Clinical trial for oral Lipitor
still enrolling
participants for study
Medical Update Memo
April 7, 2006
SUMMARY
Investigators – including those at one centre in Canada
– are still enrolling participants for a clinical trial
evaluating the effects of oral Lipitor® (atorvastatin)
compared with inactive placebo in 152 people at high risk for
developing MS. Previous studies have suggested that cholesterol-lowering
“statins” can alter immune responses in a way that
may hold promise in treating MS. The mechanism underlying the
drug’s possible promise for MS appears to be immune system
modulation, rather than a cholesterol-lowering mechanism.
DETAILS
Investigators at 14 MS centres in the North America –
including one centre in Canada –are conducting a clinical
trial evaluating the effects of oral Lipitor® (atorvastatin),
compared with inactive placebo in 152 people at high risk for
developing MS. The study is supported by the Immune Tolerance
Network, a research consortium funded by the NIH's National
Institute of Allergy and Infectious Diseases (USA). The lead
investigators are Scott Zamvil, MD, PhD, and Emmanuelle Waubant,
MD, PhD, of the University of California, San Francisco.
Previous studies have suggested that
cholesterol-lowering “statins” can alter immune
responses in a way that may hold promise in treating MS.
A report in Nature (November 7, 2002) found that Lipitor
prevented or reversed the MS-like disease EAE in mice. In
addition, a small open-label pilot study by Timothy Vollmer,
MD, and colleagues in 28 people with relapsing-remitting
MS found that the cholesterol-lowering pill Zocor® (simvastatin)
safely reduced the number of new lesions (Lancet, May 15,
2004). The mechanism underlying the drug’s possible
promise appears to be immune system modulation, rather than
a cholesterol-lowering mechanism.
The primary objective of the study is to evaluate the effects
of Lipitor to decrease or delay clinical and MRI disease activity.
Secondary objectives are to determine if Lipitor is safe in
people with CIS, to determine which immune system cells or
molecules are modified by Lipitor, to evaluate the effects
of Lipitor on brain tissue loss, and to determine potential
residual benefits after the discontinuation of therapy.
Eligibility for participation:
People eligible for participation include individuals 18-55
years of age with no previous neurological history, who experience
a clinically isolated syndrome (CIS, a single demyelinating
event, for example, an attack of optic neuritis in one eye,
or an episode of numbness on one side) lasting at least 48
hours and magnetic resonance imaging findings suggestive of
MS. Participants must receive a three- to five-day course of
corticosteroids starting within 60 days of onset of a CIS and
must be enrolled within 90 days of onset of a CIS.
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or therapy
but provides information to assist individuals in making their own decisions.
Multiple Sclerosis Society of Canada
Toll free to reach
the nearest regional office: 1 800 268-7582
To locate the MS Society office near you, please select your region:
E-mail: info@mssociety.ca (Please provide your town and
province in your e-mail)
