A clinical comparison of sumatriptan nasal spray and dihydroergotamine nasal spray in the acute treatment of migraine

A multinational, multicentre, randomised, double-blind, double-dummy, cross over study (368 patients treating two attacks) was conducted to compare the efficacy and tolerability of sumatriptan nasal spray (20 mg) with dihydroe rgotamine (DHE) nasal spray (1 mg plus optional 1 mg). At the primary effic acy time point of 60 minutes after dosing, significantly more patients obta ined headache relief (change from moderate or severe to none or mild) after treatment with sumatriptan than with DHE (53% sumatriptan, 41% DHE, p<0.00 1). Significantly more patients reported relief of nausea after sumatriptan than after DHE at 60 minutes (64% sumatriptan, 49% DHE, p=0.006). A signif icant difference between the two treatments was first observed at 45 minute s with respect to both headache relief (38% sumatriptan, 31% DHE, p=0.037) and relief of nausea (55% sumatriptan, 40% DHE, p=0.014). There were no sig nificant differences between the two treatments for other measures of effic acy. Both treatments were well tolerated, with only 10% of patients in each group reporting one or more adverse events. The most frequently reported a dverse event after sumatriptan was a bad or bitter taste, which was reporte d by 5% of patients. After DHE, 4% of patients reported symptoms of the nas al cavity/sinuses and 3% reported nausea and/or vomiting as adverse events. It is concluded that sumatriptan nasal spray is superior to DHE nasal spra y in the relief of pain and nausea associated with acute migraine headache.