By Maria Bishop
BOSTON, MA -- May 7, 2007 -- Migraine sufferers achieve a pain-free state and more quickly reduced disability with almotriptan than with placebo when treated within 1 hour of migraine pain onset, according to results of a multicenter, double-blind, parallel-group trial.
The results were presented here at the American Academy of Neurology (AAN) 59th Annual Meeting.
Jan L. Brandes, MD, assistant clinical professor of neurology, Vanderbilt University School of Medicine, Nashville, Tennessee, led a team that observed 162 who were treated with almotriptan 12.5 mg (n = 162) and 155 matched placebo patients.
Patients in this study all had migraine as defined by the International Headache Society, with/without aura. They were given a personal digital assistant (PDA) to record their responses to questions related to pain intensity, photophobia, phonophobia, nausea, vomiting, allodynia-associated symptoms, and level of functional disability at multiple timepoints during their headaches.
Two hours after their first treatment, functional disability data were available for all but 2 patients in the treatment group.
Results showed the following outcomes for the almotriptan group in comparison with the placebo group at the 2-hour evaluation: able to perform normal activities (54.4% vs 38.1%,); normal activities disturbed (32.5% vs 45.2%); required bed rest (13.1% vs 16.1%); required an emergency-room visit or hospitalization (0% vs 0.6%) (P =.007). The differences between the groups remained statistically significant 4 hours after treatment.
Lower levels of functional disability were associated with a pain-free state and an absence of migraine-associated symptoms. Absence of photophobia, phonophobia, and nausea were also associated with less disability.
Migraine generates a substantial disability burden and is classified among the major public health burdens by the World Health Organization. Functional impairment with severe migraine results in 112 million workdays missed per year, according to the researchers, which represents a substantial financial burden to employers.
This study was supported by Ortho-McNeil Neurologics, Inc.
[Presentation title: Effect of Early Intervention With Almotriptan Vs Placebo on Migraine-Associated Functional Disability: Results From the AEGIS Trial. Abstract P06.032]
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