Efficacy and safety of eletriptan 20 mg, 40 mg and 80 mg in Japanese migraineurs.
This prospective multicentre, double-blind, randomized, parallel-group, placebo-controlled trial evaluated the efficacy and safety of a single dose of eletriptan 20 mg, 40 mg and 80 mg in Japanese migraineurs. A total of 402 adult Japanese migraineurs were diagnosed using International Headache Society (IHS) criteria. At 2 h after a single dose, the headache response rates of eletriptan 20 mg, 40 mg, 80 mg and placebo were 64%, 67%, 76% and 51%, respectively, with all doses significantly superior to placebo (P<0.05). Eletriptan had a statistically significant dose response for headache relief and pain-free response at 2 h post-dose (P=0.0011 and P=0.0291, respectively). Most all-causality adverse events were mild and there were no deaths or discontinuations. Saliva samples were used to assess serum eletriptan levels 2 h post-dose. Pharmacokinetic evaluations showed no clinically significant differences between Japanese and Western subjects. Eletriptan was shown to be efficacious, safe, and well tolerated in Japanese migraineurs.
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002851:Chromatography, High Pressure Liquid; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000032:analysis / Q000493:pharmacokinetics / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D011759:Pyrrolidines / Q000008:administration & dosage / Q000009:adverse effects* / Q000032:analysis / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012008:Recurrence; D012463:Saliva / Q000737:chemistry; D016896:Treatment Outcome; D014363:Tryptamines
D007211:Indoles; D011759:Pyrrolidines; D014363:Tryptamines; C115647:eletriptan