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Circulation：新降血脂药研发陷入困境（附点评）

2011-06-01 MedSci原创 MedSci原创

Circulation降血脂药
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MedSci评：以往Meta分析多针对已发表的文献，而本例Meta分析主要针对II和III期临床试验成果（当然不少也是以文献形式发表）。这表明循证医学的数据来源是多样的，这给我们提供很好地启示。 　　 　　Circulation杂志2011年4月25日发表的一项循证医学Meta研究表明，单独采用鲨烯合酶抑制剂拉帕司他醋酸盐（lapaquistat acetate），或联合他汀类药物抑制鲨烯合酶

MedSci评：以往Meta分析多针对已发表的文献，而本例Meta分析主要针对II和III期临床试验成果（当然不少也是以文献形式发表）。这表明循证医学的数据来源是多样的，这给我们提供很好地启示。 　　 　　Circulation杂志2011年4月25日发表的一项循证医学Meta研究表明，单独采用鲨烯合酶抑制剂拉帕司他醋酸盐（lapaquistat acetate），或联合他汀类药物抑制鲨烯合酶，可剂量依赖性地有效降低低密度脂蛋白胆固醇（LDL-C）。然而，该药可导致丙氨酸氨基转移酶水平升高和罕见胆红素升高，潜在的肝脏安全性隐患导致其研发被终止。 　　该研究汇总了12项临床Ⅱ期和Ⅲ期临床研究（n=6151）的结果，研究因拉帕司他潜在的肝脏危险而被迫在高级阶段暂停。这些研究持续6至96周，均为针对血脂异常患者的随机、双盲、平行、安慰剂或活性药对照临床试验，治疗方案包括拉帕司他单药或与其他降脂药物联合治疗，包含一项持续96周的大规模安全性研究（n=2121）。多数研究均采用拉帕司他100 mg/d。结果采用LDL-C的百分率变化、次要的脂类/代谢变量和总安全性进行测量。 　　研究显示，拉帕司

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    2011-12-19 ms2536978994064944

    #困境#

    0

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    2012-04-17 ms8543593053280928

    #降血脂#

    0

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    2011-06-03 lqvr

    #研发#

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