Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b
Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b
The "SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study"
 is the follow up study of the "SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple
 Sclerosis (SWABIMS)" (see http://www.clinicaltrials.gov. Identifier: NCT00942591) SWABIMS
 evaluated the efficacy, safety and tolerability of atorvastatin 40 mg in addition to
 interferon-beta 1b compared to interferon-beta 1b monotherapy in patients with
 relapsing-remitting multiple sclerosis for 15 month. The SWABIMS Follow up study observes
 patients that finish the SWABIMS study for another 12 month with ongoing unchanged
 medication.
Background

 Multiple sclerosis is a chronic inflammatory autoimmune disease of the central nervous
 system. Statins are lipid-lowering drugs which inhibit the
 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA-) reductase, which is the main regulatory
 enzyme of cholesterol biosynthesis. In recent years many studies have demonstrated, that
 statins have anti-inflammatory and immunomodulatory properties in addition to their
 lipid-lowering effects. Therefore, statins may have therapeutic potential in immune-mediated
 disorders such as multiple sclerosis. Studies in experimental allergic encephalomyelitis
 (EAE), the animal model for the human demyelinating disease multiple sclerosis, as well as
 smaller studies in patients with relapsing-remitting multiple sclerosis showed beneficial
 effect on the course of the disease. But there are also reports of negative impact of statins
 on multiple sclerosis. Therefore, bigger studies are needed to investigate the therapeutical
 potential of statins in multiple sclerosis.

 Objective

 To assess the efficacy, safety and tolerability of the combination of atorvastatin 40mg p.o.
 daily and interferon-beta 1b sc e.o.d compared to monotherapy with interferon-beta-1b sc
 e.o.d in patients with relapsing-remitting multiple sclerosis for 12 month after completing
 the SWABIMS study.

 Methods

 Multi-center, rater-blinded, parallel-group, two arm, randomized study. Patients with
 relapsing-remitting forms of MS, respecting all inclusion/exclusion criteria, were randomized
 in the SWABIMS study in two equal-size parallel arms after three months of treatment with
 interferon-beta 1b, receiving atorvastatin 40mg/d or not in addition to interferon-beta 1b
 for 12 month.

 After successful completion of the study, patients were asked to participate in the "SWABIMS
 Follow up study" for another 12 month with ongoing medication.
Inclusion Criteria:

 -  Successful completion of the SWABIMS study

 -  Written informed consent

 Exclusion Criteria

 -  Any disease other than multiple sclerosis that would better explain the patient's
 signs and symptoms

 -  Secondary progressive MS

 -  Uncontrolled severe medical disorder

 -  Participation in any other studies