PANCREAZE is proven to improve EPI (Exocrine Pancreatic Insufficiency) symptoms2

PANCREAZE is a prescription medication that treats EPI — a condition characterized by deficiency of the exocrine pancreatic enzymes (lipase, protease and amylase), resulting in maldigestion of food.18

In clinical studies, PANCREAZE is proven to improve EPI symptoms (i.e.: abdominal pain, bloating, diarrhea, greasy stools) vs. placebo.

Improvement of Fat Absorption (CFA)*. Mean difference in CFA was approximately 30% (P<0.001). Improvement of Nitrogen Absorption (CNA)*. Mean difference in CNA was approximately 24% (P<0.001). Improvement of Fat Absorption (CFA)*. Mean difference in CFA was approximately 30% (P<0.001). Improvement of Nitrogen Absorption (CNA)*. Mean difference in CNA was approximately 24% (P<0.001).

Review the clinical study design

 

PANCREAZE is clinically proven to improve fat and protein absorption2

In clinical studies, PANCREAZE significantly improved fat absorption vs. placebo and also improved nitrogen absorption, a surrogate marker of protein absorption.

Improvement of Fat Absorption (CFA)*. Mean difference in CFA was approximately 30% (P<0.001). Improvement of Nitrogen Absorption (CNA)*. Mean difference in CNA was approximately 24% (P<0.001). Improvement of Fat Absorption (CFA)*. Mean difference in CFA was approximately 30% (P<0.001). Improvement of Nitrogen Absorption (CNA)*. Mean difference in CNA was approximately 24% (P<0.001).
 

Study design

  • Randomized, double-blind, placebo-controlled study of 40 patients, ages 8 to 57 years, with EPI due to CF.
  • The study consisted of a 7-day screening phase, ≤14-day open-label run-in phase, and ≤7-day placebo controlled, double-blind, withdrawal phase. The duration of the double-blind phase ranged from 4 to 7 days, depending on patients’ gastrointestinal transit time. During the double-blind phase, participants with a CFA ≥80% were randomized (1:1) to continue their optimized dose of PANCREAZE (10.5 or 21) or switched to placebo.
  • The primary efficacy endpoint was change in percent CFA between the 72-hour stool collections at the end of the open- label phase and double-blind phase. A key secondary variable was change in coefficient of nitrogen absorption (CNA), a surrogate for protein absorption, from the open-label phase to the double-blind phase. Another key secondary variable was prevention of the clinical signs and symptoms of EPI (abdominal pain, bloating, diarrhea, greasy stools, vomiting) during the double-blind phase.
 
Primary and key secondary efficacy assessments of the study participants chart. Primary and key secondary efficacy assessments of the study participants chart.