The Imitrex® STATdose was first approved in 1992 in 6mg dosage. Now, the FDA has approved a new Imitrex® STATdose in a 4mg dosage. This is the same STATdose injection system patients have been using; only the dosage has changed. The efficacy of the 4mg dose of Imitrex Injection was established in three double-blind studies of adult patients with acute migraine, with or without aura. In the largest of these studies, 577 migraine patients with moderate to severe migraine pain received Imitrex Injection 4mg or placebo. This study demonstrated that 67 percent of patients received headache relief (defined as reduction in pain from moderate/severe to mild/no pain) within one hour (compared to 25 percent for placebo), and some reported relief starting in 10 minutes.
The new 4mg Imitrex® STATdose is what Dr. Robert Kaniecki, a Migraineur and Pittsburgh area Migraine specialist, calls a "niche" medication. The efficacy isn't quite as high as the 6mg STATdose, but patients who may have been put off by side effects such as chest pressure (with no heart problems), some tingling, or others as well as those who felt that the 6mg was "just too strong" may do quite well with the new dosage. In his practice, the feeling that patients talked about the 6mg producing was dubbed the "blowing your head off" effect where people a troublesome sensation of a short period of pressure in their heads. Out of 30 of his patients who had experience that feeling and tried the 4mg STATdose, one patient still experienced the feeling, and the others did not experience it. Of those 28, the 4mg dosage was effective for 26 and did not produce undesired effects.
Cluster headache sufferers may also find the 4mg STATdose very helpful. The recommended daily maximum for injectable Imitrex® is 12mg. With the original product, that's a limit of two injections in a 24-hour period. The 4mg product allows the use of three injections in that time period. For cluster headache sufferers, this can be a significant advantage.
Is Imitrex® safe? Triptans, including Imitrex® carry a warning about use by patients with heart disease and other vascular conditions. The most discussed of these issues is potential dangers of taking triptans with cardiovascular disease. According to Dr. Kaniecki, only 1 person in 2.5 million experience serious cardiovascular reaction with Imitrex®. Statistically, that makes it safer than penicillin or acetaminophen. The dangers presented by an untreated Migraine attack must also be considered and the patient and doctor need to weigh the risks and advantages and make an informed decision regarding the use of Imitrex® or other triptans. For more information about triptans and cardiovascular safety, see "Triptans Pose Less Risk Than OTC Meds for Some Patients."
The newly approved 4mg Imitrex® STATdose is a welcome addition to the arsenals of Migraineurs and Cluster Headache sufferers. If you think it might be helpful to you, please discuss it with your doctor.
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GlaxoSmithKline. Press release: "FDA Approves New Formulation of Imitrex® (sumatriptan succinate) Injection." February 2, 2006.
Personal interview with Robert J. Kaniecki, M.D., Migraine specialist. February 5, 2006.
Dodick, David, Lipton, Richard B., Martin, Vincent, Papademetriou, Vasilios, Rosamond, Wayne, MaassenVanDenBrink, Antoinette, Loutfi, Hassan, Welch, K. Michael, Goadsby, Peter J., Hahn, Steven, Hutchinson, Susan, Matchar, David, Silberstein, Stephen, Smith, Timothy R., Purdy, R. Allan & Saiers, Jane (2004). "Consensus Statement: Cardiovascular Safety Profile of Triptans (5-HT1B/1D Agonists) in the Acute Treatment of Migraine." Headache: The Journal of Head and Face Pain 44 (5), 414-425. doi: 10.1111/j.1526-4610.2004.04078.x
Published February 7, 2006.