Safety Findings in Pediatric Patients During Long-Term Treatment With Teduglutide for Short-Bowel Syndrome-Associated Intestinal Failure : Pooled Analysis of 4 Clinical Studies

Show full item record



Permalink

http://hdl.handle.net/10138/340313

Citation

Hill , S , Carter , B A , Cohran , V , Horslen , S , Kaufman , S S , Kocoshis , S A , Mercer , D F , Merritt , R J , Pakarinen , M P , Protheroe , S , Thompson , J F , Vanderpool , C P B , Venick , R S , Wales , P W , Smith , S E , Yoon , M & Grimm , A A 2021 , ' Safety Findings in Pediatric Patients During Long-Term Treatment With Teduglutide for Short-Bowel Syndrome-Associated Intestinal Failure : Pooled Analysis of 4 Clinical Studies ' , Journal of Parenteral and Enteral Nutrition , vol. 45 , no. 7 , pp. 1456-1465 . https://doi.org/10.1002/jpen.2061

Title: Safety Findings in Pediatric Patients During Long-Term Treatment With Teduglutide for Short-Bowel Syndrome-Associated Intestinal Failure : Pooled Analysis of 4 Clinical Studies
Author: Hill, Susan; Carter, Beth A.; Cohran, Valeria; Horslen, Simon; Kaufman, Stuart S.; Kocoshis, Samuel A.; Mercer, David F.; Merritt, Russell J.; Pakarinen, Mikko P.; Protheroe, Susan; Thompson, John F.; Vanderpool, Charles P. B.; Venick, Robert S.; Wales, Paul W.; Smith, Sharon E.; Yoon, MinJung; Grimm, Andrew A.
Contributor organization: HUS Children and Adolescents
Lastenkirurgian yksikkö
Children's Hospital
University of Helsinki
Date: 2021-09
Language: eng
Number of pages: 10
Belongs to series: Journal of Parenteral and Enteral Nutrition
ISSN: 0148-6071
DOI: https://doi.org/10.1002/jpen.2061
URI: http://hdl.handle.net/10138/340313
Abstract: Background This analysis assessed combined safety data from 4 clinical studies of teduglutide in pediatric patients with short-bowel syndrome-associated intestinal failure (SBS-IF). Methods Safety data from teduglutide-treated patients in 4 clinical trials were pooled. The completed 12-week and 24-week phase 3 core studies (NCT01952080/EudraCT 2013-004588-30 and NCT02682381/EudraCT 2015-002252-27) enrolled children aged 1-17 years with SBS-IF. Patients could elect to enroll in ongoing open-label extensions (NCT02949362/EudraCT 2016-000863-17 and NCT02954458/EudraCT 2016-000849-30). Interim data from ongoing studies were included. Results Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks. Adverse events (AEs) were reported in all patients; the most common were vomiting (51.7%), pyrexia (43.8%), upper respiratory tract infection (41.6%), and cough (33.7%). Thirty-five patients (39.3%) had AEs considered related to teduglutide treatment; abdominal pain and vomiting were most frequent (5.6% each). Three serious AEs in 3 patients (3.4%) were considered related to teduglutide treatment: ileus, d-lactic acidosis, and gastrointestinal obstruction due to hard stools. All 3 events resolved. One cecal polyp was detected, which was not biopsied or found on repeat colonoscopy. No cases of neoplasia occurred. Conclusion Based on integrated data from 4 clinical studies, including long-term follow-up for
Subject: gastroenterology
long&#8208
term care
parenteral nutrition
pediatrics
short&#8208
bowel syndrome
3121 General medicine, internal medicine and other clinical medicine
3123 Gynaecology and paediatrics
3143 Nutrition
Peer reviewed: Yes
Rights: cc_by_nc
Usage restriction: openAccess
Self-archived version: acceptedVersion


Files in this item

Total number of downloads: Loading...

Files Size Format View
J_Parenter_Ente ... tment_With_Teduglutide.pdf 524.4Kb PDF View/Open
Safety_Findings ... _Four_Clinical_Studies.pdf 620.0Kb PDF View/Open

This item appears in the following Collection(s)

Show full item record