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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...
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)...
July 28, 2015: 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...
June 25, 2015: 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...
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...
April 16, 2015: 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
Daniel J Drucker
The Banting Medal for Scientific Achievement is the highest scientific award of the American Diabetes Association (ADA). Given in memory of Sir Frederick Banting, one of the key investigators in the discovery of insulin, the Banting Medal is awarded annually for scientific excellence, recognizing significant long-term contributions to the understanding, treatment, or prevention of diabetes. Daniel J. Drucker, MD, of the Department of Medicine, Mount Sinai Hospital and the Lunenfeld-Tanenbaum Research Institute in Toronto, Ontario, Canada, received the prestigious award at the ADA's 74th Scientific Sessions, 13-17 June 2014, in San Francisco, California...
February 2015: Diabetes
Charlene Compher, Katherine Boothe Levinson, Carolyn L Cambor, Nancy Stoner, Joseph I Boullata, Amanda Piarulli, Bruce Kinosian
Clinical trials of the glucagon-like peptide 2 analogue teduglutide resulted in approval of the drug by the Food and Drug Administration in 2012 as a treatment for parenteral nutrition-dependent short bowel syndrome in adults. This report presents the case study of a man with short bowel syndrome caused by portal vein thrombosis who had 4 years exposure to the drug at the time of his death due to cardiovascular disease.
July 2016: JPEN. Journal of Parenteral and Enteral Nutrition
Kishore Vipperla, Stephen J O'Keefe
Extensive intestinal resection impairs the absorptive capacity and results in short-bowel syndrome-associated intestinal failure (SBS-IF), when fluid, electrolyte, acid-base, micro-, and macronutrient homeostasis cannot be maintained on a conventional oral diet. Several factors, including the length and site of the resected intestine, anatomical conformation of the remnant bowel, and the degree of postresection intestinal adaptation determine the disease severity. While mild SBS patients achieve nutritional autonomy with dietary modification (eg, hyperphagia, small frequent meals, and oral rehydration fluids), those with moderate-to-severe disease may develop SBS-IF and become dependent on parenteral support (PS) in the form of intravenous fluids and/or nutrition for sustenance of life...
2014: Clinical and Experimental Gastroenterology
Palle B Jeppesen
PURPOSE OF REVIEW: The approval of teduglutide, a recombinant analog of human glucagon-like peptide (GLP) 2, by the US Food and Drug Administration (Gattex) and the European Medicines Agency (Revestive) has illustrated the potential of selected gut hormones as treatments in patients with short-bowel syndrome and intestinal failure. Gut hormones may improve the structural and functional intestinal adaptation following intestinal resection by decreasing a rapid gastric emptying and hypersecretion, by increasing the intestinal blood flow, and by promoting intestinal growth...
February 2015: Current Opinion in Endocrinology, Diabetes, and Obesity
Stefan Roepcke, Ruediger Nave, Jane Cyran, Nele Plock, Gezim Lahu, Axel Facius
OBJECTIVE: Teduglutide is a recombinant analogue of human glucagonlike peptide-2 (GLP-2) that was recently approved by the US and European regulatory agencies FDA and EMA for the treatment of short bowel syndrome (SBS). The objectives of this work were, firstly, to develop a population pharmacokinetic (popPK) model based on the available PK data of the entire clinical development program and, secondly, to utilize the model for the justification of the proposed dosing regimen. The exploratory analysis was based on a previously established structural PK model and focused primarily on the investigation of covariate effects...
December 2014: International Journal of Clinical Pharmacology and Therapeutics
Sheila M Wilhelm, Melissa Lipari, Janice K Kulik, Pramodini B Kale-Pradhan
OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of the newly approved drug, teduglutide, for the treatment of short bowel syndrome (SBS). DATA SOURCES: Literature was retrieved through PubMed (1966-March 2014) using the search term teduglutide. The authors applied the filters Humans and English language, resulting in 47 publications. STUDY SELECTION AND DATA EXTRACTION: The authors reviewed the 47 citations to extract those that were published clinical trials...
May 28, 2014: Annals of Pharmacotherapy
Palle B Jeppesen
A primary goal of intestinal rehabilitation programs is to facilitate intestinal adaptation. Adult patients with short bowel syndrome (SBS) who are dependent on parenteral nutrition and/or intravenous fluid (PN/IV) support have 2 hormonal pharmacologic treatment options available that may promote intestinal growth: a glucagon-like peptide 2 analog (teduglutide) and recombinant human growth hormone (somatropin). In two phase III clinical trials (N=169), 24 weeks of teduglutide administered to outpatients with SBS resulted in significant decreases in PN/IV volume requirements of 2...
May 2014: JPEN. Journal of Parenteral and Enteral Nutrition
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