Drug products: Cabaser®, Cabergoline 2care4, Cabergoline Hexal, Cabergoline ratiopharm, Cabergoline Sandoz, Cabergoline Teva, Dostinex, Dostinex®, Kabergolin Ebb
ATC code: G02CB03, N04BC06
Analyses of sex differences between men and women of the effect of cabergoline in Parkinson’s disease are lacking. In hyperprolactinomas, studies have shown men and women to respond equally well to cabergoline treatment, with no difference in probability of reaching normal prolactin levels.
Cabergoline is used as second line treatment in patients with Parkinson’s disease, in hyperprolactinomas, and to inhibit lactation and stop hyperlactation [2,3].The reported incidence and prevalence of Parkinson’s disease (PD) is slightly higher in men than in women. It seems that men develop PD earlier in life compared to women. Several possible explanations behind these sex differences have been suggested; the protective role of estrogens in premenopausal women, and different profiles of risk factors (environmental and/or genetic). Sex differences in clinical presentations of PD have also been reported. Since the activities of daily living might differ between men and women with PD, different treatment strategies can be recommended to men and women with PD .
Pharmacokinetics and dosing
Cabergoline administrated as single- and multiple-dose in healthy young and elderly individuals showed that young men had 25% higher Cmax than young women, while elderly men had 39% lower Cmax than elderly women. The study-authors suggested these differences were not of clinical relevance .
No published studies analyzing sex differences in the effect of cabergoline in treatment of Parkinson’s diseasehave been found.
Sex differences in the response to cabergoline in treatment of hyperprolactinemiahas been analyzed. In patients with newly diagnosed hyperprolactinemia (74 men, 145 women; aged 15-72 years), successful response to cabergoline 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 . Similarly, another study reports no sex difference in percentage reduction in tumour dimension . In another clinical study of cabergoline treatment in patients with hyperprolactinemia, men had less likelihood of achieving normal prolactin levels than women (75% vs. 90%). However, considering that the large majority of men had a macroprolactinoma (86% vs. 38% for women), which correlates with higher prolactin levels, patient’s sex had no independent influence on success rates. When only microprolactinomas were considered, the outcome was similar in men and women (92% vs. 93%) .
A retrospective case-record study (48 men, 52 women) found no significant differences in prevalence of tricuspid regurgitation at any valve between hyperprolatinaemic men and women receiving cabergoline .
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2019-11-25
- Georgiev D, Hamberg K, Hariz M, Forsgren L, Hariz GM. Gender differences in Parkinson's disease: A clinical perspective. Acta Neurol Scand. 2017;136(6):570-584. PubMed
- Dostinex (cabergoline). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2015-10-14, cited 2019-11-25]
- Cabaser (cabergoline). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2016-10-20, cited 2019-11-25].
- Del Dotto P, Bonuccelli U. Clinical pharmacokinetics of cabergoline. Clin Pharmacokinet. 2003;42(7):633-45. PubMed
- Colao A, Sarno AD, Cappabianca P, Briganti F, Pivonello R, Somma CD et al. Gender differences in the prevalence, clinical features and response to cabergoline in hyperprolactinemia. Eur J Endocrinol. 2003;148:325-31. PubMed
- Khare S, Lila AR, Patt H, Yerawar C, Goroshi M, Bandgar T et al. Gender differences in macroprolactinomas: a single centre experience. Endocr Connect. 2016;5(1):20-7. PubMed
- Verhelst J, Abs R, Maiter D, van den Bruel A, Vandeweghe M, Velkeniers B et al. Cabergoline in the treatment of hyperprolactinemia: a study in 455 patients. J Clin Endocrinol Metab. 1999;84:2518-22. PubMed
- Nachtigall LB, Valassi E, Lo J, McCarty D, Passeri J, Biller BM et al. Gender effects on cardiac valvular function in hyperprolactinaemic patients receiving cabergoline: a retrospective study. Clin Endocrinol (Oxf). 2010;72:53-8. PubMed
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk
Reviewed by: Mia von Euler, Carl-Olav Stiller, Diana Rydberg
Approved by: Karin Schenck-Gustafsson