Search in the Abstract Database

Abstracts Search 2014

* = Presenting author

P191. Low-volume bowel preparation containing picosulfate/magnesium citrate in patients aged 65 years and older compared with younger patients: safety, tolerability, and efficacy

R. Krause1, N. Grandhi2, J. Masure3, R. Joseph4, 1ClinSearch, LLC, Gastroenterology, Chattanooga, United States, 2Gastroenterology Research Consultants of Greater Cincinnati, Gastroenterology, Cincinatti, United States, 3Ferring International Center SA, Gastroenterology & Endocrinology Global Medical Affairs, Saint-Prex, Switzerland, 4Ferring Pharmaceuticals Inc, Gastroenterology Clinical R&D, Parsippany, United States

Background

Patients (pts) aged 65 years and older may be more at risk for developing adverse reactions with the administration of a bowel preparation before colonoscopy. We assessed the safety, tolerability, and efficacy of sodium picosulfate and magnesium citrate (P/MC; PICOPREP®, PREPOPIK™), a nonphosphate, low-volume, dual-action, natural orange-flavoured bowel preparation, among pts ≥65 years and pts <65 years from 2 phase 3, randomised, multicentre, assessor-blinded studies sponsored by Ferring Pharmaceuticals Inc.

Methods

The previous 2 studies investigated the efficacy, safety, and tolerability of Split-dose (SEE CLEAR I, NCT01073930) or Day Before (SEE CLEAR II, NCT01073943) administration of P/MC vs conventional day before dosing of 2L 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 scores) of P/MC among pts ≥65 years and pts <65 years.

Results

Across both studies, P/MC was administered to 111 pts (≥65 years) and 487 pts (<65 years). The overall incidence of treatment-emergent AEs was similar among P/MC pts who were ≥65 years (73%) and those who were <65 years (71%). For both studies, the most common AEs included nausea (1.8% and 3.1%), vomiting (0.9% and 1.0%), and headache (0.9% and 2.5%), and were reported at slightly lower rates among pts ≥65 years than those <65 years, respectively. Mean serum bilirubin and magnesium levels transiently increased, regardless of patient age, but returned to baseline levels within 24 hours of colonoscopy, and remained within normal ranges throughout the course of both studies. No marked changes in other serum electrolytes including sodium and potassium were reported. Among pts ≥65 years, more who received either Split-dose P/MC (86% vs 31%; P < 0.0001) or Day Before PMC (90% vs 38%; P < 0.0001) rated their bowel preparation as very easy/easy to consume than did pts who received 2L PEG+bis; >80% of pts ≥65 years who received either dosing regimen of P/MC rated the taste as excellent/good, compared with only 31% of pts ≥65 years who rated the taste of 2L PEG+bis as excellent/good. Based on Aronchick scores, both dosing regimens of P/MC were equally effective at bowel cleansing in all pts, regardless of age.

Conclusion

P/MC was safe, tolerable, and efficacious, regardless of regimen type, in pts ≥65 years and pts <65 years who were enrolled in the 2 SEE CLEAR studies.