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Oral sumatriptan in preventing headache recurrence after treatment of migraine attacks with subcutaneous sumatriptan

For a listing of the principal clinical investigators, see end of article.
From The New England Center for Headache (Dr. Rapoport), Stamford, CT; the Department of Neurology (Drs. Visser and Ferrari), University Hospital, Leiden, The Netherlands; California Clinical Trials (Dr. Cutler), Beverly Hills, CA; the Glaxo Group Research Limited (C. Alderton), Greenford, Middle-sex, UK; and Glaxo Inc. (L. Paulsgrove and Dr. Davis), Research Triangle Park, NC.
Supported by Glaxo Inc.
Presented in part at the 6th International Headache Congress, Paris, August 1993.
Received August 10, 1994. Accepted in final form December 27, 1994.
Address correspondence and reprint requests to Dr. Alan M. Rapoport, The New England Center for Headache, 778 Long Ridge Road, Stamford, CT 06902-1249.

Headache recurrence (HR) may occur within 24 hours in approximately 40% of migraine attacks initially treated successfully with 6 mg subcutaneous (SC) sumatriptan.This may be due to the short plasma half-life of sumatriptan. We studied whether an additional dose of 100 mg oral sumatriptan 4 hours after treatment of a migraine attack with 6 mg SC sumatriptan could prevent HR. Patients (n equals 667) treated up to three migraine attacks in a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial. For each attack, they initially took open-label 6 mg SC sumatriptan by autoinjector. Four hours later all patients took either 100 mg oral sumatriptan or matched placebo. Patients could take an additional optional oral dose of 100 mg sumatriptan to treat HR. The primary efficacy end point was the number of successfully treated patients without HR within 24 hours after the initial SC injection for the first study attack. Two hundred twenty-five patients were not assessable for HR, mainly because of protocol violations. Of 442 assessable patients, 82/212 in the sumatriptan-treated group (39%) and 89/230 in the placebo-treated group (39%) reported HR in attack 1. Median times to recurrence were 15.6 hours after sumatriptan and 10.3 hours after placebo (p equals 0.006). One hundred mg oral sumatriptan taken 4 hours after 6 mg SC sumatriptan does not prevent HR but significantly delays time to recurrence.

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