Safety and Efficacy of a New Sulfate-Based Tablet Preparation for Colonoscopy

Safety and Efficacy of a New Sulfate-Based Tablet Preparation for Colonoscopy

This new-based bowel prep for colonoscopy contains poorly-absorbed sulfate salt, which acts to retain water within the intestinal lumen, resulting in a copious diarrhea in bowel cleansing. This study was carried out to evaluate the safety and efficacy of these oral sulfate tablets (OST), compared with a US FDA-approved bowel prep solution containing PEG3350, electrolytes, and ascorbate (PEG-EA).

A total of 515 patients with a mean age of 57 years were enrolled in a single-blind, multi-center, noninferiority study. Subjects were assigned either PEG-EA or OST administered in split-dose regimen starting the evening before colonoscopy. PEG EA was taken according to its approved labeling (1 L of prep solution with 16 oz. of additional water) in the evening and again in the morning. OST patients took a total of 24 tablets, 12 in the evening and the following morning, taken with 16 ounces of water with each dose of 12 tablets; then drinking an additional 32 ounces of water with each dose. Colonoscopies were performed by blinded investigators. Cleansing efficacy was evaluated globally and segmentally using a 4-point scale (Excellent-no more than small bits of feces/ fluid, which can be suctioned easily; achieves clear visualization of the entire mucosa); Good-feces/ fluid requiring washing and suctioning, but still achieving clear visualization of the entire colon mucosa; Fair–enough feces after washing and suctioning to prevent clear visualization of the entire colon mucosa; Poor–large amounts of fecal residue and additional bowel preparation required.

Scores of Good or Excellent were considered to be a success. Safety was assessed by spontaneously reported adverse events, solicited ratings of expected prep symptoms and laboratory testing.

A high rate of cleaning success was seen with OST (92%), which was noninferior to PEG-EA (89%). Only a small proportion of patients rated their expected gastrointestinal symptoms as severe (less than 5%). No clinically significant differences were seen between the preps for chemistry and hematology parameters. No serious adverse experiences were reported with OST.

This preparation of sulfate tablets achieved a high level of cleansing in the study, compared with US FDA-approved preps. OST was noninferior to PEG-EA in this study and achieved significantly more excellent preps overall and in the proximal colon. The OST prep was well tolerated with a similar rate of spontaneously reported adverse experiences to PEG-EA and a low rate of severe expected gastrointestinal symptoms.

Di Palma, J., Bhandari, R., Cleveland, M., et al. “A Safety and Efficacy Comparison of a New Sulfate-Based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in Adult Subjects Undergoing Colonoscopy.” American Journal of Gastroenterology 2021; Vol. 116, pp. 319-328.

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