NEW YORK (Reuters Health) – The response of adolescents with migraine to treatment with combination sumatriptan and naproxen sodium is similar to that seen in adults, with no new safety concerns evident, according to a report in Headache online July 28.
The findings “may provide practitioners with another useful treatment option for adolescent migraineurs,” the authors comment
Susan A. McDonald, with GlaxoSmithKline in Research Triangle Park, North Carolina, and colleagues point out that treatment of adolescent migraine continues to be an area of unmet medical need. The current study primarily investigated the long-term safety and tolerability of a single fixed-dose tablet of sumatriptan 85 mg and naproxen sodium 500 mg in this population, while two other studies are looking at pharmacokinetics and efficacy.
The 12-month, open-label trial enrolled 656 patients aged 12-17 years with an average of 2-8 migraines per month. During the study period there were 12,927 exposures to sumatriptan/naproxen.
The most common treatment-related adverse events were nausea (7%), dizziness (3%), muscle tightness (3%), and chest discomfort (3%). There were no deaths and no serious events related to treatment, according to the report.
Discontinuation rates were 7% due to adverse events and 5% due to lack of efficacy, the investigators found.
Based on pain-free status within 2 hours of treatment, sumatriptan/naproxen was effective in 42% of migraine attacks. Mean quality of life scores improved significantly from baseline, the researchers report, and 86% of participants were satisfied or very satisfied overall with the treatment.
In summary, “There were no new or clinically significant findings in the safety parameters, including the frequency and nature of adverse events, as compared to those seen for the individual components or to the adverse event profile seen in adults,” the authors conclude. “Sumatriptan/naproxen sodium provided freedom from migraine pain over time and improved quality of life and medication satisfaction.”