Sumatriptan Plus Naproxen for Acute Migraine Attacks in Adults

Summary

A Cochrane review [Abstract] 1 included 12 studies with a total of 9291 patients with migraine. All studies were multicentre and diagnosed migraine (with or without aura) according to IHS criteria. Patients with frequent migraine headaches (>6 or 8 attacks per month) were excluded. The mean age of participants ranged from 40 to 43 years, and between 85% and 100% were female. Sumatriptan 85 mg or 50 mg plus naproxen 500 mg was used to treat attacks of mild to severe pain intensity. In all studies, participants self treated their headaches at home. Overall, the combination was better than placebo for pain-free and headache relief responses. At 2 hours, the NNT for pain-free response was 3.1 (95% CI 2.9 to 3.5; 8 studies, 3395 attacks) when the baseline pain was mild (50% response with sumatriptan plus naproxen vs. 18% with placebo; RR 2.76, 95%CI 2.43 to 3.13), and 4.9 (4.3 to 5.7; 4 studies, 2596 attacks) when baseline pain was moderate or severe (28% with sumatriptan plus naproxen vs. 8% with placebo; RR 3.65, 95%CI 3.0 to 4.5). Using 50 mg rather than 85 mg of sumatriptan in the combination did not significantly change the result. Treating early, when pain was still mild, was significantly better than treating once pain was moderate or severe for pain-free responses at 2 hours and during the 24 hours post dose (p=0.0001). The relative benefit of the combination vs. sumatriptan alone was 1.7 (95% CI 1.4 to 2.1; 3 trials, n=1925), the NNT was 7.4 (95% CI 6.0 to 9.9) and vs. naproxen alone it was 2.3 (95% CI 1.8 to 2.8; 3 trials, n=1944), the NNT was 10 (95% CI 7.4 to 15). Additional analyses showed that combination was significantly better than placebo or either drug alone for relief of associated symptoms (nausea, photophobia, and phonophobia) and functional disability. Dizziness, paraesthesia, somnolence, nausea, dyspepsia, dry mouth, and chest discomfort were the most commonly reported adverse events, and were somewhat more common with combination therapy than monotherapy. However, they were mostly mild or moderate in severity and rarely led to withdrawal. Also, adverse events were less frequent with naproxen than sumatriptan.