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.

journal_name

Aliment Pharmacol Ther

authors

Opekun AR Jr,Sutton FM Jr,Graham DY

doi

10.1046/j.1365-2036.1997.00245.x

subject

Has Abstract

pub_date

1997-10-01 00:00:00

pages

981-6

issue

5

eissn

0269-2813

issn

1365-2036

journal_volume

11

pub_type

临床试验,杂志文章,随机对照试验
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    pub_type: 临床试验,杂志文章,随机对照试验

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    pub_type: 临床试验,杂志文章,随机对照试验

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