Pilot study evaluating preference for 3-mg versus 6-mg subcutaneous sumatriptan.
BACKGROUND
Subcutaneous sumatriptan (6 mg) is undeniably an excellent treatment of migraine. However, some patients have avoided using 6 mg sumatriptan because of unpleasant or unwanted side effects.


OBJECTIVE
To evaluate the efficacy of subcutaneous sumatriptan (3 mg) during a moderate or severe migraine attack.


METHODS
Thirty subcutaneous sumatriptan-naive patients with a history of migraine with and without aura treated their next two moderate or severe migraines with either 3-mg or 6-mg sumatriptan injection. The primary endpoint was whether patients preferred the low-dose (3 mg) or the high-dose (6 mg) subcutaneous sumatriptan. Other objectives included percentage of patients pain free at 15 and 30 minutes, 1 and 2 hours; a pain-free response lasting between 2 and 24 hours, patient satisfaction, and acceptability of formulation. A new combination endpoint (efficacy and lack of significant side effects) was also evaluated.


RESULTS
Eighty percent of patients preferred 3-mg over 6-mg subcutaneous sumatriptan. At 1 hour postdose 57% of patients were pain free with 3 mg and 53% with 6 mg. At 2 hours postdose 87% were pain free with 3 mg and 80% with 6 mg. A sustained pain-free response was obtained by 70 to 80% of patients. When combining a pain-free response at 2 hours and a sustained pain-free response at 24 hours with no significant side effects, more patients met the endpoint with 3 mg (63 to 67%) than with 6 mg (33 to 50%).


CONCLUSIONS
Combining efficacy and tolerability endpoints may be clinically meaningful and reflective of real-world expectations. In some patients, a lower dose of sumatriptan injection may be beneficial.
Landy
Stephen H
SH
Wesley Headache and Neurology Clinic, Memphis, TN 38018, USA.
McGinnis
Judy E
JE
McDonald
Susan A
SA
D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D017060:Patient Satisfaction; D010865:Pilot Projects; D011446:Prospective Studies; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D018170:Sumatriptan / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D017366:Serotonin Receptor Agonists; D018170:Sumatriptan