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Pilot Study Evaluating Preference for
3 mg. vs. 6 mg. Subcutaneous Sumatriptan
Landy SH, McGinnis JE, McDonald, SA
Posted: June 2005  
Headache 2005;45:346-349

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-naïve 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 post dose 57% of patients were pain free with 3 mg. and 53% with 6 mg. At 2 hours post dose 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. than with 6 mg.

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.