title: Efficacy and safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis.
abstract: BACKGROUND
  Pancreatic enzyme replacement therapy is critical for adequate nutrition in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI).
  
  
  METHODS
  This was a double-blind, randomised, placebo-controlled, two-period crossover study assessing efficacy and safety of Creon 24,000-unit capsules in CF subjects > or =12 years with EPI. Patients were randomised to one of two 5-day sequences, Creon/placebo or placebo/Creon (target dose, 4000 lipase units/g fat). Primary outcome was the coefficient of fat absorption (CFA); secondary outcomes were coefficient of nitrogen absorption (CNA), symptoms, and safety.
  
  
  RESULTS
  Thirty-two subjects were randomised. Mean CFA and CNA were significantly greater with Creon than placebo (CFA, 88.6% vs. 49.6%; CNA, 85.1% vs. 49.9%; p<0.001 for both). Symptoms were improved and fewer treatment-emergent adverse events were reported with Creon than placebo. One patient discontinued for weight loss unrelated to study drug.
  
  
  CONCLUSIONS
  This study demonstrated Creon was effective in treating EPI due to CF and was safe and well tolerated.
authors.affiliation: Division of Pulmonary Biology, Cincinnati Children's Hospital Medical Center, and Division of Pulmonary, Sleep, and Critical Care Medicine, University of Cincinnati, 3333 Burnet Avenue, Cincinnati, OH, 45229-3039, USA. bruce.trapnell@cchmc.org
authors.forename: Bruce C
authors.initials: BC
authors.lastname: Trapnell
authors.forename: Karen
authors.initials: K
authors.lastname: Maguiness
authors.forename: Gavin R
authors.initials: GR
authors.lastname: Graff
authors.forename: David
authors.initials: D
authors.lastname: Boyd
authors.forename: Katrin
authors.initials: K
authors.lastname: Beckmann
authors.forename: Steven
authors.initials: S
authors.lastname: Caras
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D018592:Cross-Over Studies; D003550:Cystic Fibrosis / Q000150:complications / Q000188:drug therapy*; D010188:Exocrine Pancreatic Insufficiency / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism; D005223:Fats / Q000378:metabolism; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects; D008297:Male; D020799:Pancrelipase / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005223:Fats; D005765:Gastrointestinal Agents; D010919:Placebos; D020799:Pancrelipase