Effectiveness and safety of sumatriptan 85 mg/naproxen sodium 500 mg combination for acute migraine: prospective real-world evidence from the GRASP Study Group.

OBJECTIVE: This prospective multicenter observational study, designed by the Greek Research Alliance for the Study of Headache and Pain (GRASP), evaluated the real-world effectiveness and tolerability of oral fixed-dose sumatriptan 85 mg/naproxen sodium 500 mg across repeated migraine attacks. METHODS: Adults with episodic or chronic migraine for whom the treating physician had selected the oral fixed-dose combination as acute treatment were enrolled. Outcomes were recorded for up to three consecutive treated migraine attacks. The primary endpoint was 2-h pain freedom. Secondary endpoints included 2-h pain relief, sustained pain freedom at 24 h without rescue medication, return to normal activities, resolution of associated symptoms, treatment-timing effects, subgroup outcomes, and adverse events. RESULTS: Overall, 111 patients contributed 320 treated attacks. Two-hour pain freedom was achieved in 76/320 attacks (23.8%; 95%CI: 19.4-28.7), 2-h pain relief in 220/320 attacks (68.8%; 95%CI: 63.5-73.6), full return to normal activities in 206/320 attacks (64.4%; 95%CI: 59.0-69.4), and no rescue medication use in 246/320 attacks (76.9%; 95%CI: 72.0-81.2). Associated symptoms improved substantially, with 2-h resolution of photophobia, phonophobia, and nausea/vomiting occurring in 49.0, 51.0, and 63.7% of affected attacks, respectively. Early treatment within 1 h was associated with higher pain relief and functional recovery. Adverse events, occurring in 20.0% of attacks, were mainly gastrointestinal symptoms, dizziness, chest pressure, and somnolence/fatigue. CONCLUSION: Fixed-dose sumatriptan/naproxen sodium was associated with modest 2-h pain freedom but clinically meaningful pain relief, functional recovery, and low rescue medication use. Tolerability was consistent with the known profiles of triptans and non-steroidal anti-inflammatory drugs.