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強生/拜耳Xarelto(拜瑞妥)顯著降低高危群體主要不良心臟事件風險

2017/02/24

來源:生物谷                                                           時間:2017.2.14

20170214日訊,德國制藥巨頭拜耳(Bayer)與合作伙伴美國醫藥巨頭強生(JNJ)近日聯合宣布,評估口服抗凝血劑Xarelto(拜瑞妥,通用名:rivaroxaban,利伐沙班)用于冠狀動脈疾病(CAD)或外周動脈疾病(PAD)患者預防主要不良心臟事件(MACE)療效和安全性的大型III期臨床研究COMPASS因療效非常顯著提起達到主要終點。獨立數據監測委員會(DMC)在開展了一項中期分析后認為,該研究已達到了預先設定的優越性標準,建議提前終止。基于Xarelto顯著的療效及現有的安全性數據,拜耳、強生及人口健康研究所(PHRI)將為參與開放標簽擴展研究的患者提供Xarelto治療。值得一提的是,COMPASS研究是迄今為止調查Xarelto療效和安全性的最大規模的臨床研究。

COMPASS研究由拜耳和強生與PHRI合作開展,共入組了全球30多個國家600多個網點27402例患者。研究中,患者隨機接受Xarelto2.5mg,每日2次)+阿司匹林(100mg,每日一次)聯合治療、Xarelto5mg,每日2次)單藥治療、阿司匹林(100mg,每日一次)單藥治療。該研究的完整數據分析將在2017年召開的醫學會議上公布。

在全球范圍內,冠狀動脈疾病(CAD)和外周動脈疾病(PAD)發病率正在逐年上升,盡管目前市場上已存在有效的治療藥物,但這一患者群體中仍存在著遠未滿足的醫療需求。拜耳致力于推進持續性的臨床開發項目,解決該領域未獲滿足的醫療需求。該項III期研究的數據非常激動人心,Xarelto將為CADPAD患者群體提供一個重要的治療選擇,用于降低其主要心臟不良事件風險。

冠狀動脈疾病或外周動脈疾病患者伴有顯著升高的心肌梗死和中風風險。Xarelto是唯一一種非維生素K拮抗劑類口服抗凝血藥物,目前正在評估用于這個高風險患者群體中的療效和安全性。

冠狀動脈疾病(CAD)是導致心血管疾病的最常見原因,在全球范圍內,每年大約有730萬人死于心血管疾病。在高收入國家中,多達1/3-1/2的中年男性和女性,在其一生中存在發生CAD的風險,而且全球CAD患者的數目也在不斷攀升。截止2020年,冠狀動脈疾病的治療負擔將達到820萬傷殘調整壽命年(DALYs)。

而外周動脈疾病(PAD),盡管確診率低,但仍影響著歐洲和北美超過2700萬人,是心血管疾病的一個重要風險標志。在全球范圍內,篩查研究表明,55歲以上老年群體中,大約20%患有PAD。與CAD一樣,PAD的發病率也與年齡密切相關,隨著人口老齡化,患者的數目正在不斷上升。

Xarelto是全球用藥最廣泛的非維生素K拮抗劑類口服抗凝劑(NOAC),目前已獲批7個適應癥,與其他NOAC相比,能夠為廣泛的患者群體提供幫助,預防多種靜脈和動脈血栓栓塞疾病。Xarelto由拜耳和強生合作開發,強生負責美國的銷售,拜耳負責美國以外地區的商業化銷售。截止目前,Xarelto已獲全球130多個國家批準。(生物谷Bioon.com

原始出處:Phase III COMPASS study with Bayer's Rivaroxaban in Patients with Coronary or Peripheral Artery Disease Shows Overwhelming Efficacy and Meets Primary Endpoint Early


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