Migraine is three times as common in females as in males, and attacks may be more severe and difficult to treat in women. However, no study specifically addressed possible gender differences in response to antimigraine
therapy. The objective of this study was to review the efficacy of
frovatriptan vs. other
triptans, in the acute treatment of
migraine in subgroups of subjects classified according to gender (men vs. women) through a pooled analysis of three individual randomized Italian studies. 414 patients suffering from
migraine with or without
aura were randomized to
frovatriptan 2.5 mg or
rizatriptan 10 mg (study 1),
frovatriptan 2.5 mg or
zolmitriptan 2.5 mg (study 2),
frovatriptan 2.5 mg or
almotriptan 12.5 mg (study 3). All studies had a multicenter, randomized, double-blind, crossover design. After treating 1-3 episodes of
migraine in no more than 3 months with the first treatment, patients switched to the other treatment for the next 3 months. In this analysis, traditional
migraine endpoints were compared between the 66 men and 280 women of the intent-to-treat population. At baseline, long-term and debilitating
migraine attacks were more frequently reported by women than men. During the observation period, the proportion of
pain-free attacks at 2 h did not significantly differ between
frovatriptan and the comparators in either men (32 vs. 38 %, p = NS) or women (30 vs. 33 %, p = NS).
Pain relief was also similar between treatments for both genders (men: 56 %
frovatriptan vs. 57 % comparators; women: 55 vs. 57 %; p = NS for both). The rate of relapse was significantly lower with
frovatriptan than with the comparators in men (24 h: 10 vs. 30 %; 48 h: 21 vs. 39 %; p < 0.05) as well as in women (24 h: 14 vs. 23 %; 48 h: 28 vs. 40 %; p < 0.05). The rate of
adverse drug reactions was significantly larger with comparators, irrespectively of gender. Although
migraine presents in a more severe form in women,
frovatriptan seems to retain its good efficacy and favorable sustained antimigraine effect regardless of the gender.