title: Efficacy, tolerability and safety of oral eletriptan and ergotamine plus caffeine (Cafergot) in the acute treatment of migraine: a multicentre, randomised, double-blind, placebo-controlled comparison.
abstract: The 5-HT(1B/1D/1F) agonist eletriptan, at an oral dose of 80 mg, has been shown to be more efficacious than sumatriptan 100 mg and placebo in the treatment of migraine attacks with or without aura. Another commonly prescribed oral treatment for migraine attacks is Cafergot (1 mg ergotamine tartrate with 100 mg caffeine per tablet). The efficacy, tolerability and safety of 40- and 80-mg doses of eletriptan and 2 tablets of Cafergot were compared in a double-blind, randomised, placebo-controlled, parallel-group trial involving 733 migraine patients. Patients recorded symptoms at baseline (before treatment) and 1, 2, 4 and 24 h after dosing. Headache intensity was assessed on a 4-point scale (3 = severe pain, 2 = moderate pain, 1 = mild pain, 0 = no pain). Significantly more eletriptan-treated patients (80 mg, 68%; 40 mg, 54%) than Cafergot-treated patients (33%; p < 0.001) reported headache response (improvement from moderate-to-severe to mild or no pain) at 2 h. Substantially more eletriptan recipients reported no pain (80 mg, 38%; 40 mg, 28%; Cafergot, 10%; placebo, 5%; p < 0.001). Eletriptan headache response rates at 1 h were significantly higher (80 mg, 39%; 40 mg, 29%; Cafergot, 13%; placebo, 13%; p < 0.002 for each comparison). Both doses of eletriptan were significantly more effective than Cafergot in reducing nausea (p < 0.0001), photophobia (80 mg, p < 0.0001; 40 mg, p < 0.002), phonophobia (80 mg, p < 0.0001; 40 mg, p < 0.003) and functional impairment (p < or = 0.001) at 2 h. Adverse events were generally mild or moderate and transient. This randomised trial shows that oral eletriptan is more efficacious in the acute treatment of migraine than oral Cafergot and is well tolerated.
authors.affiliation: Department of Neurology, University of Essen, Essen, Germany. h.diener@uni-essen.de
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.forename: Jan-Peter
authors.initials: JP
authors.lastname: Jansen
authors.forename: Avinoan
authors.initials: A
authors.lastname: Reches
authors.forename: Julio
authors.initials: J
authors.lastname: Pascual
authors.forename: Daniela
authors.initials: D
authors.lastname: Pitei
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Steiner
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002110:Caffeine / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D004878:Ergotamine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D011759:Pyrrolidines / Q000009:adverse effects / Q000627:therapeutic use*; D017366:Serotonin Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014363:Tryptamines
chemical_list: D004338:Drug Combinations; D007211:Indoles; D011759:Pyrrolidines; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C037330:caffeine, ergotamine drug combination; C115647:eletriptan; D002110:Caffeine; D004878:Ergotamine