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Efficacy of Eletriptan in Triptan-Naïve Patients: Results of a Combined Analysis

Authors

  • Vincent T. Martin MD,

  • Dominique Valade MD,

  • Mary Almas MS,

  • Jayasena Hettiarachchi MD,

  • Carolyn Sikes PhD,

  • Kenneth S. Albert PhD,

  • Bruce Parsons MD


  • From the Division of General Internal Medicine, University of Cincinnati, Cincinnati, OH (Dr. Martin); Centre d'Urgence Céphalées, Hôpital Lariboisière, Paris, France (Dr. Valade); Pfizer Inc., New York, NY (Ms. Almas, Drs. Hettiarachchi, Sikes, Albert, and Parsons).

Address all correspondence to Dr. Vincent T. Martin, Division of General Internal Medicine, University of Cincinnati, PO Box 670535, Cincinnati, OH 45267-4217.

Abstract

Objective.—To compare the efficacy and tolerability of eletriptan 20 mg, 40 mg, and 80 mg in triptan-naïve patients (who have not previously used triptans) versus triptan-experienced patients (who have previously used triptans).

Methods.—Efficacy and tolerability data for eletriptan 20 mg, 40 mg, and 80 mg were pooled from 10 similarly designed, randomized, parallel-group studies, and triptan-naïve and triptan-experienced patients were compared with placebo across the 3 triptan doses. The primary efficacy endpoint was headache response at 2 hours postdose. Secondary efficacy endpoints were 2-hour pain-free response, 2-hour absence of associated symptoms, 2-hour functional response, 24-hour sustained headache response, and 24-hour sustained pain-free response.

Results.—For eletriptan 20 mg, 40 mg, and 80 mg versus placebo, respectively, triptan-naïve patients showed significantly higher 2-hour headache response (54%, 61%, 66% vs. 31%; P < .0001), 2-hour pain-free response (20%, 28%, and 31% vs. 8%; P < .0001), and 24-hour sustained headache response (34%, 45%, and 51% vs. 20%; P < .0001). A similarly significant efficacy advantage was also observed in the triptan-experienced subgroup for 2-hour headache response (46%, 63%, 69% vs. 21%; P < .0001), 2-hour pain-free response (13%, 32%, and 38% vs. 4%; P < .0001), and 24-hour sustained headache response (29%, 41%, and 45% vs. 9%; P < .0001). Previous treatment status did not influence tolerability, and all 3 doses of eletriptan were well tolerated.

Conclusions.—These data suggest that eletriptan has comparable efficacy versus placebo among both triptan-naïve and triptan-experienced patients.

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