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Baseline Characteristics of Adult Patients Treated and Never Treated with Teduglutide in a Multinational Short Bowel Syndrome and Intestinal Failure Registry

Authors :
Gabriel E. Gondolesi
Ulrich-Frank Pape
Joel B. Mason
Johane P. Allard
Loris Pironi
María Núria Virgili Casas
Lauren K. Schwartz
Francisca Joly
André Gabriel
Sasan Sabrdaran
Pinggao Zhang
Martina Kohl-Sobania
Yi-Wen Huang
Palle B. Jeppesen
Source :
Nutrients, Vol 16, Iss 15, p 2513 (2024)
Publication Year :
2024
Publisher :
MDPI AG, 2024.

Abstract

The Short Bowel Syndrome (SBS) Registry (NCT01990040) is a multinational real-world study evaluating the long-term safety of teduglutide in patients with SBS and intestinal failure (SBS-IF) in routine clinical practice. This paper describes the study methodology and baseline characteristics of adult patients who have (ever-treated) or have never (never-treated) received teduglutide. A total of 1411 adult patients (679 ever-treated; 732 never-treated) were enrolled at 124 sites across 17 countries. The mean (standard deviation [SD]) age at enrollment was 55.4 (15.46) years, and 60.2% of patients were women. Crohn’s disease was the most common cause of major intestinal resection in both ever-treated (34.1%) and never-treated patients (20.4%). A similar proportion of ever-treated and never-treated patients had a prior history of colorectal polyps (2.7% vs. 3.6%), whereas proportionally fewer ever-treated patients reported a history of colorectal cancer (1.8% vs. 6.2%) or any malignancy (17.7% vs. 30.0%) than never-treated patients. Never-treated patients received a numerically greater mean (SD) volume of parenteral nutrition and/or intravenous fluids than ever-treated patients (12.4 [8.02] vs. 10.1 [6.64] L/week). Ever-treated patients received a mean teduglutide dosage of 0.05 mg/kg/day. This is the first report of patient baseline characteristics from the SBS Registry, and the largest cohort of patients with SBS-IF to date. Overall, ever-treated and never-treated patients had similar baseline characteristics. Differences between treatment groups may reflect variations in patient selection and degree of monitoring.

Details

Language :
English
ISSN :
20726643
Volume :
16
Issue :
15
Database :
Directory of Open Access Journals
Journal :
Nutrients
Publication Type :
Academic Journal
Accession number :
edsdoj.2c8f7790380a4486ad46e20edf77ea70
Document Type :
article
Full Text :
https://doi.org/10.3390/nu16152513