Document Type
Article
Publication Date
2010
College/Unit
School of Medicine
Department/Program/Center
Medicine
Abstract
Background. Pancreatic enzyme replacement therapy is the standard of care for treatment of malabsorption in patients with cystic fibrosis (CF) and exocrine pancreatic insufficiency (PI). Aim. To evaluate efficacy and safety of a new formulation of pancrelipase (Ultrase MT20) in patients with CF and PI. Coefficients of fat absorption (CFA%) and nitrogen absorption (CNA%) were the main efficacy parameters. Safety was evaluated by monitoring laboratory analyses, adverse events (AEs), and overall signs and symptoms. Methods. Patients () were randomized in a crossover design comparing this pancrelipase with placebo during 2 inpatient evaluation periods (6-7 days each). Fat and protein/nitrogen ingestion and excretion were measured from food diaries and 72-hour stool collections. CFA% and CNA% were calculated for each period and compared. Results. Twenty-four patients provided analyzable data. This pancrelipase increased mean CFA% and CNA% (+34.7% and +25.7%, resp., for both), reduced stool frequency, and improved stool consistency compared with placebo. Placebo-treated patients reported more AEs, with gastrointestinal symptoms being the most frequently reported AE. Conclusions. This pancrelipase is a safe and effective treatment for malabsorption associated with exocrine PI in patients with CF.
Digital Commons Citation
Konstan, Michael W.; Liou, Theodore G.; Strausbaugh, Steven D.; Ahrens, Richard; Kanga, Jamshed F.; Graff, Gavin R.; Moffett, Kathryn; Millard, Susan L.; Nasr, Samya Z.; Simeon, Edith; Spenard, Jean; and Grondin, Josee, "Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic Fibrosis" (2010). Faculty & Staff Scholarship. 2837.
https://researchrepository.wvu.edu/faculty_publications/2837
Source Citation
Konstan, M. W., Liou, T. G., Strausbaugh, S. D., Ahrens, R., Kanga, J. F., Graff, G. R., Moffett, K., Millard, S. L., Nasr, S. Z., Siméon, É., Spénard, J., & Grondin, J. (2010). Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic Fibrosis. Gastroenterology Research and Practice, 2010, 1–7. https://doi.org/10.1155/2010/898193
Comments
Copyright © 2010 Michael W. Konstan et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.