Lack of dose-response with Pancrease MT for the treatment of exocrine pancreatic insufficiency in adults

Area of Science:

• Gastroenterology
• Digestive Physiology
• Pharmacology

Background:

• Pancreatic exocrine insufficiency (PEI) management requires optimal enzyme replacement therapy (ERT).
• Marketed ERT products like Pancrease vary in lipase activity, suggesting a dose-response relationship.
• Determining the most cost-effective lipase dosage for PEI remains a clinical challenge.

Purpose of the Study:

• To evaluate the effectiveness of different lipase dosages in Pancrease for adults with PEI.
• To assess the dose-response relationship between lipase administration and fecal fat reduction.

Main Methods:

• A randomized, single-blind, cross-over study design was employed.
• Adult patients with PEI received a standardized high-fat diet (100g/day).
• Participants were administered Pancrease with varying lipase units (MT4, MT10, MT16) or placebo across meals over 6 days, with fecal fat quantified over 72 hours.

Main Results:

• All tested lipase preparations reduced fecal fat excretion compared to placebo.
• Significant reductions in fecal fat were observed with 20,000 and 32,000 lipase units (P=0.02).
• The 8,000 lipase unit preparation did not achieve statistically significant fecal fat reduction (P > 0.05).

Conclusions:

• No clear dose-response relationship was established between lipase dosage and fecal fat reduction.
• The highest potency Pancrease preparation did not demonstrate superior efficacy over lower-potency forms.
• Cost-effectiveness may favor lower-potency pancreatic enzyme preparations.