Journal of Cystic Fibrosis
Volume 8, Issue 6 , Pages 370-377, December 2009

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

  • Bruce C. Trapnell

      Affiliations

    • Divisions of Pulmonary Biology and Pulmonary Medicine, 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
    • Corresponding Author InformationCorresponding author. University of Cincinnati, Cincinnati Children's Hospital Medical Center, Divisions of Pulmonary Biology and Pulmonary Medicine, and Division of Pulmonary, Sleep, and Critical Care Medicine, 3333 Burnet Avenue, Cincinnati, OH 45229. Tel.: (513) 6366361; fax: (513) 6363723.
    • ,
  • Karen Maguiness

      Affiliations

    • Section of Pediatric Pulmonology, Indiana University School of Medicine, 702 Barnhill Drive, ROC Room 4270, Indianapolis, IN, 46202, USA
    • ,
  • Gavin R. Graff

      Affiliations

    • Department of Pediatrics, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, 500 University Drive, PO Box 850, Hershey, PA, 17033-0850, USA
    • ,
  • David Boyd

      Affiliations

    • Solvay Pharmaceuticals, Inc., 1800 Parkway Place, Parkway Center, P1-3047, Marietta, GA, 30067, USA
    • ,
  • Katrin Beckmann

      Affiliations

    • Solvay Pharmaceuticals GmbH, Hans-Böckler-Allee 20, 30173 Hannover, Germany
    • ,
  • Steven Caras

      Affiliations

    • Solvay Pharmaceuticals, Inc., 1800 Parkway Place, Parkway Center, P1-3047, Marietta, GA, 30067, USA

Received 22 April 2009; received in revised form 20 August 2009; accepted 21 August 2009.

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 ≥12years 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.

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

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☆ Previously presented at Digestive Disease Week, May 30–Jun 04, 2009, Chicago, IL, USA, and the 32nd European Cystic Fibrosis Society Conference, June 10–13, 2009, Brest, France.

PII: S1569-1993(09)00122-2

doi:10.1016/j.jcf.2009.08.008

Journal of Cystic Fibrosis
Volume 8, Issue 6 , Pages 370-377, December 2009

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