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.

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.

• Authors: Carla Colombo, Clara Fredella, Maria Chiara Russo, Nadia Faelli, Valentina Motta, Lauretta Valmarana, Luigina Longo, Ciro D'Orazio
• Journal: Pancreas (Pancreas) Vol. 38 Issue 6 Pg. 693-9 (Aug 2009) ISSN: 1536-4828 [Electronic] United States
• PMID: 19531972 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Dietary Fats
• Gastrointestinal Agents
• Pancrelipase

Topics

• Cystic Fibrosis (complications)
• Dietary Fats (pharmacokinetics)
• Exocrine Pancreatic Insufficiency (drug therapy, etiology, physiopathology)
• Feces (chemistry)
• Female
• Gastrointestinal Agents (adverse effects, therapeutic use)
• Humans
• Infant
• Intestinal Absorption (drug effects, physiology)
• Malabsorption Syndromes (drug therapy, etiology, physiopathology)
• Male
• Pancrelipase (adverse effects, therapeutic use)