SAN DIEGO—Simvastatin may reduce the rate of brain atrophy by approximately 40% in patients with secondary progressive multiple sclerosis (SPMS), according to data presented at the 65th Annual Meeting of the American Academy of Neurology. The effect may be apparent after one year of treatment. Simvastatin also may affect physician- and patient-reported outcomes for these individuals.
Patients Did Not Take MS Drugs
In the MS-STAT trial, Jeremy Chataway, PhD, Consultant Neurologist at the Queen Square MS Centre, National Hospital for Neurology and Neurosurgery in London, and colleagues randomized 140 patients with SPMS in a one-to-one ratio. Patients underwent an MRI at baseline and initially received 40 mg per day of simvastatin or placebo. After one month, the dose was increased to 80 mg, and the treatment continued for two years. One month after the end of treatment, patients underwent a second MRI. The baseline and final MRIs were taken while the patients were off medication to avoid possible pseudoatrophy effects of simvastatin, said Dr. Chataway. The study’s primary outcome was the annualized rate of brain atrophy.
Jeremy Chataway, PhD
Participants responded to the MS Impact Scale-29 (MSIS-29) at baseline and at 24 months. At the same times, the researchers administered the Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC).
At baseline, subjects with SPMS had been actively progressing for at least two years, could walk as far as 500 meters (EDSS 4.0) or at least 20 meters with bilateral assistance (6.5), and had a mean EDSS score of 5.8 and a median EDSS score of 6.0. No patients were taking disease-modifying treatments. Average disease duration was 20 years, and patients had had secondary progression for about seven years. Patients’ mean age was about 50.
Simvastatin Lessened the Impact of MS
More than 90% of patients returned for their second MRI, and a majority of patients were compliant with the medication. The mean rate of change in brain volume was about 0.6% per year among controls, compared with 0.3% per year among patients taking simvastatin.
Approximately 55% of patients taking placebo had higher EDSS scores after two years, compared with 40% of patients in the statin arm. At two years, patients taking simvastatin had lower MSIS-29 scores than patients taking placebo. Simvastatin did not affect MSFC scores, however.
The drug was associated with a 30% reduction in the accumulation of T2 lesions, but the difference was not statistically significant. The researchers found no difference in adverse events or serious adverse events between the two treatment arms.
The statin appeared not to affect any of the T-cell outcomes that the investigators measured. The lack of an effect suggests that simvastatin may work through a vascular, microvascular, or permeability mechanism, concluded Dr. Chataway.
—Erik Greb
Senior Associate Editor
Suggested Reading
Sorensen PS, Lycke J, Erälinna JP, et al. Simvastatin as add-on therapy to interferon b-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial. Lancet Neurol. 2011;10(8):691-701.
Vollmer T, Key L, Durkalski V, et al. Oral simvastatin treatment in relapsing-remitting multiple sclerosis. Lancet. 2004;363(9421):1607-1608.
Zamvil SS, Steinman, L. Cholesterol-lowering statins possess anti-inflammatory activity that might be useful for treatment of MS.