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| |  Imitrex Injection And Tablets Provide Relief Of Menstrual Migraines SAN FRANCISCO, CA -- June 26, 1998 -- Glaxo Wellcome, Inc.’s Imitrex(R)(sumatriptan succinate) Injection and Imitrex(R) Tablets are effective in relieving migraine pain associated with the menstrual period, according to clinical studies being presented this week at the annual meeting of the American Association for the Study of Headache (AASH) in San Francisco. Although men do experience migraine, three times more women suffer from the disease, primarily due to the influence of hormones throughout their reproductive years. Among the 18 million women migraine sufferers in the United States, an estimated two-thirds experience migraine during their menstrual period. Migraine headaches of this type are typically the most severe and disabling and are often unresponsive to treatment. In addition to the high prevalence of migraine among women, physicians say that migraine often can isolate women from the activities and people they care about most. Recent research shows that one in three female sufferers reported that migraine has affected their ability to be in control of their lives. Nearly half (46 percent) claim they cannot control their plans or activities, or function during a migraine attack. Others (18 percent) reported lost confidence in their ability to do their work and others could not think clearly, felt extremely ill or felt depressed. Over one third (37 percent) also reported that migraine has caused a significant negative impact on their relationships with their children and their relationships with their spouses or partners (36 percent). Imitrex is a powerful, selective serotonin (5-HT(1)) receptor-agonist indicated for the acute treatment of migraine attacks with or without aura in adults. The medication is effective with a proven clinical safety profile, having been used to treat more than 160 million migraine attacks in eight million patients world-wide. "These study results have tremendous ramifications for women, the primary population of migraine sufferers. Now, they can feel confident that Imitrex Injection and Tablets work just as well for menstrual migraine as for migraine occurring any other time of the month," said Stephen Silberstein, M.D., director of the Jefferson Headache Center at Thomas Jefferson University in Philadelphia and lead author of the study. "Migraines associated with monthly periods no longer have to disable women and disrupt their lives." Two prospective studies, both double-blind, placebo-controlled, multi-centre trials, were reviewed: one with Imitrex Injection (6mg) and the other with Imitrex Tablets(100mg). The study for Imitrex Injection included 226 patients and measured migraines occurring from three days before the beginning of the period to the fifth day of the period. At one hour after taking Imitrex Injection, three times more women experienced relief (reduction of severe or moderate pain to mild or no pain) than those taking placebo (71 percent versus 22 percent) for the first migraine attack. Results were similar for the second migraine attack, with nearly three-fourths of women experiencing relief one hour after taking Imitrex Injection (70 percent), compared to less than one-quarter for those taking placebo (24 percent). In addition to experiencing relief from their head pain, patients using Imitrex Injection also experienced relief from other symptoms commonly associated with migraine. Two hours after medication, nearly three times fewer Imitrex patients experienced nausea than those taking placebo (22 percent versus 52 percent), while 22 percent of the Imitrex patients experienced sensitivity to light or sound, compared to more than half (55 percent) of those taking placebo who experienced such sensitivities. Imitrex Tablets were also effective in treating menstrual migraine. In a study of 93 patients, more than twice the number of women taking Imitrex Tablets experienced relief from migraine pain than those taking placebo (67 percent versus 33 percent) four hours after treatment. Imitrex should only be used where a clear diagnosis of migraine has been established. It is not intended for the prophylactic therapy of migraine or for use in the management of basilar or hemiplegic migraine. Imitrex is contraindicated in patients with history, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes, or other significant underlying cardiovascular diseases. Patients who experience signs or symptoms of coronary vasospasm or other vasospastic reactions following Imitrex should be evaluated before receiving additional doses. Therefore, patients with risk factors for heart disease should be evaluated by a physician to determine if Imitrex is appropriate therapy. Imitrex Injection is contraindicated in patients with uncontrolled hypertension because it may increase blood pressure. Imitrex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. More information on: Glaxo Wellcome, Imitrex
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