The MS-STAT trial, showing a significant reduction in brain atrophy in patients with secondary progressive multiple sclerosis (MS) receiving high-dose simvastatin, has now beenpublished in The Lancet.
The phase 2 study was first presented, and reported by Medscape Medical News, at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in 2012.
Lead author Jeremy Chataway, MD, National Hospital for Neurology and Neurosurgery, London, United Kingdom, toldMedscape Medical News that the results are “very exciting,” given that no drugs are available for secondary progressive MS, and he hopes the publication will help in securing funding for a phase 3 trial.
“If we had shown a 10% to 20% reduction in brain atrophy, people may have asked if that was enough to justify a larger trial. But we saw a 43% reduction, and in addition there was a small effect on disability, even though the study wasn’t powered for that. That is the icing on the cake.”
Dr. Chataway noted that the brain shrinks at about 0.6% per year in patients with MS, but this was slowed to 0.3% in patients taking simvastatin. “We know brain atrophy is related to disability, so reducing atrophy should reduce disability,” he added.
A “Tried and Tested” Drug
“Another advantage of simvastatin is that it is a tried and tested drug — the side effects are well known so there won’t be any nasty surprises, and there was no difference in side effects between active treatment and placebo in this study. In addition, this drug is very cheap,” he said.
In an accompanying Comment, Jacqueline Palace, MD, John Radcliffe Hospital, Oxford, United Kingdom, and Neil Robertson, MD, University Hospital of Wales, Cardiff, United Kingdom, say the MS-STAT study is “a promising and novel development.” But they stress that the data must be considered preliminary and need confirmation in a larger trial.
New information in the paper suggests simvastatin does not appear to be working with an immunologic mechanism because there was no effect on inflammatory or immune markers. Dr. Chataway speculated that the mechanism could have more to do with endothelial function, protecting blood vessels in the brain.
“We didn’t see the classical immunological response associated with the MS drugs used in relapsing-remitting MS, but progressive MS is a different type of disease,” he added. “We know simvastatin reduces cholesterol so it could be improving the blood supply to the brain. These patients have had MS for 20 years or more. Their brains are vulnerable. It could also be improving endothelial function or acting as a neuroprotectant.”
In the study, 140 patients with secondary progressive MS were randomly assigned to simvastatin, 80 mg daily, or placebo. The primary endpoint — the mean annualized atrophy rate — was significantly lower in the simvastatin group. In addition, there was a small, but significant, effect in 2 of the secondary disability outcomes: the physician-reported (Expanded Disability Status Scale [EDSS]) and the patient-reported (Multiple Sclerosis Impact Scale [MSIS-29]) scales.
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