Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study

• Published in: Cephalalgia 2014-02, Vol.34 (2), p.126-135
• Main Authors: Almas, Mary, Tepper, Stewart J, Landy, Stephen, Schweizer, Edward, Ramos, Elodie
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Migraine Disorders - drug therapy; Placebos; Pyrrolidines - administration & dosage; Pyrrolidines - adverse effects; Serotonin Receptor Agonists - administration & dosage; Serotonin Receptor Agonists - adverse effects; Treatment Outcome; Tryptamines - administration & dosage; Tryptamines - adverse effects; Young Adult
• ISSN: 0333-1024; 1468-2982
• DOI: 10.1177/0333102413500726

Objective The current study evaluated the consistency of eletriptan response. Methods Using a within-patient crossover design, patients with migraine completed a three-attack, open-label, lead-in period, before being treated, double-blind for four attacks, with either eletriptan 40 mg (ELE-40; N = 539) or eletriptan 80 mg (ELE-80; N = 432); placebo was randomly substituted for the treatment of one attack. Results On an a priori analysis of within-patient consistency, double-blind treatment was associated with similar 2 hour headache response rates using a ≥2/3 response criterion for ELE-40 (77%) and ELE-80 (73%), and using a 3/3 response criterion for ELE-40 (46%) and ELE-80 (47%). Within-patient consistency in achieving pain-free status at 2 hours using a ≥2/3 criterion was slightly higher on ELE-40 (42%) compared with ELE-80 (38%), and was similar using the 3/3 criterion (18% on ELE-40, 17% on ELE-80). On a repeated measures logistic regression analysis across all treated attacks, the probability of achieving a headache response at 2 hours ranged from 71% to 74% on ELE-40 vs. 17% to 28% on placebo (p