Simvastatin

How it Works

In addition to its cholesterol-lowering properties, Simvastatin is thought to exhibit anti-inflammatory effects and protect nerves from damage, hence is a viable candidate for the potential treatment of progressive MS. Specifically, simvastatin interferes with the activation and entry of harmful T cells into the central nervous system.

Research and Results

Phase II Trial: MS-STAT

MS-STAT is a phase II, double-blind clinical trial that examined the effect of high dose simvastatin in 140 progressive MS participants over two years. Participants were administered 80 mg simvastatin/day or placebo (inactive version of the drug). Trials results revealed that compared to placebo, individuals treated with simvastatin showed a significant (43%) reduction in brain atrophy, slower changes in EDSS, and improved scores on the MSIS-29, a measure of the extent to which MS affects daily life,. There was no difference between treatment groups in the Multiple Sclerosis Functional Composite (MSFC) score, which measures mobility, dexterity and cognition. The study also showed no differences between groups in levels of inflammation-associated molecules. Overall, the results of this phase II demonstrate that simvastatin has a beneficial effect on brain atrophy and disability in people with SPMS. These results are encouraging and warrant phase III trials to determine the safety and efficacy of simvastatin on a larger group of people with progressive MS, as well as when the drug is taken over a longer period of time.

In a MS-STAT follow-up study, the effect of simvastatin treatment on cognition and quality of life was assessed. Participants took part in numerous tests measuring cognitive and neuropsychiatric issues, and completed a survey on quality of life throughout the trial. The researchers discovered a positive correlation between simvastatin treatment and improved frontal lobe function and self-reported physical quality of life. There were no differences in placebo and simvastatin groups for other cognitive and neuropsychiatric measures.

Phase III Trial: MS-STAT2

A phase III clinical trial called MS-STAT2 was launched to examine disability progression following treatment with simvastatin in 1180 adults with SPMS. Participants will take either simvastatin (80mg/day) or placebo for three years. The primary outcome measure will be sustained change in disability for six months or more.

The anticipated study completion date is August 2023.