Display Settings:

Format

Send to:

Choose Destination
See comment in PubMed Commons below
J Cyst Fibros. 2009 Dec;8(6):370-7. doi: 10.1016/j.jcf.2009.08.008. Epub 2009 Oct 7.

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

Author information

  • 1Division 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

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.

PMID:
19815466
[PubMed - indexed for MEDLINE]
Free full text
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Icon for Elsevier Science
    Loading ...
    Write to the Help Desk