日本語フィールド
著者：*Daisuke Yamaguchi, Hidenori Hidaka, Takuya Matsunaga, Takashi Akutagawa, Yuichiro Tanaka, Amane Jubashi, Yuki Takeuchi, Nanae Tsuruoka, Yasuhisa Sakata, Koichi Miyahara, Naoyuki Tominaga, Hiroharu Kawakubo, Ayako Takamori, Ryo Shimoda, Takahiro Noda, Shinichi Ogata, Seiji Tsunada, Motohiro Esaki題名：Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi-center study発表情報：Dig Endosc 巻: 34 号: 1 ページ: 171-179キーワード：bowel cleansing; bowel preparation; colonoscopy; elobixibat; tolerability.概要：Background and aim: 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.
Methods: 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.
Results: 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).
Conclusions: 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).抄録：英語フィールド
Author：*Daisuke Yamaguchi, Hidenori Hidaka, Takuya Matsunaga, Takashi Akutagawa, Yuichiro Tanaka, Amane Jubashi, Yuki Takeuchi, Nanae Tsuruoka, Yasuhisa Sakata, Koichi Miyahara, Naoyuki Tominaga, Hiroharu Kawakubo, Ayako Takamori, Ryo Shimoda, Takahiro Noda, Shinichi Ogata, Seiji Tsunada, Motohiro EsakiTitle：Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi-center studyAnnouncement information:Dig Endosc Vol: 34 Issue: 1 Page: 171-179Keyword：bowel cleansing; bowel preparation; colonoscopy; elobixibat; tolerability.An abstract：Background and aim: 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.
Methods: 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.
Results: 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).
Conclusions: 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).