Dodick David W, Lipton Richard B, Goadsby Peter J, Tfelt-Hansen Peer, Ferrari Michel D, Diener Hans-Christoph, Almas Mary, Albert Kenneth S, Parsons Bruce
Department of Neurology, Mayo Clinic, Scottsdale, AZ 85259, USA.
Headache. 2008 Feb;48(2):184-93. doi: 10.1111/j.1526-4610.2007.00868.x.
To identify clinical variables associated with risk of headache recurrence within 22 hours of initial successful treatment of a migraine attack (2-hour headache response), and to analyze the effect of eletriptan in reducing the incidence of recurrence.
Data were pooled from 10 randomized, double-blind, placebo-controlled trials evaluating eletriptan 40 mg (E40), eletriptan 80 mg (E80), and sumatriptan 100 mg (S100) for acute migraine treatment. Patients who achieved a headache response (improvement from moderate/severe pain at baseline to mild/no pain at 2 hours postdose) were evaluable. A multivariable logistic regression analysis identified significant predictors of headache recurrence (return to moderate/severe pain intensity within 22 hours of initial headache response). Treatment response was assessed in two high-risk subgroups, defined by the presence of significant recurrence predictors.
Of 4312 patients responding to acute treatment within 2 hours postdose, 1232 (29%) experienced recurrence. Initial headache response within 2 hours was significantly higher for E40 (62.0%), E80 (67.4%), and S100 (57.9%) compared to placebo (25.1%; all P < .0001). Three clinical variables were significant predictors of recurrence: female gender, age > or = 35 years, and severe baseline headache pain. Among patients with all 3 risk factors (n = 742; 17% of total population), recurrence rates were lower with E40 (35.6%) and E80 (32.9%) than placebo (47.8% P < .01). The same result was observed in the subgroup of patients with 2 risk factors (female gender and age > or = 35 years; P < .0001 vs placebo). Sustained headache and pain-free response rates (a headache/pain-free response at 2 hours postdose with no headache recurrence and no rescue medication use in the subsequent 22 hours) were significantly higher with E40 and E80 than placebo in both high-risk subgroups (P < .05).
Female gender, age > or = 35 years, and severe baseline headache pain are significant predictors of headache recurrence during a migraine attack. Eletriptan is effective at reducing the incidence of headache recurrence in high-risk subgroups.
确定与偏头痛发作初始成功治疗后22小时内头痛复发风险（2小时头痛缓解）相关的临床变量，并分析依立曲坦在降低复发率方面的作用。
汇总10项随机、双盲、安慰剂对照试验的数据，这些试验评估了40毫克依立曲坦（E40）、80毫克依立曲坦（E80）和100毫克舒马曲坦（S100）用于急性偏头痛治疗的效果。达到头痛缓解（从基线时的中度/重度疼痛改善为给药后2小时的轻度/无疼痛）的患者可纳入评估。多变量逻辑回归分析确定了头痛复发（初始头痛缓解后22小时内恢复到中度/重度疼痛强度）的显著预测因素。在由显著复发预测因素定义的两个高风险亚组中评估治疗反应。
在给药后2小时内对急性治疗有反应的4312例患者中，1232例（29%）出现复发。与安慰剂（25.1%；所有P<.0001）相比，E40（62.0%）、E80（67.4%）和S100（57.9%）在2小时内的初始头痛缓解率显著更高。三个临床变量是复发的显著预测因素：女性、年龄≥35岁和基线时严重头痛疼痛。在所有三个风险因素均存在的患者中（n = 742；占总人口的17%），E40组（35.6%）和E80组（32.9%）的复发率低于安慰剂组（47.8%，P<.01）。在有两个风险因素（女性和年龄≥35岁）的患者亚组中也观察到了相同的结果（与安慰剂相比，P<.0001）。在两个高风险亚组中，E40和E80的持续头痛和无疼痛缓解率（给药后2小时出现头痛/无疼痛缓解，随后22小时内无头痛复发且未使用急救药物）均显著高于安慰剂（P<.05）。
女性、年龄≥35岁和基线时严重头痛疼痛是偏头痛发作期间头痛复发的显著预测因素。依立曲坦在降低高风险亚组中头痛复发率方面有效。
