Efficacy of frovatriptan versus other triptans in the acute treatment of menstrual migraine: pooled analysis of three double-blind, randomized, crossover, multicenter studies.
The objective of this study was to review the efficacy and safety of frovatriptan (F) versus rizatriptan (R), zolmitriptan (Z) and almotriptan (A), in women with menstrually related migraine (IHS criteria) through a pooled analysis of three individual studies. Subjects with a history of migraine with or without aura were randomized to F 2.5 mg or R 10 mg (study 1), F or Z 2.5 mg (study 2), and F or A 12.5 mg (study 3). The studies had an identical multicenter, randomized, double-blind, crossover design. After treating three episodes of migraine in no more than 3 months with the first treatment, patients had to switch to the next treatment for other 3 months. 346 subjects formed intention-to-treat population of the main study; 280 of them were of a female gender, 256 had regular menses and 187 were included in the menstrual migraine subgroup analysis. Rate of pain free at 2, 4 and 24 h was 23, 52 and 67 % with F and 30, 61 and 66 % with comparators (P = NS). Pain relief episodes at 2, 4 and 24 h were 37, 60 and 66 % for F and 43, 55 and 61 % for comparators (P = NS). Rate of recurrence was significantly (P < 0.05) lower under F either at 24 h (11 vs. 24 % comparators) or at 48 h (15 vs. 26 % comparators). Number of menstrual migraine attacks associated with drug-related adverse events was equally low (P = NS) between F (5 %) and comparators (4 %).
Department of Gynecology and Obstetrics, Women's Headache Center, University of Turin, Via Ventimiglia 3, 10126 Turin, Italy. gb.allais@tiscali.it
Gianni
G
Allais
Vincenzo
V
Tullo
Stefano
S
Omboni
Chiara
C
Benedetto
Grazia
G
Sances
Dario
D
Zava
Michel D
MD
Ferrari
Gennaro
G
Bussone
D000328:Adult; D002227:Carbazoles / Q000494:pharmacology / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008597:Menstrual Cycle / Q000187:drug effects / Q000502:physiology; D008875:Middle Aged; D020325:Migraine with Aura / Q000188:drug therapy* / Q000453:epidemiology* / Q000503:physiopathology; D017366:Serotonin Receptor Agonists / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014363:Tryptamines / Q000494:pharmacology / Q000627:therapeutic use*
D002227:Carbazoles; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C108128:frovatriptan