title: 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).
abstract: A previous phase 2 trial has suggested that statins might delay brain atrophy in secondary progressive multiple sclerosis.
  
  
  
  The objective of this study was to evaluate the effect of atorvastatin add-on therapy on cerebral atrophy in relapsing-remitting multiple sclerosis.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Italy robertalanzillo@libero.it roberta.lanzillo@unina.it.
authors.forename: Roberta
authors.initials: R
authors.lastname: Lanzillo
authors.affiliation: National Research Council (CNR) Biostructure and Bioimaging Institute (IBB), Naples Multiple Sclerosis Centre, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Quarantelli
authors.affiliation: Department of Neurology and Psychiatry, Sapienza University, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Pozzilli
authors.affiliation: Department of Neurosciences and Organs of Senses, University of Bari, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
authors.affiliation: Department of NEUROFARBA, University of Florence, Italy.
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Amato
authors.affiliation: Department of Public Health and Clinical and Molecular Medicine, University of Cagliari, Italy.
authors.forename: Maria G
authors.initials: MG
authors.lastname: Marrosu
authors.affiliation: Department of Neurology and Psychiatry, Sapienza University, Italy.
authors.forename: Ada
authors.initials: A
authors.lastname: Francia
authors.affiliation: Multiple Sclerosis Regional Center, Azienda Ospedaliera "Antonio Cardarelli", Italy.
authors.forename: Ciro
authors.initials: C
authors.lastname: Florio
authors.affiliation: Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Orefice
authors.affiliation: Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, Second University of Naples, Italy.
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Tedeschi
authors.affiliation: IRCCS Neuromed-Pozzilli (IS), Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bellantonio
authors.affiliation: Department of Neurological, Neurosurgical and Behavioural Sciences, University of Siena, Italy.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Annunziata
authors.affiliation: Neurology Unit, Fondazione Istituto San Raffaele "G. Giglio", Italy.
authors.forename: Luigi M
authors.initials: LM
authors.lastname: Grimaldi
authors.affiliation: National Research Council (CNR) Biostructure and Bioimaging Institute (IBB), Naples Multiple Sclerosis Centre, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Comerci
authors.affiliation: Department of Biomedical Advanced Sciences, Federico II University, Italy.
authors.forename: Arturo
authors.initials: A
authors.lastname: Brunetti
authors.affiliation: IDC Hermitage Capodimonte, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Bonavita
authors.affiliation: National Research Council (CNR) Biostructure and Bioimaging Institute (IBB), Naples Multiple Sclerosis Centre, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Alfano
authors.affiliation: Dimensione Ricerca S.r.l., Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Marini
authors.affiliation: Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Brescia Morra
mesh_terms: D000328:Adult; D000069059:Atorvastatin / Q000009:adverse effects / Q000627:therapeutic use*; D001284:Atrophy; D001921:Brain / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology; D004185:Disability Evaluation; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068576:Interferon beta-1b / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy; D008279:Magnetic Resonance Imaging; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D009483:Neuropsychological Tests; D010352:Patient Dropouts; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007166:Immunosuppressive Agents; D000068576:Interferon beta-1b; D000069059:Atorvastatin
keywords: Atorvastatin; brain atrophy; interferon β1b; multiple sclerosis