Department of Gastroenterology, National Hospital Organization Ureshino Medical Center, Saga, Japan.
Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
Dig Endosc. 2022 Jan;34(1):171-179. doi: 10.1111/den.14010. Epub 2021 May 24.
Elobixibat is a novel ileal bile acid transporter inhibitor. This study aimed to compare the efficacy, tolerability, and safety of the combination of elobixibat and 1 L of polyethylene glycol formulation containing ascorbic acid (PEG-Asc) solution versus the combination of sodium picosulfate and 1-L PEG-Asc solution as bowel preparation for colonoscopy.
This multi-center, randomized, observer-blinded, non-inferiority study recruited 210 outpatients who were assigned to either the elobixibat plus 1-L PEG-Asc group (group A) or the sodium picosulfate plus 1-L PEG-Asc group (group B). The quality of the bowel cleansing level was assessed by the Boston Bowel Preparation Scale (BBPS) and compared the bowel cleansing level between the groups. Data regarding bowel preparation time, patients' tolerability, and adverse events were also analyzed.
Data for 196 patients (99 in group A and 97 in group B) were analyzed finally. BBPS was comparable between group A and B (8.3 ± 0.9 vs. 8.3 ± 0.7; P = 0.88). Consequently, the adequate bowel preparation rate in groups A and B was 95.0% and 99.0%, respectively (-4.0%, 95% CI -9.3 to 1.5). Bowel preparation time in group A was similar to that in group B (348.2 ± 79.8 min vs. 330.8 ± 82.5 min; P = 0.13), whereas, sleep disturbance was significantly less frequent in group A than in group B (10.2% vs. 22.7%; P = 0.02).
The combination of elobixibat and 1-L PEG-Asc can be considered an alternative bowel preparation for colonoscopy considering the equivalent bowel cleansing effect and less frequent sleep disturbance. The Japan Registry of Clinical Trials (jRCTs41180026).
依利卢贝特是一种新型回肠胆汁酸转运体抑制剂。本研究旨在比较依利卢贝特联合 1 L 含抗坏血酸的聚乙二醇制剂（PEG-Asc）溶液与匹可硫酸钠联合 1 L PEG-Asc 溶液作为结肠镜检查肠道准备的疗效、耐受性和安全性。
这是一项多中心、随机、观察者设盲、非劣效性研究，共招募了 210 名门诊患者，将其分为依利卢贝特联合 1 L PEG-Asc 组（A 组）和匹可硫酸钠联合 1 L PEG-Asc 组（B 组）。采用波士顿肠道准备量表（BBPS）评估肠道清洁程度，并比较两组的肠道清洁程度。还分析了肠道准备时间、患者耐受性和不良反应的数据。
最终分析了 196 例患者的数据（A 组 99 例，B 组 97 例）。A 组和 B 组的 BBPS 评分相当（8.3±0.9 与 8.3±0.7；P=0.88）。因此，A 组和 B 组的充分肠道准备率分别为 95.0%和 99.0%（-4.0%，95%CI -9.3 至 1.5）。A 组的肠道准备时间与 B 组相似（348.2±79.8 min 与 330.8±82.5 min；P=0.13），而 A 组的睡眠障碍明显少于 B 组（10.2%与 22.7%；P=0.02）。
考虑到等效的肠道清洁效果和较少的睡眠障碍，依利卢贝特联合 1 L PEG-Asc 可作为结肠镜检查的另一种肠道准备选择。日本临床试验注册（jRCTs41180026）。
