Almotriptan 12.5 mg in menstrually related migraine: A randomized, double-blind, placebo-controlled study

作者：Allais Gianni^*; Bussone Gennaro; D'Andrea Giovanni; Moschiano Franca; d'Onofrio Florindo; Valguarnera Fabio; Manzoni Gian Camillo; Grazzi Licia; Allais Rita; Benedetto Chiara; Acuto Giancarlo

来源：Cephalalgia, 2011, 31(2): 144-151.

DOI：10.1177/0333102410378048

• Almotriptan
• headache
• menstrually related migraine
• placebo
• randomized controlled trial

Background: Menstrually related migraine (MRM) affects more than half of female migraineurs. Because such migraines are often predictable, they provide a suitable target for treatment in the mild pain phase. The present study was designed to provide prospective data on the efficacy of almotriptan for treatment of MRM.
Methods: Premenopausal women with MRM were randomized to almotriptan (N = 74) or placebo (N = 73), taken at onset of the first perimenstrual migraine. Patients crossed over to the other treatment for the first perimenstrual migraine of their second cycle, followed by a two-month open-label almotriptan treatment period.
Results: Significantly more patients were pain-free at two hours (risk ratio [RR] = 1.81; p = .0008), pain-free from 2-24 hours with no rescue medication (RR = 1.99; p = .0022), and pain-free from 2-24 hours with no rescue medication or adverse events (RR = 1.94; p = .0061) with almotriptan versus placebo. Nausea (p = .0007) and photophobia (p = .0083) at two hours were significantly less frequent with almotriptan. Almotriptan efficacy was consistent between three attacks, with 56.2% of patients pain-free at two hours at least twice. Adverse events were similar with almotriptan and placebo.
Conclusion: Almotriptan was significantly more effective than placebo in women with MRM attacks, with consistent efficacy in longer-term follow-up.

• 出版日期2011-1