Gender and triptan efficacy: a pooled analysis of three double-blind, randomized, crossover, multicenter, Italian studies comparing frovatriptan vs. other triptans

Abstract

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.

Age But Not Sex Is Associated With Efficacy and Adverse Events Following Administration of Intravenous Migraine Medication: An Analysis of a Clinical Trial Database

“…Regarding the lack of association between sex and migraine outcomes, we identified similar data from the outpatient setting. In a post hoc analysis of pharmaceutical data, men and women demonstrated comparable rates of short‐term and sustained headache relief after oral triptans . However, other investigators reported that women experience migraine recurrence after successful treatment with oral triptans more frequently than men .…”

“…In a post hoc analysis of pharmaceutical data, men and women demonstrated comparable rates of short-term and sustained headache relief after oral triptans. 18 However, other investigators reported that women experience migraine recurrence after successful treatment with oral triptans more frequently than men. 19,20 We were not able to replicate this latter finding in our analysis of sustained headache response, which incorporates the potential for headache recurrence.…”

Sex-Specific Pharmacotherapy for Migraine: A Narrative Review

“…It is not clear what, if any, relationship exists between the efficacy of these agents in migraine and the plasma concentration achieved (Ferrari et al, 2011;Vetvik and Macgregor, 2017). However, in comparison trials of frovatriptan versus rizatriptan, zolmitriptan, or almotriptan, all produced relatively similar efficacy to ameliorate or eliminate migraine headache, which was not different when men and women were compared (Franconi et al, 2014). A recent metaanalysis did, however, find an increased risk for women to have headache reoccurrence 24 and 48 h after triptan treatment, and concluded that this was not explained by a different initial response to these abortive drugs (van Casteren et al, 2019).…”

Migraine in Women: What Specificities? A Review

“…European studies have shown higher MIDAS scores and higher disability in women, but sex differences in the individual criteria have not been reported [17,45,46,47].…”

“…However the most constant finding is that women report longer duration of migraine attacks than men [17]. Some clinical forms are well described as catamenial migraine.…”