Neuroendocrine and side effect profile of pramipexole, a new dopamine receptor agonist, in humans.
The effects and tolerability of pramipexole, a new dopamine D2-receptor agonist, on prolactin, human growth hormone, thyrotropin, cortisol, and corticotropin levels were investigated in a randomized, double-blind, crossover study in 12 healthy volunteers. Single oral doses of 0.1, 0.2, and 0.3 mg pramipexole and placebo were studied over a period of 24 hours. Pramipexole decreased serum prolactin levels in a dose-dependent manner, with a maximum effect after 2 to 4 hours. Serum levels of human growth hormone were dose-dependently increased; however, this effect was only significant 2 hours after drug administration. Furthermore, a slight increase in serum cortisol levels and a slight decrease in serum thyrotropin levels was observed. Our findings show for the first time pharmacodynamic effects of pramipexole after single oral doses in healthy volunteers. The compound was well tolerated and showed an endocrine profile similar to other dopamine D2-agonists.
Human Pharmacology Centre, Boehringer Ingelheim KG, Germany.
J C
JC
Schilling
W S
WS
Adamus
R
R
Palluk
D000328:Adult; D052160:Benzothiazoles; D001794:Blood Pressure / Q000187:drug effects*; D015259:Dopamine Agents / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004562:Electrocardiography / Q000187:drug effects*; D013006:Growth Hormone / Q000097:blood*; D006801:Humans; D007700:Kinetics; D008297:Male; D000077487:Pramipexole; D011388:Prolactin / Q000097:blood*; D011674:Pulse / Q000187:drug effects*; D011897:Random Allocation; D011954:Receptors, Dopamine / Q000187:drug effects / Q000502:physiology; D013844:Thiazoles / Q000009:adverse effects / Q000494:pharmacology*
D052160:Benzothiazoles; D015259:Dopamine Agents; D011954:Receptors, Dopamine; D013844:Thiazoles; D000077487:Pramipexole; D011388:Prolactin; D013006:Growth Hormone