Efficacy and safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis.
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.
Trapnell
Bruce C
BC
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
Maguiness
Karen
K
Graff
Gavin R
GR
Boyd
David
D
Beckmann
Katrin
K
Caras
Steven
S
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
D005223:Fats; D005765:Gastrointestinal Agents; D010919:Placebos; D020799:Pancrelipase