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
Articolo
Data di Pubblicazione:
2009
Citazione:
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 / C. Colombo, D. Costantini, N. Faelli, V. Motta, R. Valmarana, L. Longo, S. Schiavon, C. D’Orazio. - In: PANCREAS. - ISSN 0885-3177. - 38:6(2009 Aug), pp. 693-699. [10.1097/MPA.0b013e3181a85eaf]
Abstract:
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.
Tipologia IRIS:
01 - Articolo su periodico
Elenco autori:
C. Colombo, D. Costantini, N. Faelli, V. Motta, R. Valmarana, L. Longo, S. Schiavon, C. D’Orazio
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