With an onset of headache relief as early as 15 min postdose compared with placebo, sumatriptan nasal spray is an important treatment option for patients who seek rapid headache relief and/or a convenient dosing form, whose migraine-associated nausea and vomiting render the use of an oral medication impractical, and those who prefer not to use an injectable form of migraine medication. Although the efficacy and tolerability of sumatriptan nasal spray are documented, the consistency of response to sumatriptan nasal spray across patient subgroups and migraine subtypes of importance to the prescribing clinician have not been described. To provide this information, data from four randomized, double-blind, parallel-group, placebo-controlled, multicenter studies (Glaxo Wellcome protocol numbers S2B-340, S2B-341, S2B-342, and S2B-T50), conducted between January 1993 and December 1994, were pooled and retrospectively analyzed to determine whether the efficacy and tolerability of sumatriptan nasal spray vary with gender, ethnic origin, age, weight, migraine type, concomitant or prior medication use, or pretreatment headache duration. Two-thousand-three-hundred-and-ninety-five (2395) patients treated a moderate or severe migraine with study medication in the four studies. The results demonstrate that sumatriptan nasal spray 20 mg and 10 mg were effective and well tolerated in the acute treatment of migraine consistently across a variety of patient and migraine subgroups. No clinically significant differences in headache relief or adverse event rates were observed for any of the subgroups examined. Approximately two-thirds of patients treated with sumatriptan nasal spray 20 mg compared with approximately one-third of placebo-treated patients reported headache relief 2 h postdose regardless of patient or migraine subgroup. The relationship between active treatment and placebo with respect to the overall incidence of adverse events also did not differ between patient or migraine subgroups. There is no evidence based on this analysis that sumatriptan nasal spray dosage should be adjusted in any of the subgroups examined.
