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Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic Fibrosis
Joint Authors
Graff, Gavin R.
Kanga, Jamshed F.
Spénard, Jean
Nasr, Samya Z.
Konstan, Michael W.
Moffett, Kathryn
Strausbaugh, Steven D.
Siméon, Édith
Liou, Theodore G.
Grondin, Josée
Ahrens, Richard
Millard, Susan L.
Source
Gastroenterology Research and Practice
Issue
Vol. 2010, Issue 2010 (31 Dec. 2010), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2010-12-08
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Konstan, Michael W.& Liou, Theodore G.& Strausbaugh, Steven D.& Ahrens, Richard& Kanga, Jamshed F.& Graff, Gavin R.…[et al.]. 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،Vol. 2010, no. 2010, pp.1-7.
https://search.emarefa.net/detail/BIM-506450
Modern Language Association (MLA)
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 No. 2010 (2010), pp.1-7.
https://search.emarefa.net/detail/BIM-506450
American Medical Association (AMA)
Konstan, Michael W.& Liou, Theodore G.& Strausbaugh, Steven D.& Ahrens, Richard& Kanga, Jamshed F.& Graff, Gavin R.…[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. 2010. Vol. 2010, no. 2010, pp.1-7.
https://search.emarefa.net/detail/BIM-506450
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-506450