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

Aliment Pharmacol Ther. 1997 Oct;11(5):981-6. doi: 10.1046/j.1365-2036.1997.00245.x.


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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

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


  • Gastrointestinal Agents
  • Pancreatin
  • Lipase