Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic Fibrosis

Authors

Michael W. Konstan, Rainbow Babies & Children's Hospital and Case Western Reserve University School of Medicine
Theodore G. Liou, The University of Utah
Steven D. Strausbaugh, Rainbow Babies & Children's Hospital and Case Western Reserve University School of Medicine
Richard Ahrens, The University of Iowa Hospitals and Clinics
Jamshed F. Kanga, University of Kentucky
Gavin R. Graff, The Pennsylvania State University
Kathryn Moffett, West Virginia University
Susan L. Millard, Helen DeVos Children's Hospital-Spectrum Health
Samya Z. Nasr, The University Of Michigan
Edith Simeon, Quintiles Canada Inc.
Jean Spenard, Université de Montréal
Josee Grondin, Axcan Pharma Inc.

Author ORCID Identifier

https://orcid.org/0000-0002-0557-7277

https://orcid.org/0000-0003-0121-4847

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https://orcid.org/0000-0003-0191-5205

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https://orcid.org/0000-0002-4124-316X

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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.