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)

Roberta Lanzillo, Mario Quarantelli, Carlo Pozzilli, Maria Trojano, Maria Pia Amato, Maria Giovanna Marrosu, Ada Francia, Ciro Florio, Giuseppe Orefice, Gioacchino Tedeschi, Paolo Bellantonio, Pasquale Annunziata, Luigi M.E. Grimaldi, Marco Comerci, Arturo Brunetti, Vincenzo Bonavita, Bruno Alfano, Stefano Marini, Vincenzo Brescia Morra, ARIANNA study groupGiovanni Meola

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1163-73
Number of pages11
JournalMultiple Sclerosis
Volume22
Issue number9
DOIs
Publication statusPublished - Aug 2016

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Relapsing-Remitting Multiple Sclerosis
Interferons
Atrophy
Placebos
Brain
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Multiple Sclerosis
Chronic Progressive Multiple Sclerosis
Therapeutics
Recurrence
Magnetic Resonance Imaging
Atorvastatin Calcium

Keywords

  • Journal Article

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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). / Lanzillo, Roberta; Quarantelli, Mario; Pozzilli, Carlo; Trojano, Maria; Amato, Maria Pia; Marrosu, Maria Giovanna; Francia, Ada; Florio, Ciro; Orefice, Giuseppe; Tedeschi, Gioacchino; Bellantonio, Paolo; Annunziata, Pasquale; M.E. Grimaldi, Luigi; Comerci, Marco; Brunetti, Arturo; Bonavita, Vincenzo; Alfano, Bruno; Marini, Stefano; Brescia Morra, Vincenzo; ARIANNA study group ; Meola, Giovanni.

In: Multiple Sclerosis, Vol. 22, No. 9, 08.2016, p. 1163-73.

Research output: Contribution to journalArticle

Lanzillo, R, Quarantelli, M, Pozzilli, C, Trojano, M, Amato, MP, Marrosu, MG, Francia, A, Florio, C, Orefice, G, Tedeschi, G, Bellantonio, P, Annunziata, P, M.E. Grimaldi, L, Comerci, M, Brunetti, A, Bonavita, V, Alfano, B, Marini, S, Brescia Morra, V, ARIANNA study group & Meola, G 2016, '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)', Multiple Sclerosis, vol. 22, no. 9, pp. 1163-73. https://doi.org/10.1177/1352458515611222
Lanzillo, Roberta ; Quarantelli, Mario ; Pozzilli, Carlo ; Trojano, Maria ; Amato, Maria Pia ; Marrosu, Maria Giovanna ; Francia, Ada ; Florio, Ciro ; Orefice, Giuseppe ; Tedeschi, Gioacchino ; Bellantonio, Paolo ; Annunziata, Pasquale ; M.E. Grimaldi, Luigi ; Comerci, Marco ; Brunetti, Arturo ; Bonavita, Vincenzo ; Alfano, Bruno ; Marini, Stefano ; Brescia Morra, Vincenzo ; ARIANNA study group ; Meola, Giovanni. / 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). In: Multiple Sclerosis. 2016 ; Vol. 22, No. 9. pp. 1163-73.
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T1 - 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)

AU - Lanzillo, Roberta

AU - Quarantelli, Mario

AU - Pozzilli, Carlo

AU - Trojano, Maria

AU - Amato, Maria Pia

AU - Marrosu, Maria Giovanna

AU - Francia, Ada

AU - Florio, Ciro

AU - Orefice, Giuseppe

AU - Tedeschi, Gioacchino

AU - Bellantonio, Paolo

AU - Annunziata, Pasquale

AU - M.E. Grimaldi, Luigi

AU - Comerci, Marco

AU - Brunetti, Arturo

AU - Bonavita, Vincenzo

AU - Alfano, Bruno

AU - Marini, Stefano

AU - Brescia Morra, Vincenzo

AU - ARIANNA study group

AU - Meola, Giovanni

N1 - © The Author(s), 2015.

PY - 2016/8

Y1 - 2016/8

N2 - 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.

AB - 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.

KW - Journal Article

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DO - 10.1177/1352458515611222

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C2 - 26466947

VL - 22

SP - 1163

EP - 1173

JO - Multiple Sclerosis

JF - Multiple Sclerosis

SN - 1352-4585

IS - 9

ER -