March 28, 2012
Results from the ITN020AI STAyCIS study, testing atorvastatin therapy in early multiple sclerosis, were just published in Neurology. The study, led by Scott Zamvil, MD (University of California, San Francisco), evaluated the safety and efficacy of atorvastatin (Lipitor®, Pfizer) in subjects with early signs that often lead to multiple sclerosis (MS), termed clinically isolated syndrome (CIS). Previous preclinical studies demonstrated the ability of statins to reduce disease activity in MS models. This study was the first to test whether statin medication alone reduces the risk of conversion to MS in at-risk CIS patients.
This Phase II, double-blind, placebo-controlled study enrolled 82 patients who received atorvastatin or placebo for 12 months. The primary endpoint was the proportion of subjects who developed at least 3 new brain MRI T2 lesions or experienced a clinical relapse during the 12-month treatment phase. Those who did not reach this endpoint were evaluated out to 18 months for any sustained effects.
Although the study did not reach the primary aim (no difference between treatment and placebo), the results showed that 55.3% of patients on atorvastatin did not develop new T2 lesions, compared to only 27.6% of patients in the control group, and the odds of remaining T2 lesion-free were higher for the treatment group. Statins have a different mechanism of action compared to other approved MS treatments, and given their low toxicity, high tolerability and anti-inflammatory effects they may merit further exploration for their potential clinical benefit.
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