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primary studies published RCT

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

  • Year: 2010
  • Date: 2010
  • Author: Konstan MW
Source

Gastroenterol Res Pract. 2010;2010:898193. Epub 2010 Dec 8

Study design (if review, criteria of inclusion for studies)

RCT

Participants

CF Patients (n = 31). Exocrine Pancreatic Insufficiency

Interventions

Patients were randomized in a crossover design comparing this pancrelipase with placebo during 2 inpatient evaluation periods (6-7 days each).

Outcome measures

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.

Main 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.

Authors' conclusions

This pancrelipase is a safe and effective treatment for malabsorption associated with exocrine PI in patients with CF.

Keywords: ULTRASE; Pancreatic Enzyme Replacement Therapy; pharmacological_intervention; Pancreas insufficiency; Pancreatic Diseases; Gastrointestinal Diseases; Gastrointestinal Agents; Pancrelipase;