By Ann Saul
FLORENCE, Italy -- September 22, 2009 -- Preventive treatment with topiramate may reduce the number of migraine days both within and outside of the perimenstrual period (PMP), according to a new post hoc analysis of data from the Prolonged Migraine Prevention with Topiramate (PROMPT) trial, presented at the 13th Congress of the European Federation of Neurological Societies (EFNS).
"In the past, treatment of perimenstrual migraines has concentrated on regulating the level of oestrogen, and other migraine-preventive agents such as antiepileptic drugs have been neglected," said Joop van Oene, PhD, Janssen-Cilag EMEA, Tilburg, the Netherlands, speaking here on September 13. "We conducted this analysis to determine the effectiveness of topiramate in reducing migraines in the PMP compared with migraines during the rest of the menstrual cycle."
Prevalence of migraine in women is highest between puberty and menopause. The fall of oestrogen levels appears to trigger migraines during the PMP. Migraines that occur during the PMP are usually more difficult to treat with acute medication than are those outside the PMP. Premenopausal women have migraine days more frequently during the PMP than during the rest of the menstrual cycle.
This analysis included a subgroup from the PROMPT trial including women with menstrually related migraine. The design of the PROMPT trial included 3 phases: prospective baseline (PB) phase, open-label (OL) phase, and double-blind phase, at which time patients were randomised to receive topiramate for another 26 weeks or switch to placebo. After 5 to 6 months of treatment with topiramate (OL phase), a subgroup of 198 was evaluable; these women experienced a lower number of migraine days on average than during the PB phase.
The mean number of migraine days in the PMP remained consistent compared with total migraine days during the PB and OL periods; however, during the last cycle of OL phase, the total number of migraine days, the number of PMP migraine days, and the number of non-PMP migraine days decreased significantly (P < .0001) compared with the first cycle of the PB phase.
Adverse events most commonly reported during the OL phase were paraesthesia (50% of patients), fatigue (12%), disturbance in attention (12%), anorexia/decreased appetite (11%), weight reduction (9%), and nausea (9%).
"To reduce adverse events, dosage should be no more than 50 mg/day to 100 mg/day, beginning at 25 mg/day and titrated in steps of 25 mg/day once a week," noted Dr. van Oene.
Funding for this study was provided by Janssen-Cilag EMEA.
[Presentation title: Menstrual-Related Migraine and Its Response to Preventive Treatment With Topiramate. Poster 1106]
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