1. ASSOCIATION BETWEEN ABDOMINAL COMPLAINTS AND NARCOTIC USE AMONG PATIENTS WITH SHORT BOWEL SYNDROME RECEIVING TEDUGLUTIDE Ken Fujioka, 1 Khursheed Jeejeebhoy, 2 Ulrich-Frank Pape, 3 Benjamin Li, 4 Nader N. Youssef, 4 Stéphane M. Schneider 5 1 Scripps Clinic, La Jolla, CA, USA (Fujioka.Ken@ScrippsHealth.org); 2 St. Michael’s Hospital, Toronto, ON, Canada; 3 Charité University Medicine, Berlin, Germany; 4 NPS Pharmaceuticals, Inc., Bedminster, NJ, USA; 5 University of Nice-Sophia Antipolis, Nice, France Accelerated intestinal motility in short bowel syndrome (SBS) is typically treated with narcotics; however, opioid use is associated with gastrointestinal (GI) adverse events (AEs) 1,2 Teduglutide enhances intestinal adaptation and increases intestinal absorptive capacity, and it has the potential to increase absorption of concomitant oral medications 3-6 GI AEs were commonly reported by patients with SBS participating in clinical studies whether they received placebo or teduglutide 3-5 Objective: to assess the incidence of abdominal complaints and narcotic use among patients with SBS receiving teduglutide in placebo-controlled trials INTRODUCTION AND OBJECTIVE Patients received ≥1 dose of teduglutide 0.05 mg/kg/day (approved dosage; n=77) or placebo (n=59) in 2 randomized, double-blind, 24-week, phase III studies 4,5 Data were pooled and analyzed using descriptive statistics and logistic regression with ‒Dependent variable of GI complaints identified by treatment-emergent AEs (TEAEs, including abdominal pain, nausea, abdominal distension, vomiting, and appetite disorders) ‒Independent variables of teduglutide treatment, narcotic use, and the interaction between teduglutide treatment and narcotic use MATERIALS AND METHODS Concomitant Narcotic Agents Narcotic agents (eg, opium alkaloids and derivatives, opioid anesthetics, or other opioids) were received by 38% (52/136) of patients during teduglutide phase III placebo-controlled clinical studies (Table 1) Safety Overview 3 At least 1 TEAE was reported by 88% (68/77) of patients receiving teduglutide and 83% (49/59) of patients receiving placebo Majority of the AEs were mild or moderate Common AEs were GI-related complaints Subanalysis by Treatment Group Overall, abdominal pain was more frequent among patients who received narcotics (52%) than among those who did not (21%) ‒This was true regardless of treatment group (Table 2) The probability of abdominal pain was significantly increased with narcotic use, as indicated by logistic regression analysis (P=0.0009; Figure 1) RESULTS 191 Fujioka K, et al. Association Between Abdominal Complaints and Narcotic Use Among Patients With Short Bowel Syndrome Receiving Teduglutide. Poster presented at the XIV International Small Bowel Transplant Symposium; June 10–13, 2015; Buenos Aires, Argentina Scan this QR code with your reader to receive a PDF file of the poster. To download a scan reader, go to www.i-nigma.mobi on your mobile device. www.i-nigma.mobi A large proportion of patients (38%) received concomitant narcotics in the teduglutide placebo-controlled studies, reflecting current practice for symptomatic management of SBS The finding that abdominal pain was more frequent among patients who received narcotics (52%) than among those who did not (21%) suggest that, independent of teduglutide, chronic GI complaints in patients with SBS receiving narcotics are a major symptom management challenge ‒Regression analysis showed that narcotic use, not teduglutide treatment, was associated with increased probability of abdominal pain among patients with SBS Because there is potential for increased intestinal absorption with teduglutide, these findings underscore the importance of careful monitoring and possible dose adjustment of concomitant oral medications during teduglutide therapy Consider significant early reduction of narcotic dose to prevent possible side effects (ie, abdominal pain, nausea, vomiting) due to enhanced absorption CONCLUSIONS 1. Grunkemeier DMS, et al. Clin Gastroenterol Hepatol. 2007;5:1126-1139; 2. Kumpf VJ. JPEN J Parenter Enteral Nutr. 2014;38(suppl 1):38S-44S; 3. GATTEX® (teduglutide [rDNA origin]). Full Prescribing Information, NPS Pharmaceuticals, Inc., Bedminster, NJ, 2014; 4. Jeppesen PB, et al. Gastroenterology. 2012;143:1473-1481; 5. Jeppesen PB, et al. Gut. 2011;60:902-914; 6. Jeppesen PB, et al. Gut. 2005;54:1224-1231. REFERENCES KF has served as a consultant and a study investigator for NPS Pharmaceuticals, Inc; KJ has served as a study investigator for NPS Pharmaceuticals, Inc; U-FP and SS have served as study investigators and advisory board members for NPS Pharmaceuticals, Inc; BL and NNY are employees of NPS Pharmaceuticals, Inc. This research was funded by NPS Pharmaceuticals, Inc., Bedminster, NJ. DISCLOSURES