Braintree Laboratories, Inc. Braintree, MA, United States
Douglas K. Rex, MD1, Raj Bhandari, MD2, John McGowan, MPH3, Mark V. Cleveland, PhD3, Jessica Tesoriero, BS3, Matthew L. Walker, PhD3, Jack A. Di Palma, MD4 1Indiana University School of Medicine, Indianapolis, IN; 2Delta Research Partners, Monroe, LA; 3Braintree Laboratories, Inc., Braintree, MA; 4University of South Alabama, Mobile, AL
Introduction: A new Oral Sulfate Tablet (OST) prep was recently FDA approved, and contains sodium and magnesium sulfates, along with potassium chloride to minimize electrolyte loss due to diarrhea. Two pivotal studies evaluated OST safety and efficacy compared to FDA-approved preps sodium picosulfate and magnesium citrate (P/MC) and PEG3350 plus electrolytes and ascorbate (PEG-EA). A post-hoc safety analysis of patients with a history of cardiac disorders and/or hypertension was conducted comparing OST to controls preps.
Methods: Two studies of OST were conducted in adult patients undergoing colonoscopy. Patients with a cardiac history and/or hypertension were eligible unless they had a clinically significant ECG at baseline, a NYHA classification of 3/4, or uncontrolled hypertension (systolic >170 mmHg, diastolic >100 mmHg). Dosing followed FDA approved labeling (split-dose PM/AM) for PEG-EA or P/MC. OST patients consumed 12 tablets and 48 oz of water, per-dose. Labs and ECGs were collected at baseline, day of exam, 24-48 hrs post exam, and days 7 and 30 (if follow-up was required). Treatment-emergent adverse events (AEs) were collected via spontaneous reports and solicited collection of expected GI symptoms (cramping, bloating, nausea, vomiting).
Results: 380 patients (average age 62 years, 52% female) had a history of cardiac disorders and/or hypertension (OST=201, PEG-EA=110 and P/MC=69). There were no differences in ECG parameters between treatment groups (cardiac vs non-cardiac). The proportion of patients with an abnormal ECG post dosing (normal baseline) was also similar between preps. No patients had a QT interval above 500ms.
More patients who took P/MC experienced a cardiac AE compared to OST (4% vs 0%, p=0.016). Compared to PEG-EA, fewer cardiac patients experienced dizziness with OST (3% vs 0%, p=0.043). OST cardiac patients experienced a higher rate of solicited GI symptoms, however most were mild, with very few (< 3%) rated as severe. There was no difference between cardiac and non-cardiac OST patients for any AE, and no reported serious AEs. Transient shifts from normal to abnormal (post dose) for key electrolytes (Na, K, Cl, CO2) were infrequent and similar between preps, except for Mg which was higher for both P/MC and OST due to their Mg content.
Discussion: In this post-hoc analysis, OST was shown to be as safe as PEG-EA and P/MC in cardiac patients, with no difference in safety seen when compared to non-cardiac OST patients.
Matthew Walker: Braintree Laboratories Inc. – Employee.
Jack Di Palma: Braintree Laboratories Inc. – Consultant.
Douglas K. Rex, MD1, Raj Bhandari, MD2, John McGowan, MPH3, Mark V. Cleveland, PhD3, Jessica Tesoriero, BS3, Matthew L. Walker, PhD3, Jack A. Di Palma, MD4. P2231 - Oral Sulfate Tablets Are Safe in Cardiac and Hypertensive Patients Undergoing Colonoscopy – Results of a Post-Hoc Analysis, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.