April 3, 2003 (Honolulu) -- For millions of American women, monthly menstrual periods do not just bring cramps and bloating. They also can suffer the severe throbbing pain, nausea, and sensitivity to light and sound that characterize menstrual migraine headaches .
But now that could all change. For the first time, results from several large, national studies show that a class of drugs known as triptans can prevent menstrual migraines in as many as half of women who take the medications.
In the United States, approximately 9 million women suffer from migraines and about 60% of them report an increased number of headaches in association with their menstrual periods.
These menstrual migraines, which are thought to be triggered by the drop in estrogen levels that accompany monthly periods, typically begin between two days before and one day after the start of a woman's period, according to Stephen Silberstein, MD, director of the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia.
Starting two days before their period and continuing for six days, the patients were given either placebo, a 2.5 milligram dose of Frova or a 5 milligram dose of the drug.
The study showed that headaches disappeared in half of patients treated with the higher dose of Frova. In addition, headaches stopped in over a third of patients taking the lower dose, compared with about one-fourth taking placebo.
The study, sponsored in part by Elan, maker of Frova, was presented here at American Academy of Neurology 55th annual meeting.
"Frovatriptan is already approved by the U.S. Food and Drug Administration for the treatment of acute migraines, so women can start taking it immediately," Silberstein said. "Any woman who suffers from menstrually associated migraines should ask her doctor about the medication," he said.
Triptans are a relatively new class of designer drugs that work directly to turn off migraines, according to Silberstein. The medications pack a triple whammy against the headaches: They reduce inflammation of certain blood vessels in the brain thought to cause pain; they block the release of irritating chemicals in the nerve endings; and they prevent transmission of pain signals from the lining of the brain to the brain itself, he said.
Frova isn't the only triptan showing promise for the treatment of menstrual migraines. In a second trial presented at the meeting, Robert Nett, MD, medical director of Texas Headache Associates in San Antonio, looked at another triptan drug - Imitrex (sumatriptan) - in preventing the throbbing headaches.
The trial enrolled about 450 women who had at least a one-year history of regularly occurring menstrual migraines. Within an hour after their headaches began, the women were given either a 100 milligram dose of Imitrex, a 50 milligram dose of the drug, or placebo.
By one hour after treatment, almost one-third of women given 100 milligramsof Imitrex were pain-free, as were about one-ourth of those given 50 milligrams. In contrast, 86% of women given a placebo still complained of pain, Nett reported.
By two hours later, about 60% of women treated with either dose of Imitrex reported they were able to work and go about their usual activities, compared with 36% of those taking placebo.
Compared with those on placebo, women who took Amerge were more satisfied with its ability to control menstrual migraine headaches, either by preventing their occurrence or by reducing their numbers, severity, or duration, Nett reported.
The drug was well tolerated, with just 5% of women reporting drug-related side effects, such as nausea and fatigue, compared with 3% in the placebo group.
GlaxoSmithKline, maker of Imitrex and Amerge, provided funding for both studies.
Rami Burstein, MD, an associate professor of neurobiology at Harvard Medical School who is an expert on triptans, said further study is needed to understand why some women respond to the triptans and others don't. "Does it have to do with their age, the frequency of their attacks, the duration of their attacks? We need to understand this."
But even as doctors and their patients await the research, based on the studies to date, "women should go ahead and try a triptan from two days before their period starts to two days after and see if it makes a difference," Burstein said.
Taken together, the new research shows that women with menstrualmigraine headaches now have choices, he said.