Jack A. DiPalma, MD, MACG1, Raj Bhandari, MD2, Mark Cleveland, PhD3, Jessica Tesoriero4, Matthew L. Walker, PhD4, John McGowan, MPH4, Sue Hall, PhD5; 1University of South Alabama, Mobile, AL; 2Delta Research Partners, Bastrop, LA; 3Mark Cleveland, Norwell, MA; 4Braintree Laboratories, Inc., Braintree, MA; 5Braintree Laboratories, Inc., Roswell, GA
Introduction: A new tablet bowel prep for colonoscopy has been developed containing poorly absorbed sulfate salts which pull water across the intestinal lumen resulting in copious diarrhea, thereby cleansing the bowel. This study evaluated the safety and efficacy of these oral sulfate tablets (OST) compared to an FDA-approved bowel prep containing PEG3350, electrolytes and ascorbate (PEG-EA). Methods: 515 adult patients (mean 57 yoa) were enrolled in this single-blind, multi-center study. Patients were assigned either PEG-EA or OST to be administered in a split-dose (PM/AM) regimen starting the evening prior to colonoscopy. PEG-EA was taken according to its approved labeling (1 L of prep solution with 16 oz of additional water per dose). OST patients took 12 tablets per dose with 16 oz of water. Patients drank another 32 oz of water with each dose. Colonoscopies were performed by blinded endoscopists. Cleansing efficacy was evaluated using a traditional 4-point global scale (Excellent/Good/Fair/Poor), similar to that used in pivotal studies of numerous marketed bowel preps. Scores of Good or Excellent were considered a Success. Safety was assessed by spontaneously reported adverse events (AEs), solicited ratings of expected prep symptoms, and laboratory testing. Results: A high rate of cleansing success was seen with OST (92%), which was considered non-inferior to PEG-EA (89%, p< 0.001 using a 10% margin). In addition, the OST procedures rated as Excellent for both the global assessment (66%) and right colon (64%) were significantly higher than PEG-EA (57% and 55%, respectively, p< 0.05). In patients at higher risk of failed prep (constipated, obese, prior failure or opioid users), OST was non-inferior to PEG-EA (90% vs 83%, respectively, p< 0.001). OST prep was well tolerated, with no difference from PEG-EA in spontaneously reported AE rates. Only a small proportion of patients (< 5% for both preps) rated their expected GI symptoms as severe. No clinically significant differences were seen between preps for chemistry and hematology parameters. No serious AEs were reported with OST. Discussion: Sulfate tablets achieved a high level of cleansing in the study, comparable to FDA-approved preps. OST was non-inferior to PEG-EA in this study and achieved significantly more Excellent preps overall and in the right colon. The OST prep was well tolerated, with a similar rate of spontaneously reported AEs to PEG-EA, and a low rate of severe expected GI symptoms.
Disclosures: Jack DiPalma: Braintree Laboratories Inc. – Other Financial or Material Support, Consultant Medical Director. Raj Bhandari: Braintree Laboratories Inc. – Grant/Research Support. Mark Cleveland: Braintree Laboratories Inc. – Consultant. Jessica Tesoriero: Braintree Laboratories Inc. – Employee. Matthew Walker: Braintree Laboratories Inc. – Employee. John McGowan: Braintree Laboratories Inc. – Employee. Sue Hall: Braintree Laboratories Inc. – Employee.