Efficacy and safety of same-day preparation with sodium picosulfate plus magnesium citrate on the day of colonoscopy for bowel preparation: Multicenter, single-arm, open-label study.

Abstract

Sodium picosulfate plus magnesium citrate (SP+MC) is a well-tolerated bowel preparation agent. However, Japan currently approves only two methods of taking SP+MC: the day-before and split-dose preparation, without approval of same-day preparations. This study aimed to evaluate the efficacy and safety of same-day SP+MC preparations. This was a multicenter, single-arm, nonrandomized, open-label study. We enrolled 145 Japanese patients between June and December 2023. The patients received two sachets of SP+MC dissolved in 300ml of water and 1200mL or more of clear liquid on the day of colonoscopy. Bowel cleansing efficacy, adverse events (AEs), and patient satisfaction were evaluated. Of the enrolled patients, 137 underwent colonoscopy according to our protocol. Bowel preparation was adequate in 133 patients (97.1%). The mean total Boston Bowel Preparation Score was 8.3±1.2. Five patients experienced AEs (3.6%): two (1.5%), abdominal pain; one (0.73%), ischemic enteritis; one (0.73%), vomiting or nausea; and one (0.73%), headache. All AEs were treated conservatively. None of the patients exhibited abnormal blood test results or clinical symptoms after receiving SP+MC. Regarding patient satisfaction, all patients were able to take SP+MC as directed; 136 (99.2%) expressed a preference for this bowel preparation for future colonoscopies. The same-day SP+MC preparation showed high bowel-cleansing efficacy and satisfaction in Japanese patients without serious AEs.