Efficacy and safety of PANCREAZE ® for treatment of exocrine pancreatic insufficiency due to cystic fibrosis

Journal of Cystic Fibrosis

Volumn 10, Issue 5, 2011, Pages 350-356

  Trapnell, Bruce C ^a,b   Strausbaugh, Steven D ^c   Woo, Marlyn S ^d   Tong, Shin Yir ^e   Silber, Steven A ^e   Mulberg, Andrew E ^e   Leitz, Gerhard ^e  

^a CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^b UNIVERSITY OF CINCINNATI MEDICAL CENTER   (United States)

^c CASE WESTERN RESERVE UNIVERSITY   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Coefficient of fat absorption; Cystic fibrosis; Exocrine pancreatic insufficiency; Pancreatic enzyme replacement therapy; PANCREAZE ; Pancrelipase

Indexed keywords

HISTAMINE H2 RECEPTOR ANTAGONIST; PANCREAZE; PANCRELIPASE; PLACEBO; PROTON PUMP INHIBITOR; UNCLASSIFIED DRUG;

ABNORMAL FECES; ADOLESCENT; ADULT; ARTICLE; CHILD; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; CYSTIC FIBROSIS; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENZYME REPLACEMENT; FEMALE; FLATULENCE; GASTROINTESTINAL ABSORPTION; HUMAN; LIPID ABSORPTION; LIPID DIET; MALE; NITROGEN METABOLISM; OPEN STUDY; PANCREAS EXOCRINE INSUFFICIENCY; PANCREATIC ENZYME REPLACEMENT THERAPY; PROTEIN ABSORPTION; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; UNSPECIFIED SIDE EFFECT; UPPER ABDOMINAL PAIN;

ADOLESCENT; ADULT; CHILD; CYSTIC FIBROSIS; EXOCRINE PANCREATIC INSUFFICIENCY; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; MALE; MIDDLE AGED; PANCREAS, EXOCRINE; PANCRELIPASE; PLACEBOS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 80052481755     PISSN: 15691993     EISSN: 18735010     Source Type: Journal    
DOI: 10.1016/j.jcf.2011.04.005     Document Type: Article

References (18)

1. Mascarenhas M.R. Treatment of gastrointestinal problems in cystic fibrosis. Curr Treat Options Gastroenterol 2003, 6:427-441.
2. Baker S.S., Borowitz D., Baker R.D. Pancreatic exocrine function in patients with cystic fibrosis. Curr Gastroenterol Rep 2005, 7:227-233.
3. Stern R.C., Eisenberg J.D., Wagener J.S., Ahrens R., Rock M., doPico G., 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, 95:1932-1938.
4. 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, 8:370-377.
5. Wooldridge J.L., Heubi J.E., Amaro-Galvez R., Boas S.R., Blake K.V., Nasr S.Z., et al. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros 2009, 8:405-417.
6. Graff G.R., Maguiness K., McNamara J., Morton R., Boyd D., Beckmann K., et al. Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. Clin Ther 2010, 32:89-103.
7. FitzSimmons S.C., Burkhart G.A., Borowitz D., Grand R.J., Hammerstrom T., Durie P.R., et al. High-dose pancreatic-enzyme supplements and fibrosing colonopathy in children with cystic fibrosis. N Engl J Med 1997, 336:1283-1289.
8. U. S. Food and Drug Administration. Questions and Answers: Delayed-Release Pancreatic Enzyme Product Receives FDA Approval. [Accessed on March 24, 2010]; Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm149337.htm.
9. Department of Health and Human Services, Food and Drug Administration. Exocrine pancreatic insufficiency drug products; extension to obtain marketing approval. [Accessed on March 25, 2010]; Available from: http://www.fda.gov/ohrms/dockets/dockets/03n0205/03n-0205-n000002.pdf.
10. PANCREAZE™ prescribing information [updated April 2006Accessed on March 19, 2010]; Available from:. http://www.mcneilpediatrics.net/sites/default/files/pdf/shared/pi/pancrease_mt.pdf%23zoom=100%25.
11. Stallings V.A., Stark L.J., Robinson K.A., Feranchak A.P., Quinton H. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. J Am Diet Assoc 2008, 108:832-839.
12. Beker L.T., Fink R.J., Shamsa F.H., Chaney H.R., Kluft J., Evans E., et al. Comparison of weight-based dosages of enteric-coated microtablet enzyme preparations in patients with cystic fibrosis. J Pediatr Gastroenterol Nutr 1994, 19:191-197.
13. 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, 62:564-568.
14. Brady M.S., Rickard K., Yu P.L., Eigen H. Effectiveness and safety of small vs. large doses of enteric coated pancreatic enzymes in reducing steatorrhea in children with cystic fibrosis: a prospective randomized study. Pediatr Pulmonol 1991, 10:79-85.
15. Chazalette J.P., Dain M.P., Castaigne J.P. Efficacy of pancrease: crossover comparative study versus eurobiol in cystic fibrosis. J Pediatr Gastroenterol Nutr 1988, 7(Suppl. 1):S46-S48.
16. Borowitz D. Update on the evaluation of pancreatic exocrine status in cystic fibrosis. Curr Opin Pulm Med 2005, 11:524-527.
17. Baker S.S. Delayed release pancrelipase for the treatment of pancreatic exocrine insufficiency associated with cystic fibrosis. Ther Clin Risk Manage 2008, 4:1079-1084.
18. Borowitz D., Baker R.D., Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. J Pediatr Gastroenterol Nutr 2002, 35:246-259.