Volume 383, Issue 9936, Pages (June 2014)

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Volume 383, Issue 9936, Pages 2213-2221 (June 2014) Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial Dr Jeremy Chataway, PhD, Nadine Schuerer, PhD, Ali Alsanousi, PhD, Dennis Chan, PhD, David MacManus, BSc, Kelvin Hunter, Val Anderson, PhD, Prof Charles R M Bangham, ScD, Shona Clegg, BSc, Casper Nielsen, PhD, Prof Nick C Fox, MD, David Wilkie, MA, Jennifer M Nicholas, PhD, Virginia L Calder, PhD, Prof John Greenwood, PhD, Prof Chris Frost, MA, Richard Nicholas, PhD The Lancet Volume 383, Issue 9936, Pages 2213-2221 (June 2014) DOI: 10.1016/S0140-6736(13)62242-4 Copyright © 2014 Chataway et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 1 Patient flow diagram The Lancet 2014 383, 2213-2221DOI: (10.1016/S0140-6736(13)62242-4) Copyright © 2014 Chataway et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 2 Primary MRI outcome and secondary clinical outcomes The mean and individual patient values are shown for change in whole-brain volume (A); percentage of patients with a given change in EDSS (B); change 0 to 24 months MSIS-29 (C); and change 0 to 24 months MSFC (D). For panels A, C, and D the mean is indicated by solid bar, placebo group by dark blue points, and simvastatin group by pale blue points. For change in whole-brain volume, EDSS, and MSIS-29, a positive value indicates a worse outcome. A positive value for MSFC Z score indicates an improved outcome. BSI=brain boundary shift integral. WBV=whole-brain volume. EDSS=Kurtzke expanded disability status scale. MSIS=multiple sclerosis impact scale. MSFC=multiple sclerosis functional composite. The Lancet 2014 383, 2213-2221DOI: (10.1016/S0140-6736(13)62242-4) Copyright © 2014 Chataway et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 3 Mean and 95% CI for the difference between simvastatin and placebo groups in immunological markers at 6, 12, and 24 months The difference between simvastatin and placebo in inducible levels of cytokine expression is shown for square root IFNγ (A), natural log IL-4 (B), natural log IL-10 (C), and natural log IL-17 (D). The difference between simvastatin and placebo is shown for natural log of % CD4 Fox P3 expression (E). Analyses of each marker included at least 134 participants, with number at each timepoint between 91 participants (IL-17 at 24 months) and 112 participants (IL-10 at 6 months). Means and 95% CIs are adjusted for minimisation variables and baseline measurement of the marker. The dashed line indicates zero difference between groups. The Lancet 2014 383, 2213-2221DOI: (10.1016/S0140-6736(13)62242-4) Copyright © 2014 Chataway et al. Open Access article distributed under the terms of CC BY Terms and Conditions