Neurologia II, Department of Neurology, Centro Cefalee, University of Torino, Via Cherasco 15, 10126, Turin, Italy.
J Headache Pain. 2011 Dec;12(6):609-15. doi: 10.1007/s10194-011-0366-9. Epub 2011 Aug 13.
The objectives of this study are to assess the efficacy and safety of frovatriptan, and rizatriptan in the subgroup of women with menstrually related migraine of a multicenter, randomized, double blind, cross-over study. Each patient received frovatriptan 2.5 mg or rizatriptan 10 mg in a randomized sequence: after treating 3 episodes of migraine in not more than 3 months with the first treatment, the patient had to switch to the other treatment. Menstrually related migraine was defined according to the criteria listed in the Appendix of the last IHS Classification of Headache disorders. 99 out of the 125 patients included in the intention-to-treat analysis of the main study were of a female gender: 93 had regular menstrual cycles and were, thus, included in this analysis. A total of 49 attacks classified as menstrually related migraine were treated with frovatriptan and 59 with rizatriptan. Rate of pain relief at 2 h was 58% for frovatriptan and 64% for rizatriptan (p = NS), while rate of pain free at 2 h was 31 and 34% (p = NS), respectively. At 24 h, 67 and 81% of frovatriptan-treated, and 61 and 74% of rizatriptan-treated patients were pain free and had pain relief, respectively (p = NS). Recurrence at 24 h was significantly (p < 0.01) lower with frovatriptan (10 vs. 32% rizatriptan). Frovatriptan was as effective as rizatriptan in the immediate treatment of menstrually related migraine attacks while showing a favorable sustained effect with a lower rate of migraine recurrence. These results need to be confirmed by randomized, double-blind, prospective, large clinical trials.
本研究旨在评估曲普坦和利扎曲坦在多中心、随机、双盲、交叉研究中与月经相关偏头痛亚组患者的疗效和安全性。每位患者均按照随机顺序接受曲普坦 2.5mg 或利扎曲坦 10mg 治疗：在 3 个月内最多用首种治疗方法治疗 3 次偏头痛发作后，患者必须改用另一种治疗方法。根据最后 IHS 头痛障碍分类附录中的标准定义与月经相关的偏头痛。在主要研究的意向治疗分析中，纳入的 125 例患者中有 99 例为女性：93 例患者月经周期规律，因此纳入本分析。共对 49 次分类为与月经相关的偏头痛发作进行了曲普坦和利扎曲坦治疗。治疗 2 小时后，曲普坦组的疼痛缓解率为 58%，利扎曲坦组为 64%（p=NS），而治疗 2 小时后无疼痛的比例分别为 31%和 34%（p=NS）。在 24 小时时，曲普坦组有 67%和 81%的患者无疼痛且疼痛缓解，利扎曲坦组有 61%和 74%的患者无疼痛且疼痛缓解，分别为（p=NS）。24 小时时的复发率明显（p<0.01）较低，曲普坦为 10%，而利扎曲坦为 32%。曲普坦在治疗与月经相关的偏头痛发作方面与利扎曲坦同样有效，且具有良好的持续效果，偏头痛复发率较低。这些结果需要通过随机、双盲、前瞻性、大型临床试验来证实。
