By Maria Bishop
BOSTON, MA -- May 4, 2007 -- Zolmitriptan is efficacious and well tolerated in the acute treatment of menstrual migraine, researchers reported here at the American Academy of Neurology (AAN) 59th Annual Meeting.
The drug also appears to be significantly effective for migraine prevention when delivered during the perimenstrual phase.
Michael M. Tuchman, MD, neurologist/ psychologist and medical director, clinical research department, Palm Beach Neurological Center, Palm Beach Gardens, Florida, led 2 double-blind, randomized, placebo-controlled studies involving adult women who experienced predictable menstrual migraine attacks.
In study A, 510 patients received either zolmitriptan (n = 260) or placebo to treat 1 menstrual migraine attack per menstrual cycle for 3 months. There were a total of 1,232 migraine attacks.
Study A showed that zolmitriptan achieved high headache responses from the earliest timepoint (30 minutes postdose). It also proved superior to placebo at 2 hours postdose in achieving both a headache response (48% vs 27%) and superior pain-free rate compared with placebo (26% vs 10%).
In study B, 174 patients received zolmitriptan and 160 received placebo to treat a total of 1,184 migraine attacks over 2 phases. In phase 1, patients treated up to 2 menstrual migraines per cycle for as many as 3 months with zolmitriptan 2.5 mg or placebo. Twice as many zolmitriptan recipients than placebo recipients achieved a 2-hour headache response (66% vs 33%, respectively; P <.0001).
In phase 2 of Study B, the intention was menstrual migraine prophylaxis. Patients received either placebo or zolmitriptan 2.5 mg 3 times daily or twice daily for 7 days (starting 2 days before expected onset of menses), for 3 cycles. More than half of the patients taking prophylactic zolmitriptan achieved a 50% or greater reduction in the frequency of menstrual migraine headaches (59% 3 times daily and 55% twice daily vs 38% placebo). The total mean number of menstrual migraine attacks per patients was reduced accordingly.
Zolmitriptan was well tolerated, even when administered in a multiple-dosing regimen over several days. The majority of adverse events were of mild or moderate severity, with no drug-related serious adverse events observed.
Dr. Tuchman noted that over 60% of women in the general population report a greater likelihood of experiencing a migraine attack in the perimenopausal period, a pattern that is believed to reflect the influence of estrogen on migraine.
This study was supported by AstraZeneca.
[Presentation title: Zolmitriptan Is Effective and Well Tolerated in Both Acute and Prophylactic Treatment of Menstrual Migraine. Abstract P06.025]
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