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P251. Efficacy and safety of day-before dosing of a dual-action, low-volume bowel preparation for colonoscopy: the SEE CLEAR II study

P. Katz1, D. Rex2, M. Epstein3, J. Masure4, R. Joseph5, 1Albert Einstein Healthcare Network, Philadelphia, United States, 2Indiana University School of Medicine, Indianapolis, United States, 3Digestive Disorders Associates, Annapolis, United States, 4Ferring International Center SA, Saint-Prez, Switzerland, 5Ferring Pharmaceuticals Inc, Parsippany, United States

Background

The quality of bowel preparation is linked to the time interval between the last dose of preparation and colonoscopy start time. Thus, flexibility in dosing and scheduling is warranted. Although sodium picosulfate and magnesium citrate have been used in bowel cleansing for more than 3 decades, head-to-head studies evaluating noninferiority have been limited.

Methods

This phase 3, randomised, multicentre, assessor-blinded study, conducted in the United States, investigated the efficacy and safety of day-before administration of a dual-action, low-volume bowel preparation containing sodium picosulfate and magnesium citrate (P/MC) vs 2 L polyethylene glycol solution and two 5-mg bisacodyl tablets (PEG + 2 bisacodyl tablets) in adult patients preparing for colonoscopy (NCT01073943, sponsored by Ferring Pharmaceuticals). A modified Aronchick scale was used to assess overall colon cleansing, and the Ottawa scale was used to evaluate colon cleansing of the ascending, mid, and recto-sigmoid segments. A noninferiority analysis was performed using the intent-to-treat population; if the 1-sided 97.5% confidence interval (CI) for the treatment difference between P/MC and PEG + 2 bisacodyl tablets was >−9%, noninferiority was demonstrated.

Results

A total of 598 randomised patients self-administered either P/MC (n = 296) or PEG + 2 bisacodyl tablets (n = 302). P/MC was noninferior compared with PEG + 2 bisacodyl tablets in overall colon cleansing (CI: −2.9) and in cleansing of the ascending (CI: −8.8), mid (CI: −0.1), and recto-sigmoid (CI: −1.5) segments of the colon. More patients receiving P/MC had overall colon cleansing that was graded successful compared with PEG + 2 bisacodyl tablets (83.0% vs 79.7%). The proportion of patients who were successfully cleansed was similar for P/MC and PEG + 2 bisacodyl tablets in the ascending (81.3% vs 84.0%), mid (93.2% vs 88.7%), and recto-sigmoid (92.2% vs 89.0%) segments of the colon. The incidence of treatment-emergent adverse events (TEAEs) was similar between P/MC and PEG + 2 bisacodyl tablets (73.6% vs 79.8%). Commonly reported TEAEs attributed to P/MC or PEG + 2 bisacodyl tablets were nausea (3.0% vs 4.3%), vomiting (1.4% vs 2.0%), and headache (2.7% vs 1.7%).

Conclusion

When combined with a split-dose regimen, day-before dosing of P/MC provides alternatives for dosing to reduce the interval between the last dose of bowel preparation and colonoscopy start time with consideration for the schedule of the patient and clinic.