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Pharmacy & Health News


News category: General News  Posted on Monday, June 4th, 2007

According to the findings of the latest research, combining two widely used medicines can offer quicker, longer-lasting relief from migraine pain than using each of the medications alone.

In the new research, the scientists compared the use of a new combination tablet including sumatriptan (brand name Imitrex) and naproxen sodium (Aleve) to use of either medication alone and to a placebo for migraines - both moderate and severe.

The investigators discovered that the combination treatment provided the relief from headache within two hours for the majority (65 per cent) of the study participants in comparison with around 28 per cent for placebo. Up to 55 per cent of the volunteers observed that Imitrex used alone alleviated the pain, whereas as many as 44 per cent had the feeling that naproxen brought them relief from their headache.

Combo - better than parts

"The combination product is much better than the individual products alone," said the author of the research, 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, Tennessee. "It really points more of what’s happening in the brain in the course of migraine. Sumatriptan acts to tighten the blood vessels and break off pain, whereas naproxen acts on the inflammatory process."

The findings of the research are published in the April 4 issue of the Journal of the American Medical Association.

Financial support was provided by pharmaceutical producers Pozen and Glaxo SmithKline.

No approval so far

As both medicines included in the combination tablet have already obtained approval of the government, the latest combination needs also to be approved by the US Food and Drug Administration. Lewis Brandes explained that the FDA is analyzing data concerning the medicine and may make decision by August 2007. If the pill obtains approval, the combination will probably be sold under the brand name Trexima.

Migraines may lead to such symptoms as: headache pain - frequently only on one side of the head, visual disturbances, sensitivity to light, and nausea and vomiting. Migraines may persist from hours to several days.

According to background information in the article, whilst the launching of medicines known as triptans - including sumatriptan - has improved migraine management, some individuals still do not feel any relief.

Furthermore, according to Lewis Brandes, and another headache specialist, Dr Wade Cooper, director of the St. John’s Health Chronic Headache and Migraine Institute in Madison Heights, Michigan, a lot of headache specialists already suggest taking a combination of medicines in order to fight migraine pain.

How the research was performed

The present research involved nearly 3 000 participants between 18 and 65 years of age who experience migraines. The partakers of the research, who were recruited at 118 clinics all over the United States, were randomly assigned to one of four teams: the combination therapy (a single tablet 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 obliged to take the drug when their migraine pain was moderate to severe in intensity.

More individuals observed short-term relief from headache pain and reduced sensitivity to lights and sounds on the combination therapy than on either medication alone or for the placebo. At 24 hours, observations were analogous, with more participants on the combination treatment reporting constant headache relief - as many as 48 per cent - in opposition to up to 35 per cent on sumatriptan, 30 per cent on naproxen sodium and 18 per cent on placebo.

Due to the fact that the combination medication would be used only on an as-needed basis, Lewis Brandes explained that she’s not excessively concerned that the drug would bring about any of the gastrointestinal side effects, such as stomach bleeding, that may appear with long-term use of non-steroidal anti-inflammatory medicines such as naproxen.

"We did not observe any factual increase in GI symptoms," said Lewis Brandes, who
added that she wouldn’t prescribe this medication for a patient with a history of ulcers.

May act faster

According to Cooper, the bottom line is that "as you combine naproxen with Imitrex, it usually not only helps it be more efficient, it may help Imitrex act faster."

And hence that may be the factual advantage of this combination, explained Lewis Brandes. She said that a lot of times, individuals suffering from migraines try to ride them out and wait to take their medicines. Nevertheless, if you wait too long before taking a triptan medication, it does not work as well, she added. However, when it is combined with naproxen, it turns out to be successful even when people wait to take their medication.





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