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

Abstract

BACKGROUND:

Choosing the optimum pancreatic enzyme replacement therapy for patients with exocrine insufficiency remains a problem. An enteric coated enzyme microsphere pancreatic enzyme preparation (Pancrease) has been marketed with several levels of lipase activity, implying that there is a dose-response relationship between dose and effectiveness such that the high potency form appears to be the most cost effective.

METHODS:

In a randomized, single-blind, cross-over study, we evaluated the effectiveness of a commercial enzyme preparation with different amounts of lipase per dosage unit in adults with exocrine pancreatic insufficiency. Patients received a diet comprising 100 g fat each day for 6 days. With each meal (three per day) they received two capsules of either Pancrease MT4 (8000 unit lipase), Pancrease MT10 (20,000 units lipase), Pancrease MT16 (32,000 units lipase) or placebo. A 72-h quantitative faecal collection was carried out for the last 3 days of the 6-day period.

RESULTS:

There was a reduction in faecal fat excretion with each of the preparations compared to placebo. The difference failed to reach significance with the 8000 units lipase preparation (P > 0.05) but was significant (P = 0.02) with the 20,000 units lipase and the 32,000 units lipase preparations (faecal fat excretion: placebo = 42.1 +/- 29 g, lipase 8000 = 22.1 +/- 7.3 g, lipase 20,000 = 10.2 +/- 4.5 g and lipase 32,000 = 15.8 +/- 12.5 g, P < for 20,000 units and 32,000 units lipase compared to placebo).

CONCLUSION:

A dose-response relationship between the amount of lipase administered with each meal and a reduction in faecal fat was not evident. The most potent preparation did not provide additional benefits compared to the less expensive lower potency dosage form.

• Authors: A R Opekun Jr, F M Sutton Jr, D Y Graham
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 11 Issue 5 Pg. 981-6 (Oct 1997) ISSN: 0269-2813 [Print] England
• PMID: 9354210 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Gastrointestinal Agents
• Pancreatin
• Lipase

Topics

• Adult
• Celiac Disease (drug therapy, etiology)
• Cross-Over Studies
• Dose-Response Relationship, Drug
• Exocrine Pancreatic Insufficiency (complications, drug therapy)
• Feces (chemistry)
• Gastrointestinal Agents (administration & dosage)
• Humans
• Lipase (administration & dosage)
• Middle Aged
• Pancreatin (administration & dosage)
• Single-Blind Method