To determine the tolerability and efficacy of
eletriptan in patients who had discontinued oral
sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial).
Eletriptan is a potent, selective 5-HT1B/1D receptor agonist with beneficial pharmacokinetic properties compared with
sumatriptan. In a double-blind, parallel group, placebo-controlled multicentre study, patients with and without
aura (n = 446) were randomized to 40 mg
eletriptan (E40, n = 188), 80 mg
eletriptan (E80, n = 171) or placebo (n = 87) for treatment of up to three
migraine attacks. Two-hour
headache response, based on first-dose, first-attack data, was 59% for
eletriptan 40 mg, 70% for
eletriptan 80 mg, and 30% for placebo (P < 0.0001 for both doses of
eletriptan vs. PBO; P < 0.05 for E80 vs. E40). Onset of action was rapid, with 1-h
headache response rates significantly superior for E40 and E80 vs. placebo (40%, 48%, 15%; P < 0.0005). Both E40 and E80 were significantly superior to placebo, based on first-dose, first-attack data, for 2-h
pain-free response (35%, 42%, and 7%; P < 0.0001). Both E40 and E80 demonstrated significant consistency of response, with
headache relief rates at 2 h on at least two of three attacks in 66% and 72% vs. 15% on placebo (P < 0.001). AEs were mild to moderate in severity and dose related. The most commonly reported AEs included
nausea,
vomiting,
asthenia, and chest symptoms. E40 and E80 produce an effective response in patients who had previously discontinued treatment with
sumatriptan due to lack of efficacy or side-effects.