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Randomized Controlled Trial
. 2022 Jan;34(1):171-179.
doi: 10.1111/den.14010. Epub 2021 May 24.

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

Daisuke Yamaguchi  1   2 , Hidenori Hidaka  3 , Takuya Matsunaga  4 , Takashi Akutagawa  2 , Yuichiro Tanaka  1   5 , Amane Jubashi  1 , Yuki Takeuchi  1 , Nanae Tsuruoka  2 , Yasuhisa Sakata  2 , Koichi Miyahara  3 , Naoyuki Tominaga  4 , Hiroharu Kawakubo  5 , Ayako Takamori  6 , Ryo Shimoda  2 , Takahiro Noda  3 , Shinichi Ogata  4 , Seiji Tsunada  1 , Motohiro Esaki  2
Affiliations
Randomized Controlled Trial

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

Daisuke Yamaguchi et al. Dig Endosc. 2022 Jan.

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).

Keywords: bowel cleansing; bowel preparation; colonoscopy; elobixibat; tolerability.

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Conflict of interest statement

Authors declare no conflict of interest for this article.

Figures

Figure 1
Figure 1
Study flow chart of the patient randomization and inclusion in the analyzed groups. CSP, cold snare polypectomy; EMR, endoscopic mucosal resection.
Figure 2
Figure 2
Bowel preparation protocols. Group A: elobixibat 10 mg + PEG‐Asc 1 L. Group B: sodium picosulfate 20 mL + PEG‐Asc 1 L. PEG‐Asc, polyethylene glycol formulation containing ascorbic acid.
Figure 3
Figure 3
Treatment differences between bowel preparation with elobixibat and 1‐L PEG‐Asc versus with sodium picosulfate and 1‐L PEG‐Asc. The treatment difference in the excellent or good preparation status (BBPS score 6 or higher) was −4.0% (95% CI −9.3 to 1.5) in the per‐protocol analysis and −4.8% (95% CI −10.0 to 0.7) in the intention‐to‐treat analysis, falling within the 15% non‐inferiority margin. PEG‐Asc, polyethylene glycol formulation containing ascorbic acid.
Figure 4
Figure 4
Patients’ tolerability and adverse events. Group A: elobixibat 10 mg + PEG‐Asc 1 L. Group B: sodium picosulfate 20 mL + PEG‐Asc 1 L. PEG‐Asc: polyethylene glycol formulation containing ascorbic acid. Results are presented as mean ± standard deviation or number of patients.
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References

    1. Nishihara R, Wu K, Lochhead P et al. Long‐term colorectal‐cancer incidence and mortality after lower endoscopy. N Engl J Med 2013; 369: 1095–105. - PMC - PubMed
    1. Kang SH, Jeen YT, Lee JH et al. Comparison of a split‐dose bowel preparation with 2 liters of polyethylene glycol plus ascorbic acid and 1 liter of polyethylene glycol plus ascorbic acid and bisacodyl before colonoscopy. Gastrointest Endosc 2017; 86: 343–8. - PubMed
    1. Gentile M, De Rosa M, Cestaro G, Forestieri P. 2 L PEG plus ascorbic acid versus 4 L PEG plus simethicon for colonoscopy preparation: A randomized single‐blind clinical trial. Surg Laparosc Endosc Percutan Tech 2013; 23: 276–80. - PubMed
    1. Valiante F, Pontone S, Hassan C et al. A randomized controlled trial evaluating a new 2‐L PEG solution plus ascorbic acid vs 4‐L PEG for bowel cleansing prior to colonoscopy. Dig Liver Dis 2012; 44: 224–7. - PubMed
    1. Lee HS, Byeon JS. Bowel preparation, the first step for a good quality colonoscopy. Intest Res 2014; 12: 1–2. - PMC - PubMed

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