A randomized trial of frovatriptan for the intermittent prevention of menstrual migraine.
BACKGROUND
Menstrually associated migraine (MAM) is often prolonged and difficult to manage with conventional therapies. Frovatriptan is a new selective 5HT(1B/1D) receptor agonist indicated for short-term management of migraine. It has a long half-life and good tolerability. These characteristics suggest that frovatriptan may be useful for the intermittent prevention of MAM.


METHODS
The study was a randomized, double-blind, placebo-controlled, three-way crossover design. Patients treated each of three perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg QD, and frovatriptan 2.5 mg BID. The 6-day treatment started 2 days before the anticipated start of MAM headache. The primary efficacy endpoint was incidence of MAM headache during the 6-day PMP.


RESULTS
The population comprised 546 women (mean age, 37.6 years). Use of frovatriptan reduced the occurrence of MAM headache. The incidence of MAM headache during the 6-day PMP was 67% for placebo, 52% for frovatriptan 2.5 mg QD, and 41% for frovatriptan 2.5 mg BID. Both frovatriptan regimens were superior to placebo (p < 0.0001), and the BID regimen was superior to the QD regimen (p < 0.001). Both frovatriptan regimens also reduced MAM severity (p < 0.0001), duration (p < 0.0001), and the use of rescue medication (p < 0.01 QD; p < 0.0001 BID) in a dose-dependent manner. The incidence and type of adverse events for both regimens were similar to placebo and consistent with those reported for short-term migraine management.


CONCLUSIONS
Frovatriptan given prophylactically for 6 days was effective in reducing the incidence of menstrually associated migraine. More than half of patients who used frovatriptan 2.5 mg BID had no menstrually associated migraine headache during the 6-day perimenstrual period. The findings are consistent with the long duration of action and good tolerability of frovatriptan observed in short-term migraine management.
Thomas Jefferson University, Philadelphia, PA, USA. Stephen.Silberstein@Jefferson.edu
Stephen D
SD
Silberstein
Arthur H
AH
Elkind
Curtis
C
Schreiber
Charlotte
C
Keywood
D000328:Adult; D002227:Carbazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D003277:Contraceptives, Oral, Combined / Q000494:pharmacology; D003278:Contraceptives, Oral, Hormonal / Q000494:pharmacology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004967:Estrogens / Q000502:physiology; D005260:Female; D006801:Humans; D012001:Hyperacusis / Q000209:etiology / Q000517:prevention & control; D015994:Incidence; D008597:Menstrual Cycle / Q000502:physiology*; D008881:Migraine Disorders / Q000188:drug therapy / Q000453:epidemiology / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D009325:Nausea / Q000209:etiology / Q000517:prevention & control; D010349:Patient Compliance; D020795:Photophobia / Q000209:etiology / Q000517:prevention & control; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014363:Tryptamines
D002227:Carbazoles; D003277:Contraceptives, Oral, Combined; D003278:Contraceptives, Oral, Hormonal; D004967:Estrogens; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C108128:frovatriptan