Department of Neurology, Inselspital, Bern University Hospital, and University of Bern, Switzerland.
Trials. 2009 Dec 14;10:115. doi: 10.1186/1745-6215-10-115.
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/DESIGN: 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.
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.
http://www.clinicaltrials.gov. Identifier: NCT00942591; Swissmedic reference number: 2005DR2119.
他汀类药物除了具有降低血脂的作用外，还有抗炎和免疫调节作用。目前，他汀类药物对多发性硬化症的影响仍存在争议。因此，需要进行随机临床试验，以提供他汀类药物在多发性硬化症治疗潜力方面的更好证据。多发性硬化症瑞士阿托伐他汀和干扰素-β1b 试验（SWABIMS）评估了阿托伐他汀 40mg 每日口服和皮下干扰素-β1b 每隔一天与皮下干扰素-β1b 单药治疗在复发缓解型多发性硬化症患者中的疗效、安全性和耐受性。
方法/设计：SWABIMS 是一项多中心、随机、平行组、观察者设盲、IIb 期研究，在瑞士的 8 家医院进行。80 名初治复发缓解型多发性硬化症患者将接受皮下干扰素-β1b 治疗 3 个月。之后，他们随机分为两组，每组各 40 名，分别接受或不接受阿托伐他汀 40mg/d 作为干扰素-β1b 的附加治疗，再治疗 12 个月。通过新 T2 病变患者的比例来衡量疾病活动度，作为主要终点。
SWABIMS 旨在提供关于阿托伐他汀 40mg 每日口服作为复发缓解型多发性硬化症患者干扰素-β1b 附加治疗的疗效的进一步信息。此外，还将产生重要的安全性和耐受性数据。
http://www.clinicaltrials.gov。标识符：NCT00942591；瑞士药品管理局参考号：2005DR2119。
