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Frovatriptan Helpful as Miniprophylaxis for Menstrual Migraine

  • Authors: News Author: Laurie Barclay, MD
    CME Author: Désirée Lie, MD, MSEd
  • CME Released: 7/26/2004
  • Valid for credit through: 7/26/2005
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Target Audience and Goal Statement

This article is intended for primary care physicians, gynecologists, neurologists, and other specialists who care for women of childbearing age.

The goal of this activity is to provide the latest medical news to physicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  • Review the mechanisms of MAM.
  • Describe the effect of frovatriptan in the prevention of MAM in women with regular menses.


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  • Laurie Barclay, MD

    Laurie Barclay is a freelance reviewer and writer for Medscape.


    Disclosure: Dr. Barclay has reported no significant financial interests.


  • Gary Vogin, MD

    Senior Medical Editor, Medscape


    Disclosure: Dr. Vogin has reported no significant financial interests.

CME Author(s)

  • Désirée Lie, MD, MSEd

    Clinical Professor of Family Medicine; Director, Division of Faculty Development, University of California, Irvine School of Medicine, Irvine, California


    Disclosure: Dr. Lie has reported no significant financial interests.

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Frovatriptan Helpful as Miniprophylaxis for Menstrual Migraine

Authors: News Author: Laurie Barclay, MD CME Author: Désirée Lie, MD, MSEdFaculty and Disclosures

CME Released: 7/26/2004

Valid for credit through: 7/26/2005


July 26, 2004 — Frovatriptan is effective as miniprophylaxis for menstrually associated migraines (MAMs), according to the results of a randomized trial published in the July 27 issue of Neurology.

"Women have long reported menstrually related migraines as prolonged and difficult to manage with conventional therapies," lead author Stephen D. Silberstein, MD, FACP, from Thomas Jefferson University in Philadelphia, Pennsylvania, says in a news release. "More than half of patients who used frovatriptan 2.5 mg twice daily had no menstruation-associated migraine."

Frovatriptan, a new, selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) receptor agonist indicated for acute treatment of migraine, has a long therapeutic life and generally good tolerability, suggesting that it might be useful for migraine prophylaxis.

In this double-blind, three-way crossover study, 443 patients from 36 U.S. centers were randomized to receive placebo, 2.5 mg of frovatriptan once daily or 2.5 mg of frovatriptan twice daily for each of three menstrual cycles. Treatment started two days before the anticipated start of MAM, as previously determined by each participant, and continued for six days.

The incidence of migraine was 67% with placebo, 52% with once-daily frovatriptan, and 41% with twice-daily frovatriptan ( P < .001 for both frovatriptan regimens vs. placebo and P < .001 for the twice daily regimen vs. the once daily regimen).

In a dose-dependent fashion, both frovatriptan regimens also reduced migraine severity ( P < .001), duration ( P < .001), and the use of additional migraine medication ( P < .01 for once daily dosing and P < .001 for twice-daily dosing).

"The size of our study and the level of statistical significance obtained make our results very robust," Dr. Silberstein says, adding that these findings are consistent with the long duration of action of frovatriptan observed in studies of acute treatment of migraine.

Adverse events for both regimens were similar to those seen with placebo and to those reported for short-term migraine management.

Vernalis, Ltd., a producer of frovatriptan, supported this study. Dr. Silberstein and two other authors have financial arrangements with UCB Pharma/Elan Pharmaceuticals, the comarketers of frovatriptan.

In a separate study in the same issue of Neurology, investigators from the City of London Migraine Clinic, U.K., analyzed diary data from 155 women tracking two to four menstrual cycles. Risk of migraine was increased by 25% during the five days preceding menstruation and by 71% during the two days before menstruation. On the first day of menstruation and within the next five days, risk of migraine was more than doubled. On menstrual days one to three, risk of migraine associated with vomiting was nearly fivefold.

"Our study supports new International Headache Society diagnostic criteria regarding pure menstrual migraine and menstrually related migraine," says author Anne MacGregor, MFFP, of the City of London Migraine Clinic and St. Bartholomew's Hospital in London, U.K.

The Migraine Action Association and the Golden Charitable Trust supported this study.

In an accompanying editorial, Elizabeth Loder, MD, FACP, from Spaulding Rehabilitation Hospital in Boston, Massachusetts, notes that "timing is everything" for short-term prophylaxis of menstrual migraine, with success hinging on starting treatment before headache onset.

A potential limitation in interpreting the results of the frovatriptan study could be errors in the timing of dosing of study medication relative to anticipated onset of menstrual migraine. Compared with placebo-controlled trials of naratriptan prophylaxis for menstrual migraine, the more impressive results of this study might be due to use of a loading dose.

"Other issues remain to be settled before the routine use of triptan prophylaxis for menstrual migraine can be advocated," Dr. Loder writes. "Monthly use of the 14 triptan tablets required in the Silberstein study is unlikely to be reimbursed by most third-party payers, effectively placing treatment out of reach for many women. Treatment effects are modest, and comparative trials are a necessary next step to establish the place of this regimen in the context of treatment alternatives."

Neurology. 2004;63:202-203, 261-269

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