Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine. US Sumatriptan Research Group
N. T. Mathew, J. Dexter, J. Couch, W. Flamenbaum, J. Goldstein, A. Rapoport, F. Sheftell, J. Saper, S. Silberstein, S. Solomon and al. et
Houston Headache Clinic, TX 77704.
Sumatriptan, a specific serotonin1-like receptor agonist, was studied in
the acute treatment of migraine. Two hundred forty-two adult migraineurs
participated in a randomized, double-blind study in which one dose of 1, 2,
3, 4, 6, or 8 mg of subcutaneous sumatriptan succinate was evaluated in
sequential ascending fashion. At each dose level, a placebo group was
included. Efficacy was defined as reduction of moderate or severe pain to
mild or no pain, without the use of rescue medication. Headache relief
rates showed an approximate dose-response relationship and at 1 hour were
as follows: placebo, 24%; 1 mg, 43%; 2 mg, 57%; 3 mg, 57%; 4 mg, 50%; 6 mg,
73%; and 8 mg, 80%. Relief of nausea and improvement in clinical disability
were also approximately dose related. Adverse events were dose related; the
most common types were injection site reactions and tingling. The 6-mg dose
was as effective as the 8-mg dose but was associated with fewer adverse
effects and so is optimal.
