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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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; 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.
In: Journal of Parenteral and Enteral Nutrition, Vol. 41, No. 6, 2017, p. 946-951.Research output: Contribution to journal › Journal article › Research › peer-review
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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
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
C2 - 27875291
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: 197359132