214 Comparative Efficacy of Eletriptan 40 mg Versus Sumatriptan 100 mg Ninan T. Mathew, MD; Jean Schoenen, MD; Paul Winner, DO; Nancy Muirhead, MS; Carolyn R. Sikes, PhD Objective.—To confirm the efficacy advantage of eletriptan 40 mg over sumatriptan 100 mg. Background.—Eletriptan 80 mg has demonstrated significantly greater efficacy when compared to both sumatriptan 50 mg and 100 mg in two studies. Eletriptan 40 mg demonstrated significantly greater efficacy than sumatriptan 100 mg in one previous trial. Methods.—Two thousand one hundred thirteen patients with a diagnosis of migraine according to Interna- tional Headache Society criteria were randomized using a double-blind, double-dummy, parallel-group design, and treated for a single migraine attack with either eletriptan 40 mg, sumatriptan 100 mg, or placebo. The pri- mary endpoint was 2-hour headache response. Secondary endpoints included headache response rates at 1 hour, pain-free rates, absence of associated symptoms, functional response at 1 and 2 hours, and sustained headache response. Results.—Headache response rates at 2 hours postdose were significantly higher for eletriptan 40 mg (67%) than for sumatriptan 100 mg (59%; P  .001) and placebo (26%; P  .0001). Eletriptan 40 mg consistently showed significant (P  .01) efficacy over sumatriptan 100 mg across secondary clinical outcomes, including 1-hour head- ache response; 2-hour pain-free response; absence of nausea, photophobia, and phonophobia; functional improve- ment; use of rescue medication; treatment acceptability; and sustained headache response ( P  .05). Overall, treatment-related adverse events were low, nausea being the only adverse event with an incidence of 2% or higher (4.9% with eletriptan, 4.2% sumatriptan, 2.8% placebo). Conclusion.—This trial confirmed that eletriptan 40 mg offers superior efficacy in treating migraine pain and associated symptoms and in restoring patient functioning when compared with sumatriptan 100 mg. Key words: eletriptan, sumatriptan, triptan, migraine, acute treatment, headache Abbreviations: AE adverse event (Headache 2003;43:214-222) The randomized, double-blind, placebo-con- trolled clinical trial is the cornerstone of evidence- based medicine. 1 In many illnesses such as migraine, well-controlled clinical trials have established the ef- ficacy of a wide array of drugs. Choosing among treatments with established efficacy is an individual- ized clinical decision, and the gold-standard evi- dence that informs such decisions in clinical practice is the placebo-controlled, head-to-head comparator trial. 2 In the absence of such a trial, meta-analysis has been used to provide clinicians with indirect evidence From the Houston (Tex) Headache Clinic (Dr. Mathew); the Department of Neurology, University of Liege, Belgium (Dr. Schoenen); the Premiere Research Institute, Palm Beach (Fla) Headache Center (Dr. Winner); and Pfizer Inc, New York, NY (Ms. Muirhead and Dr. Sikes). A complete list of the investigators who participated in this study appears at the end of this article. Address all correspondence to Dr. Ninan T. Mathew, Houston Headache Clinic, Suite 350, 1213 Hermann Drive, Houston, TX 77004 and reprint requests to Dr. Carolyn R. Sikes, Pfizer Inc, 235 East 42 nd Street, 10 th Floor, New York, NY 10017. Accepted for publication October 6, 2002. CONFIDENTIAL-EDUCATIONAL AND TRAINING MATERIALS. DO NOT DETAIL OR DISTRIBUTE TO ANY THIRD PARTIES.