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

Autor: Gondolesi GE; Intestinal Failure, Rehabilitation and Transplant Unit, Hospital Universitario Fundación Favaloro, Buenos Aires C1044AAA, Argentina., Pape UF; Asklepios Klinik St. Georg, Asklepios Medical School, 20099 Hamburg, Germany.; Department of Hepatology and Gastroenterology, Charité University Medicine Berlin, 13353 Berlin, Germany., Mason JB; Tufts Medical Center, Tufts University, Boston, MA 02111, USA., Allard JP; Toronto General Hospital, University of Toronto, Toronto, ON M5G 2C4, Canada., Pironi L; Department of Medical and Surgical Sciences, University of Bologna, 40138 Bologna, Italy.; Centre for Chronic Intestinal Failure, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy., Casas MNV; Endocrinology and Nutrition Department, Hospital Universitari de Bellvitge, 08907 Barcelona, Spain., Schwartz LK; NYU Langone Medical Center, New York, NY 10016, USA., Joly F; Hôpital Beaujon, University of Paris Cité, 92110 Clichy, France., Gabriel A; Takeda Development Center Americas, Inc., Cambridge, MA 02142, USA., Sabrdaran S; Takeda Development Center Americas, Inc., Cambridge, MA 02142, USA., Zhang P; Takeda Development Center Americas, Inc., Cambridge, MA 02142, USA., Kohl-Sobania M; Outpatient Clinic, Pediatric Emergency Department, University Hospital Schleswig-Holstein, 23538 Lübeck, Germany., Huang YW; Takeda Development Center Americas, Inc., Cambridge, MA 02142, USA., Jeppesen PB; Rigshospitalet, Copenhagen, Denmark.
Jazyk: angličtina
Zdroj: Nutrients [Nutrients] 2024 Aug 01; Vol. 16 (15). Date of Electronic Publication: 2024 Aug 01.
DOI: 10.3390/nu16152513
Abstrakt: 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.
Databáze: MEDLINE