A double-blind, randomized, multicenter, Italian study of frovatriptan versus almotriptan for the acute treatment of migraine

Abstract

The objective of this study was to evaluate patients’ satisfaction with acute treatment of migraine with frovatriptan or almotriptan by preference questionnaire. One hundred and thirty three subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or almotriptan 12.5 mg, treating 1–3 attacks. The study had a multicenter, randomized, double blind, cross-over design, with treatment periods lasting <3 months. At study end patients assigned preference to one of the treatments using a questionnaire with a score from 0 to 5 (primary endpoint). Secondary endpoints were pain free and pain relief episodes at 2 and 4 h, and recurrent and sustained pain free episodes within 48 h. Of the 133 patients (86%, intention-to-treat population) 114 of them expressed a preference for a triptan. The average preference score was not significantly different between frovatriptan (3.1 ± 1.3) and almotriptan (3.4 ± 1.3). The rates of pain free (30% frovatriptan vs. 32% almotriptan) and pain relief (54% vs. 56%) episodes at 2 h did not significantly differ between treatments. This was the case also at 4 h (pain free: 56% vs. 59%; pain relief: 75% vs. 72%). Recurrent episodes were significantly (P < 0.05) less frequent under frovatriptan (30% vs. 44%), also for the attacks treated within 30 min. No significant differences were observed in sustained pain free episodes (21% vs. 18%). The tolerability profile was similar between the two drugs. In conclusion, our study suggests that frovatriptan has a similar efficacy of almotriptan in the short-term, while some advantages are observed during long-term treatment.

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

“…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. 33 Patients were recruited with a history of migraine and one or more attack in the previous 6 months.…”

“…34 The third study comparing frovatriptan (2.5 mg) and almotriptan (12.5 mg) had a very similar design with respect to patients enrolled and endpoints. 35 In total, 114 patients completed the preference questionnaire. As with the other head-to-head studies there was no significant difference in patient preference, rates of pain-free (2 or 4 hours) and pain-relief (2 hours), sustained pain-free episodes and recurrent episodes were significantly less frequent with frovatriptan (30 versus 44% with almotriptan, p<0.05) and for recurrent episodes treated within 30 minutes (p<0.05).…”