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


OBJECTIVE
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 microgram/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 microgram/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 microgram/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.
Jowell
P S
PS
Duke University Medical Center, Durham, NC, USA. Paul.Jowell@duke.edu
Robuck-Mangum
G
G
Mergener
K
K
Branch
M S
MS
Purich
E D
ED
Fein
S H
SH
D000328:Adult; D000818:Animals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012633:Secretin / Q000009:adverse effects / Q000494:pharmacology*; D013552:Swine
D012633:Secretin