Affiliation:
1. Pfizer Inc., New York, NY, USA
2. Headache Center, Cleveland Clinic, Cleveland, OH, USA
3. Wesley Neurology Clinic, Memphis, TN, USA
4. Paladin Consulting Group, Princeton, NJ, USA
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. Clinicaltrials.Gov Identifier: NCT01859481
Subject
Clinical Neurology,General Medicine
Cited by
10 articles.
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