Frovatriptan is Effective and Well Tolerated in Korean Migraineurs: A Double-Blind, Randomized, Placebo-Controlled Trial.
OBJECTIVE
Frovatriptan is a selective 5-HT(1B/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.
Moon
Heui-Soo
HS
Department of Neurology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Chu
Min Kyung
MK
Park
Jeong Wook
JW
Oh
Kyungmi
K
Chung
Jae Myun
JM
Cho
Yong Jin
YJ
Kim
Eung Gyu
EG
Do
Jin Kuk
JK
Jung
Hyong Gi
HG
Kwon
Sun Uck
SU
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