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For the treatment of exocrine pancreatic
insufficiency (EPI) due to cystic fibrosis (CF)
Demonstrated significant improvements in
fat and protein absorption

PERTZYE® (pancrelipase) significantly increased fat absorption1,2

  • Mean coefficient of fat absorption was 83% with PERTZYE vs 46% with placebo (P<0.001)1,2
  • 78% improvement in fat absorption compared with placebo1,2
  • Response to treatment was similar in children (n=10) and adults (n=11) for all efficacy end points1,2
  • Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PERTZYE exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day)
PERTZYE does not require the concomitant
use of acid-suppressing drugs2

PERTZYE significantly increased protein absorption*1,2

  • Mean coefficient of nitrogen absorption was 79% with PERTZYE vs 47% with placebo (P<0.001)1,2
  • 68% improvement in nitrogen absorption compared with placebo1,2
STUDY DESIGN

A randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the efficacy and safety of PERTZYE in 24 patients aged 8 to 43 years with exocrine pancreatic insufficiency due to cystic fibrosis. Patients were randomized to receive PERTZYE at individually titrated doses (not to exceed 2,500 lipase units/kg body weight per meal) or matching placebo for 6 to 8 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 8 days.1,2 The efficacy analysis included a total of 21 patients who completed both double-blind treatment periods. The primary efficacy end point was the mean difference in coefficient of fat absorption between PERTZYE and placebo.1 Secondary end points were mean difference in coefficient of nitrogen absorption, stool frequency, and stool weight.1,2