P0428 - Use of Flavored Polyethylene Glycol and Sulfate Solution Bowel Preparation in Patients with Obesity, Diabetes, or Taking Glucagon-Like Peptide-1 Receptor Agonists

Eric J. Vargas, MD, MS¹, Daniel Pambianco, MD², Douglas Rex, MD³, Michael E.. Beckelic, BSN^4
1Mayo Clinic, Rochester, MN; ²Gastro Health, Charlottesville, VA; ³Indiana University School of Medicine, Indianapolis, IN; ⁴Braintree Laboratories, Inc., Roswell, GA

Introduction: Obesity and diabetes mellitus (DM) are risk factors for poor-quality bowel prep. Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) were first used the U.S. to improve diabetic glycemic control; however, are gaining use in obesity for weight management. GLP-1 RAs delay gastric emptying and decrease gastrointestinal motility. Limited data exist evaluating the effect of GLP-1 RAs on bowel prep quality. A recent publication suggested GLP-1 RAs may be a factor in suboptimal bowel prep.

Safety and efficacy of FPSS were evaluated in two Phase 3 trials. Overall cleansing success was achieved in 93.2% of subjects. The rate of successful cleansing was >91% across segments, including the proximal colon. As expected, most adverse events (AEs) were gastrointestinal in nature. This analysis evaluated the efficacy and tolerability of FPSS as a bowel prep in subjects with obesity, DM, or taking a GLP-1 RA.

Methods: Data from Phase 3 trials were aggregated for this post-hoc analysis. Endpoints were identical to the original trials. Overall cleansing was rated on a validated 4-point scale. Scores of Excellent/Good indicated clear visualization of the entire colonic mucosa and successful bowel prep. Failure was defined as scores of Fair/Poor. Colon segments were also graded on withdrawal. Data for FPSS subjects with obesity (BMI >30 kg/m²), DM, or taking a GLP-1 RA were analyzed. There was overlap among these groups.

Results: Four-hundred sixty subjects received FPSS. In this analysis, obesity, DM, and GLP-1 RA groups included 201, 46, and 8 subjects, respectively. Overall cleansing success was achieved in 91.5%, 95.7%, and 100% of subjects with obesity, DM, and taking a GLP-1 RA, respectively. Segmental cleansing success was achieved in ≥90% across segments, including the proximal colon. There were no statistically significant differences between obese and non-obese subjects. Consistent with original trials, most AEs were gastrointestinal and occurred in 14.4%, 13.0%, and 25.0% of FPSS subjects with obesity, DM, or taking a GLP-1 RA, respectively, as presented in Table 1.

Discussion: The use of FPSS in subjects with obesity or DM produced similar bowel prep quality as seen in Phase 3 trials. The most common AEs were gastrointestinal at a rate consistent with the Phase 3 trials. The small sample size for GLP-1 RAs limits conclusions for this group. Nevertheless, these data suggest FPSS may be a safe and effective option for patients with obesity or DM who are undergoing colonoscopy.


Disclosures:


Eric J. Vargas, MD, MS¹, Daniel Pambianco, MD², Douglas Rex, MD³, Michael E.. Beckelic, BSN⁴. P0428 - Use of Flavored Polyethylene Glycol and Sulfate Solution Bowel Preparation in Patients with Obesity, Diabetes, or Taking Glucagon-Like Peptide-1 Receptor Agonists, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.