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


CONCLUSIONS
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.
Opekun
A R
AR
Department of Medicine, Veterans Affairs Medical Center, Houston, TX 77030, USA.
Sutton
F M
FM
Graham
D Y
DY
D000328:Adult; D002446:Celiac Disease / Q000188:drug therapy* / Q000209:etiology; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D010188:Exocrine Pancreatic Insufficiency / Q000150:complications / Q000188:drug therapy*; D005243:Feces / Q000737:chemistry; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D008049:Lipase / Q000008:administration & dosage; D008875:Middle Aged; D010194:Pancreatin / Q000008:administration & dosage*; D016037:Single-Blind Method
D005765:Gastrointestinal Agents; D010194:Pancreatin; D008049:Lipase