SWiss Atorvastatin and interferon Beta-1b trial In Multiple Sclerosis (SWABIMS)--rationale, design and methodology.
BACKGROUND
Statins have anti-inflammatory and immunomodulatory properties in addition to their lipid-lowering effects. Currently, the effects of statins on multiple sclerosis are still controversial. Therefore, randomized clinical trials are needed to provide better evidence on the therapeutic potential of statins in multiple sclerosis. The SWiss Atorvastatin and Interferon Beta-1b trial in Multiple Sclerosis (SWABIMS) evaluates the efficacy, safety and tolerability of atorvastatin 40 mg per os daily and subcutaneous interferon beta-1b every other day compared to monotherapy with subcutaneous interferon beta-1b every other day in patients with relapsing-remitting multiple sclerosis.


METHODS
SWABIMS is a multi-centre, randomized, parallel-group, rater-blinded, Phase IIb-study conducted in eight hospitals in Switzerland. 80 treatment naïve patients with relapsing-remitting forms of multiple sclerosis will receive subcutaneous interferon beta-1b for three months. Afterwards, they are randomized into two equal-sized parallel arms, receiving atorvastatin 40 mg/d or not in addition to interferon beta-1b for another 12 months. Disease activity measured by the proportion of patients with new T2 lesions is the primary endpoint.


CONCLUSIONS
SWABIMS is designed to give further information about the therapeutic effect of atorvastatin 40 mg per os daily as add-on therapy to interferon beta-1b in patients with relapsing-remitting multiple sclerosis. Furthermore important safety and tolerability data will be generated.


BACKGROUND
http://www.clinicaltrials.gov. Identifier: NCT00942591; Swissmedic reference number: 2005DR2119.
Kamm
Christian P
CP
Department of Neurology, Inselspital, Bern University Hospital, and University of Bern, Switzerland. christian.kamm@insel.ch
Mattle
Heinrich P
HP
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D000069059:Atorvastatin; D004359:Drug Therapy, Combination; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000627:therapeutic use*; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D011758:Pyrroles / Q000627:therapeutic use*; D055502:Secondary Prevention; D013557:Switzerland
D000276:Adjuvants, Immunologic; D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D011758:Pyrroles; D000068576:Interferon beta-1b; D016899:Interferon-beta; D000069059:Atorvastatin