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Eletriptan for the acute treatment of migraine: results of bridging a Japanese study to Western clinical trials.

Author(s): Sakai F, Diener HC, Ryan R, Poole P

Affiliation(s): Department of Medicine, Kitasato University Hospital, Sagamihara City, Kanagawa Prefecture, Japan. fsakai@kitasato-u.ac.jp

Publication date & source: 2004-03, Curr Med Res Opin., 20(3):269-77.

Publication type: Clinical Trial; Clinical Trial, Phase II; Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial

OBJECTIVE: To compare the efficacy, safety and tolerability of eletriptan (20, 40 and 80 mg) to placebo when given to Japanese and Western patients for the acute treatment of migraine. METHODS: A double-blind, randomized, parallel-group trial with the aforementioned therapeutic objectives was conducted in Japan (N = 321). By bridging analysis, data from this study were compared to two migraine trials previously conducted in the US (N = 1190) and Europe (N = 563). RESULTS: The 2-h post-dose headache response rates (i.e., the primary efficacy endpoint) of Japanese migraineurs to eletriptan 20, 40 and 80 mg were 64, 67 and 76%, respectively; European and American migraineurs showed similar trends and, in these studies, eletriptan was significantly superior to placebo (p < 0.05). Japanese patients did demonstrate a higher placebo response than Westerners, possibly due to differences in previous triptan exposure or expectation. Adverse events were generally mild to moderate, were comparable in all three studies, and showed a modest dose-response effect. CONCLUSION: The efficacy and tolerability of eletriptan for the acute treatment of migraine is comparable in Japan, Europe and the US.

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