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.
OBJECTIVE
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.
Colombo
Carla
C
CF Center of Milano, Fondazione IRCCS Ospedale Policlinico, Mangiagalli, Regina Elena, Milano, and University of Milan, Milan, Italy. carla.colombo@unimi.it
Fredella
Clara
C
Russo
Maria Chiara
MC
Faelli
Nadia
N
Motta
Valentina
V
Valmarana
Lauretta
L
Longo
Luigina
L
D'Orazio
Ciro
C
D003550:Cystic Fibrosis / Q000150:complications*; D004041:Dietary Fats / Q000493:pharmacokinetics; D010188:Exocrine Pancreatic Insufficiency / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D005243:Feces / Q000737:chemistry; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007408:Intestinal Absorption / Q000187:drug effects / Q000502:physiology; D008286:Malabsorption Syndromes / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D008297:Male; D020799:Pancrelipase / Q000009:adverse effects / Q000627:therapeutic use*
D004041:Dietary Fats; D005765:Gastrointestinal Agents; D020799:Pancrelipase