6/10/2023

Janusmed kön och genus

Janusmed kön och genus – Rasagiline Bluefish

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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Rasagilin

Rasagilin

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Produkter

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AZILECT, Rasagilin Glenmark, Rasagilin Krka, Rasagilin ......

AZILECT, Rasagilin Glenmark, Rasagilin Krka, Rasagilin STADA, Rasagiline Accord, Rasagiline Amneal, Rasagiline Bluefish, Rasagiline Mylan, Rasagiline Sandoz
ATC-koder

N04BD02

N04BD02
Substanser

rasagilin, rasagilinmesilat, rasagilintartrat

rasagilin, rasagilinmesilat, rasagilintartrat
Sammanfattning

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.

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.
Background

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].

Pharmacokinetics and dosing
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].

Effects
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,......

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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]. # Pharmacokinetics and dosing 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]. # Effects 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]. # Adverse effects 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]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Försäljning på recept

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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].
Referenser

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  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Azilect (rasagiline mesylate). DailyMed [www]. US National Library of Medicine. [updated 2019-04-22, cited 2019-11-07].

  8. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.]

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Azilect (rasagiline mesylate). DailyMed [www]. US National Library of Medicine. [updated 2019-04-22, cited 2019-11-07].
  8. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.]
Uppdaterat

Litteratursökningsdatum 11/7/2019

Litteratursökningsdatum 11/7/2019