LACK OF DOSE-RESPONSE WITH PANCREASE MT FOR THE TREATMENT OF EXOCRINEPANCREATIC INSUFFICIENCY IN ADULTS

Background: Choosing the optimum pancreatic enzyme replacement therapy for patients with exocrine insufficiency remains a problem, An enteri c coated enzyme microsphere pancreatic enzyme preparation (Pancrease) has been marketed with several levels of lipase activity, implying tha t 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 evaluat ed 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 uni ts lipase), Pancrease MT16 (32 000 units lipase) or placebo. A 72-h qu antitative faecal collection was carried out for the last 3 days of th e 6-day period. Results: There was a reduction in faecal fat excretion with each of the preparations compared to placebo. The difference fai led 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 re lationship between the amount of lipase administered with each meal an d a reduction in faecal fat was not evident, The most potent preparati on did not provide additional benefits compared to the less expensive lower potency dosage form.