Drug products: AZILECT, Rasagilin Glenmark, Rasagilin Krka, Rasagilin STADA, Rasagiline Accord, Rasagiline Amneal, Rasagiline Bluefish, Rasagiline Mylan, Rasagiline Sandoz
ATC code: N04BD02
Substances: rasagiline, rasagiline mesilate, rasagiline tartrate
Clinical studies comparing rasagilin (1 mg/day) to placebo did not find any differences between men and women in efficacy of rasagiline as monotherapy or as an additive treatment.
Some studies report an increased risk of impulse control disturbance in men compared with women when treated with anti-Parkinson drugs, while other studies report no sex difference. Clinical studies conducted by the pharmaceutical company have not found any difference between men and women in the safety profile of rasagiline.
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 .
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 .
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 .
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 .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 .
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2019-11-07
Reviewed by: Mia von Euler, Diana Rydberg
Approved by: Karin Schenck-Gustafsson