PANCREAZE is proven to improve fat and protein absorption7
PANCREAZE is a prescription medication that treats Exocrine Pancreatic Insufficiency (EPI) — a condition characterized by deficiency of the exocrine pancreatic enzymes (lipase, protease and amylase), resulting in maldigestion of food.8
In clinical studies, PANCREAZE significantly improved fat absorption vs. placebo and also improved nitrogen absorption, a surrogate marker of protein absorption.7
Mean CFA and CNA Improvements (%)
PANCREAZE is proven to improve EPI symptoms7
(i.e.: abdominal pain, bloating, diarrhea, greasy stools) vs. placebo
| EPI SYMPTOMS | Placebo (N=20) | PANCREAZE (N=20) |
|---|---|---|
| Any | 11 (55%) | 4 (20%) |
| Abdominal pain | 6 (30%) | 3 (15%) |
| Bloating | 3 (15%) | 1 (5%) |
| Diarrhea | 4 (20%) | 0 (0%) |
| Greasy stools | 3 (15%) | 0 (0%) |
| Vomiting | 0 (0%) | 1 (5%) |
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 participants7
CFA: coefficient of fat absorption; CNA: coefficient of nitrogen absorption. Intent-to-treat analyses set with 20 participants in Placebo (12 adults; 8 children), and 20 in PANCREAZE (14 adults; 6 children); The change in CFA and CNA from open-label to double-blind was analyzed using an analysis-of-covariance model with treatment as a factor and baseline values as covariates.
