Frovatriptan is Effective and Well Tolerated in Korean Migraineurs: A Double-Blind, Randomized, Placebo-Controlled Trial.
- Author:
Heui Soo MOON
1
;
Min Kyung CHU
;
Jeong Wook PARK
;
Kyungmi OH
;
Jae Myun CHUNG
;
Yong Jin CHO
;
Eung Gyu KIM
;
Jin Kuk DO
;
Hyong Gi JUNG
;
Sun Uck KWON
Author Information
- Publication Type:Randomized Controlled Trial ; Original Article ; Multicenter Study
- Keywords: migraine; frovatriptan; Korean
- MeSH: Adult; Asian Continental Ancestry Group; Carbazoles; Headache; Humans; Incidence; Migraine Disorders; Oxalates; Thorax; Tryptamines
- From:Journal of Clinical Neurology 2010;6(1):27-32
- CountryRepublic of Korea
- Language:English
- 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.