Safety and tolerability of short-term preventive frovatriptan: a combined analysis.

摘要: Objective.— To assess the safety and tolerability profile of 5-HT1B/1D agonist frovatriptan (Frova®, Endo Pharmaceuticals Inc., Chadds Ford, PA, USA) when used as a 6-day regimen for short-term prevention menstrual migraine scheduled over multiple perimenstrual periods. Background.— Two randomized controlled trials have established efficacy reducing incidence severity 1 to 3 periods; long-term data are needed further this regimen. Methods.— multinational were included in analysis: Study was randomized, placebo-controlled double-blind parallel trial (3 periods treated) with an open-label extension additional treated), 2 (12 treated 12-15 months) study. Enrolled women experienced defined predictable attacks that started −2 days +3 (Study 1) or +4 2) relative first day menses occurred at least out cycles. Frovatriptan placebo given before anticipated continued 6 days. Adverse events, serious adverse vital signs, cardiovascular electrocardiograms, laboratory parameters assessed recorded periodically summarized using descriptive statistics. event from compared rates. Results.— The demographic characteristics study populations similar: mean age approximately 38 years, ≥94% participants white, 85% reported began on +1 cycle. history 11 years. A large percentage respective completed each period: 87% (362/416) 88% (273/309) period 1, respectively, 59% (308/525) treatment 12 2. Major reasons discontinuation events (5%, period) “other” (10% 5% period). In 2, major patient request (17.3%) (10.2%). most common emergent (placebo vs twice daily) upper respiratory infection (9% 9%), nausea (6% 8%), dizziness (7% 7%), fatigue (4% dysmenorrhea (3% influenza 6%), neck pain 4%). With exception (which different method study), prevalence rates Studies numerically similar. frequently during chest discomfort (2% 3%), 2%), hypertension (0 2%). corresponding 2% (chest pain), 3% discomfort), (hypertension). both studies, mild moderate intensity their declined period/cycle, did migraine. observed rate intercurrent 1.5 per month, 1.7 baseline. There no observable increase occurrence 5 following period, indicating lack rebound headache. Conclusions.— During up 12- 15-month similar acute use triptans. generally severity, there evidence increased risk treatment, headache not evident. presents safe viable option preventing such