Zamvil, of UCSF, has submitted a proposal to the Immune Tolerance Network(1) to conduct a multi-center clinical trial to see if the drug could be used to prevent conversion to definite multiple sclerosis in individuals who have had a first attack, known as a "clinically isolated syndrome." Ultimately, he says, separate trials may need to be done to test if the drug could be useful in different phases of the disease.

Based on the drug doses studied in the mouse models, Zamvil and his colleagues propose using the highest Food and Drug Administration (FDA)-approved dose of atorvastatin (80 mg.) for the trial. Most patients taking statins for the regulation of LDL cholesterol levels are prescribed the lower FDA-approved doses. Notably, while all currently available drugs for multiple sclerosis are administered through injection, statins are taken orally.

Use of statins is associated with a low risk of liver toxicity, and, less frequently, with a potentially more serious medical complication that results from muscle damage. For this reason, and because the drug has not been tested in multiple sclerosis, the researchers strongly urge patients and their physicians to wait for the results of the clinical trials before considering therapy with statins for multiple sclerosis.

"While the drugs are considered relatively safe, their use should be monitored closely by patients' physicians, especially when taken at the highest doses," says Zamvil.

Preventing 'definite' multiple sclerosis

The results of the mouse study are particularly compelling because many people who experience an initial attack of multiple sclerosis which includes such symptoms as visual impairment, poor ba
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Contact: Jennifer OBrien
jobrien@pubaff.ucsf.edu
415-476-2557
University of California - San Francisco
6-Nov-2002