ORAL SUMATRIPTAN IN PREVENTING HEADACHE RECURRENCE AFTER TREATMENT OFMIGRAINE ATTACKS WITH SUBCUTANEOUS SUMATRIPTAN

Headache recurrence (HR) may occur within 24 hours in approximately 40 % of migraine attacks initially treated successfully with 6 mg subcuta neous (SC) sumatriptan. This may be due to the short plasma half-life of sumatriptan. We studied whether an additional dose of 100 mg oral s umatriptan 4 hours after treatment of a migraine attack with 6 mg SC s umatriptan could prevent HR. Patients (n = 667) treated up to three mi graine attacks in a randomized, double-blind, placebo-controlled, para llel-group, multicenter clinical trial. For each attack, they initiall y took open-label 6 mg SC sumatriptan by autoinjector. Four hours late r all patients took either 100 mg oral sumatriptan or matched placebo. Patients could take an additional optional oral dose of 100 mg sumatr iptan to treat HR. The primary efficacy end point was the number of su ccessfully treated patients without KR within 24 hours after the initi al SC injection for the first study attack. Two hundred twenty-five pa tients were not assessable for HR, mainly because of protocol violatio ns. Of 442 assessable patients, 82/212 in the sumatriptan-treated grou p (39% and 89/230 in the placebo-treated group (39%) reported HR in at tack 1. Median times to recurrence were 15.6 hours after sumatriptan a nd 10.3 hours after placebo (p = 0.006). One hundred mg oral sumatript an taken 4 hours after 6 mg SC sumatriptan does not prevent HR but sig nificantly delays time to recurrence.