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

Abstract

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.

• Authors: F Sakai, H-C Diener, R Ryan, P Poole
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 20 Issue 3 Pg. 269-77 (Mar 2004) ISSN: 0300-7995 [Print] England
• PMID: 15025836 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Non-Narcotic
• Indoles
• Pyrrolidines
• Serotonin Receptor Agonists
• Tryptamines
• eletriptan

Topics

• Adolescent
• Adult
• Aged
• Analgesics, Non-Narcotic (therapeutic use)
• Australia
• Clinical Trials as Topic
• Double-Blind Method
• Europe
• Female
• Humans
• Indoles (therapeutic use)
• Japan
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Pyrrolidines (therapeutic use)
• Serotonin Receptor Agonists (therapeutic use)
• Treatment Outcome
• Tryptamines
• United States