In a multicenter, randomized, double-blind, placebo-controlled study in adult (aged 18-66 years) migraineurs, 530 patients were randomized to receive transdermal
sumatriptan or a placebo patch and remained in the study until they had treated a single moderate to severe
migraine attack or had gone 2 months without treatment. At baseline (before applying the study patch), patients recorded
headache pain intensity and the presence or absence of
migraine-associated symptoms, including
nausea. The use of
analgesic or
anti-emetic rescue medications within 2 hours of patch activation was prohibited. Post-hoc analyses were conducted to assess the proportion of patients with
nausea at baseline who experienced
headache relief and who were free from
nausea,
photophobia, and
phonophobia at 1 and 2 hours post-activation.
RESULTS: A total of 454 patients were included in the intent-to-treat population for efficacy analyses. Baseline demographic and
migraine headache characteristics were generally similar between the treatment groups. In the overall study population, transdermal
sumatriptan was significantly superior to placebo at 1 hour post-activation for
pain relief (29% vs 19%, respectively; P < .0135) and freedom from
nausea (71% vs 58%, respectively; P < .05) and at 2 hours post-activation for freedom from
pain (18% vs 9%, respectively; P < .009),
pain relief (53% vs 29%, respectively; P < .0001), freedom from
nausea (84% vs 63% respectively; P < .001), freedom from
photophobia (51% vs 36%, respectively; P < .0028), freedom from
phonophobia (55% vs 39%, respectively; P < .0002); and freedom from
migraine (16% vs 8%, respectively; P < .0135). In the post-hoc analysis, transdermal
sumatriptan was markedly superior to placebo for
pain relief and freedom from
pain,
nausea, photo-, and
phonophobia at 1 and 2 hours post-activation.
CONCLUSIONS: