TY - JOUR
T1 - Efficacy and safety of Creon® 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis
AU - Trapnell, Bruce C.
AU - Maguiness, Karen
AU - Graff, Gavin
AU - Boyd, David
AU - Beckmann, Katrin
AU - Caras, Steven
N1 - Funding Information:
This study was funded by Solvay Pharmaceuticals, Inc. who designed the study and directed the data analysis. In addition, together with study investigators, Solvay Pharmaceuticals participated in the collection and interpretation of data, in the writing of the manuscript, and in the decision to submit the manuscript for publication.
Funding Information:
The authors thank Lorrie Duan for consultation and assistance in training study site personnel. Editorial support was provided by Ed Parr, PhD, Envision Scientific Solutions, Southport, CT and funded by Solvay Pharmaceuticals .
PY - 2009/12
Y1 - 2009/12
N2 - 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 ≥ 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.
AB - 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 ≥ 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.
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U2 - 10.1016/j.jcf.2009.08.008
DO - 10.1016/j.jcf.2009.08.008
M3 - Article
C2 - 19815466
AN - SCOPUS:70450221680
SN - 1569-1993
VL - 8
SP - 370
EP - 377
JO - Journal of Cystic Fibrosis
JF - Journal of Cystic Fibrosis
IS - 6
ER -