TY - JOUR
T1 - Efficacy and tolerability of creon for children in infants and toddlers with pancreatic exocrine insufficiency caused by cystic fibrosis
T2 - An open-label, single-arm, multicenter study
AU - Colombo, Carla
AU - Fredella, Clara
AU - Russo, Maria Chiara
AU - Faelli, Nadia
AU - Motta, Valentina
AU - Valmarana, Lauretta
AU - Longo, Luigina
AU - D'Orazio, Ciro
PY - 2009/8
Y1 - 2009/8
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Coefficient of fat absorption
KW - Cystic fibrosis
KW - Infants
KW - Pancreatic enzyme replacement therapy
KW - Pancreatic exocrine insufficiency
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U2 - 10.1097/MPA.0b013e3181a85eaf
DO - 10.1097/MPA.0b013e3181a85eaf
M3 - Article
C2 - 19531972
AN - SCOPUS:68949083239
VL - 38
SP - 693
EP - 699
JO - Pancreas
JF - Pancreas
SN - 0885-3177
IS - 6
ER -