Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis
Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis
Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of
 immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is
 quite limited, they are not well tolerated and they have a very high cost. Recent works
 showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called "statins").
 In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and
 progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in
 vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the
 blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was
 associated with a decreased lesional activity assessed by MRI. Statins are well tolerated
 drugs, used for many years, with a low cost and with a putative efficacy in MS. The
 investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a
 double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.
Inclusion Criteria:

 -  Relapsing remitting MS with diagnosis defined by the McDonald criteria (McDonald et
 al., 2001) with no current disease modifying therapy (interferon, copaxone or
 immunosuppressant drugs) since at least 3 months and an EDSS score < 5.

 -  At least one gadolinium positive lesion on the MRI of the selection phase is needed.

 -  No current statin therapy.

 -  Normal renal and hepatic biological tests.

 -  No current pregnancy