Cholesterol-lowering drug shows promiseResults of a preliminary study in this week’s issue of The Lancet suggest that statins (cholesterol-lowering drugs) have potential in the treatment of multiple sclerosis (MS).Current drug treatments for MS are expensive and partially effective. Recent knowledge that statins promote an anti-inflammatory response from the immune system suggests potential in the treatment of MS. Inderjit Singh, Ph.D., scientific director of the Children’s Research Institute of MUSC, and colleagues report that 30 people with MS given 80 mg of simvastatin daily for 6 months had a 44 percent reduction in the proportion of brain lesions after three months of treatment compared with lesions when identified before treatment initiation. “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,” said Singh. “Our results, combined with the published work on the immunological effects of statins, lend support to the case for randomized controlled clinical trials to establish the safety and efficacy of statins in the treatment of relapsing-remitting multiple sclerosis.” In an accompanying commentary, 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, companies, and regulatory agencies should now work together to design and do randomized 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 jeopardized by widespread off-label use.” “The primary marker we measured was the change in the number of active brain lesions associated with multiple sclerosis using MRI scans of the trial participants at intervals during the trial,” said Lyndon Key, M.D., chairman of the Pediatrics Department at MUSC, who designed the clinical trial with Singh, William Tyor, M.D., and Timothy Vollmer, M.D. Of the 28 participants who completed the trial, three showed no change in mean number of lesions between pre- and post-treatment brain MRIs; two showed an increase in lesions; and 23 showed a decrease in lesions. “Not only were the results positive, but we used a drug that is used safely by millions of people,” Key said. “The drug can be taken orally, rather than by injection like the drugs currently used for MS, and costs about a fifth of other MS medications.” The multi-center trial was run at MUSC with Tyor, director of the MUSC Multiple Sclerosis Clinical, serving as the clinical principal investigator. Yale University's Vollmer served as the clinical principal investigator and lead clinical clinician for the study. Vollmer is currently at the Barrow Neurological Institute in Phoenix. John Corboy, M.D., at the University of Colorado’s Denver Health Sciences Center was a clinical principal investigator, and MUSC's Valerie Durkalski, Ph.D., was lead biostatistician. Singh and Key applied for and received an unrestricted educational grant
from Merck and Co. to conduct the study. This trial was done with a limited
number of participants, and all participants received the active drug.
The next steps in the research require trials with much larger numbers
of participants with some on the drug and some not. To optimize the therapy,
future trials could assess the safety of the combination of statins administered
with other effective MS therapies.
Friday, May 21, 2004
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