在日本受试者中作为稳定他类药物治疗的辅助剂的obicetrapib:随机第二阶段试验的结果
Mariko Harada-Shiba1, Michael H Davdison2, Marc Ditmarsch2
1Cardiovascular Center, Osaka Medical and Pharmaceutical University.
Journal of atherosclerosis and thrombosis
|April 3, 2024
概括
在日本成年人中,当添加到他类药物中时,obicetrapib有效地降低了LDL-C和apoB. 这种胆固醇转移蛋白抑制剂是安全的,耐受性良好,药物清除速度快.
科学领域:
- 心血管医学 心血管医学
- 药理学 药理学是指药理学的学科.
- 脂质代谢 脂质代谢是什么
背景情况:
- 作为胆固醇转移蛋白 (CETP) 抑制剂的obicetrapib有效降低了高加索人群中的LDL-C和apoB.
- 临床试验主要集中在北欧/高加索参与者身上,因此需要对不同种族群体进行评估.
研究的目的:
- 在日本人群中评估obicetrapib的疗效,安全性和耐受性.
- 在亚太地区的个人中,作为他类药物治疗的辅助剂,对obicetrapib的脂质修饰作用进行表征.
主要方法:
- 一个双盲,随机,安慰剂控制的第二阶段试验,涉及日本男性和女性.
- 奥比塞特拉皮布 (2.5,5,10毫克/天) 与稳定的他类药物治疗一起进行了8周的治疗.
- 关键终点包括LDL-C,非HDL-C,HDL-C,apoB和安全性评估中的变化.
主要成果:
- 在所有测试剂量中,欧比特拉皮显著降低了LDL-C,apoB和非HDL-C,并增加了HDL-C.
- 服用10毫克奥比塞特拉皮布的组显示,LDL-C变化为-45.8%,HDL-C变化为+159% (p<0.0001与安慰剂相比).
- 药物动力学分析表明,在4周内几乎完全消除药物,没有不良安全信号.
结论:
- 作为他类药物治疗的辅助药物,奥比塞特拉皮布有效降低了日本人口中的异位性脂蛋白.
- 该药物表现出良好的安全性和耐受性概况,与高加索参与者的研究结果一致.
- 快速消除表明,在这个族群中具有有利的药理动力学特征.
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