Drug products: Cabaser, Cabaser®, Cabergoline 2care4, Cabergoline Hexal, Cabergoline Sandoz, Cabergoline Teva, Dostinex, Dostinex®, Kabergolin IVAX
ATC code: G02CB03, N04BC06
Cabergoline is used as second line treatment in patients with Parkinson Disease, to inhibit lactation and to stop hyperlactation, and in hyperprolcatinomas. In hyperprolactinomas, studies have shown women and men to respond equally well to cabergoline treatment with no difference in probability of reaching normal prolactin levels.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of cabergoline have been found .
A clinical trial studying sex differences in presentation and response to cabergoline therapy in patients with newly diagnosed hyperprolactinemia, found that successful response to carbergoline treatment for 6 months was similar in women and men. Prolactin levels normalized more frequently in micro- than in macroadenoma patients (86% vs. 64%), without a sex difference (70% vs. 69%, p=0.9). The sizes of macro- and microprolactinomas were reduced by 38 ±29% to 52 ±24%, and there was no difference in the amount of tumor shrinkage between men and women . In another clinical study of carbergoline treatment in patients with hyperprolactinemia, men had less likelihood of achieving normal prolactin levels than women (75% vs. 90%). However, considered that the large majority of men had a macroprolactinoma (86% vs. 38% for women), which correlates with higher prolactin levels, sex had no independent influence on success rates. When only microprolactinomas were considered, the outcome was similar in men and women (92% vs. 93%) .
Another clinical trial found no significant differences in prevalence of tricuspid regurgitation at any valve between hyperprolatinaemic men and women receiving carbergoline .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2013-04-04
Reviewed by: Expertrådet för neurologiska sjukdomar
Approved by: Mia von Euler