 GMT
Brilinta的新适应症扩大了心血管疾病以外的应用
对轻中度中风患者
澳门在线赌城娱乐公司 Brilinta (替格瑞洛)已在美国被批准用于降低中风风险, 这是全世界致残和死亡的主要原因, in patients with acute ischemic stroke (National Institutes of Health 中风 Scale score ≤5) or high-risk transient ischaemic attack (TIA).
The approval by the US Food and Drug Administration (FDA) was based on positive results from the 泰利斯公司 Phase III trial that showed aspirin plus Brilinta 90mg significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischaemic stroke or TIA.1 该决定是在 优先审查指定 FDA于2020年7月批准的.
Dr. 粘土约翰斯顿, lead investigator 为 the 泰利斯公司 Phase III trial and Dean of the Dell Medical School at The University of Texas in Austin, US, 他说:“四分之一的中风患者会经历第二次中风, 在头30天内风险特别高. 的批准 Brilinta in combination with aspirin is an important advancement to reduce the risk of recurrent stroke and much-awaited good news 为 physicians and patients.”
Mene Pangalos，澳门第一赌城在线娱乐R的执行副总裁&D, 他说:“在美国, someone has a stroke every 40 seconds and the impact on a person’s life can be truly devastating. Brilinta is a well-established medicine across patients with coronary artery disease and with today’s approval, we can now expand its potential to patients with an acute ischaemic stroke or transient ischemic attack.”
泰利斯公司的试验证明了这一点 Brilinta 90毫克，每日两次，与阿司匹林一起服用30天, reduced the rate of the primary composite endpoint of stroke and death by 17% (absolute risk reduction = 1.1%; hazard ratio 0.83; 95% confidence interval 0.71-0.96, p=0.015)，与阿司匹林单独用于急性缺血性卒中(TIA)患者相比.1 这是具有统计学意义和临床意义的减少. 主要综合终点是卒中减少.
发生严重出血事件的风险为0.5%的患者服用阿司匹林加药 Brilinta 和0.阿司匹林单独占1%. 结果与已知的安全概况一致 Brilinta.1 泰利斯公司 III期试验的全部数据可在 新英格兰医学杂志.
Regulatory submissions to expand the approved indication are also under regulatory review in China and in the EU w在这里 the medicine’s name is Brilique.
Brilinta is approved in more than 110 countries 为 the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) and in more than 70 countries 为 the secondary prevention of cardiovascular events among patients who are at high-risk and have experienced a heart attack. 2020年5月，美国FDA批准了一种 新的指示 为 Brilinta to include the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.
中风
An ischaemic stroke is caused by a blockage cutting off the blood supply to a region of the brain. 短暂性缺血发作, 是大脑某一区域的血液供应暂时阻塞吗, 导致症状只持续很短的时间. 中风是全世界致残和死亡的主要原因.2 在美国， someone has a stroke every 40 seconds, and every four minutes, someone dies of stroke.3 大约四分之一的中风是复发性的, with the risk particularly high within 30 days after the initial event and even higher when looking at time periods closer to the initial event.4,5
泰利斯公司
泰雷兹是澳门在线赌城娱乐赞助的, 随机, 安慰剂对照, 双盲, 国际, 多中心, 事件驱动的III期试验涉及超过11个,来自28个国家的000名患者. 它检验了阿司匹林是否加 Brilinta is superior to aspirin alone in preventing the composite of stroke and death in patients with non-cardioembolic acute ischaemic stroke or high-risk TIA. Patients were 随机 within 24 hours of onset of acute ischaemic stroke or high-risk TIA symptoms and treated 为 30 days. 研究的治疗方法是 Brilinta 第1天180mg负荷剂量，随后在第2-30天每天两次90mg，或匹配安慰剂. 所有患者在第1天接受开放tags阿司匹林300-325mg, 然后在第2-30天每天一次75-100mg. The primary efficacy outcome was the time to the composite endpoint of stroke and death at 30 days. The primary safety outcome is time to first severe bleeding event according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator 为 Occluded Coronary Arteries (GUSTO) definition, 其中包括致命的出血, intracranial haemorrhage; and bleeding causing hemodynamic compromise requiring intervention.
Brilinta
Brilinta (替格瑞洛)是一种口服、可逆、直接作用的P2Y12 通过抑制血小板活化起作用的受体拮抗剂. Brilinta, 还有阿司匹林, has been shown to significantly reduce the risk of major adverse cardiovascular (CV) events (heart attack, 中风或心血管死亡), ACS患者或有心脏病发作史的患者. 在美国， Brilinta is also indicated 为 the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.
澳门在线赌城娱乐在CVRM
心血管，肾脏和代谢 (CVRM) together 为ms one of 澳门在线赌城娱乐公司 three therapy areas and is a key growth driver 为 the Company. 通过遵循科学来更清楚地了解心脏之间的潜在联系, 肾脏和胰腺, 澳门在线赌城娱乐 is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, 减少风险和处理合并症. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver trans为mative science that improves treatment practices and cardiovascular health 为 millions of patients worldwide.
澳门在线赌城娱乐
澳门在线赌城娱乐(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门第一赌城在线娱乐公司，专注于发现, 处方药的开发和商业化, 主要用于治疗肿瘤等三个治疗领域的疾病, 心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门在线赌城娱乐 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门在线赌城娱乐.com 并在推特上关注公司 @澳门在线赌城娱乐.
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参考文献
1. Brilinta(替格瑞洛)处方信息. 澳门在线赌城娱乐制药有限公司.
2. Johnston SC, Amarenco P, Denison H， 等. 替格瑞洛和阿司匹林或阿司匹林单独用于急性缺血性卒中或TIA. [英]医学 2020; 383:207-217.
3. 张建军，张建军，张建军，等. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. 循环. 2020;141(9):e139–e596.
4. 纸巾GJ. 二级中风预防. 柳叶刀神经 2014; 13(2):178–94.
5. AJ, Lovett JK和Rothwell PM. Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications 为 public education and organisation of services. BMJ. 2004;328:326.
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