News Release

Zolmitriptan proven effective in combating episodic cluster headaches

Peer-Reviewed Publication

American Academy of Neurology

ST. PAUL, MN - Many patients who suffer from episodic cluster headaches, which are even more painful than migraines, may find rapid relief from the drug zolmitriptan, according to the results of a multinational study reported in the May 9 issue of Neurology, the scientific journal of the American Academy of Neurology.

Zolmitriptan may be taken orally in tablet form while the current most effective way to treat acute cluster headaches is by injection of sumatriptan, a related drug. "There's a natural wish for a tablet or a nasal spray so patients don't have to inject themselves once or twice a day for weeks on end," said Peter Goadsby, MD, of the Institute of Neurology in London, and senior author of the report.

The study included 124 patients in Canada, the United Kingdom and Sweden who took 5-mg or 10-mg doses of zolmitriptan or an inactive placebo pill at the onset of one of the crippling headaches. By the primary measure of the study (a 2-point or greater improvement on a 5-point pain scale), the 10-mg dose relieved pain for 47 percent of patients, whereas the placebo worked for only 29 percent.

Both the 5- and 10-mg doses were significantly more effective than placebo on other pain measures, such as the achievement of mild or no pain at 30 minutes, meaningful headache relief, and a reduced need to resort to other pain remedies (such as analgesics or breathing oxygen). There were no serious side effects associated with either dose of the study drug. "The immediate implication for clinical practice is that the 5-mg dose of zolmitriptan is an appropriate dose to use for patients with acute episodic cluster headaches, provided that they have no more than two attacks in a day," said Goadsby.

But a more important result, said Goadsby, is that the higher dosage was even more effective. While he currently does not recommend the 10-mg oral dose for patients because its safety has not been adequately tested, the fact that it works well suggests administration routes other than injection can deliver the drug rapidly enough to combat the relatively short-lived headaches.

A nasal spray formulation of the drug would be the best alternative, said Goadsby, because it would probably act faster than a tablet and subject the body to less of the drug.

Astra-Zeneca Pharmaceuticals (the manufacturers of zolmitriptan, sold under the name Zomig) are currently considering a nasal spray, said Goadsby.

Cluster headaches are much less common than migraines, affecting only a few people in a thousand, three-quarters of them men. Cluster headaches typically last only one to two hours, but the pain is much more severe than that of migraines. The pain is usually experienced as an intense, penetrating pain behind one eye and is accompanied by other symptoms such as watering, redness and swelling of the eye.

"Cluster headache patients describe the pain as the most severe they have experienced," said Goadsby. "Women with cluster headaches will say that childbirth is no worse."

Typically, cluster headaches are episodic, affecting patients for six to 12 weeks and then going away for up to a year. About 10 percent of patients suffer from headaches year-round. For these unlucky few, the news from the study was not good: as with other drugs that have worked in episodic cluster headaches, oral zolmitriptan was not effective in patients with chronic cluster headache.

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The American Academy of Neurology, an association of more than 16,500 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research.

For more information about the American Academy of Neurology, visit its Web site at www.aan.com. For online neurological health and wellness information, visit NeuroVista at www.aan.com/neurovista.


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