Study results give hope to menstrual period migraine sufferers
RESEARCH TRIANGLE PARK, N.C., Sept. 25, 2002 -- Women who suffer from migraine headache associated with menstruation may find relief with Imitrex Tablets, according to the combined results of two studies presented at the 14th Migraine Trust International Symposium in London.
More than half of the women treated with Imitrex experienced complete relief of their migraine pain two hours after treatment (59% and 51% at 100 mg and 50 mg, respectively, versus 25% for placebo), treating when pain was mild.
In addition, at two hours 48% and 43% of patients, at 100 mg and 50 mg (versus 20% for placebo) were free of migraine pain and associated symptoms (nausea, sensitivity to light and sound). Individual results may vary.
"These data offer hope to the large portion of women who experience migraines during menstruation," said study investigator Robert Nett, M.D., medical director at Texas Headache Associates, San Antonio, Texas. "Our research shows Imitrex, taken when migraine pain is mild, is effective in providing relief of pain and the associated symptoms of menstrually associated migraine."
The American Council for Headache Education estimates about 60% of women with migraine note an increased number of headaches in association with their menstrual period, also known as menstrually associated migraine (MAM). In 10%-14% of these women, the migraine occurs around the time of the period and at no other time.
"For years I suffered with severe headaches that occurred during my period. It wasn't until my doctor diagnosed me with migraine that I was able to get the treatment I needed to alleviate my pain and get on with my life," said Lisa Lanham, a patient enrolled in the study.
Two randomized, double-blind, placebo-controlled, single-attack studies were conducted, one in North America and one in Europe, evaluating 752 females ages 18-65 with at least a one-year history of migraine, a six-month history of regularly occurring MAM, and who experienced moderate to severe MAM pain preceded by a mild pain phase.
MAM was defined as a new migraine attack beginning any time between 2 days before to 3 days after the day the menstrual period started. Imitrex Tablets or placebo were administered during the mild pain phase of a migraine, when headache pain was grade one on a four-point scale, in a double-blind fashion to provide three dose groups; sumatriptan 50 mg, sumatriptan 100 mg, and placebo.
Participants were treated within one hour of the onset of pain but only if the pain was mild. The primary endpoint was the efficacy of sumatriptan 100 mg tablets as measured by the percentage of participants experiencing complete relief of pain (i.e., grade 1 reduced to grade 0) two hours after treatment.
Imitrex was the first prescription drug in a class of drugs called triptans to receive FDA approval for the acute treatment of migraine in adults. It should only be used where a clear diagnosis of migraine has been established.
Posted: September 2002
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