Monthly Migraines in Women May Be Preventable
Library: MED
Description: Neurologists at Thomas Jefferson University Hospital, Philadelphia, may have found a long-acting therapy that could stop monthly migraines that occur in some women for days around their periods--before the headache starts. (Meeting: American Academy of Neurology)

Jeffrey Adam Baxt or Phyllis Fisher
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Note: This study is embargoed for release until 8:45 p.m. ET Tues., Apr.1, 2003 at the American Academy of Neurology Meeting in Honolulu.

Jefferson Neurologist Finds Monthly Migraines in Women May Be Preventable

Neurologists at Thomas Jefferson University Hospital, Philadelphia, may have found a long-acting therapy that could stop monthly migraines that occur in some women for days around their periods-before the headache starts.

The drug, frovatriptan succinate, was tested in a nationwide study that found it prevented menstrually associated migraines, or MAM, in as many as half the women evaluated. Participants had an average 12-year history of the condition, which affects more than five million American women. Frovatriptan is in a class of drugs called triptans, which reduce inflammation of certain blood vessels in the brain thought to cause pain.

"We're excited about this study because this is the first time we've seen a triptan actually prevent these headaches in such a large number of women before they experience pain," said Stephen Silberstein, M.D., professor of neurology at Jefferson Medical College of Thomas Jefferson University. Dr. Silberstein, who is director of the Jefferson Headache Center at Thomas Jefferson University Hospital, was principal investigator of the study. "While MAM is not a widely recognized term, millions of women have been suffering for many days each month. When the women we studied took frovatriptan for six days, many of them did not have their expected disabling migraine headaches." He will present the data Apr. 1 at the American Academy of Neurology (AAN) meeting in Honolulu.

In the United States alone, approximately nine million women suffer from migraines and about 60 percent of them, or 5.4 million, report an increased number of headaches in association with their menstrual periods.

"I literally dreaded getting my period because of the migraines I got every month," said Wanda Bernier, a Philadelphia mother of two and longtime MAM sufferer. "For almost 20 years, I had to plan my life around having a five-day migraine each and every month and taking drugs constantly to get rid of the pain."

For the women in Dr. Silberstein's study, MAM typically began between two days before and one day after the start of menstruation. The average duration of these migraines in women treated with placebo was 29 hours, and more than three-quarters of patients reported moderate or severe headache pain.

"Menstrually associated migraines can last for days. Hormonal changes trigger these headaches, which are often long in duration and especially difficult to treat," said Dr. Silberstein. "Frovatriptan remains in the blood longer, so it is particularly well-suited to treat MAM."

In the trial, 545 women were treated for three months two days before and four days during their menstrual periods with placebo, a once-daily dose of frovatriptan or a twice-daily dose of the drug. The study, which was based at Jefferson, was conducted at 36 centers nationwide.

The study showed 50 percent of patients treated in the six-day period with 2.5 mg of frovatriptan twice daily had no headache. In addition, 39 percent of patients taking 2.5 mg of frovatriptan once daily had no headache, compared to 26 percent taking placebo. Depending on the dose they received, frovatriptan significantly reduced MAM severity and duration, as well as patients' functional impairment and use of rescue medications.

"Each patient received each treatment regimen over the course of three menstrual periods," said Dr. Silberstein.

The incidence and type of side effects reported by patients taking the drug were similar to placebo, including nausea, dizziness, headache and fatigue.

In another study conducted by Dr. Silberstein and presented at AAN, frovatriptan also was found to help prevent cluster headaches during the "transitional period," the two or three weeks it takes for long-term preventive therapies, such as lithium or calcium channel blockers, to begin working.

Cluster headaches are characterized by intermittent, pulsing head pain that lasts as long as eight weeks and comes once or twice a year. Sufferers sometimes describe attacks as a stabbing pain around the eye. According to researchers, cluster headaches are less common than migraines and extremely hard to treat.

"Because treatments for cluster headaches can take weeks to be effective, physicians are always searching for therapies to prevent attacks during that transitional period," said Dr. Silberstein. "According to our research, frovatriptan may be an alternative to traditional transitional therapies, such as steroids or nerve blocks."

The Jefferson Headache Center at Thomas Jefferson University Hospital is a multidisciplinary tertiary care facility that specializes in the treatment of patients with all types of head pain, regardless of etiology. The Center's goals are to diagnose patients in an accurate and timely fashion, and to develop individualized treatment programs to reduce the frequency and intensity of headaches, thereby enabling patients to return to a normal and active lifestyle.

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