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Statins for multiple sclerosis

Abstract

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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.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Plain language summary

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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.