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Clinical Trial
. 2017 Aug;41(6):946-951.
doi: 10.1177/0148607116680791. Epub 2016 Nov 23.

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

Kishore R Iyer  1 , Marek Kunecki  2 , Joseph I Boullata  3 , Ken Fujioka  4 , Francisca Joly  5 , Simon Gabe  6 , Ulrich-Frank Pape  7 , Stéphane M Schneider  8 , María Nuria Virgili Casas  9 , Thomas R Ziegler  10 , Benjamin Li  11 , Nader N Youssef  12 , Palle B Jeppesen  13
Affiliations
Clinical Trial

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

Kishore R Iyer et al. JPEN J Parenter Enteral Nutr. 2017 Aug.

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.

Keywords: gastroenterology; intestinal failure; nutrition; parenteral nutrition; short bowel syndrome; teduglutide.

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Conflict of interest statement

Conflicts of interest: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.

Figures

Figure 1.
Figure 1.
Duration of teduglutide treatment at time of PS independence. Bars represent the length of time in weeks that a patient was on teduglutide when independence from PS was achieved. Shading on the bars represents the clinical study treatment period that the patient was enrolled and receiving teduglutide when PS independence was obtained. PS, parenteral support (parenteral nutrition and/or intravenous fluids).
See this image and copyright information in PMC

References

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