title: Safety and efficacy of Creon® micro in children with exocrine pancreatic insufficiency due to cystic fibrosis.
abstract: BACKGROUND
  Pancreatic enzyme replacement therapy is the foundation of nutritional management for exocrine pancreatic insufficiency (EPI).
  
  
  METHODS
  A 3-month, open-label, multicentre study in Russia assessing safety, efficacy, and ease-of-use of Creon(®) Micro (5000 lipase units/spoon) in children aged 1 month to <4 years with EPI due to cystic fibrosis. Efficacy assessments included growth parameters.
  
  
  RESULTS
  All 40 subjects (mean age 26.5 months) completed treatment. Adverse events occurred in 40% of the subjects (most commonly respiratory tract infection [15%], frequent bowel movements [8%], rhinitis, stomatitis, nasopharyngitis, and diarrhoea [all 5%]), none were serious or led to discontinuation. After 3 months, mean±SD increases from baseline z-scores were height/length-for-age 0.13±0.48, weight-for-age 0.20±0.39, and BMI-for-age 0.29±0.65. Treatment was rated 'easy' to administer by 95% caregivers and acceptance 'good'/'very good' by 90%.
  
  
  CONCLUSIONS
  Creon Micro was well tolerated. Growth development parameters increased over the 3-month treatment period. Treatment was considered easy to use and acceptance was good.
authors: Department of Cystic Fibrosis, Research Centre for Medical Genetics RAMS, Moskvorechye str. 1, Moscow 115478, Russia. Electronic address: kashirskayanj@mail.ru.
authors: Nataliya Y
authors: NY
authors: Kashirskaya
authors: Department of Cystic Fibrosis, Research Centre for Medical Genetics RAMS, Moskvorechye str. 1, Moscow 115478, Russia. Electronic address: nikolay.i.kapranov@gmail.com.
authors: Nikolay I
authors: NI
authors: Kapranov
authors: Abbott Laboratories GmbH, Freundallee 9A, 30173 Hannover, Germany. Electronic address: suntje.sander@abbott.com.
authors: Suntje
authors: S
authors: Sander-Struckmeier
authors: Abbott Laboratories, Leningradskoye shosse 16A, Moscow 125171, Russia. Electronic address: vladimir.kovalev@abbott.com.
authors: Vladimir
authors: V
authors: Kovalev
mesh_terms: D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000150:complications*; D003967:Diarrhea / Q000209:etiology; D004304:Dosage Forms; D056947:Enzyme Replacement Therapy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D010188:Exocrine Pancreatic Insufficiency / Q000209:etiology / Q000628:therapy; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007223:Infant; D008297:Male; D010194:Pancreatin / Q000008:administration & dosage / Q000009:adverse effects; D012141:Respiratory Tract Infections / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D004304:Dosage Forms; D005765:Gastrointestinal Agents; D010194:Pancreatin
keywords: Clinical trial; Creon; Cystic fibrosis; Exocrine pancreatic insufficiency; Pancreatic enzyme replacement therapy; Pancreatin