Delayed release pancrelipase for the treatment of pancreatic exocrine insufficiency associated with cystic fibrosis

Therapeutics and Clinical Risk Management

Volumn 4, Issue 5, 2008, Pages 1079-1084

  Baker, Susan S ^a,b  

^a UNIVERSITY AT BUFFALO   (United States)

^b CHILDREN S HOSPITAL OF BUFFALO   (United States)

Author keywords

Cystic fibrosis; Malabsorption; Pancreatic enzymes; Pancrelipase

Indexed keywords

PANCREAS ENZYME; PANCRELIPASE; TRANSMEMBRANE CONDUCTANCE REGULATOR;

ABDOMINAL PAIN; CHRONIC PANCREATITIS; CLINICAL FEATURE; CLINICAL TRIAL; CONSTIPATION; CYSTIC FIBROSIS; DELAYED DRUG RELEASE; DIARRHEA; DISEASE ASSOCIATION; DRUG APPROVAL; DRUG COATING; DRUG EFFICACY; DRUG FORMULATION; DRUG INDICATION; DRUG MECHANISM; DRUG RESPONSE; ENZYME REPLACEMENT; FOOD AND DRUG ADMINISTRATION; GENE MUTATION; GROWTH; HUMAN; LIPID ABSORPTION; MALABSORPTION; PANCREAS EXOCRINE INSUFFICIENCY; PANCREAS FUNCTION; PANCREAS FUNCTION TEST; PANCREAS INSUFFICIENCY; PATHOGENESIS; PATIENT COMPLIANCE; PATIENT MONITORING; REVIEW; SHWACHMAN SYNDROME;

EID: 56749115764     PISSN: 11766336     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (42)

1. Apley J, Naish N. 1958. Recurrent abdominal pain: a field survey of 1,000 school children. Arch Dis Child, 33:165-70.
2. Baker SS, Borowitz D, Duffy L, et al. 2005. Pancreatic enzyme therapy and clinical outcomes in patients with cystic fibrosis. J Pediatr, 146:189-93.
3. Beker LT, Russek-Cohen E, Fink RJ. 2001. Stature as a prognostic factor in cystic fibrosis survival. J Am Diet Assoc, 101:438-42.
4. Borowitz DS, Grand RJ, Durie PR. 1995. Consensus Committee. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. J Pediatr, 127:681-4.
5. Borowitz D, Baker RD, Stallings V. 2002. Consensus report on nutrition for pediatric patients with cystic fibrosis. J Pediatr Gastroenterol Nutr, 35:246-59.
6. Borowitz D, Baker SS, Duffy L, et al. 2004. Use of fecal elastase-1 to classify pancreatic status in patients with cystic fibrosis. J Pediatr, 145:322-6.
7. Borowitz D, Durie PR, Clarke LL. 2005. Gastrointestinal Outcomes and Confounders in Cystic Fibrosis.. J Pediatr Gastroenterol Nutr, 41:273-85.
8. Borowitz D, Goss CH, Simauro S, et al. 2006. Study of a novel pancreatic enzyme replacement therapy in pancreatic insufficient subjects with cystic fibrosis. J Pediatr, 149:658-62.
9. Choi JY, Muallem D, Kiselyov K, et al. 2001. Aberrant CFTR-dependent HCO(-3) transport in mutations associated with cystic fibrosis. Nature, 410:94-97.
10. Cooper R. 1996. Pancreatic function tests. In: Walker, et al. (eds) Pediatric Gastrointestinal Disease. 2nd ed. St. Louis: Mosby. p. 1621-34.
11. Corey M, McLaughlin FJ, Williams M, et al. 1988. A comparison of survival, growth and pulmonary function in patients with cystic fibrosis in Boston and Toronto. J Clin Epidemiol, 41:588-91.
12. Dalzell AM, Shepherd RW, Dean SB, et al. 1992. Nutritional rehabilitation in cystic fibrosis: a 5 year follow-up study. J Pediatr Gastroenterol Nutr, 15:141-45.
13. Department of Health and Human Services. Federal Register. 2004. Exocrine Pancreatic Insufficiency Drug Products 69:23410.
14. Department of Health and Human Services. Federal Register. 2007. Exocrine Pancreatic Insufficiency Drug Products; Extension to Obtain Marketing Approval. 72:60860-62.
15. DiMagno EP, Go VLW, Summerskill WHJ. 1973. Relations between pancreatic enzyme outputs and malabsorption in severe pancreatic insufficiency. N Engl J Med, 288:813-15.
16. FitzSimmons SC, Burkhart GA, Horowitz D, et al. 1998. High-dose pancreatic-enzyme supplements and fibrosing colonopathy in children with cystic fibrosis. N Engl J Med, 336:1283-1289.
17. Guy-Crotte O, Carrere J, Figarella C 1996. Exocrine pancreatic function in cystic fibrosis. Eur J Gastroenterol Hepatol, 8:755-9.
18. Guimbaud R, Moreau JA, Bouisson M, et al. 1997. Intraduodenal free fatty acids rather than triglycerides are responsible for the release of CCK in humans. Pancreas, 14:76-82.
19. Haynes RB, McDonald HP, Garg AX. 2002. Helping patients follow prescribed treatment: Clinical applications. JAMA, 288:2880-3.
20. Hendeles L, Dorf A, Stecenko A, et al. 1990. Treatment failure after substitution of generic pancrelipase capsules. JAMA, 263:2459-61.
21. Hyams JS, Burke G, Davis PM, et al. 1996. Abdominal pain and irritable bowel syndrome in adolescents: a community-based study. J Pediatr, 129:220-6.
22. John Hopkins University On Line Mendelian Inheritance in Man (OMIM). Accessed 2 April 2008. URL: http://www.ncbi.nlm.nih.gov/entrez/ dispomim.cgi?id=602421.
23. Kastner-Cole D, Polin CAN, Ogston SA, et al. 2005. Overweight and obesity in [delta]F508 homozygous cystic fibrosis. J Pediatr, 147:402-4.
24. Keller J, Runzi M, Goebell H, et al. 1988. Duodenal and ileal nutrient deliveries regulate human intestinal motor and pancreatic responses to a meal. Am J Physio, 272:G632-7.
25. Kraemer R, Rudeberg A, Hadom B, et al. 1978. Relative underweight in cystic fibrosis and its prognostic value. Acta Paediatr Scand, 67:33-7.
26. Kerem E, Reisman J, Corey M, et al. 1992. Prediction of mortality in patients with cystic fibrosis. N Engl J Med, 326:1187-91.
27. Layer P, von der Ohe M, Gröger G, et al. 1992. Luminal availability and digestive efficacy of substituted enzymes in pancreatic insufficiency. Pancreas, 7:745.
28. Layer P, von der Ohe MR, 'Holst JJ, et al. 1997. Altered postprandial motility in chronic pancreatitis: role of malabsorption. Gastroenterology, 112:1624-34.
29. Layer P, Keller J, Lankish PG. 2001. Pancreatic enzyme replacement therapy. Curr Gastroenterol Rep, 3:101-8.
30. Loening-Baucke V. 1998. Constipation in children. N Eng J Med, 339:1155-6.
31. Medline Plus. Accessed 2 April 2008. URL: http://www.nlm.nih.gov/ medlineplus/druginfo/medmaster/a604035.html
32. Ng SM, Jones AP. 2008. Drug therapies for reducing gastric acidity in people with cystic Fibrosis. The Cochrane Database of Systematic Reviews Accessed 2 April, 2008.
33. Pencharz PB, Durie PR. 1993. Nutritional management of cystic fibrosis. Ann Rev Nutr, 13:111-36.
34. Rasquin-Weber A, Hyman PB, Cucchiara S, et al. 1999. Childhood functional gastrointestinal disorders. Gut, 45(Suppl II):II60-8.
35. Reddy MM, Light MJ, Quinton PM. 1999. Activation of the epithelial Na(+) channel (ENaC) requires CFTR CI(-) channel function. Nature, 402:301-4.
36. Rubinstein S, Moss R, Lewiston N. 1986. Constipation and meconium ileus equivalent in patients with cystic fibrosis. Pediatrics, 78:473-9.
37. Schmitz J. 2000. Maldigestion and malabsorption. In: Walker WA, Durie PR, Hamilton JR, et al. (eds). Pediatric gastrointestinal disease: pathophysiology, diagnosis, management. 2nd ed. St. Louis: Mosby. p. 51-8.
38. Stephenson BJ, Rowe BH, Haynes RB, et al. 1993. Is this patient taking the treatment as prescribed? JAMA, 269:2779-81.
39. Sweetman S. 2007. Martindale: The Complete Drug Reference Grayslake IL: Pharmaceutical Press.
40. Stewart WF, Liberman JN, Sandler RS, et al. 1999. Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features. Am J Gastroenterol, 94:3530-40.
41. Turcios, NL. 2005. Cystic fibrosis, an overview. J Clin Gastroenterol, 34:307-17.
42. Tucker JA, Spock A, Spicer SS, et al. 2003. Inspissation of pancreatic zymogen material in cystic fibrosis. Ultrastruc Pathol, 27:323-35.