Simvastatin is used to treat high cholesterol, but has also shown promise in MS. It’s being tested in a phase 3 clinical trial.
- Current phase of trial:
- phase 3
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How does simvastatin work?
Simvastatin is a type of statin. Statins are very common drugs used to treat high cholesterol, in order to lower the risk of heart disease and other conditions. Statins are thought to be anti-inflammatory and protect nerves from damage.
We're funding research to understand how simvastatin works in secondary progressive MS. Some studies have shown that higher cholesterol levels are linked to more severe MS. So simvastatin might slow progression in MS by reducing cholesterol.
But a recent study used statistical models to show that simvastatin has a direct effect on slowing MS progression, regardless of the effect on cholesterol levels. So researchers are now exploring which other molecules might be targeted by simvastatin.
This late stage trial is testing whether simvastatin can slow progression. It involves nearly 1000 people with secondary progressive MS. It began in March 2017 and will take six years to complete. Recruitment completed in August 2021.
Phase 2 trial - MS-STAT
The trial involved 140 people with secondary progressive MS and compared two doses of simvastatin with a placebo (dummy) drug. Researchers found that people taking high dose simvastatin had reduced brain atrophy (shrinkage) better end of study disability scores compared with those taking placebo.
Results were published in the Lancet in March 2014.
In that phase 2 trial simvastatin was generally well tolerated and no one reported any major side effects. The phase 3 trial will now monitor the safety of simvastatin in a much larger number of people with MS.
General side effects
Simvastatin has been used to treat high cholesterol for many years. Commonly reported side effects include: dizziness, fainting, nosebleeds, joint or muscle pain, headache, nausea and digestive problems.
High dose simvastatin
In June 2011 the Food and Drug Administration, which is the US drugs regulator, issued new safety recommendations for simvastatin.
It said that muscle injury (or myopathy) is a risk associated with the 80mg/day higher dose, which will be used in MS-STAT2.
How does simvastastin compare with current therapies?
There are no licensed treatments that can slow or stop progression for people with secondary progressive MS.
When is simvastatin likely to become available?
A phase 3 trial will test if simvastatin could become a treatment for secondary progressive MS. This trial will take six years to complete and results are expected in 2024.
We'll keep you updated on the progress of simvastatin.