Simvastatin is an approved statin commonly used to lower cholesterol that is currently being studied as a potential treatment to slow the progression of multiple sclerosis (MS).
How simvastatin works
MS symptoms are caused when the immune system mistakenly targets the myelin sheath, a protective layer surrounding nerve fibers in the brain and spinal cord. This causes inflammation and damage to the myelin, disrupting nerve signaling.
Statins have been shown to potentially have anti-inflammatory and neuroprotective properties. Exactly how the drug alters the immune system is not clearly understood, but researchers have developed several theories. For example, statins may interact with T-cells, a type of immune cell, by preventing them from becoming active or by stopping them from entering the brain and spinal cord.
There is evidence suggesting that simvastatin can inhibit the release of pro-inflammatory cytokines (a small secreted protein that can trigger an immune response) and induce anti-inflammatory cytokines (proteins that inhibit the immune response) from the immune cells of relapsing-remitting MS (RRMS) patients. Simvastatin has been shown to bind to and block the action of complement receptor 3 (CR3), which is normally involved in triggering the damaging immune processes seen in conditions like MS.
Simvastatin in clinical trials
Several studies have been conducted to test simvastatin as a potential treatment for MS.
A Phase 4 clinical trial (NCT00492765) called SIMCOMBIN carried out in Europe with more than 300 participants suggested that simvastatin may not have a benefit as an add-on to interferon beta-1a treatment in RRMS.
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). The results are published in the medical journal The Lancet.
A large-scale Phase 3 clinical trial, called MS-STAT2, is expected to begin recruiting participants in the summer of 2017. This trial will be led by researchers at University College of London (UCL), Institute of Neurology, in collaboration with the National Institute for Health Research (NIHR), the MS Society in the U.K, the National MS Society in the U.S., and the U.K. National Health Service (NHS).
MS-STAT2 aims to enroll 1,180 patients with SPMS at over 30 trial centers across the U.K., assessing whether simvastatin can slow the progression of disability (measured by the EDSS scale) over a three-year period.
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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