J Clin Neurol.  2010 Mar;6(1):27-32. 10.3988/jcn.2010.6.1.27.

Frovatriptan is Effective and Well Tolerated in Korean Migraineurs: A Double-Blind, Randomized, Placebo-Controlled Trial

• Moon HS
• Chu MK
• Park JW
• Oh K
• Chung JM
• Cho YJ
• Kim EG
• Do JK
• Jung HG
• Kwon SU

• KMID: 2135478
• DOI: http://doi.org/10.3988/jcn.2010.6.1.27

Abstract

BACKGROUND AND PURPOSE
Frovatriptan is a selective 5-HT1B/1D agonist with a long duration of action and a low incidence of side effects. Although several placebo-controlled trials have documented the clinical efficacy and safety of frovatriptan in adults with migraine, this drug has not previously been studied in Asian including Korean patients.
METHODS
In this double-blind multicenter trial, 229 patients with migraine were randomized to receive frovatriptan 2.5 mg or placebo upon the occurrence of a moderate-to-severe migraine. The primary outcome was the 2-hour headache response rate.
RESULTS
Frovatriptan significantly increased the 2-hour headache response rate compared with placebo (52.9% vs. 34.0%, p=0.004). The headache response rates at 4, 6, and 12 hours were significantly higher in the frovatriptan group than in the placebo group, as was the pain-free rate at 2 hours (19.0% vs. 5.7%, p=0.004), 4 hours (40.7% vs. 23.0%, p=0.006), and 6 hours (56.1% vs. 34.0%, p=0.002). The median time to a headache response was significantly shorter in the frovatriptan group than in the placebo group (2.00 hours vs. 3.50 hours, p<0.001). The use of rescue medications was more common in the placebo group (p=0.005). Chest tightness associated with triptan was infrequent (2.5%), mild, and transient.
CONCLUSIONS
These results demonstrate that 2.5-mg frovatriptan is effective and well tolerated in Korean migraineurs for acute treatment of migraine attacks.

Keyword

migraine; frovatriptan; Korean

MeSH Terms

Adult
Asian Continental Ancestry Group
Carbazoles
Headache
Humans
Incidence
Migraine Disorders
Oxalates
Thorax
Tryptamines
Carbazoles
Oxalates
Tryptamines

Figure

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  Fig. 1 Subject disposition. FAS: full analysis set, PP: per protocol, ITT: intention-to-treat.

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  Fig. 2 Proportion of subjects experiencing headache relief over time.

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