In addition to their cholesterol-lowering effects, statins provide other important actions. Among several immunomodulatory actions, statins affect adhesion molecules controlling the passage of inflammatory cells through the blood-brain barrier and enzymes associated with T-cell migration through endothelial barriers. In vitro, statins also down-regulate inflammatory mediators in glial cells and macrophages. Because these effects could influence the pathophysiology of multiple sclerosis, Vollmer and colleagues conducted a preliminary study of statins in patients with relapsing-remitting multiple sclerosis.
The authors recruited 45 patients with clinically definite relapsing-remitting multiple sclerosis who had not been treated with interferons or glatiramer in the previous three months. Patients were assessed initially for three months with magnetic resonance imaging (MRI) every month. Patients who had at least one gadolinium-enhancing lesion were eligible to receive 80 mg of simvastatin daily for six months. Brain MRI scans were repeated at months 4, 5, and 6. The scans were interpreted by two experts who were unaware of treatment assignment. The outcome measures were the number and volumes of enhancing lesions plus measures of brain atrophy. Clinical outcomes such as relapse and disability status also were assessed.
Of the 45 patients recruited, 30 were eligible for the study, and 28 completed the six-month follow-up. The average age of the participants was 44 years, and 70 percent were women. During the study, the mean number of enhancing lesions was reduced by 44 percent from baseline. The volume of lesions also decreased significantly, by 41 percent. Relapse rate and disability scores did not change during the study. As expected, cholesterol levels fell, but no significant changes were detected in immunologic indexes. Two patients had clinically significant increases in liver function levels, and three reported muscle weakness, probably related to statin therapy.
The authors conclude that simvastatin in a dosage of 80 mg daily could have a significant effect on the neuropathologic basis of multiple sclerosis. An accompanying editorial stresses that these findings correlate with results of animal studies and offer new possibilities for the treatment of multiple sclerosis. Nevertheless, the studies are preliminary, and much work remains before researchers will know if this “cautious hope” offers a useful treatment strategy in patients with multiple sclerosis.