Acute treatment of migraine attacks: efficacy and safety of a nonsteroidalanti-inflammatory drug, diclofenac-potassium, in comparison to oral sumatriptan and placebo

Background. Migraine attacks are often treated with simple analgesics or wi th ergotamine-containing preparations alone or in combination with anti-eme tics. Although also sometimes used to treat migraine, nonsteroidal anti-inf lammatory drugs (NSAIDs) have not been systematically evaluated in controll ed clinical trials, particularly in comparison with the newer drug sumatrip tan. Sumatriptan is a specific migraine treatment which has recently become among the most widely prescribed acute migraine therapies. However, while effective, it has low oral bioavailability and some problematic adverse eff ects. Diclofenac-potassium is a potent NSAID available as a fast-acting ora l tablet, which has been shown to be safe and effective in several other ac ute pain indications. In the clinical trial reported here, the efficacy and safety of diclofenac-potassium in the acute treatment of migraine attacks has been tested in comparison with oral sumatriptan and placebo. Methods. S ingle oral doses of 50 mg and 100 mg diclofenac-potassium were compared to a single oral dose of 100 mg sumatriptan and placebo in a double-blind rand omized crossover trial in 156 adult patients suffering from migraine attack s, with or without aura, selected according to the International Headache S ociety diagnostic criteria. The primary efficacy criterion was migraine hea dache pain recorded on a visual analog scale at 2 h after dosing. Secondary endpoints included pain at other time points up to 8 h and the presence of accompanying symptoms (nausea, vomiting, photophobia, phonophobia). Findin gs. Diclofenac-potassium was more effective than placebo in reducing migrai ne headache pain at 2 h after dosing, which was the primary endpoint. Secon dary analyses showed that diclofenac-potassium provided significant pain re lief from 60 min after dosing and for all remaining endpoints in the 8-h ob servation period. Both 50 and 100 mg doses of diclofenac-potassium were sim ilarly effective. A similar effect was shown with sumatriptan; however, sig nificant superiority to placebo was seen only from the 90-min time point. D iclofenac-potassium was generally superior to placebo or sumatriptan in red ucing accompanying symptoms, particularly nausea. Diclofenac-potassium seem ed to be as well tolerated as placebo, with fewer adverse events reported t han after sumatriptan treatment and with more patients assessing the overal l tolerability of diclofenac-potassium better than that of sumatriptan. Int erpretation. Compared with placebo and the reference therapy sumatriptan, d iclofenac-potassium is an effective, fast-acting, and well-tolerated acute oral therapy for migraine attacks, with advantages over oral sumatriptan in terms of onset of analgesic effect, reduction of accompanying symptoms, an d tolerability profile. It may therefore be useful as an alternative oral t herapy for migraine attacks. square Acute treatment, clinical trial, diclof enac-potassium, migraine headache, NSAID, oral treatment, sumatriptan.