Statin Benefits Secondary Progressive MS
June 11, 2014
No treatments can currently abate the advanced stage of the disease, known as secondary progressive MS, which gradually causes patients to become more disabled. Statins are postulated to have immunomodulatory effects that appear to be independent of their effect on cholesterol. A benefit has been suggested in early multiple sclerosis (MS) based on reduction of magnetic resonance imaging brain lesions. However, following trials have had inconsistent results.
In this multicenter, double-blind study, investigators randomized 140 participants with secondary progressive (SP) MS to 80 mg of simvastatin or placebo daily for 2 years. Participants were 18 to 65 years old, had active progression over the preceding 2 years, and had difficulties ambulating but were not wheelchair bound. Whole brain atrophy was 43% slower annually in simvastatin recipients than in placebo recipients. The simvastatin group also had small clinical improvements over placebo on the disability scale and a patient-reported MS impact scale at 24 months.
These findings show that simvastatin reduced brain atrophy in secondary progressive multiple sclerosis patients. Whereas many progressive MS trials seek a young and less disabled cohort, this study, remarkably, recruited patients with MS duration of more than 20 years, median disability of requiring a cane to ambulate 100 meters, and median age of 51.
The results provide encouragement to proceed to a larger phase III study, but since simvastatin is already in widespread use for other conditions, patients may inquire about trying it for their MS. Participants were off disease-modifying therapy for at least 6 months, which raises the issue of whether to discontinue disease-modifying therapies or add simvastatin. A controversy remains as to whether statins negate the effects of interferon-beta. High-dose statins were well tolerated in this study but do necessitate ongoing monitoring with occasional safety issues.
It would be premature to make a conclusion about treating SPMS with simvastatin. The study findings must be confirmed, and we need to understand the clinical implications of brain atrophy reduction in this patient population. However, with the lack of effective therapies in SPMS, we face a dilemma of whether to try simvastatin in select MS patients, with appropriate counseling and monitoring. A bigger study with more patients, possibly starting in the earlier phase of the disease, may help fully establish how effective it is.