Odaka Takeo, Tominaga Kazunari
Odaka Internal and Gastrointestinal Clinic, Narashino, Chiba, Japan.
Hoshigaoka Medical Center, Hirakata, Osaka, Japan.
Curr Ther Res Clin Exp. 2020 Nov 16;93:100616. doi: 10.1016/j.curtheres.2020.100616. eCollection 2020.
Elobixibat has been approved as a new therapeutic drug for chronic constipation. Only the pharmacological efficacy and safety profile of pre-breakfast administration of elobixibat had been previously demonstrated.
We evaluated the efficacy and safety profile of pre-dinner administration of elobixibat in patients with functional constipation in a retrospective observational study.
Patients aged 20 years or older diagnosed with functional constipation by the Rome IV criteria from June 1, 2018, to January 17, 2019. The evaluation time points were at the start and 1, 2, 4, and 8 weeks after treatment. The primary end point was frequency of spontaneous bowel movements per week. The secondary end points were changes in Bristol Stool Form Scale score, onset time required for spontaneous defecation after administration, percent of patients with spontaneous defecation within 24 hours and 48 hours after the first administration, improvement of abdominal pain or abdominal bloating evaluated by a visual analog scale, and total score and each subscore of the Japanese-Translated Version of Patient Assessment of Constipation Quality of Life Questionnaire.
Pre-dinner administration of elobixibat was associated with significantly increased frequency of spontaneous bowel movements and improved Bristol Stool Form Scale score at 1, 2, 4, and 8 weeks after treatment. The mean onset time until spontaneous defecation after treatment was 4 to 5 hours, which was earlier than that by conventional constipation treatment drugs and almost constant within an individual during the treatment period. Spontaneous defecation was achieved by 85.4% within 24 hours and 90.2% within 48 hours after the first administration. Elobixibat also improved patients' quality of life, which was evaluated by the Japanese-Translated Version of Patient Assessment of Constipation Quality of Life Questionnaire without adverse events.
Pre-dinner administration of elobixibat improved constipation, abdominal pain and bloating, and patient quality of life by management of fixed defecation. ( 2020; 81:XXX-XXX).
埃洛比昔巴特已被批准作为一种治疗慢性便秘的新药。此前仅证明了早餐前服用埃洛比昔巴特的药理疗效和安全性。
在一项回顾性观察研究中，我们评估了晚餐前服用埃洛比昔巴特对功能性便秘患者的疗效和安全性。
2018年6月1日至2019年1月17日期间，年龄在20岁及以上、根据罗马IV标准诊断为功能性便秘的患者。评估时间点为治疗开始时以及治疗后1、2、4和8周。主要终点是每周自发排便的频率。次要终点包括布里斯托大便形状量表评分的变化、给药后自发排便所需的起效时间、首次给药后24小时和48小时内自发排便患者的百分比、通过视觉模拟量表评估的腹痛或腹胀的改善情况，以及日本翻译版便秘患者生活质量问卷的总分和各子分数。
治疗后1、2、4和8周，晚餐前服用埃洛比昔巴特与自发排便频率显著增加以及布里斯托大便形状量表评分改善相关。治疗后直至自发排便的平均起效时间为4至5小时，早于传统便秘治疗药物，且在治疗期间个体内几乎保持恒定。首次给药后24小时内85.4%的患者实现了自发排便，48小时内为90.2%。埃洛比昔巴特还改善了患者的生活质量，这通过日本翻译版便秘患者生活质量问卷进行评估，且无不良事件发生。
晚餐前服用埃洛比昔巴特通过固定排便管理改善了便秘、腹痛和腹胀以及患者生活质量。（2020；81：XXX - XXX）
