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Title: Imitrex (Sumatriptan Succinate) Tablets Effective in Treating Menstrual Migraines

"Imitrex (Sumatriptan Succinate) Tablets Effective in Treating Menstrual Migraines"

RESEARCH TRIANGLE PARK, NC -- October 2, 2003 -- Women who suffer from migraine headache associated with menstruation find relief when taking Imitrex® Tablets at first onset of pain.(1) These study results are published in the October issue of Obstetrics & Gynecology, the preeminent medical journal for women's health of the American College of Obstetricians and Gynecologists (ACOG).(1) Migraine is a common, often undiagnosed disorder that affects an estimated 21.5 million American women.(1) According to the American Council for Headache Education, about 60 percent of women notice an increase in the frequency of migraines related to their menstrual cycle, also known as menstrually associated migraine.(2) The randomized, double-blind, placebo-controlled, single-attack study evaluated 349 women, ages 18-65, with at least a one-year history of migraine and a six-month history of regularly occurring menstrually associated migraine typically having a mild pain phase preceding a moderate/severe pain phase. Patients were randomized to receive Imitrex Tablets 50 mg, Imitrex Tablets 100 mg, or placebo and were instructed to take the medication within one hour of the onset of mild pain associated with menstrual migraine. Pain was rated by subjects on a four-point scale, a standard used in migraine trials (0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain). The primary endpoint was 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. More than half of the women treated with Imitrex experienced complete relief of their migraine pain two hours after treatment when therapy was administered in the mild pain phase (61 percent and 51 percent at 100 mg and 50 mg respectively, versus 29 percent for placebo). In addition, at two hours 51 percent and 47 percent of patients, at 100 mg and 50 mg (versus of 25 percent for placebo) were free of migraine pain and associated symptoms (nausea, vomiting, sensitivity to light and sound). Individual results may vary. If pain returns, a second dose may be taken after two hours. "This data adds to the growing body of evidence that Imitrex is effective in providing pain-free relief for women who suffer from menstrually associated migraine," said study investigator Robert Nett, M.D., medical director at Texas Headache Associates in San Antonio. "Given these results, physicians should consider recommending Imitrex to their patients who may be experiencing migraine pain associated with their menstrual cycles." About Migraine Migraine is a neurobiological disorder that affects 28 million Americans and can be a disabling disorder, as evidenced by missed days of work, lost time with family and friends, and a disrupted daily routine.(3) Migraine is characterized by symptoms including moderate to severe headache pain, nausea, vomiting, and sensitivity to light and sound.(4) Menstrually associated migraine is clinically defined as migraine headaches that occur anywhere from two days prior to menstrual flow through the third or fourth day of the woman's period.(2) In 10-14% of women who suffer from menstrually associated migraine, the migraine occurs around the time of their period and no other time.(2) About Imitrex If the diagnosis is migraine, then migraine-specific prescription therapies, like Imitrex® (sumatriptan succinate), are available to treat the pain and associated symptoms of migraine without causing sedation. Imitrex was the first prescription drug in a class of drugs called triptans to receive U.S. Food and Drug Administration (FDA) approval for the acute treatment of migraine in adults. Imitrex has treated more than 536 million migraines over the last ten years; that's equal to treating a migraine headache every second. Imitrex should only be used where a clear diagnosis of migraine has been established. Imitrex is contraindicated in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive Imitrex. Patients with risks factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or are postmenopausal or a male over 40) should be evaluated by a health care provider to determine if Imitrex is appropriate therapy. Imitrex is contraindicated in patients with uncontrolled hypertension because it may increase blood pressure. Imitrex and any ergotamine-containing or ergot-type medication should not be used within 24 hours of each other, nor should Imitrex be used with another 5-HT1 agonist. Patients should consult with their health care provider before using Imitrex if they are pregnant or nursing.(5) This study was sponsored by GlaxoSmithKline. Please consult full prescribing information, available at http://www.Imitrex.com. References: (1) Nett, Robert, et al. "Pain-Free Efficacy After Treatment With Sumatriptan in the Mild Pain Phase of Menstrually Associated Migraine." Obstetrics & Gynecology. Vol 102. (2) American Council for Headache Education. Menstrual Migraine page, http://www.achenet.org/women/menst. Accessed September 23, 2003. (3) National Headache Foundation. Educational Resources: Migrain Page, http://www.headaches.org/consumer/topicssheet/migraine.html. Accessed September 24, 2003. (4) Migraine Update. National Institute of Neurological Disorders and Stroke, http://www.ninds.nih.gov/health_and_medical/pubs/migraineupdate.htm. Accessed September 24, 2003. (5) Prescribing Information for Imitrex(R) Tablets. SOURCE: GlaxoSmithKline

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