Results from German MS/statins trial

In addition to lowering cholesterol levels, the class of drugs known as statins have also been shown to affect the immune system, and for this reason several of these drugs are being evaluated as potential MS treatments. Statins also have the benefit of being taken in pill form instead of having to be injected like current MS drugs. Results from a recent German clinical trial of statins in MS have just been published in PLOS One. (This is an open access journal so you can read it for yourself!) In this trial, 36 RRMS subjects took 80 mg of atorvastatin (aka Lipitor) for nine months. If they were on IFN-beta already, they continued with this treatment as well, otherwise they took atorvastatin by itself. MRI and other measurements taken at months 6 and 9 were compared with the same measurements taken at baseline (prior to administration of atorvastatin). continued...

Results showed a significant decrease in contrast-enhancing lesions at the end of the study compared with baseline, and this effect was greater in the subjects who had a combination of IFN-beta and atorvastatin. However, the absolute numbers were small (for instance, the mean number of lesions in subjects overall was 2 at baseline compared with 1.5 at study end). The number and volume of T2 lesions increased over the study, but there was no control group and therefore no way to determine what effect (positive or negative) the treatment might have had on this. EDSS was unchanged and relapse rate decreased over the course of the study. In general, the treatment was tolerated well, although a few subjects had to reduce or discontinue statin treatment temporarily, or drop out altogether, due to side effects or elevated serum enzymes.

Immunological tests showed that statin treatment did not have an immunosuppressive effect, but that levels of the anti-inflammatory cytokine IL-10 were elevated. The authors conclude that atorvastatin treatment appears to be generally safe for people with MS, alone or in combination with IFN-beta, and appears to reduce the number of Gd-enhancing lesions. They recommend that to reduce side effects, future trials should have a dose escalation phase in the beginning rather than start right off with 80 mg, and that a controlled trial using statins as an add-on to other drugs would be an ethical way to further evaluate the possible benefits of this drug class in MS.