Drug products: Neupro®
ATC code: N04BC09
Studies of differences between men and women in effect of rotigotine are lacking.
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.
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
Women and men have shown to have similar plasma concentrations of rotigotine (body weight normalized) . Rotigotine treatment is initiated at a low dose and is gradually titrated according to clinical tolerability to obtain the optimum therapeutic effect. It is not necessary to adjust the dose based on patient’s sex, weight or age .
No studies with a clinically relevant sex analysis regarding the effects of rotigotine 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 .A small study on transdermal rotigotine (11 men, 17 women) showed a higher risk in men . 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 .
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2019-11-07
- 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
- Weintraub D, Siderowf AD, Potenza MN, Goveas J, Morales KH, Duda JE, Moberg PJ, Stern MB. Association of dopamine agonist use with impulse control disorders in Parkinson disease. Arch Neurol. 2006;63(7):969-73. länk
- Schreglmann SR, Gantenbein AR, Eisele G, Baumann CR. Transdermal rotigotine causes impulse control disorders in patients with restless legs syndrome. Parkinsonism Relat Disord. 2012;18:207-9. PubMed
- Carrière N, Kreisler A, Dujardin K, Destée A, Defebvre L. [Impulse control disorders in Parkinson's disease: A cohort of 35 patients]. Rev Neurol (Paris). 2012;168:143-51. PubMed
- Poletti M, Logi C, Lucetti C, Del Dotto P, Baldacci F, Vergallo A, Ulivi M, Del Sarto S, Rossi G, Ceravolo R, Bonuccelli U. A single-center, cross-sectional prevalence study of impulse control disorders in Parkinson disease: association with dopaminergic drugs. J Clin Psychopharmacol. 2013;33(5):691-4. PubMed
- Garcia-Ruiz, P J Martinez Castrillo JC, Alonso-Canovas A, Herranz Barcenas A, Vela L, Sanchez Alonso P, Mata M, Olmedilla Gonzalez N, Mahillo Fernandez I. Impulse control disorder in patients with Parkinson's disease under dopamine agonist therapy: a multicentre study. J Neurol Neurosurg Psychiatry. 2014;85(8):840-4. länk
- Neupro (rotigotine). DailyMed [www]. US National Library of Medicine. [updated 2019-01-28, cited 2019-11-07]. länk
- Neupro (rotigotine). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2019-09-19, cited 2019-11-07]. länk
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk
Reviewed by: Mia von Euler, Diana Rydberg
Approved by: Karin Schenck-Gustafsson