A double-blind, randomized, dose response study testing the pharmacological efficacy of synthetic porcine secretin

Authors


P. S.JowellDr Box 3662, DUMC, Durham, NC 27710, USA. E-mail: Paul.Jowell@.duke.edu

Abstract

Background:

Biologically derived porcine secretin has been used as a diagnostic agent in clinical gastrointestinal practice for many years. Pure synthetic porcine secretin is now available for investigational clinical use.

Aim:

To compare the pharmacology of synthetic porcine secretin and biologically derived porcine secretin in healthy volunteers.

Methods:

Secretin stimulation tests were performed in 12 volunteer subjects in a double-blind, randomized, Latin square crossover design study comparing three doses of synthetic porcine secretin (0.05, 0.2, and 0.4 μg/kg) with a standard dose of biologically derived porcine secretin (1 CU/kg). Duodenal aspirates were analysed for total volume and for bicarbonate concentration. Total bicarbonate output was calculated.

Results:

Twelve subjects completed four dosing regimens. A multiple comparison test was used to compare dosing regimens. The 0.2 and 0.4 μg/kg doses of synthetic porcine secretin were not different from the 1 CU/kg dose of biologically derived porcine secretin for volume, bicarbonate concentration and total output from 0 to 60 min. Only one patient had an adverse event, which was mild, transient flushing after the 0.2 and 0.4 μg/kg doses of synthetic porcine secretin and after the 1 CU/kg dose of biologically derived porcine secretin.

Conclusions:

Synthetic porcine secretin has identical pharmacologic effects to biologically derived porcine secretin in normal subjects. Both drugs were safe and well-tolerated. This study validates synthetic porcine secretin as a substitute for biologically derived porcine secretin.

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