Pancrelipase for pancreatic disorders: An update

Drugs of Today

Volumn 46, Issue 11, 2010, Pages 855-866

  Dhanasekaran, R ^a   Toskes, Phillip P ^a  

^a UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

KREON; METHACRYLIC ACID; PANCREAS ENZYME; PANCREAZE; PANCRELIPASE; PLACEBO; PROKINETIC AGENT; SECRETIN; TRIACYLGLYCEROL LIPASE; UNCLASSIFIED DRUG; ZENPEP; GASTROINTESTINAL AGENT;

ANAPHYLAXIS; BLOATING; CHRONIC PANCREATITIS; CLINICAL TRIAL (TOPIC); COLON DISEASE; COLON STRICTURE; DELAYED DRUG RELEASE; DIAGNOSTIC TEST; DIARRHEA; DRUG EFFICACY; DRUG FORMULATION; DRUG HYPERSENSITIVITY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; ENTERIC COATED TABLET; ENZYME THERAPY; EVIDENCE BASED MEDICINE; FIBROSING COLONOPATHY; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPERURICEMIA; HYPERURICOSURIA; MALABSORPTION; MALNUTRITION; MORBIDITY; MORTALITY; NAUSEA; NONHUMAN; OPTIMAL DRUG DOSE; PAIN; PANCREAS DISEASE; PANCREAS EXOCRINE INSUFFICIENCY; PANCREAS FUNCTION TEST; PATHOPHYSIOLOGY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; REVIEW; RISK FACTOR; SECRETIN STIMULATION TEST; STEATORRHEA; STOMACH PARESIS; SYMPTOM; TREATMENT FAILURE; TREATMENT OUTCOME; ANIMAL; DOSE RESPONSE; DRUG APPROVAL; UNITED STATES;

ANIMALS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG APPROVAL; GASTROINTESTINAL AGENTS; HUMANS; PANCREATIC DISEASES; PANCRELIPASE; QUALITY OF LIFE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79955772790     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2010.46.11.1541553     Document Type: Review

References (87)

1. O'Sullivan, J.N., Nobrega, F.T., Morlock, C.G., Brown, A.L., Jr., Bartholomew, L.G. Acute and chronic pancreatitis in Rochester, Minnesota, 1940 to 1969. Gastroenterology 1972, 62(3): 373-9.
2. Spanier, B.W., Dijkgraaf, M.G., Bruno, M.J. Epidemiology, aetiology and outcome of acute and chronic pancreatitis: An update. Best Pract Res Clin Gastroenterol 2008, 22(1): 45-63.
3. Tinto, A., Lloyd, D.A., Kang, J.Y. et al. Acute and chronic pancreatitis - Diseases on the rise: A study of hospital admissions in England 1989/90-1999/2000. Aliment Pharmacol Ther 2002, 16(12): 2097-105.
4. Toskes, P.P. Medical management of chronic pancreatitis. Scand J Gastroenterol Suppl 1995, 208: 74-80.
5. Sikkens, E.C., Cahen, D.L., Kuipers, E.J., Bruno, M.J. Pancreatic enzyme replacement therapy in chronic pancreatitis. Best Pract Res Clin Gastroenterol 2010, 24(3): 337-47.
6. Singh, V.V., Toskes, P.P. Medical therapy for chronic pancreatitis pain. Curr Gastroenterol Rep 2003, 5(2): 110-6.
7. O'Reilly, D.A., Kingsnorth, A.N. A brief history of pancreatitis. J R Soc Med 2001, 94(3): 130-2.
8. Dutta, S.K., Rubin, J., Harvey, J. Comparative evaluation of the therapeutic efficacy of a pH-sensitive enteric coated pancreatic enzyme preparation with conventional pancreatic enzyme therapy in the treatment of exocrine pancreatic insufficiency. Gastroenterology 1983, 84(3): 476-82.
9. Graham, D.Y. Enzyme replacement therapy of exocrine pancreatic insufficiency in man. Relations between in vitro enzyme activities and in vivo potency in commercial pancreatic extracts. N Engl J Med 1977, 296(23): 1314-7.
10. Hendeles, L., Dorf, A., Stecenko, A., Weinberger, M. Treatment failure after substitution of generic pancrelipase capsules. Correlation with in vitro lipase activity. JAMA 1990, 263(18): 2459-61.
11. Beverley, D.W., Kelleher, J., MacDonald, A., Littlewood, J.M., Robinson, T., Walters, M.P. Comparison of four pancreatic extracts in cystic fibrosis. Arch Dis Child 1987, 62(6): 564-8.
12. Case, C.L., Henniges, F., Barkin, J.S. Enzyme content and acid stability of enteric-coated pancreatic enzyme products in vitro. Pancreas 2005, 30(2): 180-3.
13. Campbell, P. W. III. Cystic Fibrosis Foundation tLT, FDA. Letter dated February 14.
14. Exocrine Pancreatic Insufficiency Drug Products, Draft Guidance for Submitting New Drug Applications, Notices. In: Administration. DoHaHSFaD, Ed.: wais.access.gpo.gov 2004, 23409-14.
15. Smyth, R.L., van Velzen, D., Smyth, A.R., Lloyd, D.A., Heaf, D.P. Strictures of ascending colon in cystic fibrosis and high-strength pancreatic enzymes. Lancet 1994, 343(8889): 85-6.
16. Oades, P.J., Bush, A., Ong, P.S., Brereton, R.J. High-strength pancreatic enzyme supplements and large-bowel stricture in cystic fibrosis. Lancet 1994, 343(8889): 109.
17. Stapleton, F.B., Kennedy, J., Nousia-Arvanitakis, S., Linshaw, M.A. Hyperuricosuria due to high-dose pancreatic extract therapy in cystic fibrosis. N Engl J Med 1976, 295(5): 246-8.
18. Food and Drug Administration. FDA requires pancreatic extract manufacturers to submit marketing applications. April 27, 2004. Available from: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108289.htm. (Accessed Sept. 7, 2010).
19. Barclay. FDA approves Creon delayed release capsules for pancreatic insufficiency, [updated May 7, 2009, cited 2010 September 7], Available from: www.medscape.com/viewarticle/702489.
20. FDA Approves Zenpep. 2009 [cited 2010 September 7], Available from: http: //www.drugs.com/newdrugs/eurand-granted-fda-approval-zenpep-1572.html.
21. Food and Drug Administration. FDA approves pancreatic enzyme product, Pancreaze. April 12, 2010. Available from: http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm208135.htm. (Accessed Sept. 7, 2010).
22. Layer, P., Keller, J. Lipase supplementation therapy: standards, alternatives, and perspectives. Pancreas 2003, 26(1): 1-7.
23. Thiruvengadam, R., DiMagno, E.P. Inactivation of human lipase by proteases. Am J Physiol 1988, 255(4, Pt. 1): G476-81.
24. Dominguez-Munoz, J.E. Pancreatic enzyme therapy for pancreatic exocrine insufficiency. Curr Gastroenterol Rep 2007, 9(2): 116-22.
25. Banks, P.A., Conwell, D.L., Toskes, P.P. The management of acute and chronic pancreatitis. Gastroenterol Hepatol (NY) 2010, 6(2, Suppl. 3): 1-16.
26. Loser, C. Diagnosis of chronic pancreatitis. Praxis (Bern 1994) 1998, 87(46): 1542-7.
27. Layer, P., DiMagno, E.P. Early and late onset in idiopathic and alcoholic chronic pancreatitis. Different clinical courses. Surg Clin North Am 1999, 79(4): 847-60.
28. Layer, P., Yamamoto, H., Kalthoff, L., Clain, J.E., Bakken, L.J., DiMagno, E.P. The different courses of early- and late-onset idiopathic and alcoholic chronic pancreatitis. Gastroenterology 1994, 107(5): 1481-7.
29. Dumasy, V., Delhaye, M., Cotton, F., Deviere, J. Far malabsorption screening in chronic pancreatitis. Am J Gastroenterol 2004, 99(7): 1350-4.
30. Czako, L., Takacs, T., Hegyi, P. et al. Quality of life assessment after pancreatic enzyme replacement therapy in chronic pancreatitis. Can J Gastroenterol 2003, 17(10): 597-603.
31. Stevens, T., Conwell, D.L., Zuccaro, G., Jr. et al. A randomized crossover study of secretin-stimulated endoscopic and dreiling tube pancreatic function test methods in healthy subjects. Am J Gastroenterol 2006, 101(2): 351-5.
32. Toskes, P.P. Update on diagnosis and management of chronic pancreatitis. Curr Gastroenterol Rep 1999, 1(2): 145-53.
33. Dominguez-Munoz, J.E., Hieronymus, C., Sauerbruch, T., Malfertheiner, P. Fecal elastase test: Evaluation of a new noninvasive pancreatic function test. Am J Gastroenterol 1995, 90(10): 1834-7.
34. Takeda, M., Shiratori, K., Hayashi, N., Odagiri, E., Takasaki, K. Fecal elastase-1 test: Clinical evaluation of a new noninvasive pancreatic function test. Rinsho Byori 2002, 50(9): 893-8.
35. Steinberg, W.M., Goldstein, S.S., Davis, N.D., Anderson, K.K., Shamma'a, J.M. Predictive value of a low serum trypsinogen. Dig Dis Sci 1985, 30(6): 547-51.
36. Loser, C., Brauer, C., Aygen, S., Hennemann, O., Folsch, U.R. Comparative clinical evaluation of the 13C-mixed triglyceride breath test as an indirect pancreatic function test. Scand J Gastroenterol 1998, 33(3): 327-34.
37. Nakamura, H., Morifuji, M., Murakami, Y. et al. Usefulness of a 13C-labeled mixed triglyceride breath test for assessing pancreatic exocrine function after pancreatic surgery. Surgery 2009, 145(2): 168-75.
38. Moran-Villota, S., Arteaga, M.E., Rodriguez-Leal, G.A. et al. Evaluation of lipid digestion using the 13C-mixed triglyceride breath test in patients with chronic pancreatitis. Rev Gastroenterol Mex 2007, 72(3): 202-6.
39. Dominguez-Munoz, J.E., Iglesias-Garcia, J., Vilarino-Insua, M., Iglesias-Rey, M. 13C-mixed triglyceride breath test to assess oral enzyme substitution therapy in patients with chronic pancreatitis. Clin Gastroenterol Hepatol 2007, 5(4): 484-8.
40. Toskes, P., Greenberger, N. Approach to patient with pancreatic disease. In: Fauci. A.S., Braunwald, E., Kasper, D. et al. (Eds.). Harrison's Principles of Internal Medicine, 17th ed. McGraw-Hill: New York, 2008, 2001-5.
41. Sakorafas, G.H., Tsiotou, A.G., Peros, G. Mechanisms and natural history of pain in chronic pancreatitis: a surgical perspective. J Clin Gastroenterol 2007, 41(7): 689-99.
42. Dockray, G.J. The physiology of cholecystokinin in brain and gut. Br Med Bull 1982, 38(3): 253-8.
43. Owyang, C., Louie, D.S., Tatum, D. Feedback regulation of pancreatic enzyme secretion. Suppression of cholecystokinin release by trypsin. J Clin Invest 1986, 77(6): 2042-7.
44. Mossner, J. Palliation of pain in chronic pancreatitis. Use of enzymes. Surg Clin North Am 1999, 79(4): 861-72.
45. Green, G.M. Feedback inhibition of cholecystokinin secretion by bile acids and pancreatic proteases. Ann NY Acad Sci 1994, 713: 167-79.
46. Staff, J., Jacobson, D., Tillman, C.R., Curington, C., Toskes, P. Protease-specific suppression of pancreatic exocrine secretion. Gastroenterology 1984, 87(1): 44-52.
47. Dutta, S.K., Bustin, M.P., Russell, R.M., Costa, B.S. Deficiency of fat-soluble vitamins in treated patients with pancreatic insufficiency. Ann Intern Med 1982, 97(4): 549-52.
48. DiMagno, E.P. A short, eclectic history of exocrine pancreatic insufficiency and chronic pancreatitis. Gastroenterology 1993, 104(5): 1255-62.
49. Pezzilli, R. Chronic pancreatitis: Maldigestion, intestinal ecology and intestinal inflammation. World J Gastroenterol 2009, 15(14): 1673-6.
50. Mann, S.T., Stracke, H., Lange, U., Klor, H.U., Teichmann, J. Alterations of bone mineral density and bone metabolism in patients with various grades of chronic pancreatitis. Metabolism 2003, 52(5): 579-85.
51. Moran, C.E., Sosa, E.G., Martinez, S.M., Geldern, P., Messina, D., Russo, A. et al. Bone mineral density in patients with pancreatic insufficiency and steatorrhea. Am J Gastroenterol 1997, 92(5): 867-71.
52. Dujsikova, H., Dite, P., Tomandl, J., Sevcikova, A., Precechtelova, M. Occurrence of metabolic osteopathy in patients with chronic pancreatitis. Pancreatology 2008, 8(6): 583-6.
53. Montalto, G., Soresi, M., Carroccio, A. et al. Lipoproteins and chronic pancreatitis. Pancreas 1994, 9(1): 137-8.
54. Gullo, L., Stella, A., Labriola, E., Costa, P.L., Descovich, G., Labo, G. Cardiovascular lesions in chronic pancreatitis: A prospective study. Dig Dis Sci 1982, 27(8): 716-22.
55. Gullo, L., Tassoni, U., Mazzoni, G., Stefanini, F. Increased prevalence of aortic calcification in chronic pancreatitis. Am J Gastroenterol 1996, 91(4): 759-61.
56. Dominguez-Munoz, J.E., Iglesias-Garcia, J. Oral pancreatic enzyme substitution therapy in chronic pancreatitis: Is clinical response an appropriate marker for evaluation of therapeutic efficacy? JOP 2010, 11(2): 158-62.
57. Trapnell, B.C., Maguiness, K., Graff, G.R., Boyd, D., Beckmann, K., Caras, S. Efficacy and safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros 2009 Dec, 8(6): 370-7.
58. Stern, R.C., Eisenberg, J.D., Wagener, J.S. et al. A comparison of the efficacy and tolerance of pancrelipase and placebo in the treatment of steatorrhea in cystic fibrosis patients with clinical exocrine pancreatic insufficiency. Am J Gastroenterol 2000, 95(8): 1932-8.
59. Waljee, A.K., Dimagno, M.J., Wu, B.U., Schoenfeld, P.S., Conwell, D.L. Systematic review: Pancreatic enzyme treatment of malabsorption associated with chronic pancreatitis. Aliment Pharmacol Ther 2009, 29(3): 235-46.
60. Safdi, M., Bekal, P.K., Martin, S., Saeed, Z.A., Burton, F., Toskes, P.P. The effects of oral pancreatic enzymes (Creon 10 capsule) on steatorrhea: A multicenter, placebo-controlled, parallel group trial in subjects with chronic pancreatitis. Pancreas 2006, 33(2): 156-62.
61. Graff, G.R., Maguiness, K., McNamara, J. et al. Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: A multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. Clin Ther 2010, 32(1): 89-103.
62. Whitcomb, D.C., Lehman, G.A., Vasileva, G. et al. Pancrelipase delayed-release capsules (Creon) for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery: A double-blind randomized trial. Am J Gastroenterol 2010, 105(10): 2276-86.
63. Wooldridge, J.L., Heubi, J.E., Amaro-Galvez, R. et al. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibres 2009, 8(6): 405-17.
64. Isaksson, G., Ihse, I. Pain reduction by an oral pancreatic enzyme preparation in chronic pancreatitis. Dig Dis Sci 1983, 28(2): 97-102.
65. Malesci, A., Gaia, E., Fioretta, A. et al. No effect of long-term treatment with pancreatic extract on recurrent abdominal pain in patients with chronic pancreatitis. Scand J Gastroenterol 1995, 30(4): 392-8.
66. Halgreen, H., Pedersen, N.T., Worning, H. Symptomatic effect of pancreatic enzyme therapy in patients with chronic pancreatitis. Scand J Gastroenterol 1986, 21(1): 104-8.
67. Winstead, N.S., Wilcox, C.M. Clinical trials of pancreatic enzyme replacement for painful chronic pancreatitis - A review. Pancreatology 2009, 9(4): 344-50.
68. Trolli, P.A., Conwell, D.L., Zuccaro, G., Jr. Pancreatic enzyme therapy and nutritional status of outpatients with chronic pancreatitis. Gastroenterol Nurs 2001, 24(2): 84-7.
69. Vuoristo, M., Vaananen, H., Miettinen, T.A. Cholesterol mal-absorption in pancreatic insufficiency: Effects of enzyme substitution. Gastroenterology 1992, 102(2): 647-55.
70. Pancreatin. Pancrelipase. United States Pharmacopeial Convention (Rockville, MD, 2007). United States Pharmacopeial Convention, Inc.
71. Carriere, F., Grandval, P., Gregory, P.C. et al. Does the pancreas really produce much more lipase than required for fat digestion? JOP 2005, 6(3): 206-15.
72. DiMagno, E.P., Go, V.L.W., Summerskill, W.H.J. Relations between pancreatic enzyme outputs and malabsorption in severe pancreatic insufficiency. N Engl J Med 1973, 288(16): 813-5.
73. DiMagno, E.P., Clain, J.E. (Eds.). The Exocrine Pancreas: Biology, Pathobiology, and Diseases. Raven Press: New York, 1993.
74. Ferrone, M., Raimondo, M., Scolapio, J.S. Pancreatic enzyme pharmacotherapy. Pharmacotherapy 2007, 27(6): 910-20.
75. DiMagno, E.P., Malagelada, J.R., Go, V.L., Moertel, C.G. Fate of orally ingested enzymes in pancreatic insufficiency. Comparison of two dosage schedules. N Engl J Med 1977, 296(23): 1318-22.
76. Dominguez-Munoz, J.E., Iglesias-Garcia, J., Iglesias-Rey, M., Figueiras, A., Vilarino-Insua, M. Effect of the administration schedule on the therapeutic efficacy of oral pancreatic enzyme supplements in patients with exocrine pancreatic insufficiency: A randomized, three-way crossover study. Aliment Pharmacol Ther 2005, 21(8): 993-1000.
77. Rämö, O.J., Puolakkainen, P.A., Seppälä, K., Schröder, T.M. Self-administration of enzyme substitution in the treatment of exocrine pancreatic insufficiency. Scand J Gastroenterol 1989, 24(6): 688-92.
78. Lankisch, P.G. What to do when a patient with exocrine pancreatic insufficiency does not respond to pancreatic enzyme substitution, a practical guide. Digestion 1999, 60 Suppl 1: 97-103.
79. Walkowiak, J., Nousia-Arvanitakis, S., Henker, J., Stern, M., Sinaasappel, M., Dodge, J.A. Indirect pancreatic function tests in children. J Pediatr Gastroenterol Nutr 2005, 40(2): 107-14.
80. Carroccio, A., Pardo, F., Montalto, G. et al. Use of famotidine in severe exocrine pancreatic insufficiency with persistent maldigestion on enzymatic replacement therapy. A long-term study in cystic fibrosis. Dig Dis Sci 1992, 37(9): 1441-6.
81. Heijerman, H.G., Lamers, C.B., Bakker, W. Omeprazole enhances the efficacy of pancreatin (pancrease) in cystic fibrosis. Ann Intern Med 1991, 114(3): 200-1.
82. Francisco, M.P., Wagner, M.H., Sherman, J.M., Theriaque, D., Bowser, E., Novak, D.A. Ranitidine and omeprazole as adjuvant therapy to pancrelipase to improve fat absorption in patients with cystic fibrosis. J Pediatr Gastroenterol Nutr 2002, 35(1): 79-83.
83. Dominguez-Munoz, J.E., Iglesias-Garcia, J., Iglesias-Rey, M., Vilarino-Insua, M. Optimising the therapy of exocrine pancreatic insufficiency by the association of a proton pump inhibitor to enteric coated pancreatic extracts. Gut 2006, 55(7): 1056-7.
84. Chowdhury, R.S., Forsmark, C.E., Davis, R.H., Toskes, P.P., Verne, G.N. Prevalence of gastroparesis in patients with small duct chronic pancreatitis. Pancreas 2003, 26(3): 235-8.
85. FitzSimmons, S.C., Burkhart, G.A., Borowitz, D. et al. High-dose pancreatic-enzyme supplements and fibrosing colonopathy in children with cystic fibrosis. N Engl J Med 1997, 336(18): 1283-9.
86. Prescott, P., Bakowski, M.T. Pathogenesis of fibrosing colonopathy: The role of methacrylic acid copolymer. Pharmacoepidemiol Drug Saf 1999, 8(6): 377-84.
87. van Velzen, D., Ball, L.M., Dezfulian, A.R., Southgate, A., Howard, C.V. Comparative and experimental pathology of fibrosing colonopathy. Postgrad Med J 1996, 72(Suppl. 2): S39-48.