Alimentary pharmacology & therapeutics · 1994
Effects of pantoprazole on endocrine function in healthy male volunteers.
Клиническое исследованиеСравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Dammann H G, Bethke T, Burkhardt F, Wolf N, Khalil H, Luehmann R
Аннотация
METHOD: In a randomized, double-blind, two-period crossover study, pantoprazole 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 cortisol and testosterone (primary criteria), and tri-iodothyronine, thyroxine, thyroid-stimulating hormone, thyronine-binding protein, parathyroid hormone, insulin, glucagon, renin, aldosterone, follicle-stimulating hormone, luteotrophic hormone, prolactin and somatotrophic hormone were compared. In addition, intragastric 24-h pH, 24-h H(+)-activity, and volume of nocturnal gastric juice were determined by gastric aspiration technique.
RESULTS: Pantoprazole did not influence plasma levels of testosterone, circadian cortisol concentrations or plasma cortisol levels after exogenous adrenocorticotropic hormone stimulation, as compared to placebo (P > 0.05, Koch's test). Furthermore, there were no clinically relevant changes with any of the other endocrine parameters. Pantoprazole significantly increased the median 24-h pH (group median 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 significantly differ between the two treatments. Pantoprazole was well tolerated and the frequency of adverse events was similar to placebo. No drug-related changes in laboratory values were observed.
CONCLUSION: Pantoprazole did not influence endocrine function in healthy male volunteers during short-term treatment.
RESULTS: Pantoprazole did not influence plasma levels of testosterone, circadian cortisol concentrations or plasma cortisol levels after exogenous adrenocorticotropic hormone stimulation, as compared to placebo (P > 0.05, Koch's test). Furthermore, there were no clinically relevant changes with any of the other endocrine parameters. Pantoprazole significantly increased the median 24-h pH (group median 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 significantly differ between the two treatments. Pantoprazole was well tolerated and the frequency of adverse events was similar to placebo. No drug-related changes in laboratory values were observed.
CONCLUSION: Pantoprazole did not influence endocrine function in healthy male volunteers during short-term treatment.