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Efficacy, safety and tolerability of oral eletriptan in the acute treatment of migraine: results of a phase III, multicentre, placebo-controlled study across three attacks.

Author(s): Stark R, Dahlof C, Haughie S, Hettiarachchi J, Eletriptan Steering Committee

Affiliation(s): Alfred Hospital, Prahran, Australia. richard.stark@med.monash.edu.au

Publication date & source: 2002-02, Cephalalgia., 22(1):23-32.

Publication type: Clinical Trial; Clinical Trial, Phase III; Evaluation Studies; Multicenter Study; Randomized Controlled Trial

The efficacy, safety and tolerability of the 5-HT1B/D receptor agonist eletriptan (40 mg and 80 mg) in acute treatment of migraine was evaluated in a multinational, randomized, double-blind, parallel-group, placebo-controlled, three-attack study treating 1153 patients. In the initial attack, significantly more eletriptan patients reported headache relief and complete pain relief at 2 h vs. placebo (40 mg 62% and 32%, 80 mg 65% and 34%, placebo 19% and 3%; P < 0.0001). Headache relief occurred faster after eletriptan, with more patients at both doses reporting relief 30 min (P < 0.01) and 1 h (P < 0.0001) after treatment than after placebo. There was a significantly lower recurrence rate with eletriptan 80 mg compared with placebo (P < 0.01). Adverse events for all treatments were generally mild or moderate and self-limiting. Eletriptan 40 mg and eletriptan 80 mg both appear to be effective and well-tolerated acute migraine treatments.

Page last updated: 2006-01-31

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