Abstract
BackgroundStatins 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/DesignSWABIMS 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.DiscussionSWABIMS 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.Trial Registrationhttp://www.clinicaltrials.gov. Identifier: NCT00942591; Swissmedic reference number: 2005DR2119
Highlights
Statins have anti-inflammatory and immunomodulatory properties in addition to their lipid-lowering effects
In a phase II open-label baseline-to-treatment trial of high dose atorvastatin monotherapy (80 mg/d) in relapsing-remitting MS (RRMS) there was a significant decrease in the number and volume of Gd-enhancing lesions in 24 RRMS patients, and a trend towards less Gd-enhancing lesions in 12 patients treated with the combination of atorvastatin (80 mg/d) and interferon beta (IFNB) [8]
The primary endpoint is the disease activity measured by the proportion of patients with new T2 lesions after 15 months of treatment compared to baseline at month 3, when patients are randomized to receive atorvastatin or not
Summary
Statins have anti-inflammatory and immunomodulatory properties in addition to their lipid-lowering effects. The effects of statins on the course multiple sclerosis are still unknown. Experimental and clinical studies have given differing results and results from randomized trials are missing. The Swiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS) is a multi-centre, randomized, parallel-group, rater-blinded Phase IIb-study conducted to assess the efficacy, safety and tolerability of atorvastatin 40 mg (p.o.) daily and IFNB-1b e.o.d compared to monotherapy with IFN-1b e.o.d. in patients with RRMS. SWABIMS will likely give further information about the therapeutic potential of atorvastatin 40 mg p.o. daily as add-on therapy to IFNB-1b e.o.d in patients suffering from RRMS. SWABIMS will provide important safety and tolerability data of atorvastatin in patients with RRMS
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