Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic Fibrosis. (4th November 2010)

• Record Type: Journal Article
• Authors: 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.; Siméon, Édith; Spénard, Jean; Grondin, Josée
• Other Names: Gionchetti Paolo Academic Editor.
• Is Part Of: Gastroenterology research and practice. Volume 2010(2010)
• Publication Date: 2010-11-04
• Subjects: Gastroenterology -- Periodicals; Digestive organs -- Diseases -- Periodicals; 616.33005
• DOI: 10.1155/2010/898193
• Languages: English
• ISSNs: 1687-6121

Abstract

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.