LANCET: Common statin slows brain atrophy in SPMS by 43% over 2 years study finds

[ActiveMSers]

Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial

Dr Jeremy Chataway PhD a b c e f Corresponding AuthorEmail Address, Nadine Schuerer PhD d, Ali Alsanousi PhD e, Dennis Chan PhD g, David MacManus BSc b c, Kelvin Hunter b c, Val Anderson PhD b c, Prof Charles R M Bangham ScD f, Shona Clegg BSc c, Casper Nielsen PhD c, Prof Nick C Fox MD a c, David Wilkie MA f, Jennifer M Nicholas PhD e f h, Virginia L Calder PhD d, Prof John Greenwood PhD d, Prof Chris Frost MA h, Richard Nicholas PhD e f

Summary

Background
Secondary progressive multiple sclerosis, for which no satisfactory treatment presently exists, accounts for most of the disability in patients with multiple sclerosis. Simvastatin, which is widely used for treatment of vascular disease, with its excellent safety profile, has immunomodulatory and neuroprotective properties that could make it an appealing candidate drug for patients with secondary progressive multiple sclerosis.

Methods
We undertook a double-blind, controlled trial between Jan 28, 2008, and Nov 4, 2011, at three neuroscience centres in the UK. Patients aged 18—65 years with secondary progressive multiple sclerosis were randomly assigned (1:1), by a centralised web-based service with a block size of eight, to receive either 80 mg of simvastatin or placebo. Patients, treating physicians, and outcome assessors were masked to treatment allocation. The primary outcome was the annualised rate of whole-brain atrophy measured from serial volumetric MRI. Analyses were by intention to treat and per protocol. This trial is registered with ClinicalTrials.gov, number NCT00647348.

Findings
140 participants were randomly assigned to receive either simvastatin (n=70) or placebo (n=70). The mean annualised atrophy rate was significantly lower in patients in the simvastatin group (0·288% per year [SD 0·521]) than in those in the placebo group (0·584% per year [0·498]). The adjusted difference in atrophy rate between groups was −0·254% per year (95% CI −0·422 to −0·087; p=0·003); a 43% reduction in annualised rate. Simvastatin was well tolerated, with no differences between the placebo and simvastatin groups in proportions of participants who had serious adverse events (14 [20%] vs nine [13%]).

Interpretation
High-dose simvastatin reduced the annualised rate of whole-brain atrophy compared with placebo, and was well tolerated and safe. These results support the advancement of this treatment to phase 3 testing.

Full Article:
http://www.thelancet.com/journals/la...242-4/fulltext

[ActiveMSers]

This is going to be burning up the MS boards with a potential treatment for SPMS. It's still way early, but this is undoubtedly encouraging. - Dave

Another article:

"In the progressive stage of MS the brain shrinks by about 0.6% a year. Our main measure of success was to reduce the rate of brain atrophy", explains study leader Dr Jeremy Chataway of University College London Hospitals / UCL in the UK.*

Analysis of pre-treatment and post-treatment brain MRI scans showed a reduction in the average atrophy rate to 0.3% a year with simvastatin, a 43% reduction (when adjusted for factors such as age and gender) compared with placebo. Additionally, small but significant improvements were noted in both a doctor (EDSS) and patient-reported (MSIS-29) disability scale. Simvastatin was generally well tolerated and serious adverse events were similar between the two groups (20% placebo vs 13% simvastatin).

http://www.sciencecodex.com/the_lanc...lerosis-129937

And another

TUESDAY, March 18, 2014 (HealthDay News) -- High doses of the cholesterol-lowering drug simvastatin -- sold under the brand name Zocor -- appeared to slow brain shrinkage in patients with multiple sclerosis, according to a small, early study from England.

In patients with the secondary progressive (chronic) stage of multiple sclerosis, brain shrinkage was reduced 43 percent for those taking Zocor compared to patients taking placebos, the researchers said.

"This effect is provisional and requires a larger phase 3 study, but holds promise for all types of MS," said Dr. Jacqueline Palace, a consultant neurologist with Oxford University Hospitals and co-author of an accompanying journal editorial.

"Because it is a repurposed drug and already has a good safety profile and is cheap, it could become available fairly quickly if further studies confirm the suggested effect," Palace said.

http://health.usnews.com/health-news...ms-progression