Objective.—To compare the efficacy and tolerability of eletriptan 20 mg, 40 mg, and 80 mg in triptan-naïve patients (who have not previously used triptans) versus triptan-experienced patients (who have previously used triptans).
Methods.—Efficacy and tolerability data for eletriptan 20 mg, 40 mg, and 80 mg were pooled from 10 similarly designed, randomized, parallel-group studies, and triptan-naïve and triptan-experienced patients were compared with placebo across the 3 triptan doses. The primary efficacy endpoint was headache response at 2 hours postdose. Secondary efficacy endpoints were 2-hour pain-free response, 2-hour absence of associated symptoms, 2-hour functional response, 24-hour sustained headache response, and 24-hour sustained pain-free response.
Results.—For eletriptan 20 mg, 40 mg, and 80 mg versus placebo, respectively, triptan-naïve patients showed significantly higher 2-hour headache response (54%, 61%, 66% vs. 31%; P < .0001), 2-hour pain-free response (20%, 28%, and 31% vs. 8%; P < .0001), and 24-hour sustained headache response (34%, 45%, and 51% vs. 20%; P < .0001). A similarly significant efficacy advantage was also observed in the triptan-experienced subgroup for 2-hour headache response (46%, 63%, 69% vs. 21%; P < .0001), 2-hour pain-free response (13%, 32%, and 38% vs. 4%; P < .0001), and 24-hour sustained headache response (29%, 41%, and 45% vs. 9%; P < .0001). Previous treatment status did not influence tolerability, and all 3 doses of eletriptan were well tolerated.
Conclusions.—These data suggest that eletriptan has comparable efficacy versus placebo among both triptan-naïve and triptan-experienced patients.