TUESDAY, April 3 (HealthDay News) -- Combining two commonly used medications can provide faster, long-lasting relief of migraine pain than using either drug alone, concludes a new study.
The study compared the use of a new combination pill that includes sumatriptan (brand name Imitrex) and naproxen sodium (Aleve) to use of either drug alone and to a placebo for moderate to severe migraines.
The researchers found that the combination therapy provided headache relief within two hours for as many as 65 percent of the study volunteers compared to about 28 percent for placebo. Up to 55 percent reported that Imitrex alone provided relief, while as many as 44 percent felt that naproxen gave them relief from their headache.
"The combination product is superior to the individual products alone," explained study author, Dr. Jan Lewis Brandes, a neurologist with the Nashville Neuroscience Group and an assistant clinical professor of neurology at Vanderbilt University School of Medicine in Nashville, Tenn. "It really targets more of what's happening in the brain during migraine. Sumatriptan works to constrict the blood vessels and interrupt pain, while naproxen works on the inflammatory process."
Results of the study are in the April 4 issue of the Journal of the American Medical Association.
Funding was provided by pharmaceutical manufacturers Pozen and Glaxo SmithKline.
While both medications included in the combination pill have already received government approval, the new combination must also be approved by the U.S. Food and Drug Administration. Lewis Brandes said the FDA is reviewing data on the medication and may make a decision by August 2007. If approved, the combination will likely be sold under the brand name Trexima.
Almost 30 million Americans suffer from migraines, according to the National Headache Foundation. Migraines may cause headache pain -- often just on one side of the head, visual disturbances, sensitivity to light, and nausea and vomiting. Migraines may last hours or even days.
While the introduction of medications known as triptans -- including sumatriptan -- has improved migraine management, some people still don't get relief, according to background information in the article.
And, according to Lewis Brandes, and another headache expert, Dr. Wade Cooper, director of the St. John's Health Chronic Headache and Migraine Institute in Madison Heights, Mich., many headache experts already recommend a combination of medications to combat migraine pain.
The current study included almost 3,000 people between 18 and 65 who suffer from migraines. The study participants, who were recruited at 118 clinics across the United States, were randomly assigned to one of four groups: the combination therapy (a single pill containing 85 milligrams sumatriptan and 500 milligrams naproxen sodium); 500 milligrams naproxen sodium (Aleve) alone; 85 milligrams sumatriptan (Imitrex) alone; or a placebo. They were told to take the medication when their migraine pain was moderate to severe in intensity.
More people reported short-term relief from headache pain and lessened sensitivity to lights and sounds on the combination therapy than on either drug alone or for the placebo. At 24 hours, results were similar, with more people on the combination therapy reporting sustained headache relief -- as many as 48 percent -- versus up to 35 percent on sumatriptan, 30 percent on naproxen sodium and 18 percent on placebo.
Because the combination drug would only be used on an as-needed basis, Lewis Brandes said she's not overly concerned that the medication would cause any of the gastrointestinal side effects, such as stomach bleeding, that can occur with long-term use of non-steroidal anti-inflammatory medications such as naproxen.
"We didn't see any real increase in GI symptoms," said Lewis Brandes, who did add that she wouldn't prescribe this medication for someone with a history of ulcers.
The bottom line, according to Cooper, is that "when you combine naproxen with Imitrex, it not only tends to help it be more effective, it may help Imitrex work faster."
And that may be the real benefit of this combination, said Lewis Brandes. She said a lot of times, people with migraines try to ride them out and wait to take their medications. However, if you wait too long before taking a triptan medication, it doesn't work as well, she explained. But, when combined with naproxen, it appears to be effective even when people wait to take their medication.
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