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

Abstract

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 < 0.0001), and from 66% to 74% on ELE-80 vs. 21% to 27% on placebo ( P < 0.0001). The incidence, per attack, of adverse events was low for both ELE-40 and ELE-80. Few adverse events occurred with incidence ≥10% on ELE-40 (asthenia, 5.0%) or ELE-80 (asthenia, 10%; nausea, 5.8%). Discontinuations because of adverse events were 0.2% on ELE-40, and 1.6% on ELE-80 CONCLUSION: In this multiple attack study, eletriptan was well-tolerated and demonstrated consistent and significant efficacy in the treatment of migraine.

• Authors: Mary Almas, Stewart J Tepper, Stephen Landy, Edward Schweizer, Elodie Ramos
• Journal: Cephalalgia : an international journal of headache (Cephalalgia) Vol. 34 Issue 2 Pg. 126-35 (Feb 2014) ISSN: 1468-2982 [Electronic] England
• PMID: 23946318 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Pyrrolidines
• Serotonin Receptor Agonists
• Tryptamines
• eletriptan

Topics

• 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, adverse effects)
• Serotonin Receptor Agonists (administration & dosage, adverse effects)
• Treatment Outcome
• Tryptamines (administration & dosage, adverse effects)
• Young Adult