News Release

Statins show early promise for treating multiple sclerosis

NB. Please note that if you are outside North America, the embargo for LANCET press material is 0001 hours UK Time 14 May 2004.

Peer-Reviewed Publication

The Lancet_DELETED

Results of a preliminary study in this week's issue of THE LANCET suggest that statins (cholesterol-lowering drugs) could have potential in the treatment of multiple sclerosis (MS).

Drug treatments for MS are expensive and only partially effective. Recent knowledge that statins promote an anti-inflammatory response from the immune system suggest a potential in the treatment of MS.

Inderjit Singh from the Medical University of South Carolina, USA, and colleagues report how 30 people with MS given 80 mg simvastatin daily for 6 months had a 44% reduction in the proportion of brain lesions after three months of treatment compared with lesions identified before treatment initiation.

Dr Singh comments: "These findings suggest that an 80 mg daily dose of oral simvastatin over a 6 month period could inhibit the inflammatory components of multiple sclerosis that lead to neurological disability…Our results, combined with the published work on the immunological effects of statins lend support to the case for randomised controlled clinical trials to establish the safety and efficacy of statins in the treatment of relapsing-remitting multiple sclerosis".

In an accompanying Commentary (p 1570), Chris Polman from VU Medical Centre, Amsterdam, Netherlands, concludes: "…[this] study is a big step forward because it is the first to provide some evidence of an effect with a statin in multiple sclerosis-but it is only an initial step. Additional data are required to more precisely determine the clinical effects of statins, to explore the optimum dose, the therapeutic window, and the differential potency of statins, and to evaluate whether combination therapy might be more effective than monotherapy. Physicians, scientists, drug companies, and regulatory agencies should now work together to design and do randomised studies that have adequate power to address these and other important issues. It is the joint responsibility of all involved to ensure that some of the potential charms of statins (low-hurdle access, convenience, low cost) do not develop into a dangerous boomerang, in case proper studies become jeopardised by widespread off-label use".

The potential for statins as treatment for MS is also discussed in a review in the June issue of THE LANCET NEUROLOGY (page 369-71). Author Hans-Peter Hartung comments: "The obvious advantage of statins over existing MS therapies is their oral route of dosing. Statins might be beneficial for MS patients as monotherapy or as an add-on to established disease modifying drugs. As the evidence of the benefit of statins in MS is currently insufficient, large controlled clinical trials are needed. The first of these trials is about to start".

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Contact: Dr Inderjit Singh, Medical University of South Carolina, 316 Clinical Science Building, 171 Ashley Avenue, Charleston, SC 29425, USA;
T) please add telephone number;
E) singhi@musc.edu

Professor Chris H Polman, VU Medical Centre Amsterdam, 1007 MB Amsterdam, Netherlands;
T ) 31-204-440-742;
E) ch.polman@vumc.nl

Professor Hans-Peter Hartung, Department of Neurology, Heinrich Heine University, Moorenstrasse 5, D-40225 Düsseldorf, Germany;
T) 49-211-8117-880;
E) hans-peter.hartung@uni-duesseldorf.de

Lancet 2004; 363: 1570, 1607-08


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