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Title: Headache Recurrence and Efficacy of Eletriptan in Caucasian and Japanese Patients: Presented at IHS

"Headache Recurrence and Efficacy of Eletriptan in Caucasian and Japanese Patients: Presented at IHS"

By Claire Sowerbutt KYOTO, JAPAN -- October 17, 2005 -- A pooled analysis of efficacy data from a study of eletriptan in the prevention of headache recurrence indicate that while 40 mg is efficacious in Western patients, 20 mg is very effective in Japanese patients. "The purpose of this study was 2-fold: 1 was to examine the efficacy of eletriptan on headache recurrence and the other was to do a comparison between patients in Japan and patients in the US," said Bruce Parsons, MD, PhD, team leader for Eletriptan, Pfizer Medical World Wide, New York, New York, who presented the data here on October 12[^th during the 12^th Congress of the International Headache Society (IHS).

Recurrence is one of the main reasons that people become discouraged with their migraine medication, Dr. Parsons said.

"It's much easier to find a medication that works for a few hours rather than a medication that keeps patients well for 24," he said. "When we think of efficacy and migraine treatment we should also focus on the more sustained response, because in reality that's what patients really care about."

With respect to the rationale for evaluating efficacy in the Japanese population independently of other populations, he explained that the approved dosing outside Japan is different from that within Japan.

For the analysis in Western patients, investigators pooled data from 3 placebo-controlled, double-blind studies (n = 590 for eletriptan 20 mg, n = 596 for placebo). The Japanese data were assessed from a single double-blind, placebo-controlled study conducted in Japan (n = 80 for eletriptan 20 mg, and n = 84 for placebo).

Results show a higher headache response rate at 2 hours postdose in Japanese patients treated with 20 mg than in their Western counterparts -- 64% versus 51% for eletriptan and placebo, respectively, in Japan, and 54% versus 24%, and 47% versus 22% in the 2 Western studies, for eletriptan and placebo respectively.

The placebo response was more than 25% higher in the Japanese patients, compared with their Western counterparts, Parsons noted.

"When we look at the 20-mg data, we see that the response in Western patients is not particularly robust," he said. "In Japan, however, the 20 mg does very nicely in terms of headache response at 2 hours, and, unlike the West, 20 mg is very good at preventing recurrence in Japan, the rate is slightly less than 10%. In the West it's not very different from that of placebo."

"We know that Japanese patients often require a lower dose than their Western counterparts," Parsons said. "We think the difference in response between Japanese and Western patients may be due to differences in metabolism of the drugs, and this is true for a number of drugs. Essentially, the rate of metabolism may be less for some drugs."

"Therefore," he concluded, "a 20-mg dose may be more comparable in Japanese patients to a 40-mg dose in the West. The other factor, which is not due to metabolism, is that in Japan the average length of attack is somewhat shorter than that in the West."

[Presentation title: Eletriptan and Headache Recurrence. Poster F046]

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