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Dose Ranging Efficacy and Safety of Subcutaneous Sumatriptan in the Acute Treatment of Migraine
Ninan T. Mathew, MD;
James Dexter, MD;
James Couch, MD, PhD;
Walter Flamenbaum, MD;
Jerome Goldstein, MD;
Alan Rapoport, MD;
Fred Sheftell, MD;
Joel Saper;
Stephen Silberstein, MD;
Seymour Solomon, MD;
Kenneth Welch, MD;
US Sumatriptan Research Group
Arch Neurol. 1992;49(12):1271-1276.
Abstract
• 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 I, 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.
Author Affiliations
From The Houston (Tex) Headache Clinic (Dr Mathew); Department of Neurology, University of Missouri, Columbia (Dr Dexter); Southern Illinois University, Springfield (Dr Couch); Health and Science Research, Englewood, NJ (Dr Flamenbaum); San Francisco (Calif) Headache Clinic (Dr Goldstein); New England Center for Headache, Stamford, Conn (Drs Rapoport and Sheftell); Michigan Headache & Neurological Institute, Ann Arbor (Dr Saper); Germantown Hospital and Medical Center, Philadelphia, Pa (Dr Silberstein); Montefiore Headache Center, Bronx, NY (Dr Solomon); and Department of Neurology, Henry Ford Hospital, Detroit, Mich (Dr Welch).
Footnotes
Accepted for publication June 9, 1992.
Presented at the IV International Headache Congress, Sydney, Australia, October 18, 1989.
Reprint requests to The Houston Headache Clinic, 1213 Hermann Dr, Houston, TX 77704 (Dr Mathew).
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