Statin shows early promise in advanced multiple sclerosis
Source: Dean Hoch/Dreamstime.com
High-dose simvastatin therapy slows the worsening of brain atrophy in patients with secondary progressive multiple sclerosis (MS), results of a phase II trial published in The Lancet reveal (online 19 March 2014).
In the two-year trial, simvastatin 80mg per day reduced the annual rate of brain atrophy by 43 per cent relative to placebo (see Panel) and was safe and well tolerated, leading the researchers to call for further evaluation of the approach in phase III trials.
“At the moment, we don’t have anything that can stop patients from becoming more disabled once MS reaches the progressive phase,” said study co-author Richard Nicholas, from Imperial College London.
“Discovering that statins can help slow that deterioration is quite a surprise. This is a promising finding, particularly as statins are already cheap and widely used.”
To date, no licensed drugs have shown a convincing impact on this later stage of the disease, which is characterised by disability and a worsening of symptoms and carries the greatest burden to both patients and society.
Noting that longitudinal studies have shown an association between atrophy progression and disability, the authors say that the slower pace of brain atrophy they observed is positive.
But lead author Jeremy Chataway, from University College London, said in a statement: “Caution should be taken regarding over-interpretation of brain imaging findings, because these might not necessarily translate into clinical benefit. However, our promising results warrant further investigation in larger phase III disability-driven trials.”
Study method and results
The MS-STAT trial enrolled 140 patients with secondary progressive MS from three UK neuroscience centres and randomly assigned them to receive simvastatin 80mg per day or placebo for 24 months.
The annualised rate of whole-brain atrophy, measured using serial volumetric magnetic resonance imaging, was 0.288 per cent per year in the simvastatin group versus 0.584 per cent per year in the placebo group. This translates into an adjusted difference in atrophy rate of -0.254 per cent per year (P=0.003) or a 43 per cent reduction with simvastatin relative to placebo.
There were also signals of a clinically relevant treatment effect, with simvastatin-treated patients showing a small but significant improvement in doctor- and patient-reported disability scales. Furthermore, simvastatin was well tolerated and the rate of serious adverse events was similar between the statin and placebo groups.
Citation: The Pharmaceutical JournalURI: 11136232
Recommended from Pharmaceutical Press