Bertiger, Gerald2 ; Epstein, Michael3 ; Lu, Liang4 ; Kitamura, Mikiya5 ; Bradesi, Sylvie1 ; Seifu, Yodit1 ; Brogadir, Stuart1
- Ferring Pharmaceuticals Inc., Parsippany, NJ, United States.
- Hillmont G.I., Flourtown, PA, United States.
- Digestive Disorders Associates, Annapolis, MD, United States.
- Ferring International Pharma-Science Centre (China) Co. Ltd., Beijing, China.
- Ferring Pharmaceuticals Co. Ltd., Tokyo, Japan.
Pristine cleansing and a positive bowel preparation experience are critical to promote patient adherence to screening recommendations and a successful colonoscopy. Low-volume preparations may improve patient experience and potentially improve adherence. We conducted a pooled analysis of clinical trial safety and tolerability data for sodium picosulfate and magnesium citrate (P/MC), a nonphosphate, low-volume, dual-action bowel preparation.
Methods: We analyzed pooled data from 4 large, phase 3, randomized, multicenter, assessor-blinded studies which evaluated the safety and tolerability of P/MC (split-dose or day-before dose). All trials monitored adverse event (AE) frequency, type, severity, serious AEs (SAEs), AEs leading to discontinuation, and adverse drug reactions (AEs judged possibly/probably related to study drug by investigators). To evaluate tolerability, the majority of patients were asked a version of 3 questions: 1) Were you able to consume the entire preparation as instructed? 2) Would you ask your doctor for this preparation again if you need another colonoscopy in the future? 3) Would you refuse the same preparation again if it were to be prescribed to you in the future? Results: A total of 1171 patients across the 4 studies were randomized to the P/MC group (split-dose, n=663; daybefore dose, n=508) and were included in the analysis. Mean (SD) age was 51.9 (12.7) years, with 15.9% patients aged 65 to 83 years; 56.3% were female; 46.0%, white; and 5.0%, African American. Adverse drug reactions occurred in 146 patients (12.5%). Reported AEs commonly associated with bowel preparation included nausea, headache, and vomiting, which occurred in 5.3%, 2.2%, and 1.5% of P/MC patients, respectively. Most AEs were mild to moderate in severity, with 9 patients (0.8%) experiencing a severe AE. No patients reported an AE leading to discontinuation. Among respondents that received P/MC, 99.4% reported that they consumed the entire preparation as instructed, 92.8% reported that they would ask their doctor for the same preparation in a future colonoscopy, and 3.4% reported that they would refuse this preparation if prescribed again. Results were similar across P/MC dose regimens for the first 2 questions. With regards to the third question, 2.1% of patients given split-dose P/MC said they would refuse repeat prescription vs 4.7% of patients given day-before P/MC.
Conclusions: In this large, pooled sample, P/MC was well tolerated across dosing regimens among adults undergoing colonoscopy with a relatively low incidence of AEs