A retrospective analysis of 2 Italian clinical trials has found that the addition of atorvastatin to interferon-beta may result in a delayed long-term effect on disability in patients with relapsing-remitting multiple sclerosis. Findings from this study were recently published in Multiple Sclerosis and Related Disorders.
Patients with relapsing-remitting multiple sclerosis and Expanded Disability Status Scale (EDSS) score of ≤3.0 from the ACTIVE and ARIANNA trials were included in the analysis. During the trials, participants were randomly assigned to either atorvastatin (n=27) or placebo (n=42) as add-on therapy to interferon-beta for a 24-month treatment period. At 3-month intervals, researchers recorded relapses, 1-point EDSS progression, and progression to EDSS 4.0. In addition, the investigators assessed the correlation between treatment with atorvastatin and the annualized relapse rate.
Prior atorvastatin use was associated with a reduced rate of 1-point EDSS progression (hazard ratio 0.440; 95% CI, 0.225-0.861; P =.017) and of reaching of EDSS 4.0 (hazard ratio 0.310; P =.013) after 8.4 ± 2.3 (3.7–11.9) years from the trial’s start. During the observation period, there was no association between atorvastatin treatment and time to first relapse and annualized relapse rate.
The small patient sample, the retrospective nature of the analysis, and the inclusion of patients from only 1 center in Italy represent the limitations of the study.
The researchers explain that the reason no associations were found between statins and relapses “could be due to use of disease-modifying therapies that are mainly designed to prevent relapses and were used accordingly after trial termination, ‘masking’ any possible effect of statins on relapses.”
Disclosure: Roberta Lanzillo, Marcello Moccia, Jeremy Chataway, and Vincenzo Brescia Morra disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.
Lanzillo R, Moccia M, Russo CV, et al. Therapeutic lag in reducing disability progression in relapsing-remitting multiple sclerosis: 8-year follow-up of two randomized add-on trials with atorvastatin. Mult Scler Relat Disord. 2019;28:193-196.