Twelve-Month Tolerability and Safety of Sumatriptan-Naproxen Sodium for the Treatment of Acute Migraine

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Mayo Clinic Proceedings (Impact Factor: 6.26). 02/2007; 82(1):61-8. DOI: 10.4065/82.1.61
Source: PubMed


To evaluate the long-term safety and tolerability of sumatriptan-naproxen sodium for the treatment of moderate to severe acute migraines and to assess the safety of administration of an optional second dose.
A 12-month, multicenter, open-label safety study was conducted in adults treated for migraine attacks of moderate to severe intensity from April 14, 2004, to August 18, 2005. Safety evaluations included adverse events and laboratory tests.
Of 600 patients enrolled, 565 (94%) were treated for at least 1 migraine. Of treated patients, 414 (73%) and 362 (64%) completed 6 and 12 months of treatment, respectively. Of the 24,485 attacks treated, 17,144 (70%) were treated with only 1 dose. On average, patients treated 5 migraine attacks per month, with a median of 6 days between attacks. The most common treatment-related adverse events were nausea, muscle tightness, and dizziness. Fourteen patients reported 1 or more serious adverse event with only 1 judged probably related to treatment. No deaths occurred. Eight percent of patients discontinued participation in the study because of adverse events or pregnancy. The rates of adverse events reported were no higher after treatment with 2 tablets (at least 2 hours apart) compared with 1 tablet.
In this 12-month data set of more than 24,000 migraine attacks in 565 patients, sumatriptan-naproxen sodium formulated in a single tablet was well tolerated when used episodically for the treatment of acute migraine. The adverse events did not differ from those expected for the individual components alone, and no new or unexpected findings occurred.

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    • "This was largely confirmed in two large RCDBTs, including almost 3,000 migraine patients, which compared the effect of a combination drug of sumatriptan 85 mg and naproxen 500 mg in one tablet, with monotherapy of the same drugs and doses, and with placebo [135]. An open-label safety study on 565 patients treating more than 24,000 attacks during a year showed that this combination drug was well tolerated [136]. Patients had typical triptan side effects, but few gastrointestinal problems, and there was only one serious cardiovascular event. "
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