Sample size consisted of 530 enrolled participants. Of them, 61 did not have a qualifying migraine within 2 months and were excluded. Of the 469 participants, 454 applied the TDS and provided postbaseline assessments, configuring the ITT population (Fig. 1).
The four treatment groups of interest (with and without nausea at baseline and using sumatriptan TDS or placebo) were very similar from a demographic standpoint (Table). Overall, the mean age of all treated subjects was 40.8 years. A total of 382 subjects (81.4%) were white, 69 subjects (14.7%) were black (African American), and 11 subjects (2.3%) were Asian; 389 (84.9%) were female and 71 subjects (15.1%) were male. No notable demographic differences were seen as a function of treatment group or in individuals with or without nausea. Similarly, there were no notable differences between the treatment groups with respect to severity, location, or other characteristics of migraine history.
Incidence of TEN
A total of 130 participants treated with sumatriptan TDS and 109 participants treated with placebo did not have nausea at the time of treatment and were analyzed for TEN. According to the GEE model, the overall incidence of TEN over 24 hours post-treatment was statistically significantly lower with the sumatriptan TDS than with placebo (Wald = −0.613; 95% confidence interval: −0.980, −0.246; P = .0011). The differences were greater at earlier time points and were significant at 1 hour (P < .01), 2 hours (P < .001), and 3 hours (P < .01) (Fig. 2).
Proportion of patients with treatment-emergent nausea after treatment with sumatriptan or placebo transdermal systems (TDSs). The incidence of treatment-emergent nausea over 24 hours post-treatment was statistically significantly lower with the sumatriptan TDS than with placebo (P = .0011).
Efficacy in Participants With or Without Nausea
A statistically significantly greater proportion of patients who received the sumatriptan TDS were headache-free (18% vs 9%, respectively; P = .0092) or had headache relief (52.9% vs 28.6%, P < .01) 2 hours after TDS activation compared to placebo.
Of participants treated with sumatriptan TDS, 130 had no nausea, whereas 96 had nausea at baseline when treated (Table). Patients with nausea at baseline were nearly twice as likely to have severe headache pain as patients without nausea at baseline (31% vs 16%). Despite this, the efficacy of sumatriptan TDS was similar, independent of the presence or absence of nausea at baseline (for pain-free [Fig. 3a] or pain relief [Fig. 3b]). Similarly, findings were seen for improvement in photophobia (Fig. 4a) and phonophobia (Fig. 4b) from 2 through 24 hours post-activation.
Proportion of patients with or without nausea at baseline that were pain-free (A) or had pain relief (B) after treatment with sumatriptan transdermal system.
Proportion of patients with or without nausea at baseline that reported no photophobia (A) or phonophobia (B) after treatment with sumatriptan transdermal system.
The proportion of patients who reported ≥1 treatment-emergent adverse effects (AEs) was higher with the sumatriptan TDS compared with placebo (50% vs 44%, respectively); 2.1% of those receiving sumatriptan TDS vs 1.3% in those receiving placebo discontinued the study. Most AEs were application-site reactions that resolved within 2 days. Triptan sensations were experienced by 3.4% of patients treated with the sumatriptan TDS (1.7% atypical sensations and 1.7% pain and other pressure sensations) vs 0.4% for placebo.
Tolerability was virtually identical in individuals receiving sumatriptan TDS independent of nausea at baseline (Fig. 5). AE after sumatriptan TDS occurred in 51% of individuals with nausea at baseline vs 50.4% of those without nausea. Moderate or severe AEs happened respectively in 21.4% and 18.1%.
Tolerability among individuals receiving sumatriptan transdermal system (TDS) as a function of nausea at baseline. AE = adverse event.