AHA 2013:Evolocumab降脂治疗前景较好(OSLER研究)

2013-11-27 高晓方 译 医学论坛网

于AHA 2013科学年会公布的美国OSLER研究表明,在超过1年的长期治疗过程中,PCSK9抑制剂Evolocumab(AMG 145)在高胆固醇血症患者中显示出持续疗效,并且安全性和耐受性令人鼓舞。论文11月19日在线发表于《循环》(Circulation)。【原文下载】  此项研究为4项evolocumab II期试验的后续长期开发标签研究,并从1359例高胆固醇血

于AHA 2013科学年会公布的美国OSLER研究表明,在超过1年的长期治疗过程中,PCSK9抑制剂Evolocumab(AMG 145)在高胆固醇血症患者中显示出持续疗效,并且安全性和耐受性令人鼓舞。论文11月19日在线发表于《循环》(Circulation)。【原文下载】 

此项研究为4项evolocumab II期试验的后续长期开发标签研究,并从1359例高胆固醇血症患者纳入了1104例(81%)患者。无论既往研究中治疗分组如何,患者均已2:1的比率接受开放标签皮下evolocumab(420mg/4周)联合标准治疗(SOC)(n=736)或单纯SOC治疗(n=368)。evolocumab+SOC和SOC组分别有92%和89%的患者完成52周随访。


 



结果显示,52周时首次接受evolocumab治疗的患者出现LDL-C平均降低52.3%(P<0.001)。在既往研究中接受过evolocumab治疗的evolocumab+SOC组患者中,LDL-C仍表现为持续降低。在既往研究中停止evolocumab治疗的患者中,LDL-C恢复至近基线水平。evolocumab+SOC和SOC组的不良事件发生率分别为81.4%和73.1%,严重不良事件分别为7.1%和6.3%。

原文出处:

Koren MJ, Giugliano RP, Raal FJ, Sullivan D, Bolognese M, Langslet G, Civeira F, Somaratne R, Nelson P, Liu T, Scott R, Wasserman SM, Sabatine MS; for the OSLER Investigators.Efficacy and Safety of Longer-Term Administration of Evolocumab (AMG 145) in Patients With Hypercholesterolemia: 52-Week Results From the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) Randomized Trial.Circulation. 2013 Nov 19.【原文下载】 


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    2014-01-01 snf701207
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    2013-11-29 zhaohui6731
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