Braintree Laboratories, Inc. Braintree, MA, United States
Jack A. Di Palma, MD1, Raj Bhandari, MD2, John McGowan, MPH3, Mark V. Cleveland, PhD3, Jessica Tesoriero, BS3, Matthew L. Walker, PhD3, Douglas K. Rex, MD4 1University of South Alabama, Mobile, AL; 2Delta Research Partners, Monroe, LA; 3Braintree Laboratories, Inc., Braintree, MA; 4Indiana University School of Medicine, Indianapolis, IN
Introduction: A new Oral Sulfate Tablet (OST) bowel prep was recently FDA approved, and contains the established osmotic agents sodium and magnesium sulfate, as well as potassium chloride to mitigate diarrheal electrolyte losses. Two pivotal studies in adults were conducted to evaluate OST safety compared to the FDA-approved preps sodium picosulfate and magnesium citrate (P/MC) and PEG3350 plus electrolytes and ascorbate (PEG-EA). A post-hoc analysis compared the pooled OST group to the comparators in the elderly and those with moderate renal insufficiency.
Methods: Elderly patients (65-85 yoa) and those with moderate renal insufficiency (GFR 30-60 ml/min/1.73 m2) were included. Patients with severe renal insufficiency or ESRD were excluded from the studies. Patients took the preps in a split-dose (PM/AM) regimen per approved FDA labeling. OST patients consumed 12 tablets and 48 oz of water, per-dose. ECGs and chemistries were collected at baseline, day of colonoscopy, 24-48 hrs post exam, and 7 and 30 days post exam (if required). Adverse events (AEs) were collected via spontaneous reports and solicited collection of typical prep symptoms.
Results: 313 patients in the studies were elderly or had moderate renal insufficiency (OST = 161, PEG-EA = 97, P/MC = 55). Average age was 69 years, with 55% being female. Chemistry data confirmed that OST had negligible impact on renal indicators, with fewer than 1% shifting abnormal for creatinine or GFR. This was consistent with the control preps and the non-elderly/renal group. Few elderly/renal subjects (< 5%) experienced an increase in creatinine > 0.3 mg/dL, or GFR decrease > 25%, confirming the preps did not adversely impact renal function. Electrolyte shifts were rare and similar between preps. PEG-EA had fewer Mg shifts due to it’s formula containing no Mg. ECG parameters showed no differences between preps, or when compared to the non-elderly/renal OST group.
There was no difference in spontaneously-reported AEs between preps in the elderly/renal group. No OST patients experienced a renal/urinary AE. OST patients reported a higher rate of solicited GI symptoms, however these were generally mild with < 2% rated as severe. There was no difference in frequency between elderly/renal and non-elderly/renal OST patients for any AE. No OST patient in this group experienced a serious AE.
Discussion: This post-hoc analysis confirms that OST is safe for use in the elderly, and patients with moderate renal insufficiency.
Disclosures: Jack Di Palma: Braintree Laboratories Inc. – Consultant. Raj Bhandari indicated no relevant financial relationships. John McGowan: Braintree Laboratories Inc. – Consultant. Mark Cleveland: Braintree Laboratories Inc. – Consultant. Jessica Tesoriero: Braintree Laboratories Inc. – Employee. Matthew Walker: Braintree Laboratories Inc. – Employee. Douglas Rex: Aries Pharmaceutical – Consultant. Boston Scientific – Consultant. Endokey – Consultant. Erbe USA Inc – Grant/Research Support. GI Supply – Consultant. Medivators – Grant/Research Support. Medtronic – Consultant. Norgine – Consultant. Olympus Corporation – Consultant, Grant/Research Support. Satisfai Health – Stockholder/Ownership Interest (excluding diversified mutual funds). Sebela Pharmaceuticals – Consultant, Grant/Research Support.
Jack A. Di Palma, MD1, Raj Bhandari, MD2, John McGowan, MPH3, Mark V. Cleveland, PhD3, Jessica Tesoriero, BS3, Matthew L. Walker, PhD3, Douglas K. Rex, MD4. P2230 - A Post-Hoc Safety Analysis of Oral Sulfate Tablet Preparation in Elderly Patients and Patients With Renal Insufficiency, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.