慢性便秘患者中埃米格西巴特的疗效和安全性-印度的一项随机,多中心,双盲,安慰剂控制,并行组研究
Piyush Agarwal1, Brajesh Kumar Jha2, Jaganmohan Somagoni2
1Global Clinical Management, Dr. Reddy's Laboratories Pvt. Ltd, Hyderabad, 500 016, India. piyushagarwal@drreddys.com.
在印度慢性便秘患者中,Elobixibat在为期两周的治疗期间显著改善了自发肠道排便的频率. 该药物耐受性良好,与安慰剂相比,在完全自发性肠道排便方面反应率更高.
科学领域:
- 胃肠病学 胃肠病学
- 药理学 药理学是指药理学的学科.
背景情况:
- 埃洛比克西巴特是一种局部作用的叶胆酸转运体 (IBAT) 抑制剂.
- 它加速结肠过渡以缓解功能性便秘.
研究的目的:
- 确定埃米格西巴特在印度患者慢性便秘的短期治疗中的疗效和安全性.
- 为了评估epipixibat对两周内自发排便频率的影响.
主要方法:
- 一个随机的,双盲的,安慰剂控制的,III期研究.
- 150名患有慢性便秘的患者被随机分配给epipixibat或安慰剂两周.
- 主要终点是每周自发排便频率与基线的变化.
主要成果:
- 与安慰剂相比,Elobixibat显著增加了每周自发肠道排便的频率 (1.15差异,p=0.008).
- 显著更高的比例的患者实现了完全自发性肠道运动的反应与epipixibat (49.33%对26.76%,p=0.005).
- 腹部疼痛是最常见的不良事件,发生在7.89%的 elobixibat 患者和4.05%的安慰剂患者中.
结论:
- 埃洛比克西巴特 (Elobixibat) 耐受性良好,并且有效改善印度慢性便秘患者的肠道运动频率.
- 短期使用埃米格西巴特的治疗在两周内显示出显著的疗效.
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