Abstract
Background
Multiple sclerosis (MS) is an inflammatory demyelinating disease of the human central nervous system. Statins, prescribed as cholesterol lowering agents, have shown possible effects for treating MS in experimental and preliminary clinical studies.
Objectives
To evaluate the efficacy and safety of statins administered alone or as add-on to approved treatments for MS.
Search methods
The Trials Search Coordinator searched the Cochrane MS Group Trials Register (1 August 2011). We searched the Chinese National Knowledge Infrastructure (CNKI) (1979 to 1 August 2011), trials registers and conference proceedings. Pharmaceutical companies and authors of included studies were contacted for additional information.There were no language restrictions.
Selection criteria
Randomised controlled trials comparing statins with placebo, or comparing statins in combination with approved treatments alone for patients with MS.
Data collection and analysis
Three review authors independently assessed trial quality and extracted data.
Main results
Four trials involving 458 participants were included. All trials compared statins (two evaluating atorvastatin and two simvastatin) plus interferon beta-1a with interferon beta-1a alone for treating MS. The methodological quality was good for three studies and poor for remaining one. None of them showed statistically significant difference between both treatment groups in reducing relapses, preventing disease progression or developing new T2 or gadolinium-enhanced lesions on MRI after 9, 12, 24 months follow up period. Statins resulted to be safe and well tolerated, no serious adverse effects were reported. Changes on quality of life after receiving statins were not reported in the trials.
Authors’ conclusions
There is no convincing evidence to support the use of either atorvastatin or simvastatin as an adjunctive therapy in MS.
Plain language summary
The use of Statins, cholesterol lowering agents, in patients with multiple sclerosis (MS)
MS is an inflammatory demyelinating disease of the human central nervous system and it is thought to be related to abnormal working of the immune system. Preliminary studies have shown that statins, cholesterol lowering agents, have potential immunological regulation effects which may be beneficial for MS. Furthermore, statins are usually orally administered, are less expensive than other MS treatment, and are easily available.
The authors of this review evaluated the efficacy and safety of statins in relapsing-remitting MS patients. Among the pertinent literature, four studies, involving a total of 458 patients treated with statins as add-on treatment to interferon beta-1a were identified.
Two studies took into consideration atorvastatin, while the other two analysed simvastatin. Only three studies were found of good methodological quality.
The authors did not find convincing evidence that either atorvastatin or simvastatin can reduce relapses or prevent disease progression with a follow up at one and two years. No serious adverse events were reported and statins resulted to be safe and well tolerated. At present, the whole data do not support the use of statins as an adjunctive therapy in MS.
