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Volumn 8, Issue 6, 2009, Pages 370-377

Efficacy and safety of Creon® 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis

Author keywords

Coefficient of fat absorption; Coefficient of nitrogen absorption; Pancreatic enzyme replacement therapy; Pancreatin; Pancrelipase; Randomised, controlled trial

Indexed keywords

KREON; LIPID; NITROGEN; PLACEBO;

EID: 70450221680     PISSN: 15691993     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jcf.2009.08.008     Document Type: Article
Times cited : (60)

References (23)
  • 3
    • 21444443190 scopus 로고    scopus 로고
    • Pancreatic exocrine function in patients with cystic fibrosis
    • Baker S.S., Borowitz D., and Baker R.D. Pancreatic exocrine function in patients with cystic fibrosis. Curr Gastroenterol Rep 7 (2005) 227-233
    • (2005) Curr Gastroenterol Rep , vol.7 , pp. 227-233
    • Baker, S.S.1    Borowitz, D.2    Baker, R.D.3
  • 4
    • 70450224817 scopus 로고    scopus 로고
    • Nutrition in cystic fibrosis
    • Koletzko B. (Ed), Karger, Basel, Switzerland
    • Wilschanski M. Nutrition in cystic fibrosis. In: Koletzko B. (Ed). Pediatric Nutrition in Practice (2008), Karger, Basel, Switzerland 224-228
    • (2008) Pediatric Nutrition in Practice , pp. 224-228
    • Wilschanski, M.1
  • 5
    • 33746853011 scopus 로고    scopus 로고
    • The effects of oral pancreatic enzymes (Creon 10 capsule) on steatorrhea: a multicenter, placebo-controlled, parallel group trial in subjects with chronic pancreatitis
    • Safdi M., Bekal P.K., Martin S., Saeed Z.A., Burton F., and 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 33 (2006) 156-162
    • (2006) Pancreas , vol.33 , pp. 156-162
    • Safdi, M.1    Bekal, P.K.2    Martin, S.3    Saeed, Z.A.4    Burton, F.5    Toskes, P.P.6
  • 7
    • 0033897668 scopus 로고    scopus 로고
    • 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
    • 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 95 (2000) 1932-1938
    • (2000) Am J Gastroenterol , vol.95 , pp. 1932-1938
    • Stern, R.C.1    Eisenberg, J.D.2    Wagener, J.S.3    Ahrens, R.4    Rock, M.5    doPico, G.6
  • 8
    • 0030905117 scopus 로고    scopus 로고
    • High-dose pancreatic enzyme supplements and fibrosing colonopathy in children with cystic fibrosis
    • 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. New Engl J Med 336 (1997) 1283-1289
    • (1997) New Engl J Med , vol.336 , pp. 1283-1289
    • FitzSimmons, S.C.1    Burkhart, G.A.2    Borowitz, D.3    Grand, R.J.4    Hammerstrom, T.5    Durie, P.R.6
  • 9
    • 70450222857 scopus 로고    scopus 로고
    • Published April 27, Accessed March 9, 2009
    • U.S. Food and Drug Administration. Questions and answers on exocrine pancreatic insufficiency drug products. http://www.fda.gov/CDER/DRUG/infopage/pancreatic_drugs/pancreatic_QA.htm . Published April 27, 2004. Accessed March 9, 2009.
    • (2004) Questions and answers on exocrine pancreatic insufficiency drug products
  • 10
    • 70450223474 scopus 로고    scopus 로고
    • FDA requires pancreatic extract manufacturers to submit marketing applications
    • Published April 27, Accessed 8 August 2008
    • U.S. Food and Drug Administration. FDA requires pancreatic extract manufacturers to submit marketing applications. FDA News. http://www.fda.gov/bbs/topics/news/2004/NEW01058.html. Published April 27, 2004. Accessed 8 August 2008.
    • (2004) FDA News
  • 11
    • 70450222656 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration Center for Drug Evaluation and Research, Published April 13, Accessed March 9 2009
    • U.S. Food and Drug Administration Center for Drug Evaluation and Research. Guidance for Industry: Exocrine Pancreatic Insufficiency Drug Products - Submitting NDAs. http://www.fda.gov/cder/guidance/6275fnl.htm. Published April 13, 2006. Accessed March 9 2009.
    • (2006) Guidance for Industry: Exocrine Pancreatic Insufficiency Drug Products - Submitting NDAs
  • 12
    • 70450221454 scopus 로고    scopus 로고
    • Efficacy and safety of a new formulation of CREON® in patients with exocrine pancreatic insufficiency due to CF
    • Trapnell B.C., Maguiness K., and Graff G.R. Efficacy and safety of a new formulation of CREON® in patients with exocrine pancreatic insufficiency due to CF. J Cystic Fibrosis 8 (2009) S80
    • (2009) J Cystic Fibrosis , vol.8
    • Trapnell, B.C.1    Maguiness, K.2    Graff, G.R.3
  • 13
    • 0036735017 scopus 로고    scopus 로고
    • Consensus report on nutrition for pediatric patients with cystic fibrosis
    • Borowitz D., Baker R.D., and Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. J Pediatr Gastroenterol Nutr 35 (2002) 246-259
    • (2002) J Pediatr Gastroenterol Nutr , vol.35 , pp. 246-259
    • Borowitz, D.1    Baker, R.D.2    Stallings, V.3
  • 15
    • 42649103313 scopus 로고    scopus 로고
    • Clinical Practice Guidelines on Growth and Nutrition Subcommittee; Ad Hoc Working Group. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review
    • Stallings V.A., Stark L.J., Robinson K.A., Feranchak A.P., and Quinton H. Clinical Practice Guidelines on Growth and Nutrition Subcommittee; Ad Hoc Working Group. 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 108 (2008) 832-839
    • (2008) J Am Diet Assoc , vol.108 , pp. 832-839
    • Stallings, V.A.1    Stark, L.J.2    Robinson, K.A.3    Feranchak, A.P.4    Quinton, H.5
  • 17
    • 34447599642 scopus 로고
    • A new method for the determination of nitrogen in organic matter
    • Kjeldahl J.T. A new method for the determination of nitrogen in organic matter. Z Anal Chem 22 (1883) 366-382
    • (1883) Z Anal Chem , vol.22 , pp. 366-382
    • Kjeldahl, J.T.1
  • 18
    • 0035041926 scopus 로고    scopus 로고
    • Antipsychotic-induced weight gain: a review of the literature
    • Allison D.B., and Casey D.E. Antipsychotic-induced weight gain: a review of the literature. J Clin Psychiatry 62 Suppl 7 (2001) 22-31
    • (2001) J Clin Psychiatry , vol.62 , Issue.SUPPL. 7 , pp. 22-31
    • Allison, D.B.1    Casey, D.E.2
  • 19
    • 0037034257 scopus 로고    scopus 로고
    • The Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin
    • Knowler W.C., Barrett-Connor E., Fowler S.E., Hamman R.F., Lachin J.M., Walker E.A., et al. The Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 346 (2002) 393-403
    • (2002) N Engl J Med , vol.346 , pp. 393-403
    • Knowler, W.C.1    Barrett-Connor, E.2    Fowler, S.E.3    Hamman, R.F.4    Lachin, J.M.5    Walker, E.A.6
  • 21
    • 70450223269 scopus 로고    scopus 로고
    • 246 EUR-1008 (a new pancreatic enzyme product, PEP) was shown to be safe and effective in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI)
    • Heubi J.E., Boas S.R., Blake K., Nasr S.Z., Woo M.S., Graff G.R., et al. 246 EUR-1008 (a new pancreatic enzyme product, PEP) was shown to be safe and effective in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). J Cystic Fibrosis 6 (2007) S61
    • (2007) J Cystic Fibrosis , vol.6
    • Heubi, J.E.1    Boas, S.R.2    Blake, K.3    Nasr, S.Z.4    Woo, M.S.5    Graff, G.R.6
  • 22
    • 33751119814 scopus 로고    scopus 로고
    • Study of a novel pancreatic enzyme replacement therapy in pancreatic insufficient subjects with cystic fibrosis
    • Borowitz D., Goss C.H., Limauro S., Konstan M.W., Blake K., Casey S., et al. Study of a novel pancreatic enzyme replacement therapy in pancreatic insufficient subjects with cystic fibrosis. J Pediatr 149 (2006) 658-662
    • (2006) J Pediatr , vol.149 , pp. 658-662
    • Borowitz, D.1    Goss, C.H.2    Limauro, S.3    Konstan, M.W.4    Blake, K.5    Casey, S.6
  • 23
    • 70450222856 scopus 로고    scopus 로고
    • In vitro comparison of physical parameters, enzyme activity, acid resistance, and pH dissolution characteristics of enteric-coated pancreatic enzyme preparations: implications for clinical variability and pharmacy substitution
    • Kuhn R.J., Eyting S., Henniges F., and Potthoff A. In vitro comparison of physical parameters, enzyme activity, acid resistance, and pH dissolution characteristics of enteric-coated pancreatic enzyme preparations: implications for clinical variability and pharmacy substitution. J Pediatr Pharmacol Ther 12 (2007) 115-128
    • (2007) J Pediatr Pharmacol Ther , vol.12 , pp. 115-128
    • Kuhn, R.J.1    Eyting, S.2    Henniges, F.3    Potthoff, A.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.