EFFECTS OF PANTOPRAZOLE ON ENDOCRINE FUNCTION IN HEALTHY MALE-VOLUNTEERS

Method: In a randomized, double-blind, two-period crossover study, pan toprazole 40 mg or placebo were given orally to 12 male volunteers for 2 weeks each. There was a wash-out period of at least 1 week between the two treatment periods. The effects of pantoprazole or placebo on c ortisol and testosterone (primary criteria), and tri-iodothyronine, th yroxine, thyroid-stimulating hormone, thyronine-binding protein, parat hyroid hormone, insulin, glucagon, renin, aldosterone, follicle-stimul ating hormone, luteotrophic hormone, prolactin and somatotrophic hormo ne were compared. In addition, intragastric 24-h pH, 24-h H+-activity, and volume of nocturnal gastric juice were determined by gastric aspi ration technique. Results: Pantoprazoie did not influence plasma level s of testosterone, circadian cortisol concentrations or plasma cortiso l levels after exogenous adrenocorticotropic hormone stimulation, as c ompared to placebo (P > 0.05, Koch's test). Furthermore, there were no clinically relevant changes with any of the other endocrine parameter s. Pantoprazole significantly increased the median 24-h pH (group medi an 4.3 vs. 1.8; P < 0.001) and decreased 24-h H+-activity (4.0 vs. 22. 6 mmol/L; P < 0.001). The volume of nocturnal gastric juice did not si gnificantly differ between the two treatments. Pantoprazole was well t olerated and the frequency of adverse events was similar to placebo. N o drug-related changes in laboratory values were observed. Conclusion: Pantoprazole did not influence endocrine function in healthy male vol unteers during short-term treatment.