Efficacy and safety of sumatriptan plus naproxen sodium in the acute treatment of migraine: Systematic review and meta-analysis of randomized controlled trials

Abstract

To assess the efficacy and safety of combined sumatriptan and naproxen sodium compared with sumatriptan monotherapy in the acute treatment of migraine. Clinical trials were identified through electronic searches (MEDLINE, CINALH, EBM review and the Cochrane Library) up to February 2011 and historical searches of relevant articles. Studies were included in the meta-analysis if they were 1) double-blind, randomized, controlled trials that evaluated sumatriptan plus naproxen sodium against sumatriptan in moderate or severe migraine in adult patients, and 2) reporting the efficacy in terms of headache relief, pain-free, relief of migraine-associated symptoms, sustained headache relief, sustained pain-free, or headache recurrence. Two authors independently extracted data and assessed study quality. Disagreements were resolved by a third investigator. Treatment effects and adverse effects were expressed as risk ratio (RR). Three trials involving a total of 1952 patients were included in the meta-analysis. Sumatriptan plus naproxen sodium was more effective than sumatriptan alone in providing headache relief and pain-free within 2 hours (pooled RR 1.20; 95%CI 1.11-1.30, p < 0.00001, and 1.42; 95%CI 1.23-1.65, p < 0.00001, respectively). It was also superior to sumatriptan monotherapy in achieving headache relief at 4 hours, relief of migraine-associated symptoms, sustained headache relief, and sustained pain-free responses. The risk of headache recurrence reduced significantly with sumatriptan plus naproxen sodium (pooled RR 0.64, 95% CI 0.51-0.80, p = 0.0001). Combined therapy of sumatriptan and naproxen sodium was as well tolerated as sumatriptan monotherapy. Its effectiveness relative to currently available treatments has yet to be further defined by appropriate head-to-head clinical trials.