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Two-Drug Combo Helps Teens With Migraines
Many doctors already prescribe Treximet off-label to this age group, expert says
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Tuesday, May 15, 2012
Although the findings basically support what doctors are already doing, "it is nice to have this officially shown in a study in adolescents," said Dr. Ellen Drexler, associate director of neurology at Maimonides Medical Center in New York City.
Because the combination of Imitrex (sumatriptan) and naproxen sodium (Aleve and other brand names) isn't approved for use by the U.S. Food and Drug Administration for this age group, doctors must prescribe it "off label" to adolescents.
"There are no FDA-approved abortive [migraine] treatments for children," said Dr. Noah Rosen, director of the Headache Center at the Cushing Neuroscience Institute in Great Neck, N.Y. "This is the first really large-scale abortive treatment study for adolescents."
The study, funded and carried out by researchers at GlaxoSmithKline, which makes the sumatriptan/naproxen combined tablet, known as Treximet, appears in the May 14 issue of Pediatrics.
Migraines in children and adolescents are physiologically no different from migraines in adults, said Drexler, although migraines in younger people tend not to last as long.
Although treatments are similar to those used in adults, not many trials have formally tested their effectiveness in children and adolescents.
The class of drugs known as triptans are the most studied, but none of those trials have shown a great benefit, possibly because of a large placebo response, the study authors wrote.
Some 8 percent to 23 percent of children aged 11 and older experience migraines, the researchers stated.
For this study, the authors randomly assigned almost 600 teens and preteens -- 12 to 17 years old -- to either a placebo or one of three doses of the sumatriptan/naproxen combination over a period of 12 weeks.
The doses were 10 milligrams (mg) sumatriptan and 60 mg naproxen, 30/180 mg and 85/500 mg, respectively.
Between 23 percent and 29 percent of those who took one of the doses of sumatriptan/naproxen reported being pain-free within two hours of taking the drug, vs. 10 percent in the placebo group.
"This is a significant amount of people to be pain-free," said Rosen.
The 85/500 mg version of the drug showed greater benefit when taking into account pain relief and sensitivity to light and sound. Nausea rates, however, were no better than in the placebo group.
Participants receiving one of the other two doses of the drug combination had lower rates of nausea.
Rosen said that most previous studies looked at pain reduction only.
Side effects were minimal and the same in all groups.
The authors did state that the 10/60 mg combination may be the best choice for lower-weight adolescents with shorter-duration migraines, given that it was effective and reduced nausea.
Treximet was approved by the FDA for use in adults in 2008. It's unclear if GlaxoSmithKline will apply for a pediatric indication for the drug from the agency.
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