Frovatriptan for Acute Treatment of Migraine Associated with Menstruation: Results from an Open-Label Postmarketing Surveillance Study

Newman, Lawrence C.; Harper, Samira Q.; Jones, Beverly A.; Campbell, John C.

doi:10.1089/jwh.2008.1031

Cited by 15 publications

(13 citation statements)

References 25 publications

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“…Though both studies share the limitations of subgroup analyses, they are useful because no such prospective studies on triptans in menstrual migraine have yet been carried out. Results of our study adds to the evidence of previous randomized, placebo controlled or open label studies proving the efficacy of frovatriptan as intermittent preventive [25–29] or acute treatment of menstrual migraine [30–32]. In published reports, prophylactic treatment with frovatriptan, started 2 days before the expected onset of headache and continued for 6 days, was always superior to placebo in reducing the frequency of menstrual migraine.…”

Section: Discussionsupporting

confidence: 66%

“…Sumatriptan, the first triptan to be marketed, has been shown to be well tolerated and effective in providing pain relief in menstrually associated migraine when administered in the mild pain phase, also in combination with analgesics [6–12]. Second generation triptans such as zolmitriptan [13–15], naratriptan [16], rizatriptan [17–21] and more recently almotriptan [14, 22] and frovatriptan [23] have been also successfully tested: the different pharmacokinetic and pharmacodynamic features of these triptans as respect to sumatriptan potentially render them particularly suitable for treating menstrual migraine. Following extensive evidence from prospective, double-blind, randomized, controlled studies, recent guidelines now recommend sumatriptan 50 and 100 mg or rizatriptan 10 mg for acute treatment of menstrually related migraine, and frovatriptan 2.5 mg or naratriptan 1 mg twice daily for preventive treatment of this condition [4, 24].…”

Section: Introductionmentioning

confidence: 99%

“…Frovatriptan has been proved to be effective also in the acute management of menstrual migraine [30], including oral-contraceptive-induced menstrual migraine a subtype of menstrual migraine caused by estrogen withdrawal occurring during the week of pill suspension [31]. More recently, in an open-label post-marketing surveillance study conducted in women with migraine associated with menses, acute frovatriptan treatment improved patients’ ratings of treatment effectiveness and tolerability as compared to previously used triptans [32]. …”

Section: Introductionmentioning

confidence: 99%

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Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study versus rizatriptan

et al. 2011

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The objectives of this study are to assess the efficacy and safety of frovatriptan, and rizatriptan in the subgroup of women with menstrually related migraine of a multicenter, randomized, double blind, cross-over study. Each patient received frovatriptan 2.5 mg or rizatriptan 10 mg in a randomized sequence: after treating 3 episodes of migraine in not more than 3 months with the first treatment, the patient had to switch to the other treatment. Menstrually related migraine was defined according to the criteria listed in the Appendix of the last IHS Classification of Headache disorders. 99 out of the 125 patients included in the intention-to-treat analysis of the main study were of a female gender: 93 had regular menstrual cycles and were, thus, included in this analysis. A total of 49 attacks classified as menstrually related migraine were treated with frovatriptan and 59 with rizatriptan. Rate of pain relief at 2 h was 58% for frovatriptan and 64% for rizatriptan (p = NS), while rate of pain free at 2 h was 31 and 34% (p = NS), respectively. At 24 h, 67 and 81% of frovatriptan-treated, and 61 and 74% of rizatriptan-treated patients were pain free and had pain relief, respectively (p = NS). Recurrence at 24 h was significantly (p < 0.01) lower with frovatriptan (10 vs. 32% rizatriptan). Frovatriptan was as effective as rizatriptan in the immediate treatment of menstrually related migraine attacks while showing a favorable sustained effect with a lower rate of migraine recurrence. These results need to be confirmed by randomized, double-blind, prospective, large clinical trials.

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Section: Discussionsupporting

confidence: 66%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study versus rizatriptan

et al. 2011

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“…Of other trials for the acute treatment of menstrual attacks of migraine not included in the review, there was one non-comparator study of frovatriptan combined with an NSAID,39 one post hoc analysis of an open-label post-marketing surveillance study,70 and one open-label study of women with OCM 71…”

Section: Frovatriptan For the Acute Treatment Of Menstrual Migrainementioning

confidence: 99%

A review of frovatriptan for the treatment of menstrual migraine

MacGregor¹

2014

IJWH

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The objective of this review is to provide an overview of menstrual migraine (MM) and of frovatriptan and to assess clinical trial data regarding the efficacy and safety of frovatriptan for the acute and short-term prophylaxis of MM. Randomized controlled trials comparing frovatriptan with placebo or a triptan comparator for the acute or prophylactic treatment of MM were selected for review. MM affects up to 60% of women with migraine. Compared with attacks at other times of the cycle, menstrual attacks are longer, more severe, less responsive to treatment, more likely to relapse, and more disabling than attacks at other times of the cycle. No drugs are licensed for acute treatment of MM; triptans are recommended for treatment of moderate to severe attacks for menstrual and nonmenstrual attacks. Perimenstrual prophylaxis is indicated for patients with predictable MM that does not respond to symptomatic treatment alone. Treatment is unlicensed, but options include triptans, nonsteroidal anti-inflammatory drugs, and hormone manipulation. Frovatriptan is distinctive from other triptans due to its long elimination half-life of 26 hours, which confers a longer duration of action. Post hoc analyses from randomized trials of MM show similar pain relief and pain-free rates for frovatriptan compared with other triptans (2 hours pain-free: relative risk [RR] 1.27, 95% confidence interval [CI] 0.91–1.76) but significantly lower relapse rates (24 hours sustained pain-free: RR 0.34, 95% CI 0.18–0.62). Data from randomized controlled trials show a significant reduction in risk of MM in women using frovatriptan 2.5 mg once daily (RR 1.56, 95% CI 1.31–1.86) or twice daily (RR 1.98, 95% CI 1.68–2.34) for perimenstrual prophylaxis compared with placebo. The twice daily dosing was more effective than once daily (RR 1.27, 95% CI 1.11–1.46). These findings support the use of frovatriptan as a first-line acute treatment for MM and for perimenstrual prophylaxis.

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“…Sumatriptan has been shown to be well tolerated and effective in providing pain relief in MRM when administered in the mild pain phase, also in combination with analgesics [6–12]. Second generation triptans such as zolmitriptan [13–15], naratriptan [16], rizatriptan [17–21] and more recently almotriptan [14, 22] and frovatriptan [23] have been also successfully tested, their different pharmacokinetic and pharmacodynamic features as respect to sumatriptan potentially rendering them particularly suitable for treating menstrual migraine. Recent guidelines now recommend sumatriptan 50 and 100 mg or rizatriptan 10 mg for acute treatment of MRM, and frovatriptan 2.5 mg or naratriptan 1 mg twice daily for preventive treatment of this condition [4, 24].…”

Section: Introductionmentioning

confidence: 99%

Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, multicenter, Italian, comparative study versus zolmitriptan

et al. 2011

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Menstrually related migraine (MRM) is a particularly difficult-to-treat pain condition, associated with substantial disability. Aim of this study was to compare the efficacy and safety of frovatriptan and zolmitriptan in the treatment of MRM attacks, analyzing data from a multicenter, randomized, double blind, cross-over study. We analyzed the subset of 76 regularly menstruating women who participated in one head-to-head multicenter, randomized, double blind, cross-over clinical trial and who took the study drugs to treat MRM attacks. In a randomized sequence, each patient received frovatriptan 2.5 mg or zolmitriptan 2.5 mg: after treating three episodes of migraine in no more than 3 months with the first treatment, the patient had to switch to the other treatment. MRM was defined according to the criteria listed in the Appendix of the last Classification of Headache disorders of the International Headache Society. A total of 73 attacks, classified as MRM, were treated with frovatriptan and 65 with zolmitriptan. Rate of pain relief at 2 h was 52% for frovatriptan and 53% for zolmitriptan (p = NS), while rate of pain free at 2 h was 22 and 26% (p = NS), respectively. At 24 h, 74 and 83% of frovatriptan-treated and 69 and 82% of zolmitriptan-treated patients were pain free and had pain relief, respectively (p = NS). Recurrence at 24 h was significantly (p < 0.05) lower with frovatriptan (15 vs. 22% zolmitriptan). Frovatriptan proved to be effective in the immediate treatment of MRM attacks, similarly to zolmitriptan, but showed lower recurrence rates, and thus a better sustained relief.

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Frovatriptan for Acute Treatment of Migraine Associated with Menstruation: Results from an Open-Label Postmarketing Surveillance Study

Abstract: Acute frovatriptan treatment improved patient ratings of treatment effectiveness and tolerability in women with migraine associated with menses.

Cited by 15 publications

References 25 publications

Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study versus rizatriptan

Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study versus rizatriptan

A review of frovatriptan for the treatment of menstrual migraine

Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, multicenter, Italian, comparative study versus zolmitriptan

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