Objective: 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.
Methods: 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.
Results: 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).
Conclusion: 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.