Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine: A Multicenter, Double‐Blind, Placebo‐Controlled Study Conducted in the United States

Objective.—To investigate the efficacy, consistency, safety, and tolerability of oral eletriptan in the acute treatment of three migraine attacks. Background.—Eletriptan is a selective 5‐HT 1B/1D agonist member of a class of agents known to be effective in the acute treatment of migraine. Methods.—Thirteen hundred thirty‐four patients were randomized to 20 mg, 40 mg, or 80 mg of eletriptan, or placebo and could treat up to three attacks. The primary efficacy endpoint was 2‐hour headache response for the first attack. Secondary endpoints included associated symptom relief, and pain‐free, sustained pain‐free, and consistency of response. Results.—Eletriptan 20 mg, 40 mg, and 80 mg achieved significantly ( P   <  .0001) better headache response rates than placebo at 2 hours (47%, 62%, and 59%, respectively, versus 22%) and 4 hours (64%, 76%, and 79%, respectively, versus 25%). Headache response was observed to be rapid, showing improvement at 0.5 hour and 1 hour. Two‐hour pain‐free response rates for eletriptan 20 mg, 40 mg, and 80 mg were 14%, 27%, and 27%, respectively, compared with 4% for placebo. Sustained pain‐free response rates were significantly ( P   <  .001) better for eletriptan 20 mg (10%), 40 mg (20%), and 80 mg (18%) compared with placebo (3%). Eletriptan had a higher consistency of intrapatient response than placebo in two of three (68% to 82%) and three of three attacks (32% to 60%) versus 16% and 8%, respectively. All eletriptan doses yielded significant functional improvement at 2 hours. Adverse events were generally mild or moderate and transient, with eletriptan 20 mg having an adverse event profile comparable to placebo. Conclusions.—Eletriptan is efficacious, displaying high consistency of response over multiple attacks, and is well tolerated for the acute treatment of migraine.