Objective: To evaluate the efficacy and tolerability of oral zolmitriptan as a short-term preventative therapy for menstrual migraine.
Methods: This was a randomized, double-blind, parallel group, placebo-controlled, multicentre, two-phase study. The results of the second phase are reported here (the first phase evaluated zolmitriptan in the acute treatment of menstrual migraine and is reported elsewhere). Women who successfully completed phase I (with either a positive or negative outcome, and who still fulfilled the inclusion criteria) were randomized to zolmitriptan 2.5 mg oral tablet three times daily, zolmitriptan 2.5 mg twice daily or placebo three times daily. Patients were treated for three consecutive menstrual cycles, starting 2 days prior to the expected onset of menses, for 7 days in total.
Results: Two hundred and fifty-three patients completed phase I and were eligible for phase II. The intention-to-treat population comprised 244 patients (zolmitriptan three times daily [n = 83]; zolmitriptan twice daily [n = 80]; placebo [n = 81]). Both zolmitriptan regimens demonstrated superior efficacy versus placebo, as measured by the proportion of patients with a ≥50% reduction in the frequency of menstrual migraine attacks (zolmitriptan three times daily [58.6%], p = 0.0007 vs placebo; zolmitriptan twice daily [54.7%], p = 0.002 vs placebo; placebo three times daily [37.8%]). The mean frequency of breakthrough migraine attacks per menstrual cycle was reduced accordingly. Fewer breakthrough attacks were treated with escape medication in the zolmitriptan three times daily (61.6% of attacks; p = 0.0004 vs placebo) and twice daily (60.7%; p = 0.0055 vs placebo) treatment groups than in the placebo group (74.4%). Short-term preventative therapy with zolmitriptan was well tolerated.
Conclusion: Zolmitriptan 2.5 mg oral tablet is effective and well tolerated as a short-term preventative therapy for menstrual migraine attacks.
Lipton RB, Stewart WF, Diamond S, et al. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache 2001; 41: 646–57PubMedCrossRefGoogle Scholar
MacGregor EA, Brandes J, Eikermann A, et al. Impact of migraine on patients and their families. The Migraine And Zolmitriptan Evaluation (MAZE) survey: phase III. Curr Med Res Opin 2004; 20: 1143–50Google Scholar
Stewart WF, Lipton RB, Chee E, et al. Menstrual cycle and headache in a population sample of migraineurs. Neurology 2000; 55: 1517–23PubMedCrossRefGoogle Scholar
Massiou H. Is menstrually associated migraine difficult to treat? Cephalalgia 1999; 19Suppl. 24: 13–8PubMedGoogle Scholar
Couturier EGM, Bomhof MAM, Knuistingh Neven A, et al. Menstrual migraine in a representative Dutch population sample: prevalence, disability and treatment. Cephalalgia 2003; 23: 302–8PubMedCrossRefGoogle Scholar
MacGregor EA, Hackshaw A. Prevalence of migraine on each day of the natural menstrual cycle. Neurology 2004; 63: 351–3PubMedCrossRefGoogle Scholar
Granella F, Sances G, Allais G, et al. Characteristics of menstrual and nonmenstrual attacks in women with menstrually related migraine referred to headache centres. Cephalalgia 2004; 24: 707–16PubMedCrossRefGoogle Scholar
Newman LC, Lipton RB, Lay CL, et al. A pilot study of oral sumatriptan as intermittent prophylaxis of menstruation-related migraine. Neurology 1998; 51: 307–9PubMedCrossRefGoogle Scholar
Newman L, Mannix LK, Landy S, et al. Naratriptan as short-term prophylaxis of menstrually associated migraine: a randomized, double-blind, placebo-controlled study. Headache 2001; 41: 248–56PubMedCrossRefGoogle Scholar
Silberstein SD, Elkind AH, Schreiber C, et al. A randomized trial of frovatriptan for the intermittent prevention of menstrual migraine. Neurology 2004; 63: 261–9PubMedCrossRefGoogle Scholar
Moschiano F, Allais G, Grazzi L, et al. Naratriptan in the short-term prophylaxis of pure menstrual migraine. Neurol Sci 2005; 26Suppl. 2: S162–6PubMedCrossRefGoogle Scholar
Campbell JC, Tobin J, Oleka N, et al. Frovatriptan for the short-term prevention of menstrual migraine: a retrospective subanalysis in triptan-experienced women. Headache 2006; 46: 843–4Google Scholar
MacGregor A, Pawsey S, Campbell J, et al. Use of frovatriptan for the short-term prevention of pure menstrual and menstrually-related migraine headaches: results of a 12-month, open-1abel, safety and tolerability trial. Headache 2006; 46: 844–5Google Scholar
Brandes JL, Smith T, Diamond M, et al. Open-1abel, long-term tolerability of naratriptan for short-term prevention of menstrually related migraine. Headache 2007; 47: 886–94PubMedCrossRefGoogle Scholar
Mannix LK, Savani N, Landy S, et al. Efficacy and tolerability of naratriptan for short-term prevention of menstrually related migraine: data from two randomized, double-blind, placebo-controlled studies. Headache 2007; 47: 1037–49PubMedCrossRefGoogle Scholar
Rapoport AM, Ramadan NM, Adelman JU, et al. Optimizing the dose of zolmitriptan (Zomig, *311C90) for the acute treatment of migraine. Neurology 1997; 49: 1210–8PubMedCrossRefGoogle Scholar
Solomon GD, Cady RK, Klapper JA, et al. Clinical efficacy and tolerability of 2.5mg zolmitriptan for the acute treatment of migraine. The 042 Clinical Trial Study Group. Neurology 1997; 49: 1219–25PubMedCrossRefGoogle Scholar
The long-term tolerability and efficacy of oral zolmitriptan (Zomig, 311C90) in the acute treatment of migraine: an international study. International 311C90 Long-term Study Group. Headache 1998; 38: 173–83CrossRefGoogle Scholar
Tuchman M, Edvinsson L, Geraud G, et al. Zolmitriptan provides consistent migraine relief when used in the long-term. Curr Med Res Opin 1999; 15: 272–81PubMedCrossRefGoogle Scholar
Loder E, Silberstein SD, Abu-Shakra S, et al. Efficacy and tolerability of oral zolmitriptan in menstrually associated migraine: a randomized, prospective, parallel-group, double-blind, placebo-controlled study. Headache 2004; 44: 120–30PubMedCrossRefGoogle Scholar
Tuchman M, Hee A, Emeribe U, et al. Efficacy and tolerability of zolmitriptan oral tablet in the acute treatment of menstrual migraine. CNS Drugs 2006; 20: 1019–26PubMedCrossRefGoogle Scholar
International Headache Society, Headache Classification Committee. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 1988; 8Suppl. 7: 1–96Google Scholar
Dixon R, Warrander A. The clinical pharmacokinetics of zolmitriptan. Cephalalgia 1997; 17Suppl. 18: 15–20PubMedGoogle Scholar
International Headache Society, Headache Classification Committee. The international classification of headache disorders. 2nd ed. Cephalalgia 2004; 24Suppl. 1: 1–160Google Scholar