Frovatriptan versus zolmitriptan for the acute treatment of migraine: a double-blind, randomized, multicenter, Italian study

Abstract

The objective of this study is to assess patients’ satisfaction with migraine treatment with frovatriptan (F) or zolmitriptan (Z), by preference questionnaire. 133 subjects with a history of migraine with or without aura (IHS criteria) were randomized to F 2.5 mg or Z 2.5 mg. The study had a multicenter, randomized, double-blind, cross-over design, with each of the two treatment periods lasting no more than 3 months. At the end of the study, patients were asked to assign preference to one of the treatments (primary endpoint). The number of pain-free (PF) and pain-relief (PR) episodes at 2 h, and number of recurrent and sustained pain-free (SPF) episodes within 48 h were the secondary study endpoints. Seventy-seven percent of patients expressed a preference. Average score of preference was 2.9 ± 1.3 (F) versus 3.0 ± 1.3 (Z; p = NS). Rate of PF episodes at 2 h was 26% with F and 31% with Z (p = NS). PR episodes at 2 h were 57% for F and 58% for Z (p = NS). Rate of recurrence was 21 (F) and 24% (Z; p = NS). Time to recurrence within 48 h was better for F especially between 4 and 16 h (p < 0.05). SPF episodes were 18 (F) versus 22% (Z; p = NS). Drug-related adverse events were significantly (p < 0.05) less under F (3 vs. 10). In conclusion, our study suggests that F has a similar efficacy of Z, with some advantage as regards tolerability and recurrence.

Efficacy of frovatriptan and other triptans in the treatment of acute migraine of hypertensive and normotensive subjects: a review of randomized studies

“…The three studies shared a similar design, whose details are extensively reported in the original publications [8][9][10]. In brief, the studies included subjects of both genders, aged 18-65 years, with a current history of migraine with or without aura, according to International Headache Society criteria [12], and with at least one, but no more than six migraine attacks per month for 6 months prior to entering the study.…”

“…Each patient received frovatriptan 2.5 mg or rizatriptan 10 mg (first study) [8], frovatriptan 2.5 mg or zolmitriptan 2.5 mg (second study) [9], and frovatriptan 2.5 mg or almotriptan 12.5 mg (third study) [10], in a randomized sequence. After treating 1-3 episodes of migraine in no more than 3 months with the first treatment, the patient had to switch to the other treatment and treated a maximum of three episodes of migraine in no more than 3 months with the second treatment.…”

“…To bridge this void we settled a retrospective analysis of three previously published randomized, double-blind, cross-over, Italian studies [8][9][10]. In this analysis we compared the efficacy of frovatriptan, an antimigraine agent of the triptan class characterized by a long duration of action and thus a protracted analgesic activity [11], with that of other triptans, in patients classified according to a history of high blood pressure.…”

Overview of Triptans in the Treatment of Acute Migraine

“…Frovatriptan has been evaluated in three double-blind, cross-over, headto-head trials versus rizatriptan, 33 zolmitriptan 34 and almotriptan. 35 The main aim of the study comparing frovatriptan and rizatriptan was to evaluate patient satisfaction for the treatment of acute migraine with either drug.…”

“…Thus, the efficacy of these two triptans is similar but frovatriptan has a greater duration of action. 33 Frovatriptan (2.5 mg) and zolmitriptan (2.5 mg) were compared in a study of 133 patients with a history of migraine using similar endpoints to the trial reported by Savi et al 34 Both treatments were assigned similar preference scores (2.9±1.3 versus 3.0±1.3 for frovatriptan and rizatriptan, respectively). No significant differences were noted for pain-free or pain-relief episodes at 2 hours, recurrence rate, or sustained pain-free, but recurrence time favoured frovatriptan in particular between hours 4-16 (p<0.05).…”