A Safety and Efficacy Evaluation of a New Oral Sulfate Solution and PEG-ELS Combination Bowel Preparation for Colonoscopy

Abstract

Purpose: This study evaluated the safety and efficacy of a combination bowel preparation for colonoscopy consisting of 6 oz of oral sulfate solution followed by 2L of PEG-ELS (OS+PEG) given in both evening only (PM) or split dose (PM/AM) administrations. Methods: Adult outpatients scheduled for colonoscopy were enrolled into two separate single-blind, multicenter studies. In Study 1 (PM only dosing), patients took either OS+PEG (SuClear®) on the evening prior to colonoscopy, or 10mg bisacodyl plus 2L of PEG-ELS (HalfLytely®). In Study 2 (split-dosing), patients took either OS+PEG (OS in PM / PEG in AM) or PEG with ascorbic acid (PEG-EA) (MoviPrep®). Colonoscopies were performed by investigators blinded to treatment assignment. Cleansing was graded using a 4 point scale (Excellent:no more than small bits of adherent feces/fluid, Good: small amounts of feces or fluid not interfering with exam, Fair: enough feces or fluid to prevent a completely reliable exam, Poor: large amounts of fecal residue, additional cleansing required) where scores of Good or Excellent were considered “successful”. Patients completed a rating scale for expected preparation symptoms. Safety was also assessed by adverse event reports and laboratory testing. In Study 1, preparation completion time was also reported. Results: OS+PEG was non-inferior to PEG+Bis and PEG-EA in achieving successful cleansing, with both OS+PEG regimens having >90% success (p<0.001). For PM only dosing, more OS+PEG preparations were graded as Excellent than with PEG+Bis (p=0.01). The time to complete the preparation was shorter with OS+PEG in Study 1 (3.7 hrs) than PEG+Bis (5.5 hrs, p<0.001). There were no clinically significant differences between OS+PEG and the comparator preps in laboratory parameters (including serum electrolytes and creatinine). In Study 1, OS+PEG patients rated their overall discomfort slightly higher than PEG+Bis patients (p=0.032). In Study 2, PEG-EA patients rated their bloating slightly higher than OS+PEG (p=0.03), while OS+PEG patients experienced slightly more vomiting (p=0.04). Conclusion: OS+PEG provided equivalent cleansing to the marketed control preparations when administered in a PM only or split dose regimen. When given in a PM only dose, it was superior to PEG+Bis in Excellent preparations and its predictable regimen resulted in a shortened prep time. With OS+PEG, there appears to be no qualitative difference between PM only and split-dose regimens, with both achieving high cleansing success rates. There were no clinically significant safety differences between OS+PEG and the control preparations, and it can therefore be considered a safe and effective option for bowel preparation. Disclosure - Mr. McGowan - Employee: Braintree Laboratories; Dr. Cleveland - Employee: Braintree Laboratories; Dr. Rex - Speaker's Bureau: Ferring Laboratories, Speaker's Bureau: Braintree Laboratories; Dr. Di Palma - Speaker's Bureau: Braintree Laboratories, Other: Medical Director, Braintree Laboratories.Table: Table. Bowel Preparation Cleansing Efficacy