佩马菲布拉特延长释放配方的临床药理在患有高甘油三血症-A第二期的患者中,多中心,主动控制,随机,单盲,交叉研究
Shizuya Yamashita1, Eiichi Araki2,3, Hidenori Arai4
1Department of Cardiology, Rinku General Medical Center.
Journal of atherosclerosis and thrombosis
|September 25, 2024
概括
延长释放 (XR) 佩马纤维酸片有效降低过高甘油三患者的甘油三,显示可比立即释放 (IR) 片的有效性和安全性. 每天0.4毫克的XR剂量表现出最大的有效性,没有安全问题.
科学领域:
- 药理学和治疗学 药理学和治疗学
- 心血管疾病管理管理
- 代谢综合征研究 代谢综合征研究
背景情况:
- 过高甘油三血是心血管疾病的重要危险因素.
- 选择性PPARα调节剂,如pemafibrate,为治疗失脂症提供了一种治疗方法.
- 优化药物输送系统,如延长释放 (XR) 配方,可以改善患者的治疗结果.
研究的目的:
- 为了比较每天一次的延长释放 (XR) 片与每天两次的即时释放 (IR) 片的疗效,安全性和药理学.
- 评估pemafibrate在降低血清甘油三 (TG) 的有效性,在患有高甘油三血症的患者.
- 为了评估餐饮条件 (禁食与食) 对pemafibrate的Tg降低效应的影响.
主要方法:
- 一个多中心的,随机的,单盲的,主动控制的,交叉的2期临床药理学研究.
- 患有高甘油三血症的患者被分配给每天IR0.2毫克,XR0.4毫克或XR0.8毫克.
- 主要终点是八周治疗后,禁食血清甘油三糖 (TG) 的百分比变化.
主要成果:
- 所有pemafibrate配方均显著降低了与基线相比的禁食血清TG.
- 在降低TG方面,XR 0.4 mg/天和XR 0.8 mg/天不低于IR 0.2 mg/天.
- 与禁食相比,食的TG降低效应通常更强;在不同组中没有观察到重大安全差异.
结论:
- 每天一次的延长释放 (XR) 佩马纤维酸在所有测试剂量中有效降低过高甘油三患者的甘油三.
- 在日本批准的0.4毫克/天XR剂量,实现了与IR0.2毫克/天剂量相比的TG降低.
- 纤维酸XR在0.8毫克/天的剂量下表现出良好的安全性,支持其用于管理高甘油三血症.
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