Efficacy and safety of oral sulfate solution for bowel preparation in Japanese patients undergoing colonoscopy: Noninferiority-based, randomized, controlled study

Yutaka Saito, Shiro Oka, Naoto Tamai, Toyoki Kudo, Nobutoshi Kuniyoshi, Tatsuya Shirakura, Yoshio Omae, Yukihiro Hamahata, Takehiro Arai, Shinji Tanaka, Noriya Uedo, Seiji Shimizu, Masakatsu Fukuzawa, Toshio Uraoka, Shiori Ichinose, Haruhiko Ogata, Kiyonori Kobayashi, Shoichi Saito, Hisao Tajiri, Yutaka Saito, Shiro Oka, Naoto Tamai, Toyoki Kudo, Nobutoshi Kuniyoshi, Tatsuya Shirakura, Yoshio Omae, Yukihiro Hamahata, Takehiro Arai, Shinji Tanaka, Noriya Uedo, Seiji Shimizu, Masakatsu Fukuzawa, Toshio Uraoka, Shiori Ichinose, Haruhiko Ogata, Kiyonori Kobayashi, Shoichi Saito, Hisao Tajiri

Abstract

Objectives: To compare the efficacy and safety of oral sulfate solution administered using the same-day dose and the split-dose regimens with those of polyethylene glycol plus ascorbate solution, used for bowel preparation in Japanese patients undergoing colonoscopy.

Methods: This multicenter (n = 13), randomized, active-controlled, colonoscopist- and image evaluator-blinded, noninferiority study with parallel-group comparison recruited 632 patients from December 2018 to June 2019. Of these, 602 patients were divided into the oral sulfate solution same-day dose group (n = 200); oral sulfate solution split-dose group (n = 202); and polyethylene glycol plus ascorbate same-day dose group (n = 200). Differences in the efficacy rates between the polyethylene glycol plus ascorbate group and each oral sulfate solution group were calculated using the asymptotic method. The safety of the oral sulfate solution was evaluated, based on the occurrence of adverse events and reactions.

Results: Both oral sulfate solution protocols were confirmed as noninferior to the polyethylene glycol plus ascorbate protocol for bowel-cleansing. The occurrence of adverse reactions was significantly lower in the oral sulfate solution same-day dose group than in the polyethylene glycol plus ascorbate group (P = 0.010). The occurrence of adverse reactions was not significantly different between the oral sulfate solution split-dose and the polyethylene glycol plus ascorbate group.

Conclusions: Oral sulfate solution is not only safe and efficacious but also not inferior to polyethylene glycol plus ascorbate solution (active control). It could be used for bowel preparation in Japanese patients scheduled for colonoscopy (Clinical trial registration number: NCT03794310).

Keywords: colonoscopy; human; oral sulfate solution; polyethylene glycol; sulfate.

Conflict of interest statement

Nihon Pharmaceutical Co., Ltd. contracted and paid all hospitals on the basis of good clinical practice. Author H. Tajiri has received consulting fees from Nihon Pharmaceutical Co., Ltd. Author S. Ichinose is an employee of Nihon Pharmaceutical Co., Ltd. The remaining authors have no conflicts of interest to declare. The work was supported by Nihon Pharmaceutical Co., Ltd.

© 2021 The Authors. Digestive Endoscopy published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.

Figures

Figure 1
Figure 1
Flow chart of this study. *1 Discontinued from the study because the patient was using or had used a prohibited concomitant drug (n = 1). *2 Discontinued from the study because the patient was using or had used a prohibited concomitant drug (n = 4), faced an adverse event (n = 3), had difficulty continuing with the clinical study (n = 1), or withdrew consent (n = 3). *3 Discontinued from the study because the patient was using or had used a prohibited concomitant drug (n = 1), faced an adverse event (n = 2), or had difficulty continuing with the clinical study (n = 2).

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