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Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi‐center study

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...

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Autores principales: Yamaguchi, Daisuke, Hidaka, Hidenori, Matsunaga, Takuya, Akutagawa, Takashi, Tanaka, Yuichiro, Jubashi, Amane, Takeuchi, Yuki, Tsuruoka, Nanae, Sakata, Yasuhisa, Miyahara, Koichi, Tominaga, Naoyuki, Kawakubo, Hiroharu, Takamori, Ayako, Shimoda, Ryo, Noda, Takahiro, Ogata, Shinichi, Tsunada, Seiji, Esaki, Motohiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9290049/
https://www.ncbi.nlm.nih.gov/pubmed/33971037
http://dx.doi.org/10.1111/den.14010
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author Yamaguchi, Daisuke
Hidaka, Hidenori
Matsunaga, Takuya
Akutagawa, Takashi
Tanaka, Yuichiro
Jubashi, Amane
Takeuchi, Yuki
Tsuruoka, Nanae
Sakata, Yasuhisa
Miyahara, Koichi
Tominaga, Naoyuki
Kawakubo, Hiroharu
Takamori, Ayako
Shimoda, Ryo
Noda, Takahiro
Ogata, Shinichi
Tsunada, Seiji
Esaki, Motohiro
author_facet Yamaguchi, Daisuke
Hidaka, Hidenori
Matsunaga, Takuya
Akutagawa, Takashi
Tanaka, Yuichiro
Jubashi, Amane
Takeuchi, Yuki
Tsuruoka, Nanae
Sakata, Yasuhisa
Miyahara, Koichi
Tominaga, Naoyuki
Kawakubo, Hiroharu
Takamori, Ayako
Shimoda, Ryo
Noda, Takahiro
Ogata, Shinichi
Tsunada, Seiji
Esaki, Motohiro
author_sort Yamaguchi, Daisuke
collection PubMed
description 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).
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spelling pubmed-92900492022-07-20 Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi‐center study Yamaguchi, Daisuke Hidaka, Hidenori Matsunaga, Takuya Akutagawa, Takashi Tanaka, Yuichiro Jubashi, Amane Takeuchi, Yuki Tsuruoka, Nanae Sakata, Yasuhisa Miyahara, Koichi Tominaga, Naoyuki Kawakubo, Hiroharu Takamori, Ayako Shimoda, Ryo Noda, Takahiro Ogata, Shinichi Tsunada, Seiji Esaki, Motohiro Dig Endosc Original Articles 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). John Wiley and Sons Inc. 2021-05-24 2022-01 /pmc/articles/PMC9290049/ /pubmed/33971037 http://dx.doi.org/10.1111/den.14010 Text en © 2021 The Authors. Digestive Endoscopy published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Yamaguchi, Daisuke
Hidaka, Hidenori
Matsunaga, Takuya
Akutagawa, Takashi
Tanaka, Yuichiro
Jubashi, Amane
Takeuchi, Yuki
Tsuruoka, Nanae
Sakata, Yasuhisa
Miyahara, Koichi
Tominaga, Naoyuki
Kawakubo, Hiroharu
Takamori, Ayako
Shimoda, Ryo
Noda, Takahiro
Ogata, Shinichi
Tsunada, Seiji
Esaki, Motohiro
Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi‐center study
title Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi‐center study
title_full Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi‐center study
title_fullStr Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi‐center study
title_full_unstemmed Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi‐center study
title_short Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi‐center study
title_sort efficacy of elobixibat as bowel preparation agent for colonoscopy: prospective, randomized, multi‐center study
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9290049/
https://www.ncbi.nlm.nih.gov/pubmed/33971037
http://dx.doi.org/10.1111/den.14010
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