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Efficacy of Zomig (Zolmitriptan) Unaffected by Migraine's Relationship to Menses

NEW YORK, NY -- July 2, 2001 -- Sixty percent of women who are migraine sufferers experience migraine during, or right after their menstrual cycles. A new analysis being released today at the American Headache Society Meeting in New York shows that ZomigŪ (zolmitriptan), a product of AstraZeneca , is effective in treating migraine regardless of its relationship to menses.

"There is a perception that migraine attacks related to menses are more severe and resistant to acute treatment than those unrelated to menses, but there is little existing clinical data to support this," says SusanAbu-Shakra, M.D., AstraZeneca Associate Medical Director, CNS Therapeutic Area.

"However, these headaches may feel worse due to bloating, cramping and other symptoms that accompany menses. Zomig demonstrates equal efficacy in the treatment of migraine associated with a woman's menstrual cycle and in migraine unrelated to menstruation."

Overall, up to 14 percent of women who suffer from migraine are afflicted with headaches only during their menstrual cycle, suggesting there is a correlation between hormonal fluctuations and migraine headache. Approximately, 33 percent of women with migraine start getting headaches at or soon after menarche (the onset of menstruation at puberty).

The analysis of a female subpopulation showed that Zomig is a consistently effective treatment for migraine regardless of its relationship to menses. Zomig was significantly more effective than placebo in the treatment of moderate or severe menstrually and non-menstrually associated migraine. Migraine headaches were classified as severe in approximately 28 percent of menstrually and 27 percent of non-menstrually associated attacks. Two-hour headache response rates were 60 percent for Zomig versus 39 percent for placebo.

The efficacy of Zomig (zolmitriptan) 2.5 mg was comparable in both menstrually and non-menstrually associated attacks. In the active comparator trials, Zomig produced a two-hour headache response rate in 68 percent of menstrually associated attacks. In the two long-term studies, the efficacy of Zomig was consistent, with two-hour response rates ranging from 80 percent to 83 percent in menstrually associated migraine and 81 percent to 82 percent in non-menstrually associated migraine. Furthermore, within individual patients, response rates were similar in both types of attacks irrespective of the percentage of attacks treated during menses.

The analysis included 4,345 menstruating women who prospectively recorded details of their menstrual cycles in seven Zomig clinical trials. These trials included: three placebo-controlled trials (only Zomig 2.5 mg data included), two multiple-attack comparative trials with sumatriptan, and two long-term open-label studies with Zomig 2.5 or 5 mg (data were combined when both dosages were used). Migraine attacks were defined as related to menses if they occurred within two days before or three days after the onset of menstruation. Efficacy data were collected from diary cards.

Zomig (zolmitriptan) Tablets and Zomig-ZMT™ (zolmitriptan) Orally Disintegrating Tablets are indicated for the acute treatment of migraine with or without aura in adults. Zomig is not intended to prevent attacks from happening but to relieve pain regardless of when it occurs. The drug is contraindicated for patients with uncontrolled hypertension, ischemic heart disease, or other significant underlying heart disease. In addition, Zomig should not be administered to patients who are hypersensitive to zolmitriptan or any of the inactive ingredients of Zomig. It should not be taken by patients who have certain types of heart disease or uncontrolled high blood pressure. Zomig-ZMT (zolmitriptan) contains aspartame, a component of phenylalanine. Very rarely, some people without recognized heart disease may have serious heart-related problems. Also, if patients think they may have risk factors for heart disease such as smoking, high blood pressure, high cholesterol, or a family history of heart disease, or if they are pregnant, nursing, or taking medications, patients should talk to their healthcare provider. The most common side effects associated with taking Zomig include dizziness; tightness, pressure or pain in the neck, throat, or jaw; fatigue; tingling sensations; drowsiness; or nausea.


SOURCE: AstraZeneca

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