Simvastatin is from the statins class of therapies that are commonly used to lower cholesterol. The therapy has been shown to inhibit inflammatory and immune-related disease processes such as those observed in multiple sclerosis, Type 1 diabetes, and rheumatoid arthritis. Exactly how the drug alters the immune system is not yet known.
Several studies have been conducted to test simvastatin as a potential treatment for multiple sclerosis.
The Phase 2 MS-STAT study (NCT00647348) showed that simvastatin can reduce the rate of brain atrophy in people with secondary progressive multiple sclerosis (SPMS). Patients who took simvastatin (80 mg daily for two years) had a 43 percent lower rate of brain atrophy and better scores on the Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Impact Scale (MSIS-29).
However, Phase 4 studies of simvastatin in combination with beta interferon in people with relapsing-remitting multiple sclerosis (RRMS) showed no added benefit in reducing patient relapse rates or other disability measures compared with beta interferon alone.
Several additional studies involving the therapeutic use of statins have been completed and may provide additional information about the usefulness of the medications in MS.
Simvastatin is taken orally. The most common reported side effects include nose bleeds, runny nose, or blocked nose; headache; and gastric disorders at lower doses. Muscle pain or muscle injury was reported at higher doses. In 2011, the U.S. Food and Drug Administration (FDA) issued a new safety recommendation citing muscle injury (myopathy) as a risk associated with high doses of simvastatin.
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