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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