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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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Iyer, Kishore R ; Kunecki, Marek ; Boullata, Joseph I ; Fujioka, Ken ; Joly, Francisca ; Gabe, Simon ; Pape, Ulrich-Frank ; Schneider, Stéphane M ; Virgili Casas, María Nuria ; Ziegler, Thomas R ; Li, Benjamin ; Youssef, Nader N ; Jeppesen, Palle B. / Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome. In: Journal of Parenteral and Enteral Nutrition. 2017 ; Vol. 41, No. 6. pp. 946-951.

Bibtex

@article{304588f228bf406b946ef3b495da5b1c,
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}",
note = "{\circledC} 2016 American Society for Parenteral and Enteral Nutrition.",
year = "2017",
doi = "10.1177/0148607116680791",
language = "English",
volume = "41",
pages = "946--951",
journal = "Journal of Parenteral and Enteral Nutrition",
issn = "0148-6071",
publisher = "Sage Science Press (US)",
number = "6",

}

RIS

TY - JOUR

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

N1 - © 2016 American Society for Parenteral and Enteral Nutrition.

PY - 2017

Y1 - 2017

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

VL - 41

SP - 946

EP - 951

JO - Journal of Parenteral and Enteral Nutrition

JF - Journal of Parenteral and Enteral Nutrition

SN - 0148-6071

IS - 6

ER -

ID: 49680101