April 1, 2002
NMSS Research Programs Department
A small clinical trial was done of the oral cholesterol-lowering drug Zocor® in 30 individuals with relapsing-remitting MS:
Zocor appeared to reduce the number of new MRI-detected brain lesions
over the six-month treatment period, and demonstrated other signs of possible
Previous studies have suggested that this and other statin drugs can alter immune responses in a way that may be beneficial for treating MS;
Larger, controlled trials will be required to determine the drug’s safety and effectiveness against MS; such trials are in planning stages.
A small, pilot study found that the cholesterol-lowering pill Zocor® (simvastatin, Merck & Co., Inc.) safely reduced the number of new lesions in 30 people with relapsing-remitting multiple sclerosis. Dr. Timothy Vollmer (formerly of Yale University and now at Barrow Neurological Institute, Phoenix) and colleagues reported their results at the 2003 Annual Meeting of the American Academy of Neurology. Larger, controlled studies will need to be conducted to ascertain the effectiveness of Zocor for MS.
Previous studies have suggested that cholesterol-lowering “statins” can alter immune responses in a way that may hold promise in treating multiple sclerosis. Dr. Oliver Neuhaus (Karl-Franzens-Universitat, Graz, Austria) and colleagues reported that in cells taken from individuals with MS, several forms of statins – including mevastatin, simvastatin (Zocor®) and lovastatin (Mevacor®) – were capable of inhibiting several different immune responses and markers of inflammation typically involved in MS (Neurology, October 8, 2002). Simvastatin was the most potent, followed by lovastatin and mevastatin. However, in those studies, statins stimulated the release of some messenger proteins known to increase inflammation as well, making their ultimate value in treating MS uncertain. . Additional studies on statins have been published, including one by Drs. Scott Zamvil (University of California, San Francisco) and Sawsan Youssef (Stanford University) and colleagues. They reported in the November 7, 2002 issue of Nature that Lipitor (atorvastatin, Pfizer, Inc.) prevented or reversed the MS-like disease EAE in mice. The mechanism underlying the drug’s ability to treat EAE appears to be immune system modulation, not a cholesterol-lowering mechanism.
These promising results in laboratory studies provide some information about biological mechanisms of statins. Meanwhile, results are now being reported from a small, early study of Zocor in people with relapsing-remitting MS.
Three centers (Yale University, New Haven, CT; Medical College of South Carolina, Charleston; University of Colorado at Denver) participated in this first human study of a statin in MS. Forty-five subjects were enrolled, undergoing MRI (magnetic resonance imaging) scans monthly for three months. Those that had at least one new lesion were then eligible for six months of treatment with 80 mg. of Zocor daily. During the study period, participants underwent neurological assessments and MRI scans, and blood samples were also taken. The primary outcome that investigators looked at was the difference in the mean number of new lesions between scans taken during pre-treatment, and during months 4, 5 and 6 of the treatment period. Secondary outcomes were drug safety, other MRI results, and changes in neurological assessments and immune system activity. This was an “open-label” study, meaning that all patients received Zocor, and the effects of this treatment were not compared with those of an inactive placebo.
Preliminary analysis of the results indicates a significant (43%) decrease in the mean number of new lesions, and in the volume of new lesions. No serious adverse events related to treatment occurred. Analysis of immune responses suggested a positive shift away from inflammation, but there were no differences observed in neurological status or disability in this short study.
This small study, indicating possible benefit on lesion development
and immune activity, shows promising results for Zocor in treating people
with relapsing-remitting MS. However, the safety and effectiveness of this
treatment must be ascertained in larger, controlled trials. Such studies
of this and other statins are now in the planning stages. Individuals concerned
about the role of statins in MS should discuss the results of this study
with their personal physicians.
© 2003 The National Multiple Sclerosis Society