Systematic review: Efficacy and safety of pancreatic enzyme supplements for exocrine pancreatic insufficiency

Alimentary Pharmacology and Therapeutics

Volumn 31, Issue 1, 2010, Pages 57-72

  Taylor, J R ^b   Gardner, T B ^c   Waljee, A K ^b   Dimagno, M J ^b   Schoenfeld, P S ^a,b,d  

^a VA ANN ARBOR HEALTHCARE SYSTEM   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^d VA Center for Excellence in Health Sciences Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PANCREAS ENZYME;

CLINICAL TRIAL; CROSSOVER PROCEDURE; DATA EXTRACTION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; EMBASE; GASTROINTESTINAL SYMPTOM; HUMAN; LIPID ABSORPTION; MALABSORPTION; MEDLINE; PANCREAS EXOCRINE INSUFFICIENCY; PRIORITY JOURNAL; REVIEW; SUPPLEMENTATION; SYSTEMATIC REVIEW; WEIGHT GAIN;

CROSS-OVER STUDIES; CYSTIC FIBROSIS; DIARRHEA; ENZYMES; EXOCRINE PANCREATIC INSUFFICIENCY; HUMANS; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 71449083547     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2009.04157.x     Document Type: Review

References (37)

1. Federal Register cited (69 82); Docket No. 2003N-0205. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-9652.htm (accessed 25 October 2009).
2. Waljee AK, Dimagno MJ, Wu BU, Schoenfeld PS, Conwell DL. Systematic review: pancreatic enzyme treatment of malabsorption associated with chronic pancreatitis. Aliment Pharmacol Ther 2009 29 : 235 246.
3. Francisco MP, Wagner MH, Sherman JM, Theriaque D, Bowser E, Novak DA. Ranitidine and omeprazole as adjuvant therapy to pancrelipase to improve fat absorption in patients with cystic fibrosis. J Pediatr Gastroenterol Nutr 2002 35 : 79 83.
4. Borowitz D, Konstan MW, O'Rourke A, Cohen M, Hendeles L, Murray FT. Coefficients of fat and nitrogen absorption in healthy subjects and individuals with cystic fibrosis. J Pediatr Pharmacol Ther 2007 12 : 47 52.
5. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996 17 : 1 12.
6. Armbrecht U, Svanvik J, Stockbrügger R. Enzyme substitution in chronic pancreatitis: effects on clinical and functional parameters and on the hydrogen (H2) breath test. Scand J Gastroenterol Suppl 1986 126 : 55 9.
7. Beverley DW, Kelleher J, MacDonald A, Littlewood JM, Robinson T, Walters MP. Comparison of four pancreatic extracts in cystic fibrosis. Arch Dis Child 1987 62 : 564 568.
8. Brady MS, Garson JL, Krug SK, et al. An enteric-coated high-buffered pancrelipase reduces steatorrhea in patients with cystic fibrosis: a prospective, randomized study. J Am Diet Assoc 2006 106 : 1181 1186.
9. Gullo L, Pezzilli A, Cassano A, Ligabue A, Ventrucci M. Clinical effectiveness of a new enteric-coated pancreatic enzyme extract in the treatment of pancreatic steatorrhea. Curr Ther Res 1988 44 : 105 109.
10. Halgreen H, Pedersen NT, Worning H. Symptomatic effect of pancreatic enzyme therapy in patients with chronic pancreatitis. Scand J Gastroenterol 1986 21 : 104 108.
11. Marotta F, Girdwood AH, Marks IN, O'Keefe SJD, Young GO. Enteric-coated pancreatic enzyme supplementation. A dose-response study. Pathophysiology 1995 2 : 247 250.
12. Mischler EH, Parrell S, Farrell PM, Odell GB. Comparison of effectiveness of pancreatic enzyme preparations in cystic fibrosis. Am J Dis Child 1982 136 : 1060 1063.
13. Morrison G, Morrison JM, Redmond AO, et al. Comparison between a standard pancreatic supplement and a high enzyme preparation in cystic fibrosis. Aliment Pharmacol Ther 1992 6 : 549 555.
14. Opekun AR Jr., Sutton FM Jr., Graham DY. Lack of dose-response with Pancrease MT for the treatment of exocrine pancreatic insufficiency in adults. Aliment Pharmacol Ther 1997 11 : 981 986.
15. Paris JC. A multicentre double-blind placebo-controlled study of the effect of a pancreatic enzyme formulation (Panzytrat 25000) on impaired lipid digestion in adults with chronic pancreatitis. Drug Investig 1993 5 : 229 237.
16. Pasquali C, Fogar P, Sperti C, Basso D. Efficacy of a pancreatic enzyme formulation in the treatment of steatorrhea in patients with chronic pancreatitis. Curr Ther Res 1996 57 : 358 365.
17. Patchell CJ, Desai M, Weller PH, et al. Creon 10,000 Minimicrospheres vs. Creon 8,000 microspheres - an open randomised crossover preference study. J Cyst Fibros 2002 1 : 287 291.
18. Robinson PJ, Olinsky A, Smith AL, Chitravanshi SB. High compared with standard dose lipase pancreatic supplement. Arch Dis Child 1989 64 : 143 145.
19. Shah A, Dinwiddie R, Madge S, Prescott P, Hudson G. High dose Nutrizym 22 in cystic fibrosis. Eur J Pediatr 1993 152 : 763 764.
20. Thomson M, Clague A, Cleghorn GJ, Shepherd RW. Comparative in vitro and in vivo studies of enteric-coated pancrelipase preparations for pancreatic insufficiency. J Pediatr Gastroenterol Nutr 1993 17 : 407 413.
21. Vantini I, Fioretta A, Caliari S, Benini L, Brentegani MT, Castellani G. Effects of two pancreatic enzyme-containing enteric-coated microsphere preparations on steatorrhea in chronic alcoholic pancreatitis. Curr Ther Res 1990 48 : 268 274.
22. Vyas H, Matthew DJ, Milla PJ. A comparison of enteric coated microspheres with enteric coated tablet pancreatic enzyme preparations in cystic fibrosis. A controlled study. Eur J Pediatr 1990 149 : 241 243.
23. Bowler IM, Wolfe SP, Owens HM, Sheldon TA, Littlewood JM, Walters MP. A double blind lipase for lipase comparison of a high lipase and standard pancreatic enzyme preparation in cystic fibrosis. Arch Dis Child 1993 68 : 227 230.
24. Delchier JC, Vidon N, Saint-Marc Girardin MF, et al. Fate of orally ingested enzymes in pancreatic insufficiency: comparison of two pancreatic enzyme preparations. Aliment Pharmacol Ther 1991 5 : 365 378.
25. Delhaye M, Meuris S, Gohimont AC, Buedts K, Cremer M. Comparative evaluation of a high lipase pancreatic enzyme preparation and a standard pancreatic supplement for treating exocrine pancreatic insufficiency in chronic pancreatitis. Eur J Gastroenterol Hepatol 1996 8 : 699 703.
26. Dutta SK, 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 : 476 482.
27. Gan KH, Heijerman HG, Geus WP, Bakker W, Lamers CB. Comparison of a high lipase pancreatic enzyme extract with a regular pancreatin preparation in adult cystic fibrosis patients. Aliment Pharmacol Ther 1994 8 : 603 607.
28. Gouerou H, Dain MP, Parrondo I, Poisson D, Bernades P. Alipase versus nonenteric-coated enzymes in pancreatic insufficiency. A french multicenter crossover comparative study. Int J Pancreatol 1989 5 : 45 50.
29. Halm U, Loser C, Lohr M, Katschinski M, Mossner J. A double-blind, randomized, multicentre, crossover study to prove equivalence of pancreatin minimicrospheres versus microspheres in exocrine pancreatic insufficiency. Aliment Pharmacol Ther 1999 13 : 951 957.
30. Kalnins D, Ellis L, Corey M, et al. Enteric-coated pancreatic enzyme with bicarbonate is equal to standard enteric-coated enzyme in treating malabsorption in cystic fibrosis. J Pediatr Gastroenterol Nutr 2006 42 : 256 261.
31. Konstan MW, Stern RC, Trout JR, et al. Ultrase MT12 and Ultrase MT20 in the treatment of exocrine pancreatic insufficiency in cystic fibrosis: safety and efficacy. Aliment Pharmacol Ther 2004 20 : 1365 1371.
32. Lancellotti L, Cabrini G, Zanolla L, Mastella G. High- versus low-lipase acid-resistant enzyme preparations in cystic fibrosis: a crossover randomized clinical trial. J Pediatr Gastroenterol Nutr 1996 22 : 73 8.
33. Santini B, Antonelli M, Battistini A, et al. Comparison of two enteric coated microsphere preparations in the treatment of pancreatic exocrine insufficiency caused by cystic fibrosis. Dig Liver Dis 2000 32 : 406 411.
34. Williams J, MacDonald A, Weller PH, Fields J, Pandov H. Two enteric coated microspheres in cystic fibrosis. Arch Dis Child 1990 65 : 594 597.
35. DiMagno EP. Gastric acid suppression and treatment of severe exocrine pancreatic insufficiency. Best Pract Res Clin Gastroenterol 2001 15 : 477 486.
36. Safdi M, Bekal PK, Martin S, Saeed ZA, Burton F, Toskes PP. 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 : 156 162.
37. Yadav D, Hawes RH, Brand RE, et al. Alcohol consumption, cigarette smoking, and the risk of recurrent acute and chronic pancreatitis. Arch Intern Med 2009 169 : 1035 1045.