Objective.— To evaluate the efficacy and safety of transdermal sumatriptan in migraine patients who have baseline nausea.
Background.— Migraine-associated nausea and vomiting can limit the effectiveness of acute treatment with oral agents by causing delays, avoidance, or incomplete absorption of medication due to post-dose vomiting.
Methods.— 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.— Transdermal sumatriptan is superior to oral triptans for migraine patients whose baseline nausea causes them to delay or avoid acute treatment.