Cholesterol Drugs May Slow MS

Statin Shows Promise in First Human Trial

From the WebMD Archives

May 13, 2004 -- Millions of people take statins to lower their cholesterol, and now an early human trial shows the drugs could have a role in the treatment of multiple sclerosis.

Experts in the field say the findings are encouraging, but say that larger, more rigorously designed studies will be needed to prove the effectiveness of statins as MS drugs.

"It is true that the patients in this study experienced reductions in lesions, but it is not uncommon for this to occur without treatment," neurologist Hans-Peter Hartung, MD, PhD, tells WebMD. "So it is unclear whether this effect was unequivocally related to the drug."

Better Than Existing Drugs?

If the findings are confirmed, however, all agree that statins would have important advantages over currently available multiple sclerosis treatments. All five MS drugs now on the market must be given by injection. They are also very expensive and only modestly effective.

The first human trial to evaluate statin use in MS patients followed animal studies linking their use to a reversal of paralysis and a slowing of disease progression in mice with an MS-like disease. Statins, although used to lower cholesterol, have been shown to have an anti-inflammatory effect by regulating parts of the immune system.

Most experts now say that multiple sclerosis is an autoimmune disease -- one in which the immune system mistakenly attacks a person's own tissue rather than foreign invaders. It causes inflammation within the central nervous system, the brain, and spinal cord. Inflammation caused by the disease destroys a protective coating surrounding the nerves in multiple areas of the brain and spinal cord. This protective coating -- known as the myelin sheath -- helps conduct electrical impulses. The loss of myelin results in the symptoms of multiple sclerosis, where nerves lose the ability to conduct electrical impulses normally.

The newly published study included 30 patients with relapsing, remitting multiple sclerosis. It is the most common form of MS where patients have clear episodes of worsening of symptoms and complete recovery periods.

In the study volunteers were treated with an 80-milligram daily oral dosage of Zocor for six months. At the start of the study, all patients had evidence of at least one brain lesion linked to their MS, as measured by MRI scanning.

Researchers performed a series of brain scans during the study period. The number of brain lesion prior to and after treatment with Zocor was compared. They reported a 44% decline in the number of brain lesions after three months of treatment, and a 41% decline in their volume.

The study is published in the May 15 issue of the journal The Lancet, and Zocor manufacturer Merck, Inc. paid for the research.

'Other Issues'

Hartung says a trial looking at the results of treatment with the statin and comparing it with treatment with a placebo pill in nearly 300 patients with multiple sclerosis should help answer lingering questions about the effectiveness of statins within two or three years.

National MS Society spokesman Nicholas LaRocca, PhD, tells WebMD that future studies must address other issues. LaRocca is the society's director of health care delivery and policy.

"There are many statins on the market, so if they do have a role in multiple sclerosis treatment, is one more effective than the other?" he asks. "And is it really safe to give these drugs at such high doses over a long period of time? Whatever statins do, they aren't likely to cure MS so, like the current treatments they would have to be used on a long-term basis."

And while animal studies showed that statins reduce certain inflammatory responses, they appeared to promote other inflammatory responses.

"Obviously you wouldn't want to give an MS patient a treatment that is pro-inflammatory," LaRocca says.

Show Sources

SOURCES: Vollmer et al. The Lancet, May 15, 2004; vol. 363: pp 1607-1608. Inderjit Singh, MD, Medical University of South Carolina, Charleston, S.C. Hans-Peter Hartung, MD, PhD, professor and chairman, department of neurology. Heinrich Heine University, Dusseldorf, Germany. Nicholas LaRocca, PhD, director of healthcare delivery and policy, National MS Society.
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