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.