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Beatriz P Costa, Ana C Gonçalves, Ana M Abrantes, Raquel Alves, Paulo Matafome, Raquel Seiça, Ana B Sarmento-Ribeiro, M Filomena Botelho, Francisco Castro-Sousa
BACKGROUND: Previous studies suggest that intestinal epithelial stem cells (IESC), critical drivers of homeostasis and regeneration, include two subpopulations: crypt-based columnar and "position +4" stem cells, identified by Lgr5 and Bmi1 biomarkers, respectively. Teduglutide is an enterotrophic counterpart of glucagon-like peptide 2. This study aimed to investigate the response of putative IESC to surgical injury and teduglutide administration on an animal model of intestinal resection and anastomosis...
March 31, 2017: Journal of Investigative Surgery: the Official Journal of the Academy of Surgical Research
Lore Billiauws, Julie Bataille, Vanessa Boehm, Olivier Corcos, Francisca Joly
The European Society for Clinical Nutrition has published recommendations on the 'definition and classification of intestinal failure (IF)'. Two criteria must be present: a 'decreased absorption of macronutrients and/or water and electrolytes due to a loss of gut function' and the 'need for parenteral support'. Home parenteral support (HPS) is the primary treatment for chronic IF but is associated with complications. Areas covered: The principal cause of chronic IF is short bowel syndrome (SBS). The aim of treatment is to maximize intestinal absorption and reduce or eliminate the need for HPS to achieve the best possible quality of life...
May 2017: Expert Opinion on Biological Therapy
Siddhartha Oke, Merlin N M Walter, Tahera Ansari, Simon M Gabe
PURPOSE OF REVIEW: To examine the most recent literature on the clinical trials associated with the relevant growth factors that have been of interest in the treatment of short bowel. RECENT FINDINGS: Short bowel is a rare but devastating condition that condemns patients to lifelong parenteral support. Historically, treatment options negating the need for parenteral support were limited. Therapeutic growth factor use is of interest, but the clinical trial data are inconclusive...
May 2017: Current Opinion in Gastroenterology
Esther S Kim, Susan J Keam
Subcutaneous teduglutide (Revestive(®)), a glucagon-like peptide-2 analogue that increases intestinal absorption, is approved in the EU for the treatment of short bowel syndrome (SBS) in patients aged ≥1 year who are stable following a period of postsurgical intestinal adaptation. In a phase III trial in adults with SBS intestinal failure (IF) dependent on parenteral support (PS), a significantly greater proportion of teduglutide 0.05 mg/kg/day than placebo recipients achieved a ≥20% reduction in weekly PS volume from baseline to week 20 and maintained it to week 24...
February 14, 2017: Drugs
K Chen, J Xie, C Tang, J Zhao, C Olivier, P B Jeppesen, J Signorovitch
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
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
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...
November 22, 2016: JPEN. Journal of Parenteral and Enteral Nutrition
Beth A Carter, Valeria C Cohran, Conrad R Cole, Mark R Corkins, Reed A Dimmitt, Christopher Duggan, Susan Hill, Simon Horslen, Joel D Lim, David F Mercer, Russell J Merritt, Peter F Nichol, Luther Sigurdsson, Daniel H Teitelbaum, John Thompson, Charles Vanderpool, Juliana F Vaughan, Benjamin Li, Nader N Youssef, Robert S Venick, Samuel A Kocoshis
OBJECTIVE: To determine safety and pharmacodynamics/efficacy of teduglutide in children with intestinal failure associated with short bowel syndrome (SBS-IF). STUDY DESIGN: This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds. Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0...
February 2017: Journal of Pediatrics
Ken Fujioka, Khursheed Jeejeebhoy, Ulrich-Frank Pape, Benjamin Li, Nader N Youssef, Stéphane M Schneider
BACKGROUND: Narcotic agents are frequently administered to manage increased intestinal motility in patients with short bowel syndrome, but long-term use is associated with gastrointestinal (GI) complaints. This analysis evaluated the incidence of narcotic use and abdominal adverse events among patients with short bowel syndrome receiving teduglutide. MATERIALS AND METHODS: Pooled data from patients who received ≥1 dose of teduglutide 0.05 mg/kg/d (n = 77) or placebo (n = 59) in either of 2 randomized, double-blind, phase III studies were analyzed...
August 9, 2016: JPEN. Journal of Parenteral and Enteral Nutrition
Bharati Kochar, Millie D Long, Edward Shelton, Lorraine Young, Francis A Farraye, Vijay Yajnik, Hans Herfarth
BACKGROUND: Teduglutide is a GLP-2 analogue indicated for treatment of adults with short bowel syndrome (SBS). Because of the rarity of SBS, real-world safety or efficacy data are not available in patients with Crohn's disease (CD) and SBS treated with teduglutide. AIM: To evaluate teduglutide's safety and efficacy in CD patients with SBS. METHODS: We conducted a retrospective cohort study at 3 tertiary centers in the United States between 2012 and 2014...
July 18, 2016: Journal of Clinical Gastroenterology
Ulrich-Frank Pape, Sebastian Maasberg, Andreas Pascher
PURPOSE OF REVIEW: Intestinal failure because of more or less extensive resection of parts of the small and large intestine (short bowel syndrome) results from the reduction of absorptive surface of the remaining intestine and frequently results in dependence on parenteral nutrition. Parenteral nutrition, although lifesaving, is associated with short and long-term complications as well as with reduced quality of life and overall survival. RECENT FINDINGS: Pharmacological enhancement of the physiological intestinal adaptive response by subcutaneous application of the glucagon-like peptide 2 analogue teduglutide results in an improved, hyperadaptive response...
April 2016: Current Opinion in Organ Transplantation
Lauren K Schwartz, Stephen J D O'Keefe, Ken Fujioka, Simon M Gabe, Georg Lamprecht, Ulrich-Frank Pape, Benjamin Li, Nader N Youssef, Palle B Jeppesen
OBJECTIVES: In the pivotal 24-week, phase III, placebo-controlled trial, teduglutide significantly reduced parenteral support (PS) requirements in patients with short bowel syndrome (SBS). STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide. METHODS: Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment...
February 4, 2016: Clinical and Translational Gastroenterology
Georg Lamprecht
Intestinal failure is characterized by intestinal water and electrolyte losses as well as malabsorption of macronutrients. It often requires individually composed parenteral support (so call compounding). Teduglutide, a DPP-IV resistant GLP2 analogue, is available a pharmacologic treatment, which stimulates intestinal absorption and can facilitate infusion free days. Catheter infections are the most common complication of home parenteral support. The incidence can be minimized using Taurolidin as a catheter block solution...
December 2015: Deutsche Medizinische Wochenschrift
Stephen J D O'Keefe
In this review, I focus on the extreme of the short bowel syndrome where the loss of intestine is so great that patients cannot survive without intravenous feeding. This condition is termed short bowel intestinal failure. The review outlines the principles behind diagnosis, assessing prognosis and management. The advent of intravenous feeding (parenteral nutrition) in the 1970s enabled patients with massive (>90%) bowel resection to survive for the first time and to be rehabilitated back into normal life...
2015: Nestlé Nutrition Institute Workshop Series
Jane K Naberhuis, Andrew S Deutsch, Kelly A Tappenden
BACKGROUND: Teduglutide, a glucagon-like peptide-2 (GLP-2) analogue, is available for long-term use by parenteral nutrition (PN)-dependent adults to promote intestinal adaptation but is not approved for use in pediatric patients. The objective of this study was to assess teduglutide-stimulated induced intestinal adaptation, potential synergies with partial enteral nutrition (PEN), and distinct temporal markers of adaptation in a neonatal piglet model of short bowel syndrome (SBS). MATERIALS AND METHODS: Neonatal piglets (48 hours old; n = 72) underwent an 80% jejunoileal resection and were randomized to 1 of 4 treatment groups, in a 2 × 2 factorial design, with PN or PEN (80% standard PN/20% standard enteral nutrition) and teduglutide (0...
August 24, 2015: JPEN. Journal of Parenteral and Enteral Nutrition
Laura E Zyczynski, Jonathan B McHugh, Thomas E Gribbin, Scott M Schuetze
A 69-year-old woman was diagnosed with alveolar rhabdomyosarcoma (ARMS) of the nasopharynx. She has a history of catastrophic thromboembolic event in the abdomen that caused short-gut syndrome and dependence on total parenteral nutrition (TPN) twelve hours per day. She was treated for short-gut syndrome with teduglutide, a glucagon-like peptide-2 (GLP-2) analog, which led to reduction of TPN requirements. However, a few months later, she developed metastatic alveolar rhabdomyosarcoma. Though a causative relationship is unlikely between the peptide and ARMS due to the brief time course between teduglutide therapy and sarcoma diagnosis, neoplastic growth may have been accelerated by the GLP-2 analog, causing release of IGF-1...
2015: Case Reports in Oncological Medicine
Johanna Iturrino, Michael Camilleri, Andres Acosta, Jessica O'Neill, Duane Burton, Jithinraj Edakkanambeth Varayil, Paula J Carlson, Alan R Zinsmeister, Ryan Hurt
BACKGROUND: Glucagon-like peptide 2 (GLP-2) agonists decrease the need for parenteral nutrition (PN) in short bowel syndrome (SBS); mechanisms evaluated to date have focused on the intestinotrophic effect of GLP-2 agonists such as increased absorptive capacity of the remnant intestine and increased citrulline levels. Other mechanisms may also play a role in effects of GLP-2 agonists. AIM: To measure effects of a GLP-2 agonist, teduglutide (TED), compared with placebo (PLA) on gastric emptying (GE), overall gut transit, fluid balance, intestinal monosaccharide absorption, and permeability in patients with SBS on home PN (HPN)...
November 2016: JPEN. Journal of Parenteral and Enteral Nutrition
Charlene Compher, Joseph I Boullata, Octavia Pickett-Blakely, Phyllis Schiavone, Nancy Stoner, Bruce P Kinosian
BACKGROUND: Patients with intestinal failure, who are dependent on parenteral nutrition (PN) to supplement their limited absorption of dietary nutrients, are subject to complications associated with long-term PN therapy. Medication therapy that results in improved dietary nutrient absorption may enable these patients to reduce or even become independent from PN therapy and its related complications. The glucagon-like peptide 2 (GLP-2) analogue teduglutide was approved for use in such patients by the U...
November 2016: JPEN. Journal of Parenteral and Enteral Nutrition
Douglas L Seidner, Francisca Joly, Nader N Youssef
OBJECTIVES: In clinical trials, treatment with the glucagon-like peptide 2 analog teduglutide was associated with improved fluid and nutrient absorption and increased intestinal villus height and crypt depth in patients with short bowel syndrome (SBS). Plasma citrulline, an amino acid produced by enterocytes, is considered a measure of enterocyte mass. This analysis assessed changes in plasma citrulline levels in patients with SBS in 2 phase III clinical studies of teduglutide. METHODS: Both teduglutide studies (0...
June 25, 2015: Clinical and Translational Gastroenterology
Jane K Naberhuis, Kelly A Tappenden
BACKGROUND: Teduglutide (Gattex; NPS Pharma, Bedminster, NJ), a recombinant analogue of human glucagon-like peptide 2 (GLP-2), is the first long-term medical therapy approved for the treatment of adults dependent on parenteral nutrition (PN). OBJECTIVE: To assess the efficacy and safety of teduglutide in reducing PN (parenteral nutrient and/or fluid) requirements in PN-dependent adults. METHODS: Studies were identified using predefined search criteria and multiple databases, including Medline and Embase...
November 2016: JPEN. Journal of Parenteral and Enteral Nutrition
Kate McKeage
Teduglutide (Gattex(®)) is a recombinant analogue of human glucagon-like peptide-2 and is indicated for the treatment of adults with short bowel syndrome (SBS) dependent on parenteral support (PS). In a pivotal, 24-week clinical trial in SBS patients, subcutaneous teduglutide 0.05 mg/kg once daily increased absorption from the remnant intestine as evidenced by significant reductions in PS volume requirements versus placebo. Improvements attained in absorption in the first 6 months of therapy were maintained during the extension trial (total teduglutide treatment periods of up to 30 months), with evidence indicating that benefits accrue over time...
May 2015: Clinical Drug Investigation
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