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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
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-na´ve 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