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Zolmitriptan

Klassificering: A

Preparat: Zolmitriptan 2care4, Zolmitriptan Arrow, Zolmitriptan Ebb, Zolmitriptan Jubilant, Zolmitriptan Orifarm, Zolmitriptan Rivopharm, Zolmitriptan STADA, Zolmitriptan Teva, Zomig, Zomig Nasal, Zomig Rapimelt, Zomig®, Zomig® Nasal, Zomig® Rapimelt, Zomigon, Zomigoro Rapimelt

ATC kod: N02CC03

Substanser: zolmitriptan

Sammanfattning

Effekten av zolmitriptan vid akut migrän är likvärdig hos kvinnor och män.
Biverkningsprofilen av zolmitriptan är likartad mellan könen.

Additional information

Migraine is twice as common in women as in men [1-3]. In a Swedish population-based study the one-year prevalence was 9.5% in men and 16.7 % in women [4] which is slightly lower than three months prevalence reported from the US [1].

Among adults with migraine, sex and gender differences were found in a cross-sectional longitudinal internet-based study (11 049 women, 4 084 men). Compared with men, women had significantly higher amount of monthly headache days, were more likely to have been diagnosed with migraine and to report headache-related disability and cutaneous allodynia. Among prescription medication users, women took more triptans than men, while men were more likely to take opioids and, besides oral formulations, use nasal spray and injectable medication. Men also used more daily oral preventive medication than women [5].

Women who have migraine with aura have an increased risk of ischemic stroke compared to women without migraine [6]. A prospective controlled study showed that in patients with active migraine, female sex was significantly associated with the risk of ischemic stroke [7].

It should be noted that most studies include more women than men, and the low number of men included can affect the ability to make statistically significant analyses.Zolmitriptan is used to treat acute migraine attacks [8]. Another indication for (parenteral) triptans is cluster headache [9]. This is a trigeminal autonomic cephalgia with very painful, unilateral and short-lasting headache attacks. Cluster headache is rare with an estimated prevalence of 0.1%. In contrast to migraine, cluster headache is more common in men than in women [9]. The men-women ratio has recently been estimated to 2.5, older studies show a more pronounced male risk [10]. Smoking is a risk factor for cluster headache and the increased risk in women has been associated with more smoking in women [9, 10].

Pharmacokinetics and dosing

There are small pharmacokinetic studies of zolmitriptan showing varying results, none which were adjudicated to be of clinical importance [11, 12]. Other studies found differences in pharmacokinetics only between young men and women (18-39 years) but not in the elderly (65-75 years) [13, 14]. Although some sex differences in zolmitriptan pharmacokinetics have been reported in young adults [11-14], no dosage adjustment based on patient’s sex is recommended. [15].

Effects

Headache relief after administration of zolmitriptan has been evaluated in open-label clinical trials. Two-hour headache response rates to an initial dose of 2.5 mg or 5 mg zolmitriptan were 85% and 79-81%, respectively. Responses were unaffected by patient’s sex [16, 17]. Also, the pharmaceutical company reports that the efficacy of zolmitriptan was similar in men and women, for both drug formulations [8].

Results from randomized, double-blind studies of migraineurs (66 men, 280 women) show no sex differences in response to frovatriptan 2.5 mg, rizatriptan 10 mg, zolmitriptan 2.5 mg or almotriptan 12.5 mg [18].

Adverse effects

Tolerability of zolmitriptan was evaluated in an international, open-label study (288 men, 1769 women). The types of adverse events observed were similar in men and women, although the incidence of adverse events was slightly higher in women (78%) than men (61%) [17].

A placebo-controlled clinical trial (1540 men, 1210 women) reported that the nature and type of adverse events were similar in men and women, although the frequency of reported adverse events was higher in women (48%) than men (30%). This sex difference was also observed in patients who received placebo and may reflect a difference between men and women in adverse event reporting. The frequency of serious adverse events did not differ between men and women [19]. Contrary to this, the pharmaceutical company reports that there were no sex differences in incidence of adverse events in controlled clinical trials [8].

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Other information

Swedish population studies on dispensed triptans found a marked gender difference with a 3.6 times higher prevalence of triptan use in women [20, 21]. In contrast, over the counter use did not show any difference between men and women [21].

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande zolmitriptan (ATC-kod N02CC03) på recept i Sverige år 2019, totalt 21 709 kvinnor och 5 399 män. Det motsvarar 4,3 respektive 1,1 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 40-59 år hos båda könen. I genomsnitt var läkemedel innehållande zolmitriptan 3,7 gånger vanligare hos kvinnor [22].

Sumatriptan och zolmitriptan kan köpas utan recept, men cirka 90 % av alla triptaner hämtas ut på recept [20].

Uppdaterat: 2022-02-02

Litteratursökningsdatum: 2019-09-25

Referenser

  1. Smitherman TA, Burch R, Sheikh H, Loder E. The prevalence, impact, and treatment of migraine and severe headaches in the United States: a review of statistics from national surveillance studies. Headache. 2013;53(3):427-36. PubMed
  2. Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010;11(4):289-99. PubMed
  3. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343-9. PubMed
  4. Dahlöf C, Linde M. One-year prevalence of migraine in Sweden: a population-based study in adults. Cephalalgia. 2001;21:664-71. PubMed
  5. Lipton RB, Munjal S, Alam A, Buse DC, Fanning KM, Reed ML, Schwedt TJ, Dodick DW. Migraine in America Symptoms and Treatment (MAST) Study: Baseline Study Methods, Treatment Patterns, and Gender Differences. Headache. 2018;58(9):1408-1426. länk
  6. Kurth T, Slomke MA, Kase CS, Cook NR, Lee IM, Gaziano JM, et al. Migraine, headache, and the risk of stroke in women: a prospective study. Neurology. 2005;64(6):1020-1026. länk
  7. Milhaud D, Bogousslavsky J, van Melle G, Liot P. Ischemic stroke and active migraine. Neurology. 2001;57(10):1805-11. PubMed
  8. Zomig (zolmitriptan). DailyMed [www]. US National Library of Medicine. [updated 2019-05-31, cited 2019-09-25]. länk
  9. Hoffmann J, May A. Diagnosis, pathophysiology, and management of cluster headache. Lancet Neurol. 2018;17(1):75-83. PubMed
  10. Russell MB. Epidemiology and genetics of cluster headache. Lancet Neurol. 2004;3(5):279-83. PubMed
  11. Seaber EJ, Peck RW, Smith DA, Allanson J, Hefting NR, van Lier JJ et al. The absolute bioavailability and effect of food on the pharmacokinetics of zolmitriptan in healthy volunteers. Br J Clin Pharmacol. 1998;46:433-9. PubMed
  12. Lionetto L, Casolla B, Mastropietri F, D'Alonzo L, Negro A, Simmaco M et al. Pharmacokinetic evaluation of zolmitriptan for the treatment of migraines. Expert Opin Drug Metab Toxicol. 2012;8:1043-50. PubMed
  13. Peck RW, Seaber EJ, Dixon RM, Layton GR, Weatherley BC, Jackson SH et al. The pharmacodynamics and pharmacokinetics of the 5HT1B/1D-agonist zolmitriptan in healthy young and elderly men and women. Clin Pharmacol Ther. 1998;63:342-53. PubMed
  14. Yates RA, Tateno M, Nairn K, Ikegami A, Dane A, Kemp J. The pharmacokinetics of the antimigraine compound zolmitriptan in Japanese and Caucasian subjects. Eur J Clin Pharmacol. 2002;58:247-52. PubMed
  15. Zomig (zolmitriptan). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2018-11-30, cited 2019-09-25].
  16. Tuchman M, Edvinsson L, Geraud G, Korczyn A, Mauskop A, Pfaffenrath V. Zolmitriptan provides consistent migraine relief when used in the long-term. Curr Med Res Opin. 1999;15:272-81. PubMed
  17. The International 311C90 Long-term Study Group. The long-term tolerability and efficacy of oral zolmitriptan (Zomig, 311C90) in the acute treatment of migraine An international study The International 311C90 Long-term Study Group. Headache. 1998;38:173-83.
  18. Franconi F, Finocchi C, Allais G, Omboni S, Tullo V, Campesi I et al. Gender and triptan efficacy: a pooled analysis of three double-blind, randomized, crossover, multicenter, Italian studies comparing frovatriptan vs other triptans. Neurol Sci. 2014;35 Suppl 1:99-105. PubMed
  19. Edmeads JG, Millson DS. Tolerability profile of zolmitriptan (Zomig; 311C90), a novel dual central and peripherally acting 5HT1B/1D agonist International clinical experience based on > 3000 subjects treated with zolmitriptan. Cephalalgia. 1997;17 Suppl 18:41-52. PubMed
  20. von Euler, M, Keshani, S, Baatz, K, Wettermark, B. PP261 - Utilization of triptanes in Sweden; analyses of over the counter and prescriptions sales. Clinical Therapeutics. 2013;8, Suppl(35):e99.
  21. Frisk P, Sporrong SK, Ljunggren G, Wettermark B, von Euler M. Utilisation of prescription and over-the-counter triptans: a cross-sectional study in Stockholm, Sweden. Eur J Clin Pharmacol. 2016;72(6):747-54. PubMed
  22. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk

Författare: Linnéa Karlsson Lind

Faktagranskat av: Mia von Euler, Diana Rydberg

Godkänt av: Karin Schenck-Gustafsson