Efficacy and safety of a new formulation of pancrelipase (Ultrase MT20) in the treatment of malabsorption in exocrine pancreatic insufficiency in cystic fibrosis

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, Édith Siméon, Jean Spénard, Josée Grondin

Research output: Contribution to journalArticle

5 Citations (Scopus)

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.

Original languageEnglish (US)
Article number898193
JournalGastroenterology Research and Practice
DOIs
StatePublished - Dec 1 2010

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Pancrelipase
Exocrine Pancreatic Insufficiency
Cystic Fibrosis
Safety
Fats
Placebos
Nitrogen
Therapeutics
Enzyme Replacement Therapy
Diet Records
Standard of Care
Cross-Over Studies
Signs and Symptoms
Inpatients
Eating

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cite this

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. / Efficacy and safety of a new formulation of pancrelipase (Ultrase MT20) in the treatment of malabsorption in exocrine pancreatic insufficiency in cystic fibrosis. In: Gastroenterology Research and Practice. 2010.
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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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Efficacy and safety of a new formulation of pancrelipase (Ultrase MT20) in the treatment of malabsorption in exocrine pancreatic insufficiency in cystic fibrosis. / 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.

In: Gastroenterology Research and Practice, 01.12.2010.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of a new formulation of pancrelipase (Ultrase MT20) in the treatment of malabsorption in exocrine pancreatic insufficiency in cystic fibrosis

AU - Konstan, Michael W.

AU - Liou, Theodore G.

AU - Strausbaugh, Steven D.

AU - Ahrens, Richard

AU - Kanga, Jamshed F.

AU - Graff, Gavin R.

AU - Moffett, Kathryn

AU - Millard, Susan L.

AU - Nasr, Samya Z.

AU - Siméon, Édith

AU - Spénard, Jean

AU - Grondin, Josée

PY - 2010/12/1

Y1 - 2010/12/1

N2 - 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.

AB - 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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