Atorvastatin added to interferon beta for relapsing multiple sclerosis: a randomized controlled trial

Kamm, Christian ; El-Koussy, Marwan ; Humpert, Sebastian ; Findling, Oliver ; von Bredow, Ferdinand ; Burren, Yuliya ; Schwegler, Guido ; Schött, Dagmar ; Donati, Filippo ; Müller, Martin ; Goebels, Norbert ; Müller, Felix ; Slotboom, Johannes ; Tettenborn, Barbara ; Kappos, Ludwig ; Naegelin, Yvonne ; Mattle, Heinrich

In: Journal of Neurology, 2012, vol. 259, no. 11, p. 2401-2413

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    Summary
    Statins have anti-inflammatory and immunomodulatory properties in addition to lipid-lowering effects. The present study evaluated the effect of atorvastatin added to interferon beta-1b in multiple sclerosis (MS) in a multicenter, randomized, parallel-group, rater-blinded study performed in eight Swiss hospitals. Seventy-seven patients with relapsing-remitting MS started interferon beta-1b every other day. After 3months, they were randomized 1:1 to receive atorvastatin 40mg/day or not in addition to interferon beta-1b until month 15. The primary endpoint was the proportion of patients with new lesions on T2-weighted images at month 15 compared to baseline at month three. At study end, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.14; 95% CI 0.36-3.56; p=0.81). All predefined secondary endpoints including number of new lesions and total lesion volume on T2-weighted images, total number of new Gd-enhancing lesions on T1-weighted images, total brain volume, volume of grey matter, volume of white matter, EDSS, MSFC, relapse rate, time to first relapse, number of relapse-free patients and neutralizing antibodies did not show any significant differences (all p values >0.1). Transient elevations of liver enzymes were more frequent with atorvastatin (p=0.02). In conclusion, atorvastatin 40mg/day in addition to interferon beta-1b did not have a beneficial effect on relapsing-remitting MS compared to interferon beta-1b monotherapy over a 12-month period