Drug products: Derinik, Mirapexin, MIRAPEXIN®, Oprymea, Oprymea®, Pramipexol Aurobindo, Pramipexol Sandoz, Pramipexol STADA, Pramipexol Teva Pharma, Pramipexole Accord, Pramipexole Bluefish, Pramipexole Orion, Pramipexole Sandoz, Pramipexole Teva, SIFROL, Sifrol®, SIFROL®
ATC code: N04BC05
Substances: pramipexole, pramipexole dihydrochloride monohydrate
Clinical trials conducted by the pharmaceutical company have not demonstrated any difference in effect or adverse events between men and women with Parkinson’s disease treated with pramipexol. In patients treated for RLS (Restless Legs Syndrome) nausea and fatigue has been more frequently reported in women.
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 .
In a pharmacokinetic study in healthy volunteers (8 men, 8 women), AUC and Cmax of pramipexol were significantly higher in women for the dose 1.5 mg. The mean creatinine clearance was lower in women than in men (80.9 ±15.6 vs. 112 ±12.8 mL/min/1.73 m2). However, women had higher mean age in this study, and aging leads to a decline in glomerular filtration rate. Also, the normal range of glomerular filtration rate, measured by inulin clearance, is lower for women. Therefore, the influence of patient’s sex could not be distinguished from the influence of age and the resulting reduced creatinine clearance . Pramipexole clearance has been shown to be about 30% lower in women than in men, but this difference can be accounted for by differences in body weight. There was no difference in half-life between men and women .
Therapy with pramipexole should be initiated at a low dose and gradually titrated upwards according to clinical tolerability to obtain the optimum therapeutic effect. It is not necessary to adjust the initial dose based on patient’s sex .
Clinical studies conducted by the pharmaceutical company found no difference between men and women in effect of pramipexol in Parkinson’s Disease . No other published studies with a clinically relevant sex analysis regarding the effects of pramipexole have been found.
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 .However, in a transversal study of patients on a single nonergolinic dopamine agonist (pramipexole, ropinirole, or rotigotine) (145 men, 88 women) no difference in risk between men and women was reported .
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