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首页> 外文期刊>Current opinion in lipidology >Low-density lipoprotein cholesterol reduction by inhibition of PCSK9
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Low-density lipoprotein cholesterol reduction by inhibition of PCSK9

机译：通过抑制PCSK9降低低密度脂蛋白胆固醇

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PURPOSE OF REVIEW: To review the phase 1 and 2 trials with fully human monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 published in the last 18 months and provide comprehensive data that targeting proprotein convertase subtilisin/kexin type 9 very effectively reduces LDL-cholesterol (LDL-C). RECENT FINDINGS: The trials studied a number of different populations including patients with LDL receptor defects (heterozygous familial hypercholesterolemia) and non-familial hypercholesterolemia, background statin or diet only treatment, and those intolerant to statins. The LDL-C lowering has been large, consistent and greater than the largest reductions achievable by the most efficacious statins. These subcutaneously administered drugs produce very rapid reductions in LDL-C, maximal in 7 days, with dosing frequency that may be every 2 or 4 weeks. Unexpected, consistent and robust reductions in Lp(a) have also been reported. Based on these short-term trials of 8-12 weeks in over 1500 patients the drugs have been very well tolerated and the emergent safety profile has not identified any specific areas of concern. SUMMARY: Provided these compounds continue to exhibit an acceptable safety profile in ongoing phase 3 trials they will be as crucial to LDL-C control and reduction of cardiovascular disease, as statins.
机译：审查目的：回顾过去18个月中发表的针对原蛋白转化酶枯草杆菌蛋白酶/ kexin 9型的完全人类单克隆抗体的1期和2期试验，并提供针对原蛋白转化酶枯草杆菌蛋白酶/ kexin 9型的非常有效地降低LDL-胆固醇的全面数据（LDL-C）。最近的研究结果：该试验研究了许多不同的人群，包括LDL受体缺陷（杂合子家族性高胆固醇血症）和非家族性高胆固醇血症，他汀类药物或仅饮食的治疗以及不耐受他汀类药物的患者。 LDL-C降低幅度较大，持续且大于最有效的他汀类药物可实现的最大降低幅度。这些皮下给药的药物可使LDL-C迅速降低，在7天内达到最大值，给药频率可能为每2或4周一次。还已经报告了Lp（a）的意外，稳定和稳定的降低。根据在1500例患者中进行的为期8-12周的短期试验，药物耐受性非常好，新出现的安全性资料尚未发现任何需要关注的具体领域。总结：如果这些化合物在正在进行的第3期试验中继续显示出可接受的安全性，它们与他汀类药物一样对于LDL-C控制和心血管疾病的缓解至关重要。

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