肌酸延长释放片的有效性和安全性:一个第三阶段,多中心,随机,双盲,主动控制,并行组比较试验
Hidenori Arai1, Shizuya Yamashita2, Eiichi Araki3,4
1National Center for Geriatrics and Gerontology.
Journal of atherosclerosis and thrombosis
|April 14, 2024
概括
新的延长释放 (XR) 佩马纤维酸片在降低甘油三水平方面与即时释放 (IR) 版同样有效. XR 0.4 mg剂量显示出更强的甘油三降低效果,使其适合患有高甘油三水平的患者.
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.
- 代谢障碍 代谢障碍 代谢障碍
背景情况:
- 佩马菲布拉特是一种选择性PPARα调节剂,用于治疗脂质不良症.
- 它可以作为即时释放 (IR) 片,每天服用两次.
- 已经开发出一种延长释放 (XR) 配方,可每天服用一次.
研究的目的:
- 为了确认XR (0.2或0.4毫克/天) 与IR (0.2毫克/天) 相比,pemafibrate的非劣质性.
- 为了评估降低患有过高甘油三血症的患者的甘油三水平的疗效.
主要方法:
- 一个第三阶段,多中心,随机,双盲研究.
- 包括患有禁食甘油三醇≥200 mg/dL的患者.
- 与基线相比,12周的禁食甘油三糖的百分比变化.
主要成果:
- 两种XR方案 (0.2和0.4毫克/天) 与IR配方 (0.2毫克/天) 不逊色.
- 三糖水平下降了48.0% (IR 0.2毫克),43.8% (XR 0.2毫克) 和48.0% (XR 0.4毫克).
- 每天0.4毫克的XR剂量显示出更强大的甘油三降低作用,特别是在基线甘油三≥500毫克/分升的患者中.
结论:
- 每天一次的延长释放 (XR) 与每天两次的即时释放 (IR) 相比没有劣势.
- 每天0.4毫克的XR剂量提供了更显著的降低甘油三水平.
- 纤维素XR,特别是0.4毫克剂量,是管理高甘油三血症的可行选择.
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