Recently, McGowan Institute for Regenerative Medicine
faculty member David Whitcomb, MD, PhD (pictured), Professor of Medicine, Cell Biology and Physiology, and Human Genetics at the University of Pittsburgh; Chief of the Division of Gastroenterology, Hepatology, and Nutrition; as well as the founder and Director of the Center for Genomic Sciences, presented findings from a Phase III study in a poster titled “Efficacy and safety of pancrelipase delayed-release capsules (CREON®) in patients with pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery.”
Among FDA-approved pancreatic enzyme replacement therapies (PERTs), this study provides important new data to evaluate PERT dosing specifically in patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery. The data from the study demonstrate that CREON® (pancrelipase) Delayed-Release Capsules significantly improve a key measure of fat absorption in adults with EPI due to CP or pancreatic surgery. The study findings were presented at the American College of Gastroenterology Annual Scientific Meeting in San Diego, California.
EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food and, if untreated, can lead to diarrhea, weight loss, and ultimately malnutrition. EPI can occur as a complication of a variety of diseases or conditions, including cystic fibrosis, pancreatic cancer, gastrointestinal surgery, and chronic pancreatitis.
"The maldigestion associated with EPI due to CP and pancreatic surgeries can result in malnutrition as well as debilitating pain and GI symptoms that negatively impact quality of life for these patients," said Dr. Whitcomb. "These data support the use of PERT to improve the absorption of fat in patients receiving diets of at least 100 g of fat per day, which serves as an important demonstration to clinicians that EPI can be effectively treated without restricting patients' diets to be very low in fat."
According to the study results, adults with CP or who have undergone pancreatic surgery, who took CREON®, had an improved coefficient of fat absorption (CFA) as compared to the placebo group. CFA is calculated based on measures of fat ingestion and fat excretion; assessing the CFA of a patient is another way to measure the absorption of fat as a percentage of fat intake in patients being tested for EPI. The primary efficacy endpoint was the change in CFA from baseline to the end of the double-blind treatment period. The CFA improved by 32.1% in the CREON® group compared to 8.8% in the placebo group, representing a statistically significant difference between CREON® and placebo (P<0.0001).
Illustration: McGowan Institute for Regenerative Medicine.
Bio: Dr. David Whitcomb