Comparing Pancreatic Enzyme Products for Patients with Cystic Fibrosis

APRIL 06, 2016
Andrew Smith
A trial of the pancrelipase formulation Zenpep found the product to be as safe and effective as Creon for the treatment of exocrine pancreatic insufficiency in cystic fibrosis patients aged 12 years and older.
Investigators randomized 96 patients (mean baseline age, 19.2 years; 60.4% male) between the 2 products and then switched patients from 1 product to the other halfway through the trial. All patients were on stabilized treatment plans and ate standardized diets throughout the trial, which compared 25,000 lipase-unit doses of the 2 time-released enzyme supplements.
In all, 83 of the patients completed both sequences of the trial, which used coefficient of fat absorption over 72 hours as its primary efficacy endpoint. Analysis of lab test results found the least squared mean for the coefficient of fat absorption to be 84.1% (SE, 1.1) among Zenpep users and 85.3% (SE, 1.1) among Creon users (p = 0.297).
“Zenpep is comparable with Creon in efficacy and safety for the treatment of adolescents and adults with cystic fibrosis-associated exocrine pancreatic insufficiency,” the study authors wrote in the Journal of Cystic Fibrosis.
Zenpep — like Creon, Pancreaze, Ultresa, Viokace and Pertzyle — contains a mixture of digestive enzymes (including lipases, proteases, and amylases) extracted from pig pancreases and used to help people with exocrine pancreatic insufficiency digest fats, proteins and sugars.
Such products had been available without a prescription for decades, but there was little research to demonstrate the safety and efficacy of individual brands, which were sold without approval from the US Food and Drug Administration (FDA).

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