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For the treatment of exocrine pancreatic
insufficiency (EPI) due to cystic fibrosis (CF)
Decreased stool weight and frequency

PERTZYE® (pancrelipase) was associated with significantly fewer bowel movements in a 72-hour period1,2

  • Mean of 6.1 stools with PERTZYE vs 10.1 with placebo (P<0.001)1,2
  • Nearly 40% reduction in stool frequency compared with placebo1,2
  • The most common adverse reactions (10%) are: diarrhea, dyspepsia, and cough2

PERTZYE was associated with a significantly greater reduction in overall stool weight in a 72-hour period1,2

  • Mean of 655.9 g with PERTZYE vs 1308.5 g with placebo (P<0.001)1,2
  • Nearly 50% reduction in stool weight 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