Drug well tolerated; no differences found in effectiveness of different dosing protocols
MONDAY, May 14 (HealthDay News) -- Treatment with sumatriptan and naproxen sodium (suma/nap) is well tolerated and effective in reducing migraine pain in adolescents, according to a study published online May 14 in Pediatrics.
Frederick J. Derosier, D.O., from GlaxoSmithKline in Research Triangle Park, N.C., and colleagues conducted a randomized trial involving teens (aged 12 to 17 years) who had two to eight migraines per month. The first moderate-to-severe attack was treated with placebo. Those with pain two hours after dosing were randomly assigned to receive a placebo (145 patients), 10/60 mg suma/nap (96), 30/180 mg suma/nap (97), or 85/500 mg suma/nap (152) for the second attack.
The researchers found that two-hour pain-free rates (adjusted for age and baseline severity) were significantly higher with suma/nap 10/60 mg (29 percent), 30/180 mg (27 percent), and 85/500 mg (24 percent) versus placebo (10 percent) for the second attack. There were no significant differences among the three doses. For sustained pain-free two to 24 hours, two-hour photophobia-free, and two-hour phonophobia-free, there were significant differences between 85/500 mg dosing and placebo. All active doses were well tolerated.
"All doses of suma/nap were well tolerated, providing similarly effective acute treatment of adolescent migraine pain and associated symptoms, as compared with placebo," the authors conclude.
Several authors disclosed financial ties to pharmaceutical companies, including GlaxoSmithKline, which manufactures sumatriptan and naproxen sodium and funded the study.
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