Lanzillo, R., Quarantelli, M., Pozzilli, C., Trojano, M., Amato, M.P., Marrosu, M.G., Francia, A., Florio, C., Orefice, G., Tedeschi, G., Bellantonio, P., Annunziata, P., Grimaldi, L.M., Comerci, M., Brunetti, A., Bonavita, V., Alfano, B., Marini, S., Brescia Morra, V.
No evidence for an effect on brain atrophy rate of atorvastatin add-on to interferon β1b therapy in relapsing-remitting multiple sclerosis (the ARIANNA study)
(2016) Multiple Sclerosis, 22 (9), pp. 1163-1173.
https://www.scopus.com/inward/record.uri?eid=2-s2.0-84979581719&partnerID=40&md5=1efece7e8bacbab087d89b4901da92df
DOI: 10.1177/1352458515611222
AFFILIATIONS: Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Via Pansini 5, Italy;
National Research Council (CNR), Biostructure and Bioimaging Institute (IBB), Naples Multiple Sclerosis Centre, Italy;
Department of Neurology and Psychiatry, Sapienza University, Italy;
Department of Neurosciences and Organs of Senses, University of Bari, Italy;
Department of NEUROFARBA, University of Florence, Italy;
Department of Public Health, Clinical and Molecular Medicine, University of Cagliari, Italy;
Multiple Sclerosis Regional Center, Azienda Ospedaliera Antonio Cardarelli, Italy;
Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, Second University of Naples, Italy;
IRCCS Neuromed-Pozzilli (IS), Italy;
Department of Neurological, Neurosurgical and Behavioural Sciences, University of Siena, Italy;
Neurology Unit, Fondazione Istituto San Raffaele G. Giglio, Italy;
Department of Biomedical Advanced Sciences, Federico II University, Italy;
IDC Hermitage Capodimonte, Italy;
Dimensione Ricerca S.r.l., Italy
ABSTRACT: Background: A previous phase 2 trial has suggested that statins might delay brain atrophy in secondary progressive multiple sclerosis. Objectives: The objective of this study was to evaluate the effect of atorvastatin add-on therapy on cerebral atrophy in relapsing-remitting multiple sclerosis. Methods: This randomised, placebo-controlled study compared atorvastatin 40 mg or placebo add-on therapy to interferon β1b for 24 months. Brain magnetic resonance imaging, multiple sclerosis functional composite score, Rao neuropsychological battery and expanded disability status scale were evaluated over 24 months. Results: A total of 154 patients were randomly assigned, 75 in the atorvastatin and 79 in the placebo arms, with a comparable drop-out rate (overall 23.4%). Brain atrophy over 2 years was not different in the two arms (-0.38% and -0.32% for the atorvastatin and placebo groups, respectively). Relapse rate, expanded disability status scale, multiple sclerosis functional composite score or cognitive changes were not different in the two arms. Patients withdrawing from the study had a higher number of relapses in the previous 2 years (P=0.04) and a greater probability of relapsing within 12 months. Conclusions: Our results suggest that the combination of atorvastatin and interferon β1b is not justified in early relapsing-remitting multiple sclerosis and adds to the body of evidence indicating an absence of significant radiological and clinical benefit of statins in relapsing-remitting multiple sclerosis. © SAGE Publications.
CORRESPONDENCE ADDRESS: Lanzillo, R.; Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Via Pansini 5, Italy; email: robertalanzillo@libero.it
