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Konstan MW, Liou TG, Strausbaugh SD, et al. Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic Fibrosis. Gastroenterol Res Pract. 2010;2010:898193doi: 10.1155/2010/898193.
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, E., 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, 2010898193. https://doi.org/10.1155/2010/898193
Konstan, Michael W, et al. "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 vol. 2010 (2010): 898193. doi: https://doi.org/10.1155/2010/898193
Konstan MW, Liou TG, Strausbaugh SD, Ahrens R, Kanga JF, Graff GR, Moffett K, Millard SL, Nasr SZ, Siméon E, Spénard J, Grondin J. Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic Fibrosis. Gastroenterol Res Pract. 2010;2010:898193. doi: 10.1155/2010/898193. Epub 2010 Dec 08. PMID: 21197074; PMCID: PMC3004382.
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Gastroenterol Res Pract. 2010;2010:898193. doi: 10.1155/2010/898193. Epub 2010 Dec 08.

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

Michael W Konstan, Theodore G Liou, Steven D Strausbaugh, Richard Ahrens, Jamshed F Kanga, Gavin R Graff, Kathryn Moffett, Susan L Millard, Samya Z Nasr, Edith Siméon, Jean Spénard, Josée Grondin

Affiliations

  1. Cystic Fibrosis Center, Rainbow Babies & Children's Hospital and Case Western Reserve University School of Medicine, 11100 Euclid Avenue, Cleveland, OH 44106, USA.

PMID: 21197074 PMCID: PMC3004382 DOI: 10.1155/2010/898193

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 (n = 31) 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., P < .0001 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.

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