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)
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)(487 views)(PDF restricted18 views) Lanzillo R, Quarantelli M, Pozzilli C, Trojano M, Amato MP, Marrosu MG, Francia A, Florio C, Orefice G, Tedeschi G, Bellantonio P, Annunziata P, Grimaldi LM, Comerci M, Brunetti A, Bonavita V, Alfano B, Marini S, Brescia Morra V
Mult Scler (ISSN: 1352-4585, 1477-0970, 1352-4585linking), 2016 Aug; 22(9): 1163-1173.
Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Italy robertalanzillo@libero.it roberta.lanzillo@unina.it.
National Research Council (CNR) Biostructure and Bioimaging Institute (IBB), Naples Multiple Sclerosis Centre, Italy.
Department of Public Health and 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.
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.
References: Not available.
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)
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 beta1b 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 beta1b 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.
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)
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)