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KMID : 0911820010020010053
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Korean Journal of Headache
2001 Volume.2 No. 1 p.53 ~ p.60
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A Double-Blinded, Placebo-Controlled, Multicenter Cross-over Study of 2.5㎎ Naratriptan in Acute Migraineurs
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Noh Yong-Woo
Lee Tae-Gyu
Park Kyu-Hyun
Kim Seung-Min
Chung Kyung-Cheon
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Abstract
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Background: Naratriptan is one of the new ’triptans’ for the acute migraine treatment, but its effect for Asian patients is not Known to our awareness.
Methods: From December 1999 to November 2000 we studied the efficacy and safety of 2.5㎎ oral naratriptan with a randomized, placebo-controlled, cross-over, multi-center design in Korea. The study was implemented at the out-patient clinic in three university hospitals. For diagnosis of migraine, we used the Headache Classification proposed by the International Headache Society(1998). We randomly assigned 102 migraineurs, of whom 62 completed the study. The priamay endpoint was significant headache improvement after 4 hours of intervention, either 2.5㎎ naratriptan or placebo.
Results: The rate of significant headache improvement after 4 hours is statistically higer with 2.5㎎ naratritan administration(56.7%) than with placebo(34.8%) (p=0.01). When 2.5㎎ oral narastriptan was administered, the clinical
disability score was siginificantly improved after 1, 2, and 4 hours. There was no difference in adverse effects between naratriptan and placebo. With the relevant laboratory monitoring, naratriptan 2.5㎎ was safe at least in single oral dose. The headache recurrence rate after 24 hours, frequency of other medication use during migraine attacks, associate symptoms after 4 hours were better with naratriptan than placebo, but these were not statistically significant(p>0.05).
Conclusion: Comparing to previous studies on randomized trials of naratriptan, the rate of significant headache improvement(56.7%) was slightly lower in our study. This may partly reflect racial genetic/neuropharmacological difference, such as serotonin receptors, in Asians. We suggest that 2.5㎎ oral naratriptan is effective and safe for the acute migraine treatment in Asians, as well as Caucasians.
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KEYWORD
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Naratriptan, Acute migraine treatment, Double-Blinded, Placebo-Controlled
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