Long-term efficacy of subcutaneous sumatriptan using a novel self-injector.

An open, multicenter study investigated the long-term efficacy, tolerability, and acceptability to patients of subcutaneous sumatriptan 6 mg, administered using a novel cartridge system self-injector, for the acute treatment of migraine. Eighty patients treated all migraine attacks for 6 months at home with a subcutaneous injection of sumatriptan 6 mg. A second injection could be taken after 1 to 24 hours if relief was inadequate, or if the headache recurred, and rescue medication could be taken 1 hour after the second injection. The primary end point was the percentage of attacks in which headache improved from severe or moderate before treatment to mild or absent at 1 hour after the first injection. A total of 1566 attacks were treated by the 80 patients and 69 patients completed 6 months of treatment. Headache relief was reported 1 hour after the first injection in a mean of 78% of attacks (83% in the first 3 months and 76% in the second 3 months). A second injection was required in a mean of 40% of attacks, and headache was mild or absent 1 hour after the second injection in a mean of 77% of attacks. Rescue medication was required after the second injection in a mean of 14% of attacks. At the end of the study, 87% of patients said that they would take the medication again, and at each clinic visit over 80% said that they found the injector easy to use. Adverse events were similar to those reported previously with sumatriptan and were mostly mild to moderate in intensity, short-lived, and resolved spontaneously. Subcutaneous sumatriptan 6 mg is an effective, well tolerated, and well accepted, long-term, acute treatment for migraine when self-injected by patients using the novel self-injector.