Teduglutide: A review of its use in the treatment of patients with short bowel syndrome

Drugs

Volumn 73, Issue 9, 2013, Pages 935-947

  Burness, Celeste B ^a   McCormack, Paul L ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; CITRULLINE; PLACEBO; TEDUGLUTIDE;

ABDOMINAL PAIN; ACUTE CHOLECYSTITIS; AMINO ACID SUBSTITUTION; BODY COMPOSITION; COLORECTAL POLYP; COMA; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; ENERGY ABSORPTION; GASTROINTESTINAL ABSORPTION; GLOMERULUS FILTRATION RATE; HEART REPOLARIZATION; HEMORRHOID HEMORRHAGE; HUMAN; HYPERSOMNIA; HYPERVOLEMIA; IMMUNOGENICITY; INTESTINE STENOSIS; LONG TERM CARE; METABOLIC BALANCE; MULTICENTER STUDY (TOPIC); NAUSEA; PANCREAS DISEASE; PARENTERAL NUTRITION; PHASE 3 CLINICAL TRIAL (TOPIC); PLASMA CLEARANCE; PLASMA CONCENTRATION-TIME CURVE; QUALITY OF LIFE; RECOMMENDED DRUG DOSE; REVIEW; SHORT BOWEL SYNDROME; SINGLE DRUG DOSE; VISUAL ANALOG SCALE;

ANIMALS; CLINICAL TRIALS, PHASE III AS TOPIC; DOUBLE-BLIND METHOD; HUMANS; PEPTIDES; SHORT BOWEL SYNDROME;

EID: 84879475056     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-013-0070-y     Document Type: Review

References (36)

1. Buchman AL, Scolapio J, Fryer J. AGA technical review on short bowel syndrome and intestinal transplantation. Gastroenterology. 2003;124(4):1111-34. (Pubitemid 36389810)
2. O'Keefe SJ, Buchman AL, Fishbein TM, et al. Short bowel syndrome and intestinal failure: consensus definitions and overview. Clin Gastroenterol Hepatol. 2006;4(1):6-10. (Pubitemid 43129518)
3. Misiakos EP, Macheras A, Kapetanakis T, et al. Short bowel syndrome: current medical and surgical trends. J Clin Gastroenterol. 2007;41(1):5-18. (Pubitemid 46045665)
4. Drozdowski LA, Clandinin MT, Thomson AB. Morphological, kinetic, membrane biochemical and genetic aspects of intestinal enteroplasticity. World J Gastroenterol. 2009;15(7):774-87.
5. Jeppesen PB, Hartmann B, Thulesen J, et al. Glucagon-like peptide 2 improves nutrient absorption and nutritional status in short-bowel patients with no colon. Gastroenterology. 2001;120(4):806-15. (Pubitemid 32193176)
6. Nightingale J, Woodward JM. Guidelines for management of patients with a short bowel. Gut. 2006;55(Suppl 4):iv1-12.
7. Seidner DL, Schwartz LK, Winkler MF, et al. Increased intestinal absorption in the era of teduglutide and its impact on management strategies in patients with short bowel syndrome-associated intestinal failure. JPEN J Parenter Enteral Nutr. 2013;37(2):201-11.
8. Steiger E. Guidelines for pharmacotherapy, nutritional management, and weaning parenteral nutrition in adult patients with short bowel syndrome: introduction. J Clin Gastroenterol. 2006;40(Suppl 2):S73-4. (Pubitemid 44309511)
9. Oley Foundation. North American home parenteral and enteral nutrition patient registry annual report. 1994. http://www.oley.org/documents/Patient- Registry-AnnualReportFinal.pdf. Accessed 8 May 2013.
10. McMellen ME, Wakeman D, Longshore SW, et al. Growth factors: possible roles for clinical management of the short bowel syndrome. Semin Pediatr Surg. 2010;19(1):35-43.
11. Food and Drug Administration. FDA briefing information for the 16 October 2012 meeting of the GastroIntestinal Drugs Advisory Committee. 2012. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/GastrointestinalDrugsAdvisoryCommittee/UCM323504.pdf. Accessed 8 May 2013.
12. Scolapio JS. Short bowel syndrome: recent clinical outcomes with growth hormone. Gastroenterology. 2006;130(2 Suppl 1):S122-6. (Pubitemid 43208869)
13. NPS Pharmaceuticals. Gattex (teduglutide): US prescribing information. 2012. http://www.npsp.com/file-depot/0-10000000/0-10000/262/folder/2023/Gattex- PI-IFU-FINAL-2012-12-21.pdf. Accessed 8 May 2013.
14. European Medicines Agency. Revestive (teduglutide): summary of product characteristics. 2012. http://www.ema.europa.eu/docs/en-GB/document-library/ EPAR-Product-Information/human/002345/WC500132926.pdf. Accessed 8 May 2013.
15. Marier JF, Beliveau M, Mouksassi MS, et al. Pharmacokinetics, safety, and tolerability of teduglutide, a glucagon-like peptide-2 (GLP-2) analog, following multiple ascending subcutaneous administrations in healthy subjects. J Clin Pharmacol. 2008;48(11):1289-99.
16. Marier J-F, Mouksassi M-S, Gosselin NH, et al. Population pharmacokinetics of teduglutide following repeated subcutaneous administrations in healthy participants and in patients with short bowel syndrome and Crohn's disease. J Clin Pharmacol. 2010;50(1):36-49.
17. Hartmann M, Timmer W, Schultz A, et al. A thorough QT study of teduglutide in healthy subjects. Clin Pharmacol Drug Dev. 2012;1(2):57-66.
18. Berg J, Kim E, Li Y, et al. A randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the effects of teduglutide on gastric emptying in healthy subjects [abstract no. Sa1959]. Digestive Disease Week 2012 (DDW); 20-22 May 2012; San Diego.
19. Berg JK, Kim EH, Li B, et al. A randomized, double-blind, placebo-controlled study to assess the effects of teduglutide on gastric emptying in healthy subjects [abstract no. 1520397]. American Society for Parenteral and Enteral Nutrition (ASPEN) Clinical Nutrition Week 2013 (CNW13); 9-12 Feb 2013; Phoenix.
20. Jeppesen PB, Sanguinetti EL, Buchman A, et al. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005;54(9):1224-31. (Pubitemid 41192479)
21. Jeppesen PB, Gilroy R, Pertkiewicz M, et al. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011;60(7):902-14.
22. Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012;143(6):1473-81.
23. Wallis K, Walters JRF, Gabe S. Short bowel syndrome: the role of GLP-2 on improving outcome. Curr Opin Clin Nutr Metab Care. 2009;12(5):526-32.
24. Van Citters GW, Lin HC. The ileal brake: a fifteen-year progress report. Curr Gastroenterol Rep. 1999;1(5):404-9.
25. Tappenden KA, Edelman J, Joelsson B. Teduglutide enhances structural adaptation of the small intestinal mucosa in patients with short bowel syndrome. J Clin Gastroenterol. 2013. doi: 10.1097/MCG.0b013e3182828f57
26. Papadia C, Sherwood RA, Kalantzis C, et al. Plasma citrulline concentration: a reliable marker of small bowel absorptive capacity independent of intestinal inflammation. Am J Gastroenterol. 2007;102(7):1474-82. (Pubitemid 46976295)
27. O'Keefe SJ, Jeppesen PB, Gilroy R, et al. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel syndrome intestinal failure. Clin Gastroenterol Hepatol. 2013. doi: 10.1016/j.cgh.2012. 12.029.
28. Nave R, Halabi A, Herzog R, et al. Pharmacokinetics of teduglutide in subjects with renal impairment. Eur J Clin Pharmacol. 2012. doi: 10.1007/s00228-012-1455-7.
29. Schwartz L, Fujioka K, Jeppesen PB, et al. Continued improvement and maintenance of parenteral nutrition and/or intravenous fluid support volume reduction in patients with long-term teduglutide treatment: results of an ongoing long-term open-label study [abstract no. 1520168 plus poster]. American Society for Parenteral and Enteral Nutrition (ASPEN) Clinical Nutrition Week 2013 (CNW13); 9-12 Feb 2013; Phoenix.
30. Jeppesen PB, Pertkiewicz M, Forbes A, et al. Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide - analyses from a randomised, placebo-controlled study. Clin Nutr. 2013. doi: 10.1016/j.clnu.2013.03.016.
31. Gilroy R, Allard J, Jeppesen PB, et al. Treatment out to 1 year with a GLP-2 analog, teduglutide, safely reduces parenteral nutrition (PN) needs in PN-dependent short bowel syndrome patients [abstract no. 273]. Am J Gastroenterol. 2008;103(s1):S105.
32. Fujioka K, Seidner DL, Delmaestro E, et al. Long-term safety and tolerability of teduglutide in patients with intestinal failure associated with short bowel syndrome: combined data from phase III trials [abstract no. 1520553 plus poster]. American Society for Parenteral and Enteral Nutrition (ASPEN) Clinical Nutrition Week 2013 (CNW13); 9-12 Feb 2013; Phoenix.
33. NPS Pharmaceuticals. A one-year, open-label study with teduglutide for subjects who completed study CL0600-021 (STEPS 3) (ClinicalTrials.gov identifier NCT01560403) US National Institutes of Health, ClinicalTrials.gov. 2012. http://www.clinicaltrials.gov/ct2/show/NCT01560403. Accessed 8 May 2013.
34. European Medicines Agency. Revestive: EPAR-Public assessment report. 2012. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public- assessment-report/human/002345/WC500132928.pdf. Accessed 8 May 2013.
35. NPS Pharmaceuticals. Risk evaluation and mitigation strategy (REMS). 2013. http://www.gattexrems.com/. Accessed 8 May 2013.
36. Buchman AL. Teduglutide and short bowel syndrome: every night without parenteral fluids is a good night. Gastroenterology. 2012;143(6):1416-20.