Safety, Tolerability, and Efficacy of a Low-volume Picosulfate/Magnesium Citrate Bowel Preparation in Patients ≥65 Years

Abstract

Purpose: Patients ≥65 years may be more susceptible to adverse reactions with the administration of a bowel preparation before colonoscopy. We assessed the safety and tolerability of sodium picosulfate and magnesium citrate (P/MC; PREPOPIKTM), a nonphosphate, low-volume, dual-action, natural orange-flavored bowel preparation, among patients ≥65 years using data from two previous phase 3, randomized, multicenter, assessor-blinded studies. Methods: The previous two studies investigated the efficacy, safety, and tolerability of Split-dose (SEE CLEAR I) or Day Before (SEE CLEAR II) administration of P/MC compared with conventional day before dosing of 2 L polyethylene glycol-3350 solution and two 5-mg bisacodyl tablets (2L PEG+bis; HALFLYTELY®) among adults preparing for colonoscopy. This post hoc analysis assessed safety (adverse events [AEs] and laboratory values), tolerability (patient-reported questionnaire), and efficacy (Aronchick and Ottawa scores) of P/MC among patients who were <65 years and patients ≥65 years. Results: Across both studies, P/MC was administered to 111 patients aged ≥65 years and 487 patients aged <65 years. The overall incidence of treatment-emergent AEs was similar among P/MC patients who were ≥65 years (73%) and those who were <65 years (71%). The most common AEs for both studies included nausea (1.8% and 3.1%), headache (0.9% and 2.5%), and vomiting (0.9% and 1.0%), and were reported at slightly lower rates among patients ≥65 years than those <65 years, respectively. Changes in mean serum bilirubin and magnesium levels were transient, returned to baseline levels within 24 hours of colonoscopy, and remained within normal ranges throughout the course of both studies, regardless of patient age. There were no marked changes in other serum electrolytes including sodium and potassium. When comparing patients who received P/MC with those who received 2L PEG+bis, more patients ≥65 years who received either Split-dose P/MC (86% vs 31%; P<.0001) or day before PMC (90% vs 38%; P<.0001) rated their bowel preparation as very easy/easy to consume than did patients ≥65 years who received 2L PEG+bis. More than 80% of patients ≥65 years who received either dosing regimen of P/MC rated the taste as excellent/good, compared with only 31% of patients ≥65 years who rated the taste of 2L PEG+bis as excellent/good. Based on Aronchick and Ottawa scores, both dosing regimens of P/MC were equally effective at bowel cleansing in patients ≥65 years and patients <65 years. Conclusion: Split-dose and day before P/MC was safe, tolerable, and efficacious in patients ≥65 years and <65 years who were enrolled in the two SEE CLEAR studies. Disclosure: This study was supported by funding from Ferring Pharmaceuticals Inc, Parsippany, New Jersey. Disclosure - Dr. Grandhi has received grant/research support, participated in speakers' bureaus, and/or acted as a consultant for Takeda. Dr. Katz has received grant/research support, participated in speakers' bureaus, and/or acted as a consultant for Intec Pharma, Ironwood, Novartis Consumer, and Takeda. Dr. Krause has received grant/research support, participated in speakers' bureaus, and/or acted as a consultant for Ferring Pharmaceuticals, Forest Research Institute, and Ironwood. Dr. Joseph is an employee of Ferring Pharmaceuticals, Inc.