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首页> 外文期刊>The American Journal of Cardiology >Results of Bococizumab, A Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, from a Randomized, Placebo-Controlled, Dose-Ranging Study in Statin-Treated Subjects With Hypercholesterolemia
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Results of Bococizumab, A Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, from a Randomized, Placebo-Controlled, Dose-Ranging Study in Statin-Treated Subjects With Hypercholesterolemia

机译：Bococizumab，一种针对原蛋白转化酶枯草杆菌蛋白酶/ Kexin 9型的单克隆抗体的结果，来自于接受他汀治疗的高胆固醇血症患者的随机，安慰剂对照，剂量范围研究

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Bococizumab is a humanized monoclonal antibody binding proprotein convertase subtilisin/kexin type 9, which may be a potential therapeutic option for reducing low-density lipoprotein cholesterol (LDL-C) levels in patients with hypercholesterolemia. In this 24-week, multicenter, double-blind, placebo-controlled, dose-ranging study (NCT01592240), subjects with LDL-C levels >= 80 mg/dl on stable statin therapy were randomized to Q14 days subcutaneous placebo or bococizumab 50, 100, or 150 mg or Q28 days subcutaneous placebo or bococizumab 200 or 300 mg. Doses of bococizumab were reduced if LDL-C levels persistently decreased to <= 25 mg/dl. The primary end point was the absolute change in LDL-C levels from baseline to week 12 after placebo or bococizumab administration. Continuation of bococizumab administration through to week 24 enabled the collection of safety data over an extended period. Of the 354 subjects randomized, 351 received treatment (placebo [n = 100] or bococizumab [n = 251]). The most efficacious bococizumab doses were 150 mg Q14 days and 300 mg Q28 days. Compared with placebo, bococizumab 150 mg Q14 days reduced LDL-C at week 12 by 53.4 mg/dl and bococizumab 300 mg Q28 days reduced LDL-C by 44.9 mg/dl; this was despite dose reductions in 32.5% and 34.2% of subjects at week 10 or 8, respectively. Pharmacokinetic/pharmacodynamic model-based simulation assuming no dose reductions predicted that bococizumab would lower LDL-C levels by 72.2 and 55.4 mg/dl, respectively. Adverse events were similar across placebo and bococizumab groups. Few subjects (n = 7; 2%) discontinued treatment because of treatment-related adverse events. In conclusion, bococizumab significantly reduced LDL-C across all doses despite dose reductions in many subjects. Model-based simulations predicted greater LDL-C, reduction in the absence of bococizumab dose reduction. The Q14 days regimen is being evaluated in phase 3 clinical trials. (C) 2015 The Authors. Published by Elsevier Inc.
机译：Bococizumab是人源化单克隆抗体，结合前蛋白转化酶枯草杆菌蛋白酶/ kexin 9型，可能是降低高胆固醇血症患者低密度脂蛋白胆固醇（LDL-C）水平的潜在治疗选择。在这项为期24周的多中心，双盲，安慰剂对照的剂量范围研究（NCT01592240）中，接受稳定的他汀类药物治疗的LDL-C水平> = 80 mg / dl的受试者被随机分配至Q14天皮下安慰剂或bococizumab 50 ，100或150 mg或Q28天皮下安慰剂或bococizumab 200或300 mg。如果LDL-C水平持续降低至<= 25 mg / dl，则减少bococizumab的剂量。主要终点是安慰剂或博科西单抗给药后从基线到第12周LDL-C水平的绝对变化。持续进行Bococizumab给药至第24周，使得可以在较长时间内收集安全性数据。在随机分配的354名受试者中，有351名接受了治疗（安慰剂[n = 100]或bococizumab [n = 251]）。最有效的波可珠单抗剂量为150 mg Q14天和300 mg Q28天。与安慰剂相比，第14天的150 mg博科西单抗在第12周时降低LDL-C 53.4 mg / dl，第28天bococizumab 300 mg的Q28日使LDL-C降低44.9 mg / dl。尽管在第10周或第8周分别减少了32.5％和34.2％的受试者剂量，但这仍然是可行的。基于药代动力学/药效学模型的模拟（假设未降低剂量）预测博科西珠单抗将使LDL-C水平分别降低72.2和55.4 mg / dl。安慰剂组和博科西单抗组的不良事件相似。很少有受试者（n = 7; 2％）由于与治疗相关的不良事件而中止治疗。总之，尽管在许多受试者中剂量减少，但博科单抗在所有剂量下均显着降低LDL-C。基于模型的模拟预测，在不存在Bococizumab剂量减少的情况下，LDL-C会更大，并且会减少。第3天临床试验正在评估Q14天方案。 （C）2015作者。由Elsevier Inc.发布

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