Long-term results of teduglutide treatment for chronic intestinal failure - Insights from a national, multi-centric patient home-care service program.


Journal

Clinical nutrition ESPEN
ISSN: 2405-4577
Titre abrégé: Clin Nutr ESPEN
Pays: England
ID NLM: 101654592

Informations de publication

Date de publication:
10 2022
Historique:
received: 15 08 2022
accepted: 22 08 2022
entrez: 2 10 2022
pubmed: 3 10 2022
medline: 5 10 2022
Statut: ppublish

Résumé

Teduglutide is a Glucagon-like peptide-2 (GLP-2) agonist indicated for the treatment of patients with parenteral support (PS) dependent short bowel syndrome (SBS) with chronic intestinal failure (cIF). Its application is accompanied by a structured nation-wide home-care service program in Germany. We investigated care characteristics and outcome parameters in a clinical real-world observational setting. Data generated within a therapy-accompanying home-care service program for adult SBS-cIF patients were analyzed retrospectively for patients treated up to 1 year (data cut: April 2020). In total, 52 teduglutide-treated patients were included by 6 German cIF centers. At teduglutide administration start, 49/52 patients were on PS, 3 of them without macronutrients. The majority of patients received individualized parenteral nutrition (PN) (n = 32/46), while 13/46 were on commercial premixed bags. PS application was done by patients themselves (37%), home-care nurses (19%), relatives (8%) or by a combination of those (16%). In patients with PS dependency at baseline and available follow-up data (n = 40-44), teduglutide treatment resulted in significantly reduced PN days, caloric needs, infusion time, and infusion volume after 6 and 12 months. After 1 year, reduction of infusion time was positively correlated with a reduction of PN calories and volume; 30 patients (68%) were responders (PS-volume reduction ≥20%), and 6 patients (14%) were completely weaned off PS. Sleep disturbances per night were significantly reduced after 3 months of treatment and stool characteristics improved in consistency and significantly in frequency, while meal frequency remained stable. Teduglutide treatment associated reduction in PS volume and calories was accompanied by reduced infusion days, infusion times, sleep disturbances, stable oral intake surrogates, and improved stool characteristics, all of these potential parameters for improving quality of life. Furthermore, analyzed care characteristics reflect SBS-cIF treatment as a complex, resource-intensive and demanding task for both, healthcare system and patients.

Sections du résumé

BACKGROUND & AIMS
Teduglutide is a Glucagon-like peptide-2 (GLP-2) agonist indicated for the treatment of patients with parenteral support (PS) dependent short bowel syndrome (SBS) with chronic intestinal failure (cIF). Its application is accompanied by a structured nation-wide home-care service program in Germany. We investigated care characteristics and outcome parameters in a clinical real-world observational setting.
METHODS
Data generated within a therapy-accompanying home-care service program for adult SBS-cIF patients were analyzed retrospectively for patients treated up to 1 year (data cut: April 2020).
RESULTS
In total, 52 teduglutide-treated patients were included by 6 German cIF centers. At teduglutide administration start, 49/52 patients were on PS, 3 of them without macronutrients. The majority of patients received individualized parenteral nutrition (PN) (n = 32/46), while 13/46 were on commercial premixed bags. PS application was done by patients themselves (37%), home-care nurses (19%), relatives (8%) or by a combination of those (16%). In patients with PS dependency at baseline and available follow-up data (n = 40-44), teduglutide treatment resulted in significantly reduced PN days, caloric needs, infusion time, and infusion volume after 6 and 12 months. After 1 year, reduction of infusion time was positively correlated with a reduction of PN calories and volume; 30 patients (68%) were responders (PS-volume reduction ≥20%), and 6 patients (14%) were completely weaned off PS. Sleep disturbances per night were significantly reduced after 3 months of treatment and stool characteristics improved in consistency and significantly in frequency, while meal frequency remained stable.
CONCLUSIONS
Teduglutide treatment associated reduction in PS volume and calories was accompanied by reduced infusion days, infusion times, sleep disturbances, stable oral intake surrogates, and improved stool characteristics, all of these potential parameters for improving quality of life. Furthermore, analyzed care characteristics reflect SBS-cIF treatment as a complex, resource-intensive and demanding task for both, healthcare system and patients.

Identifiants

pubmed: 36184208
pii: S2405-4577(22)00456-9
doi: 10.1016/j.clnesp.2022.08.027
pii:
doi:

Substances chimiques

Gastrointestinal Agents 0
Peptides 0
Glucagon-Like Peptides 62340-29-8
teduglutide 7M19191IKG

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

222-230

Informations de copyright

Copyright © 2022 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest S. Greif J. Wehkamp, and S. Maasberg have been consultants for Shire Pharmaceuticals (Takeda), Y. Zopf, H. Herrmann and M. von Websky received lecture honoraria from Shire Pharmaceuticals (Takeda), Y. Zopf and H. Herrmann received support for attending meetings and/or travel from Shire Pharmaceuticals (Takeda), E. Blüthner has received Grant/Research Support from Takeda, payment from Takeda for presentations and lectures and for participation in advisory boards, U.-F. Pape and G. Lamprecht have been a site investigator of the STEPS-trial and have received consultant and lecture honoraria from Shire Pharmaceuticals (Takeda), as well as research funding from Shire Pharmaceuticals (Takeda). I. Schiefke, S. Fusco, T. Jacob, J. Büttner, F. Tacke have nothing to declare.

Auteurs

Sophie Greif (S)

Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hepatology and Gastroenterology, Berlin, Germany. Electronic address: sophie.greif@charite.de.

Sebastian Maasberg (S)

Department of Internal Medicine and Gastroenterology, Asklepios Klinik St. Georg, Hamburg, Germany.

Jan Wehkamp (J)

Department of Gastroenterology, Hepatology and Infectious Diseases, University Hospital Tübingen, Tübingen, Germany.

Stefano Fusco (S)

Department of Gastroenterology, Hepatology and Infectious Diseases, University Hospital Tübingen, Tübingen, Germany.

Yurdagül Zopf (Y)

Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports, Universitätsklinikum Erlangen, Erlangen, Germany.

Hans Joachim Herrmann (HJ)

Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports, Universitätsklinikum Erlangen, Erlangen, Germany.

Georg Lamprecht (G)

Division of Gastroenterology and Endocrinology, Department of Medicine II, Rostock University Medical Center, Rostock, Germany.

Torid Jacob (T)

Division of Gastroenterology and Endocrinology, Department of Medicine II, Rostock University Medical Center, Rostock, Germany.

Ingolf Schiefke (I)

Department for Gastroenterology, Hepatology, Diabetology and Endocrinology, Klinikum St.Georg gGmbH, Leipzig, Germany.

Martin W von Websky (MW)

Department of Surgery, University Hospital of Bonn, Bonn, Germany.

Janine Büttner (J)

Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hepatology and Gastroenterology, Berlin, Germany.

Elisabeth Blüthner (E)

Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hepatology and Gastroenterology, Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany.

Frank Tacke (F)

Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hepatology and Gastroenterology, Berlin, Germany.

Ulrich-Frank Pape (UF)

Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hepatology and Gastroenterology, Berlin, Germany; Department of Internal Medicine and Gastroenterology, Asklepios Klinik St. Georg, Hamburg, Germany.

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