SUMATRIPTAN IN ACUTE MIGRAINE USING A NOVEL CARTRIDGE SYSTEM SELF-INJECTOR

This double-blind, randomized, placebo-controlled, parallet-group, mul ticenter study assessed the efficacy. acceptability. safety, and toler ability of subcutaneous sumatriptan 6 mg administered using a novel ca rtridge system self-injector for the acute treatment of migraine. Eigh ty-six patients treated one migraine attack at home with sumatriptan o r placebo. A second identical injection was available after 1 hour for inadequate relief or if the headache recurred. Rescue medication was available 1 hour later. The primary end point was headache relief (imp rovement in headache from moderate or severe to mild or no pain) withi n 60 minutes of the first injection. Secondary end paints included the acceptability of the self-injector, requirement for and efficacy of a second dose, relief of nonheadache symptoms. use of rescue medication , and adverse events. Significantly more patients taking sumatriptan t han placebo reported headache relief 1 hour after the first injection (88% vs 11%. P<0.001). The device was well accepted by patients; about 90% found it easy to use and wanted to take further medication using it. Significantly fewer patients taking sumatriptan than placebo requi red a second injection (33% vs 92%, P<0.001) or rescue medication afte r the second injection (35% vs 67% P<0.05). Significantly more patient s taking sumatriptan than placebo reported headache relief after the s econd injection (83% vs 32%, P<0.01), and resolution of nonheadache mi graine symptoms (54% vs 23%, P<0.01). Sumatriptan was generally well t olerated. Subcutaneous sumatriptan 6 mg self-administered using the no vel self-injector is an effective, well accepted, and well tolerated a cute treatment of migraine.