Diabetes, Controlled Hypertension, and Obesity Have Little Effect on the Safety and Tolerability of Day before Sodium Picosulfate and Magnesium Citrate Bowel Preparation

Abstract

Purpose: Day-before dosing of a bowel preparation for colonoscopy provides a flexible dosing option, which may be important for patients with comorbidities such as diabetes, hypertension, and/or obesity who may be more susceptible to adverse events (AEs). We performed a post hoc analysis of results from the SEE CLEAR II study to assess the safety and tolerability of Day Before sodium picosulfate and magnesium citrate (P/MC; PREPOPIKTM), a nonphosphate, low-volume, dual-action, natural orange-flavored bowel preparation, among patients with one or more comorbidities that include diabetes, controlled hypertension, and/or obesity (BMI ≥30). Methods: The SEE CLEAR II study was a phase 3, randomized, multicenter, assessor-blinded study. The study investigated the efficacy, safety, and tolerability of day before 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®) in adults preparing for colonoscopy (Katz P, et al. Am J Gastroenterol 2013;108:401-409). In this post hoc analysis, safety was assessed by evaluating AEs; tolerability was assessed by a patient-reported questionnaire. Results: A total of 176 patients receiving P/MC and 177 patients receiving 2L PEG+bis had ongoing diabetes, controlled hypertension, and/or obesity. The most common AEs for each comorbidity subgroup included nausea, headache, and vomiting. For instance, the incidence of nausea was similar when comparing patients with or without diabetes (0% vs 2.9%), with or without controlled hypertension (0% vs 6.5%), and with or without obesity (3.3% vs 0%). Similar patterns were seen for headache and vomiting among patients in these comorbidity subgroups. More patients with diabetes, controlled hypertension, and/or obesity who received P/MC rated their bowel preparation as “very easy”/”easy” to complete and rated their experience with the bowel preparation as “excellent”/”good” than patients in these subgroups who received 2L PEG+bis (Table 1). This is similar to the patient tolerability profile that was found in the overall study.TableConclusion: Colon cleansing with day before P/MC was safe and tolerable among patients in the SEE CLEAR II study who had diabetes, controlled hypertension, and/or obesity. Disclosure: This study was supported by funding from Ferring Pharmaceuticals Inc, Parsippany, New Jersey. Disclosure - Dr. Epstein has received grant/research support, participated in speakers' bureaus, and/or acted as a consultant for Abbott Laboratories, Otsuka Pharmaceuticals, Prometheus, and Sucampo. 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, Takeda, and Ferring Pharmaceuticals Inc. Dr. Joseph is an employee of Ferring Pharmaceuticals Inc.