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Friday

 

OPPOSING VIEW ON THIS STUDY FROM 2 DOCS: Statins/Simvastatin slows brain atrophy in secondary progressive multiple sclerosis

Dr. Jacqueline Palace and Dr. Neil Robertson wrote in this  editorial that these encouraging results need further exploration: "Simvastatin slows brain atrophy: A high dose of simvastatin decreased whole-brain atrophy by 43% per year over 24 months, compared with placebo, in a phase II, randomized, controlled trial in patients with secondary progressive multiple sclerosis."
The study "is a promising and novel development," for a disease that has no long-term progression-modifying therapies. "This form of multiple sclerosis has been largely neglected by a pharmaceutical industry that has so far focused on the early inflammatory processes. A substantial advantage of this study is the fairly low cost, availability, and documented safety profile of the drug."

Simvastatin’s effect on neurodegeneration rather than inflammation also suggests a novel mechanism that might be utilized in combination with anti-inflammatory treatments.

"Caution in interpretation of these preliminary data is, however, needed. ... The expected effects of simvastatin on inflammation were not shown. Furthermore, the disability outcome was a surrogate measure and not the usual outcome used in phase III trials. This finding is relevant because single disability measures show great variability in the short term, and the trial was clearly underpowered to identify an effect on arguably the least sensitive of disability measures (EDSS). The meaning of an effect on atrophy, without a reduction in lesion activity, in predicting the future effect on sustained disability outcomes is unknown."

Nonetheless, the authors wrote, the study uncovers a potential that needs exploration. (Lancet 2014 March 19 [doi: 10.1016/S0140-6736(13)62641-0]).

"Further phase III studies to measure the effect of simvastatin on sustained disability, particularly in patients with nonrelapsing secondary progressive and primary progressive multiple sclerosis, are clearly needed, but this trial represents a promising point from which to develop trials of progressive disease."

Dr. Palace leads the neuromyelitis optica service at John Radcliffe Hospital, Oxford, England. Dr. Robertston is professor of neurology in the Institute of Psychological Medicine and Clinical Neurosciences at Cardiff (Wales) University. Both reported financial relationships, including personal remuneration, from several pharmaceutical companies marketing drugs for multiple sclerosis.
source: www.clinicalneurologynews.com


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