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Background. The headache in migraine attacks may be caused by dilatation of certain cranial arteries or arteriovenous anastomoses, by neurogenic dural plasma extravasation, or by both of these mechanisms. Sumatriptan, a novel selective agonist of 5-hydroxytryptamine-like receptors, blocks these phenomena. We investigated its efficacy in migraine.

Methods. We studied 639 patients with migraine attacks in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. We assessed the effect of subcutaneous injections of 6 or 8 mg of sumatriptan or placebo on the severity of headache and associated migraine symptoms 30, 60, and 120 minutes after treatment. Patients who were not free of pain after 60 minutes subsequently received placebo if they had initially received placebo or 8 mg of sumatriptan, and 6 mg of sumatriptan or placebo if they had initially received 6 mg of sumatriptan.

Results. After 60 minutes, the severity of headache was decreased in 72 percent (95 percent confidence interval, 68 to 76 percent) of the 422 patients given 6 mg of sumatriptan, 79 percent (95 percent confidence interval, 71 to 87 percent) of the 109 patients given 8 mg of sumatriptan, and 25 percent (95 percent confidence interval, 17 to 33 percent) of the 105 patients given placebo (data on 3 patients could not be evaluated). As compared with the placebo group, 47 percent (95 percent confidence interval, 38 to 57 percent) more patients who had received 6 mg of sumatriptan and 54 percent (95 percent confidence interval, 43 to 65 percent) more patients who had received 8 mg of sumatriptan had a decrease in the severity of headache (P<0.001 for both comparisons). After 120 minutes, 86 to 92 percent of the 511 patients treated with sumatriptan (202 assigned to 6 mg plus placebo, 203 to 6 mg plus 6 mg, and 106 to 8 mg plus placebo) had improvement in the severity of headache, as compared with only 37 percent of the 104 patients who received placebo once or twice (P<0.001 for all comparisons). Twenty-one patients were excluded from the analysis because of missing data (19) or protocol violations (2). The response rates did not differ significantly among the sumatriptan regimens. Adverse events were minor and transient in all groups.

Conclusions. We conclude that a single 6-mg dose of sumatriptan given subcutaneously is a highly effective, rapid-acting, and well-tolerated treatment for migraine attacks. The administration of a second dose 60 minutes later to patients not responding well to an initial dose affords little additional benefit. (N Engl J Med 1991; 325: 316-21.)

: MIGRAINE is a common disorder that can severely affect patients' quality of life and daily function. The patients typically have attacks of unilateral, pulsating, severe or moderately severe headache aggravated by routine physical activity and associated with anorexia, nausea, vomiting, photophobia, and phonophobia.1 The attacks may last from 4 to 72 hours and are sometimes preceded by transient focal neurologic symptoms (aura).1 Up to 15 percent of patients may have recurrent attacks.2 3 4 5 Current pharmacologic treatment is directed at acute symptomatic relief or involves prophylactic treatment to reduce the frequency of attacks. The efficacy of both types of treatment is poor, [horizontal ellipsis]

Owned, published, and (C) copyrighted, 1991, by the MASSACHUSETTS MEDICAL SOCIETY