(AAN) High-dose simvastatin slows brain atrophy in SPMS...

 
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PostPosted: Thu Mar 28, 2013 4:15 pm    Post subject: (AAN) High-dose simvastatin slows brain atrophy in SPMS... Reply with quote

Presented at the annual AAN conference in San Diego, March 16-23, 2013:

Quote:
[PL02.001] THE MS-STAT TRIAL: High Dose Simvastatin Slows Brain Atrophy and Delays Disability in Secondary Progressive Multiple Sclerosis: A Phase II Placebo-Controlled Trial

Jeremy Chataway, London, United Kingdom, Nadine Schuerer, London, United Kingdom, Ali Alsanousi, London, United Kingdom, Dennis Chan, East Sussex, United Kingdom, David MacManus, London, United Kingdom, Kelvin Hunter, London, United Kingdom, Val Anderson, London, United Kingdom, Jo Foster, London, United Kingdom, Charles Bangham, London, United Kingdom, Shona Clegg, London, United Kingdom, Casper Nielsen, London, United Kingdom, Nick Fox, London, United Kingdom, David Wilkie, London, United Kingdom, Jennifer Nicholas, London, United Kingdom, Virginia Calder, London, United Kingdom, John Greenwood, London, United Kingdom, Chris Frost, London, United Kingdom, Richard Nicholas, London, United Kingdom

OBJECTIVE:

To assess whether high-dose (80mg) simvastatin can slow the annualized rate of whole brain atrophy in secondary progressive multiple sclerosis (SPMS).

BACKGROUND:

The central unresolved issue in multiple sclerosis is secondary progression, where neuroaxonal loss drives an irreversible and progressive accumulation of neurological deficit. 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitors (statins) have numerous anti-inflammatory effects and a range of potential neuroprotective effects which makes them attractive candidates in mixed inflammatory/neurogenerative disease states.

DESIGN/METHODS:

In this double-blind, placebo-controlled phase II trial, 140 patients were randomised in a 1:1 ratio and followed for 2 years. The primary outcome was the rate of whole brain atrophy per year, measured by brain boundary shift integral (BSI). Clinical disability measures, new or enlarging T2 lesions, relapse count and safety were measured. Cytokine secretion after stimulation was measured for IFN gamma, IL-4, IL-10, IL-17 and CD4Fox P3 expression.

RESULTS:

The mean atrophy rate was lower in the simvastatin arm at 0.298 (SD 0.562) percent per year than in the placebo arm at 0.589 (0.528) percent per year. The adjusted difference in atrophy rate between the groups was -0.254 (95% CI: -0.423 to -0.085; p=0.003).

At 24 months there was a statistically significant difference in favour of the active arm over placebo for the Expanded Disability Status Score (difference -0.254; 95% CI: -0.464 to -0.069) and Multiple Sclerosis Impact Scale (-4.78; 95% CI: -9.39 to -0.02).

There was no difference in relapse rate or T2 lesion activity. No significant differences were observed for any of the immunological analyses. It was well tolerated.

CONCLUSIONS:

Simvastatin reduced the annualized rate of whole-brain atrophy by 43%. Moreover, a small, but significant, effect was observed in two of the secondary outcomes. It would be an attractive candidate drug to take forward to phase III.

ClinicalTrials.gov, number NCT00647348.
Category - MS and Related Diseases: Clinical Science


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