Eletriptan in acute migraine: A double-blind, placebo-controlled comparison to sumatriptan

Objective: To compare the efficacy, safety, and tolerability of oral eletri ptan (20 mg, 40 mg, and 80 mg) with that of oral sumatriptan (100 mg) and p lacebo for the acute treatment of migraine. Background: Eletriptan is a pot ent and selective agonist at human recombinant 5HT(1B/1D) receptors, with e fficacy in animal models that predict antimigraine activity. In healthy vol unteers, the pharmacokinetics of eletriptan are characterized by linear and rapid oral absorption. Methods: Randomized, double-blind, parallel-group s tudy conducted in 857 outpatients with a diagnosis of migraine according to the International Headache Society (IHS) criteria. Of these, 692 took stud y medication for one acute migraine attack and provided on-drug efficacy da ta. Subjects received either placebo, 190 mg of sumatriptan or 20 mg, 40 mg , or 80 mg of eletriptan for the treatment of an acute migraine attack. The primary endpoint was the percentage of patients with a headache response ( improvement in pain intensity from moderate or severe to mild or none) at 2 hours after treatment. Results: At the primary endpoint (2 hours after dos ing), headache response rates were 24% (30/126) for placebo; 55% (63/115) f or sumatriptan, 100 mg; 54% (70/129) for eletriptan, 20 mg; 65% (76/117) fo r eletriptan, 40 mg; and 77% (91/118) for eletriptan, 80 mg. There was a di fference compared with placebo (p < 0.001) for all doses of eletriptan, and at 2 hours there was a difference between sumatriptan, 100 mg, and eletrip tan, 80 mg (p < 0.001). Headache-free rates at 2 hours were superior to pla cebo (6%; p < 0.001) for both the 80-mg dose of eletriptan (37%) and the 40 -mg dose (29%), with the 80-mg dose also being superior to 100 mg of sumatr iptan (23%; p < 0.05). Eletriptan and sumatriptan were well tolerated, and the majority of adverse events were mild or moderate in intensity and trans ient. Conclusion: In this placebo-controlled trial, eletriptan, at selected doses, demonstrated superior efficacy, onset of action and patient accepta bility in the acute treatment of migraine when compared with oral sumatript an and placebo.