About this item:

219 Views | 157 Downloads

Author Notes:

E-mail address: kishore.iyer@mountsinai.org

K. R. Iyer, M. Kunecki, J. I. Boullata, K. Fujioka, F. Joly, S. Gabe, U.-F. Pape, S. M. Schneider, M. N. V. Casas, T. R. Ziegler, and P. B. Jeppesen were study investigators

B. Li was the lead statistician for the analysis and N. N. Youssef was the clinical lead for NPS Pharmaceuticals, Inc.

The study design was approved by NPS Pharmaceuticals, Inc.

K. R. Iyer, M. Kunecki, J. I. Boullata, K. Fujioka, F. Joly, S. Gabe, U.-F. Pape, S. M. Schneider, M. N. V. Casas, T. R. Ziegler, and P. B. Jeppesen contributed to the study concept and design, study supervision, and acquisition of data; and all authors participated in the analysis and interpretation of data, drafting of the manuscript, and critical revision of the manuscript for important intellectual content.

All authors had access to the study data, reviewed and approved the final manuscript, and agree to be fully accountable for ensuring the integrity and accuracy of the work.

KRI has served as a site investigator, advisory board member, and consultant for NPS Pharmaceuticals, Inc.

MK and TRZ have served as site investigators for NPS Pharmaceuticals, Inc.

JIB, SG, and U-FP have served as site investigators and advisory board members for NPS Pharmaceuticals, Inc.

MNVC has served as a site investigator for NPS Pharmaceuticals, Inc, and an advisory board member for Shire.

KF has served as a consultant, speaker, and study investigator for NPS Pharmaceuticals, Inc.

FJ and SMS have served as speakers, study investigators, and advisory board members for NPS Pharmaceuticals, Inc.

BL and NNY were employees of NPS Pharmaceuticals, Inc, at the time the studies were conducted.

PBJ received research support and was a consultant, advisory board member, and study investigator for NPS Pharmaceuticals, Inc.

This article originally appeared online on November 23, 2016.

Subjects:

Research Funding:

This research was funded by NPS Pharmaceuticals, Inc, Lexington, Massachusetts, USA. NPS Pharmaceuticals, Inc, is a wholly owned indirect subsidiary of Shire.

Editorial support was provided by Heather Heerssen, PhD, of Complete Healthcare Communications, LLC (Chadds Ford, Pennsylvania, USA) and was funded by NPS Pharmaceuticals, Inc, which is a wholly owned indirect subsidiary of Shire.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Nutrition & Dietetics
  • intestinal failure
  • parenteral nutrition
  • nutrition
  • gastroenterology
  • short bowel syndrome
  • teduglutide
  • DEPENDENCE

Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome

Show all authors Show less authors

Tools:

Journal Title:

Journal of Parenteral and Enteral Nutrition

Volume:

Volume 41, Number 6

Publisher:

, Pages 946-951

Type of Work:

Article | Final Publisher PDF

Abstract:

Background: In phase III clinical studies, treatment with teduglutide was associated with clinically meaningful reductions (≥20% from baseline) in parenteral support (PS; parenteral nutrition and/or intravenous fluids) requirements in adult patients with intestinal failure associated with short bowel syndrome (SBS-IF). This analysis reports clinical characteristics of patients who achieved complete independence from PS during teduglutide treatment. Materials and Methods: Post hoc analysis of adult patients who achieved complete PS independence during treatment with teduglutide 0.05 mg/kg/d. Data were pooled from 5 teduglutide clinical trials (2 phase III placebo-controlled trials [NCT00081458 and NCT00798967] and their respective extension studies [NCT00172185, NCT00930644, NCT01560403] ). Descriptive statistics were used; no between-group comparisons were performed because of the small sample size and lack of comparator. Results: Of 134 patients, 16 gained oral or enteral autonomy after a median of 5 years of PS dependence and 89 weeks of teduglutide treatment. Demographic and baseline disease characteristics varied among patients (median age, 55 years; 50% men; median baseline PS volume, 5.1 L/wk; median residual small intestine length, 52.5 cm). Most patients who achieved PS independence had colon-in-continuity; however, there was no significant difference in the frequency of PS independence among patients who maintained colon-in-continuity vs those who did not. Conclusion: Findings from this post hoc analysis suggest that oral or enteral autonomy is possible for some patients with SBS-IF who are treated with teduglutide, regardless of baseline characteristics and despite long-term PS dependence.

Copyright information:

© 2016 American Society for Parenteral and Enteral Nutrition

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/).

Creative Commons License

Export to EndNote