Abstract
PurposeThe purpose of this article is to investigate the efficacy and safety of frovatriptan plus dexketoprofen 25 or 37.5 mg (FroDex25 or FroDex37.5, respectively) compared to that of frovatriptan 2.5 mg (Frova) in menstrually related migraine (MRM).AimThe aim of this article is to analyze a subgroup of 76 women who treated an MRM attack in this multicenter, randomized, double-blind, parallel-group study.MethodsThe primary end-point was the proportion of patients who were pain free (PF) at two hours. Secondary end-points included pain-relief (PR) at two hours and 48 hours sustained pain free (SPF).ResultsPF rates at two hours were 29% under Frova, 48% under FroDex25 and 64% under FroDex37.5 (p < 0.05). PR at two hours was Frova 52%, FroDex25 81% and FroDex37.5 88%, while 48 hours SPF was 18% under Frova, 30% under FroDex25 and 44% under FroDex37.5.ConclusionCombining frovatriptan+dexketoprofen produced higher PF rates at two hours compared to Frova while maintaining efficacy at 48 hours. Tolerability profiles were comparable.
Highlights
The International Headache Society (IHS) defines menstrually related migraine (MRM) as attacks, in a menstruating woman, fulfilling the criteria for migraine without aura occurring on days –2 to þ3 of menstruation in at least two of three menstrual cycles and at other times of the cycle [1]
No events caused withdrawal from the study. This subanalysis of a direct comparative pilot study showed that the combination of frovatriptan þ dexketoprofen 25 mg or 37.5 mg was effective in the treatment of MRM, while maintaining a good tolerability profile
Our study did not include a placebo arm and for the secondary endpoints lacked a correction for multiple statistical testing. In this sub-population analysis, we have shown that the association of frovatriptan plus dexketoprofen (FroDex) may be better than frovatriptan 2.5 mg (Frova) alone in the treatment of MRM and may be an additional option in this difficult-to-treat type of migraine
Summary
The International Headache Society (IHS) defines menstrually related migraine (MRM) as attacks, in a menstruating woman, fulfilling the criteria for migraine without aura occurring on days –2 to þ3 of menstruation in at least two of three menstrual cycles and at other times of the cycle [1].These migraine attacks represent a challenge both for the patient and the headache specialist as they have been shown to be more impairing and longer lasting than non-MRM attacks [2].The first step of the acute treatment of MRM includes triptans followed by nonsteroidal antiinflammatory drugs (NSAIDs) [3]. Combining a triptan and an NSAID has the potential to provide greater symptom relief than therapy with either drug alone because of the different pharmacodynamic targets of the two components: dilated blood vessels for triptans and inflammatory mediators such as prostaglandins (PGs) for NSAIDs [6,7]. This could be true in MRM, which is a difficult-to-treat type of migraine. PGs may play an important role in the pathogenesis of MRM [8,9]
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