Researchers at the IRCCS Centro Neurolesi “Bonino-Pulejo” and the University of Messina in Italy have performed a review on the immunomodulatory activity reported for statins in the treatment of multiple sclerosis (MS) and on clinical trial results, reports Multiple Sclerosis News Today.
The study, Role Of Statins In The Treatment Of Multiple Sclerosis, was published in the journal Pharmacological Research.
Statins have been shown to have immunomodulatory and anti-inflammatory properties, making them an attractive therapeutic option for immune-mediated disorders such as MS.
Previous studies conducted in vitro and in animal models showed evidence that statins also have potential neuroprotective properties, although the mechanism behind it is poorly understood. Based on these three properties— immunomodulatory, anti-inflammatory and neuroprotective — they have now been tested in clinical trials as a therapy for MS, either alone or in combination with interferon-beta. Unfortunately, the translation of the results obtained in animal models with statins yielded conflicting results in human clinical trials.
Researchers found some clinical trial studies indicated oral statins were only partially effective as a monotherapy in the treatment of relapsing-remitting MS. When tested in combination with interferon-beta, some studies found an increase in clinical disease activity, relapses and new lesions in the brain. Other studies, however, have reported the combination therapy of statin and interferon-beta had no effect on relapse rate, neither on the development of brain lesions in patients with relapsing-remitting MS. Yet, other studies found statins offer clinical benefits in comparison with interferon-beta treatment alone, namely in the number of relapses and lesions in MS patients.
The research team concluded that the therapeutic combination of statins plus interferon-beta is apparently well-tolerated and safe but could not find decisive proof that statins and interferon-beta improves relapsing remitting MS outcomes in comparison to treatment with interferon-beta only.
The research team suggests further large, prospective, randomized, double-blind, placebo-controlled trials should be conducted to assess and provide definitive proof of whether statins are effective, either as monotherapy or combined with interferon-beta, as a treatment for MS.
Source: Multiple Sclerosis News Today © BioNews Services 2015 (02/04/15)
As well as lowering cholesterol and cutting stroke risk, statins may slow the progression of advanced multiple sclerosis.
Globally, 2.5 million people have MS. Of these, two-thirds will develop the advanced form of the disease within 15 years of diagnosis. Although several treatments exist for the early phase of the disease – called relapsing-remitting MS – there is no treatment for the more advanced phase, called secondary progressive MS (SPMS).
A team led by Jeremy Chataway of University College London randomly assigned 140 people with SPMS either a daily dose of statins or a placebo for two years. They found that those taking the drug experienced 43 per cent less brain shrinkage – a marker of disease progression – per year compared with those taking a placebo. Statin recipients also deteriorated more slowly than placebo recipients as measured by two scales of disability.
Because of the short length of the trial, the researchers had expected to see a 20 to 30 per cent slowing in brain shrinkage at best, and did not expect to see any improvements in disability score because symptoms change so gradually. "The primary outcome was the [brain] atrophy rate, so any improvement in quality of life was a bonus," says Chataway. "It was unexpected, and the icing on the cake given the small scale of the study."
All the difference
The differences in the disability scores were modest but would have made a difference to the research participants. One measure, rated by doctors, ran from zero to 10, with zero being perfectly healthy. Both groups began the trial with average scores of about 5.8. After the trial, the average score for statin recipients was 5.93, compared with 6.35 for those on placebo. "It doesn't sound much, but going from 6 to 6.5 can mean moving from reliance on one walking stick to two, while scoring 7.0 can mean confinement to a wheelchair," says Chataway.
A second scale, run from 29 to 116 (most severe) and rated by research participants, echoed the improvements noticed by doctors. Those on statins, averaged 70.1 after two years, compared with 76.1 for those on placebo, from baseline scores of 70. All the ratings were done "blind", to avoid bias.
Chataway now hopes to mount a larger, three-year trial in up to 900 people with MS to confirm that the improvements in disability were down to the statin and not mere chance.
Journal reference: The Lancet, DOI: 10.1016/S0140-6736(13)62242-4
Source: New Scientist © Copyright Reed Business Information Ltd 2014 (19/03/14)