323 Age-Dependent Tolerability and Adenoma Detection With a Ready-to-Drink Low-Volume Bowel Preparation: Subgroup Analysis From a Randomized, Assessor-Blinded, Multicenter Study

INTRODUCTION: Poor patient adherence to bowel preparation may lead to negative outcomes, including incomplete colonoscopy, missed lesions at colonoscopy, and need for repeat colonoscopy. Older adults (≥65 y) may be more sensitive to negative attributes associated with existing bowel preparations. Here, we present a subanalysis by age of patient tolerability, efficacy, and polyp detection with a ready-to-drink preparation of sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution). METHODS: A phase 3, randomized, multicenter study compared the efficacy and safety of split-dose SPMC oral solution to a powder formulation for colon cleansing in adults undergoing elective colonoscopy for screening, surveillance, or diagnosis. We present a subgroup analysis by age (< 50 y, 50-64 y, ≥65 y). Study protocol was approved by Schulman IRB (#000253). The primary efficacy endpoint was assessed by a blinded endoscopist for overall colon cleansing quality using a modified Aronchick Scale (AS). Tolerability was assessed by the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations. Any polyps found during the colonoscopy were removed, recorded as AEs, and sent for histological analysis. Polyp detection rate (PDR) and adenoma detection rate (ADR) were calculated as the percentage of any participants who had ≥1 polyp or adenoma, respectively (NCT03017235). RESULTS: Of 448 patients in the SPMC group, 71 (15.8%) were < 50 y, 253 (56.5%) were 50-64 y, and 124 (27.7%) were ≥65 y. Responders by AS (“excellent” or “good” ratings) were 91.5% of those < 50 y, 88.5% of those 50-64 y, and 83.9% of those ≥65 y (Figure 1). Greater than 97.6% of participants in any age group had < 25% of the bowel preparation remaining, and ³89% found it easy or acceptable to ingest (Figure 2). PDR and ADR increased with increasing age group (Figure 3). Select drug-related AEs previously associated with SPMC oral solution, by ascending age group, were nausea (7.0%, 3.2%, 0.8%), headache (4.2%, 2.8%, 1.6%), vomiting (2.8%, 1.2%, 0.8%), and hypermagnesemia (1.4%, 2.0%, 2.4%). CONCLUSION: Tolerability of SPMC oral solution increased with age group, with the majority of patients ³65 years old stating it was easy to ingest. PDR and ADR increased with age. Older adults may benefit from a bowel preparation that is more tolerable, which may improve preparation compliance, quality of colon cleansing, and adenoma detection.

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