A tablet combining sumatriptan and naproxen is more effective than either medication alone for treating acute migraine, reported Dr. Jan Lewis Brandes of the Nashville Neuroscience Group and her associates.
The combination medication also was found to be well tolerated in two clinical trials that “constitute the first placebo-controlled assessments of a triptan and an NSAID contained in a single fixed-dose tablet,” the researchers reported
“These studies used more rigorous evaluation of efficacy than any approved acute migraine treatment to date,” they added.
Triptans and NSAIDs, two of the most frequently used antimigraine agents, target different aspects of the vascular and inflammatory processes that are believed to underlie migraine.
“It is hypothesized that migraine attacks arise from neurally induced cranial vasodilation that produces painful inflammation of the surrounding nerves. Peripheral and central pain pathways appear to be sequentially recruited and sensitized as a migraine attack develops,” Dr. Brandes and associates explained.
Triptans are thought to address the initial peripheral sensitization in migraine, while NSAIDS are thought to address central sensitization. Therefore, the investigators assessed the safety and efficacy of a tablet specifically formulated for both clinical trials, which contained 85 mg sumatriptan and 500 mg naproxen.
The study subjects–1,441 in study 1 and 1,470 in study 2–were recruited from and treated at 118 sites across the country, including primary care practices, and neurology and headache clinics. Mean patient age was 40 years, and over 85% of the study population was female.
Patients were randomly assigned in nearly equal numbers to receive the combination therapy, sumatriptan alone, naproxen alone, or placebo.
The combination medication was significantly more effective than placebo or either of the single-drug formulations in every outcome assessed: acute relief of headache pain, photophobia, phonophobia, nausea, and vomiting at 2 hours, as well as sustained relief of these same symptoms at 24 hours, Dr. Brandes and associates reported (JAMA 2007;297:1443–54).
The only serious adverse event that occurred in both clinical trials involved a woman who experienced heart palpitations after taking sumatriptan alone. However, this subject had numerous CVD risk factors, as well as depression and anxiety, and she was taking medications for all of the disorders. The palpitations were deemed to be of no clinical significance.
Future studies of the combined therapy should assess whether different combinations of doses might be more efficacious, the researchers noted.
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