Abstract
BackgroundStatins have anti-inflammatory and immunomodulatory properties in addition to lipid-lowering effects.ObjectivesTo report the 12-month extension of a phase II trial evaluating the efficacy, safety and tolerability of atorvastatin 40 mg/d added to interferon beta-1b (IFNB-1b) in relapsing-remitting multiple sclerosis (RRMS).MethodsIn the randomized, multicenter, parallel-group, rater-blinded core study, 77 RRMS patients started IFNB-1b. At month three they were randomized 1∶1 to receive atorvastatin 40 mg/d or not in addition to IFNB-1b until month 15. In the subsequent extension study, patients continued with unchanged medication for another 12 months. Data at study end were compared to data at month three of the core study.Results27 of 72 patients that finished the core study entered the extension study. 45 patients were lost mainly due to a safety analysis during the core study including a recruitment stop for the extension study. The primary end point, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.926; 95% CI 0.265–14.0007; p = 0.51). All secondary endpoints including number of new lesions and total lesion volume on T2-weighted images, total number of Gd-enhancing lesions on T1-weighted images, volume of grey and white matter, EDSS, MSFC, relapse rate, number of relapse-free patients and neutralizing antibodies did not show significant differences either. The combination therapy was well tolerated.ConclusionsAtorvastatin 40 mg/day in addition to IFNB-1b did not have any beneficial effects on RRMS compared to IFNB-1b monotherapy over a period of 24 months.Trial RegistrationClinicalTrials.gov NCT01111656
Highlights
Statins have anti-inflammatory and immunomodulatory properties in addition to its cholesterol-lowering effects [1]
Atorvastatin 40 mg/day in addition to interferon beta-1b (IFNB-1b) did not have any beneficial effects on relapsing-remitting multiple sclerosis (MS) (RRMS) compared to IFNB1b monotherapy over a period of 24 months
From August 2006 to March 2009, 27 out of 72 patients who finished the core study entered the extension study. 45 patients were lost mainly due to a safety analysis during the core study including a recruitment stop for the extension study imposed by the local institutional review board (IRB), because a study of Birnbaum et al suggested a negative effect of statins in combina
Summary
Statins have anti-inflammatory and immunomodulatory properties in addition to its cholesterol-lowering effects [1]. We performed the SWiss Atorvastatin and Interferon Beta-1b trial in Multiple Sclerosis (SWABIMS), a multi-centre, randomized, parallel-group, rater-blinded study that evaluated the efficacy, safety and tolerability of atorvastatin 40 mg per os daily and subcutaneous interferon beta-1b (IFNB-1b) every other day compared to monotherapy with subcutaneous IFNB-1b every other day on relapsing-remitting MS (RRMS) over a period of 12 months [7,8]. SWABIMS did not show any beneficial effect of atorvastatin added to IFNB-1b which is in line with other combination trials of statins and IFNB in RRMS (Table 1) [9,10,11,12,13,14,15]. Statins have anti-inflammatory and immunomodulatory properties in addition to lipid-lowering effects
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