ATC kod: N04BD02
Kliniska studier som jämfört rasagilin (1 mg/dag) med placebo har inte kunnat påvisa könsskillnader i effektivitet, varken vid monoterapi eller som tilläggsbehandling.
Vissa studier rapporterar en ökad risk för impulskontrollstörning hos män jämfört med kvinnor vid behandling med parkinsonläkemedel, medan andra studier inte visar några könsskillnader. Kliniska studier av rasagilin utförda av läkemedelsföretaget har inte funnit könsskillnader i säkerhetsprofilen av rasagilin.
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 [1].
No differences in rasagiline pharmacokinetics have been reported between men and women and no sex differentiation in dosing has been recommended by the pharmaceutical company [7].
A double-blind randomized monotherapy trial conducted by the pharmaceutical company, comparing rasagiline 1 mg/day with placebo, could not detect any differences in effectiveness based on patient’s age or sex. Similarly, no trials of rasagiline as adjunctive therapy, comparing rasagiline 1 mg/day and placebo, found differences in effectiveness based on patient’s age or sex [7].
The increased risk of impulse control disorder with use of dopamine agonists is well known [2-6]. One observational study on dopamine agonists (n=642, approx. 2/3 men) reports a higher frequency of impulse control disorder in men compared to women in patients using dopamine agonists [4].Controlled clinical trials of rasagiline as monotherapy or adjunctive therapy, have not found any significant differences in the safety profile based on patient’s age or sex [7].
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Fler män än kvinnor hämtade ut tabletter innehållande rasagilin (ATC-kod N04BD02) på recept i Sverige år 2019, totalt 2 224 män och 1 258 kvinnor. Det motsvarar 0,4 respektive 0,3 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 70-84 år hos båda könen. I genomsnitt var tabletter innehållande rasagilin två gånger vanligare hos män [8].
Uppdaterat: 2020-09-08
Litteratursökningsdatum: 2019-11-07
Faktagranskat av: Mia von Euler, Diana Rydberg
Godkänt av: Karin Schenck-Gustafsson