Colombo C, Fredella C, Russo MC, Faelli N, Motta V, Valmarana L, Longo L, D'Orazio C
Efficacy and Tolerability of Creon for Children in Infants and Toddlers With Pancreatic Exocrine Insufficiency Caused by Cystic Fibrosis: An Open-Label, Single-Arm, Multicenter Study. [JOURNAL ARTICLE]
Pancreas 2009 Jun 12.
OBJECTIVES:: To evaluate the efficacy and safety of a pancreatic enzyme preparation specifically developed for infants and small children with cystic fibrosis (CF).
METHODS:: Twelve patients with CF younger than 24 months with pancreatic exocrine insufficiency and a coefficient of fat absorption (CFA) less than 70% were treated with Creon for Children (Solvay Pharmaceuticals GmbH, Hannover, Germany) minimicrospheres for 8 weeks. The primary end point was the mean change from baseline in the CFA after 2 weeks of treatment, based on 72-hour fat balance assessments.
RESULTS:: Two weeks' treatment with Creon for Children resulted in a significant increase in the mean CFA from 58.0% at baseline to 84.7% (P = 0.0013) in the full analysis sample. There was a significant reduction of mean stool fat (from 13.3 to 5.3 g/d; P = 0.001) and mean fecal energy loss (from 238.5 to 137.9 kJ/d; P = 0.018) at 2 weeks. Dietary fat intake did not change, whereas an improvement was observed in stool frequency and characteristics. Patient weight and height increased over 8 weeks of treatment. No serious adverse event was reported.
CONCLUSIONS:: Creon for Children was well tolerated and significantly decreased fat malabsorption in infants with pancreatic exocrine insufficiency due to CF.
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