Zolmitriptan nasal spray may be safe and effective in treating painful cluster headaches

Zolmitriptan nasal spray, used to treat migraine headaches, also may be safe and effective in treating painful cluster headaches, according to an article posted online today that will appear in the November 2006 print issue of Archives of Neurology.

Cluster headaches are characterized by attacks of excruciating pain that typically involve one side of the head and last between 15 and 180 minutes, according to background information in the article. Because the pain is so severe, rapid and effective treatments are needed. Medications known as triptans are typically used to treat migraines; some, including sumatriptan and oral zolmitriptan, have been shown to be effective for cluster headaches as well. Zolmitriptan nasal spray is a new formulation that is absorbed through the nasal passages and acts more quickly. One preliminary study has suggested that the medication could be effective for cluster headache.

Elizabeth Cittadini, M.D., The National Hospital for Neurology and Neurosurgery, Queen Square, London, and colleagues evaulated the use of the nasal spray in 92 patients (80 men, 12 women, average age 40 years) with cluster headaches. Without treatment, the patients' headaches lasted at least 45 minutes. Over the course of the study, the participants each treated three headache attacks: one with placebo, one with 5 milligrams of zolmitriptan nasal spray and one with 10 milligrams of zolmitriptan nasal spray, in random order. Patients were assessed at five, ten, 15 and 30 minutes after taking the medication. If their headache did not subside at 30 minutes, they were allowed to take a different drug to relieve pain.

Because some patients dropped out of the study or did not have enough headaches during the study period, 69 patients were included in the final analysis, which was based on 65 attacks treated with 5 milligrams of zolmitriptan nasal spray, 63 attacks treated with a 10-milligram dose and 61 attacks treated with placebo. Patients reported headache relief after 30 minutes in 38 (61 percent) of the attacks treated with the 10-milligram dose, 27 (42 percent) of those treated with the 5-milligram dose and 14 (23 percent) of those treated with placebo. Thirty-one patients (50 percent) taking 10 milligrams of the nasal spray were pain-free at 30 minutes, compared with 18 (28 percent) of those taking the 5-milligram dose and 10 (16 percent) who took placebo.

Although one patient dropped out of the study due to adverse effects--including shortness of breath, vomiting and joint or muscle stiffness--no serious side effects were reported. "The very minimal dropout rate and low number of adverse events reported suggest that intranasal zolmitriptan is well tolerated in patients treating acute cluster headaches," the authors write.

"The data provide evidence that zolmitriptan nasal spray can be used as a first-line abortive therapy, along with sumatriptan nasal spray or inhaled oxygen, in the management of cluster headaches," they conclude.



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