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

Carla Colombo, Clara Fredella, Maria Chiara Russo, Nadia Faelli, Valentina Motta, Lauretta Valmarana, Luigina Longo, Ciro D'Orazio

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)693-699
Number of pages7
JournalPancreas
Volume38
Issue number6
DOIs
Publication statusPublished - Aug 2009

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Keywords

  • Clinical trial
  • Coefficient of fat absorption
  • Cystic fibrosis
  • Infants
  • Pancreatic enzyme replacement therapy
  • Pancreatic exocrine insufficiency

ASJC Scopus subject areas

  • Hepatology
  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

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