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; Marek Kunecki; Joseph I Boullata; Ken Fujioka; Francisca Joly; Simon Gabe; Ulrich-Frank Pape; Stéphane M Schneider; María Nuria Virgili Casas; Thomas R Ziegler; Benjamin Li; Nader N Youssef; Palle B Jeppesen

doi:10.1177/0148607116680791

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, Marek Kunecki, Joseph I Boullata, Ken Fujioka, Francisca Joly, Simon Gabe, Ulrich-Frank Pape, Stéphane M Schneider, María Nuria Virgili Casas, Thomas R Ziegler, Benjamin Li, Nader N Youssef, Palle B Jeppesen

Department of Clinical Medicine

37 Citations (Scopus)

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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.

Original language	English
Journal	Journal of Parenteral and Enteral Nutrition
Volume	41
Issue number	6
Pages (from-to)	946-951
ISSN	0148-6071
DOIs	https://doi.org/10.1177/0148607116680791
Publication status	Published - 1 Aug 2017

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Iyer, K. R., Kunecki, M., Boullata, J. I., Fujioka, K., Joly, F., Gabe, S., Pape, U.-F., Schneider, S. M., Virgili Casas, M. N., Ziegler, T. R., Li, B., Youssef, N. N., & Jeppesen, P. B. (2017). Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome. Journal of Parenteral and Enteral Nutrition, 41(6), 946-951. https://doi.org/10.1177/0148607116680791

Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome. / Iyer, Kishore R; Kunecki, Marek; Boullata, Joseph I et al.
In: Journal of Parenteral and Enteral Nutrition, Vol. 41, No. 6, 01.08.2017, p. 946-951.

Research output: Contribution to journal › Journal article › Research › peer-review

Iyer, KR, Kunecki, M, Boullata, JI, Fujioka, K, Joly, F, Gabe, S, Pape, U-F, Schneider, SM, Virgili Casas, MN, Ziegler, TR, Li, B, Youssef, NN & Jeppesen, PB 2017, 'Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome', Journal of Parenteral and Enteral Nutrition, vol. 41, no. 6, pp. 946-951. https://doi.org/10.1177/0148607116680791

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

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.",

author = "Iyer, {Kishore R} and Marek Kunecki and Boullata, {Joseph I} and Ken Fujioka and Francisca Joly and Simon Gabe and Ulrich-Frank Pape and Schneider, {St{\'e}phane M} and {Virgili Casas}, {Mar{\'i}a Nuria} and Ziegler, {Thomas R} and Benjamin Li and Youssef, {Nader N} and Jeppesen, {Palle B}",

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language = "English",

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T1 - Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome

AU - Iyer, Kishore R

AU - Kunecki, Marek

AU - Boullata, Joseph I

AU - Fujioka, Ken

AU - Joly, Francisca

AU - Gabe, Simon

AU - Pape, Ulrich-Frank

AU - Schneider, Stéphane M

AU - Virgili Casas, María Nuria

AU - Ziegler, Thomas R

AU - Li, Benjamin

AU - Youssef, Nader N

AU - Jeppesen, Palle B

PY - 2017/8/1

Y1 - 2017/8/1

N2 - 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.

AB - 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.

U2 - 10.1177/0148607116680791

DO - 10.1177/0148607116680791

M3 - Journal article

C2 - 27875291

SN - 0148-6071

VL - 41

SP - 946

EP - 951

JO - Journal of Parenteral and Enteral Nutrition

JF - Journal of Parenteral and Enteral Nutrition

IS - 6

ER -

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

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