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Lack of dose–response with Pancrease MT for the treatment of exocrine pancreatic insufficiency in adults
Author(s) -
OPEKUN Jr A. R.,
SUTTON Jr F. M.,
GRAHAM D. Y.
Publication year - 1997
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.1997.00245.x
Subject(s) - lipase , placebo , medicine , triacylglycerol lipase , excretion , endocrinology , exocrine pancreatic insufficiency , potency , enzyme , pancreas , biology , biochemistry , in vitro , pathology , alternative medicine
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.