Pilot Study Evaluating Preference for 3-mg Versus 6-mg Subcutaneous Sumatriptan

Authors

  • Stephen H. Landy MD,

  • Judy E. McGinnis RN,

  • Susan A. McDonald MA


  • From the Wesley Headache and Neurology Clinic, Memphis, TN (Drs. Landy and McGinnis); and GlaxoSmithKline, Research Triangle Park, NC (Ms. McDonald).

Address all correspondence to Dr. Stephen H. Landy, Wesley Headache and Neurology Clinic, 8000 Centerview Parkway, Suite 101, Memphis, TN 38018.

Abstract

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 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.

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