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

The efficacy, safety and tolerability of the 5-HT1B/1D 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.