TUESDAY, Feb. 24, 2004 (HealthDayNews) -- America's 30 million or so migraine sufferers may have another weapon to ward off painful attacks: an epilepsy drug.
A new study finds the drug, topiramate, can significantly reduce the frequency of migraine in those hardest hit by the condition.
What's more, topiramate (sold under the brand name Topamax) helps prevent headache episodes without inducing weight gain -- a side effect common to other migraine drugs, and one that often causes patients to quit their medication.
With topiramate, one doesn't have to sacrifice having an improvement in migraine with gaining anywhere from five to 25 pounds, explains study author Dr. Jan Lewis Brandes, a neurologist with the Nashville Neuroscience Group and Vanderbilt University. Her team's findings appear in the Feb. 25 issue of the Journal of the American Medical Association.
Despite intense research, the exact cause of migraine continues to elude scientists. However, migraine patients know all too well the debilitating headache, nausea and sensory disturbances that can accompany an attack. While some may experience an attack only once every few months, experts say about 30 percent suffer from chronic migraine, with multiple episodes, often severe, every month.
Drugs taken at the onset of an attack can lessen its duration and severity, but what chronic migraine patients really need is an effective preventive agent. Currently, three medications approved by the U.S. Food and Drug Administration are available to U.S. patients, including one other antiepileptic, divalproex sodium (brand name Depakote), Brandes says.
"Unfortunately, with Depakote you can see weight gain," Brandes says. A significant percentage of migraine patients will discontinue using Depakote or other drugs as they watch their waistlines expand, she adds.
Topamax has long been approved by the FDA for prevention of epileptic seizures and appears to have a good long-term safety record, even in high doses, Brandes says.
Brandes sought and received funding for this study from Johnson & Johnson, whose Ortho-McNeil division makes Topamax and who monitored the research. She and other researchers have served as speakers or have received research grants from the company.
Dr. Seymour Diamond, executive chairman of the National Headache Foundation, says he and other specialists have been prescribing topiramate off-label to migraine patients for years. "I have been using it because there have been reports in the literature about its efficacy," he said. "Many of my patients have benefited from it."
In their study, Brandes' team had 468 patients suffering from chronic migraine -- anywhere from three to 12 attacks per month -- received either placebo or twice-daily doses of topiramate over a six-month period. Patients ranged in age from 12 to 65 years of age; 87 percent were female, as are most "migraineurs."
Patients receiving 100 milligrams per day of topiramate saw their number of attacks drop from an average of 5.8 per month to just 3.5, while patients receiving 200 milligrams per day saw migraine frequency fall from about five attacks per month to just three, the study found.
Nearly half the patients in these two groups experienced at least a 50 percent reduction in migraine frequency, Brandes says, with about 6 percent achieving complete freedom from headaches.
However, more than 10 percent of patients taking topiramate experienced side effects, with a small percentage dropping out of the study for this reason. The most serious side effects included tingling, fatigue, diarrhea, confusion and memory loss.
Topiramate does offer one side effect migraine patients might welcome, however. Unlike some of the other options available for migraine prevention, it tends to cause appetite suppression, so one of the side effects can be weight loss, Brandes says. Patients typically lost between five and 20 pounds over the six-month study period, with weight loss tapering off the longer the drug was used, she says.
Diamond calls the results of the study "encouraging." He believes topiramate is a valuable option for patients resistant to more traditional, first-line medications. "I welcome any drug like this," Diamond says, "because not everything works for everybody."
Topiramate has already received an approval letter for its use in migraine from an FDA advisory board -- usually a precursor to full agency approval, Brandes says. In the meantime, both Diamond and Brandes see nothing wrong with patients asking their doctor to try the drug off-label. "The safety data has been out with topiramate from the epilepsy trials at much higher doses for many years, so I think it's a very reasonable thing to do," Brandes says.
More information
For more on migraines, visit the National Headache Foundation or the National Institute of Neurological Disorders and Stroke.
