title: Atorvastatin added to interferon β for relapsing multiple sclerosis: a randomized controlled trial.
abstract: Statins have anti-inflammatory and immunomodulatory properties in addition to lipid-lowering effects. The present study evaluated the effect of atorvastatin added to interferon beta-1b in multiple sclerosis (MS) in a multicenter, randomized, parallel-group, rater-blinded study performed in eight Swiss hospitals. Seventy-seven patients with relapsing-remitting MS started interferon beta-1b every other day. After 3 months, they were randomized 1:1 to receive atorvastatin 40 mg/day or not in addition to interferon beta-1b until month 15. The primary endpoint was the proportion of patients with new lesions on T2-weighted images at month 15 compared to baseline at month three. At study end, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.14; 95 % CI 0.36-3.56; p = 0.81). All predefined secondary endpoints including number of new lesions and total lesion volume on T2-weighted images, total number of new Gd-enhancing lesions on T1-weighted images, total brain volume, volume of grey matter, volume of white matter, EDSS, MSFC, relapse rate, time to first relapse, number of relapse-free patients and neutralizing antibodies did not show any significant differences (all p values >0.1). Transient elevations of liver enzymes were more frequent with atorvastatin (p = 0.02). In conclusion, atorvastatin 40 mg/day in addition to interferon beta-1b did not have a beneficial effect on relapsing-remitting MS compared to interferon beta-1b monotherapy over a 12-month period.
authors.affiliation: University Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Freiburgstrasse, 3010, Bern, Switzerland.
authors.forename: Christian Philipp
authors.initials: CP
authors.lastname: Kamm
authors.forename: Marwan
authors.initials: M
authors.lastname: El-Koussy
authors.forename: Sebastian
authors.initials: S
authors.lastname: Humpert
authors.forename: Oliver
authors.initials: O
authors.lastname: Findling
authors.forename: Ferdinand
authors.initials: F
authors.lastname: von Bredow
authors.forename: Yuliya
authors.initials: Y
authors.lastname: Burren
authors.forename: Guido
authors.initials: G
authors.lastname: Schwegler
authors.forename: Dagmar
authors.initials: D
authors.lastname: Schött
authors.forename: Filippo
authors.initials: F
authors.lastname: Donati
authors.forename: Martin
authors.initials: M
authors.lastname: Müller
authors.forename: Norbert
authors.initials: N
authors.lastname: Goebels
authors.forename: Felix
authors.initials: F
authors.lastname: Müller
authors.forename: Johannes
authors.initials: J
authors.lastname: Slotboom
authors.forename: Barbara
authors.initials: B
authors.lastname: Tettenborn
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Naegelin
authors.forename: Heinrich Paul
authors.initials: HP
authors.lastname: Mattle
mesh_terms: D000293:Adolescent; D000328:Adult; D000069059:Atorvastatin; D004359:Drug Therapy, Combination; D005260:Female; D006538:Heptanoic Acids / Q000008:administration & dosage*; D006801:Humans; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology*; D011446:Prospective Studies; D011758:Pyrroles / Q000008:administration & dosage*; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006538:Heptanoic Acids; D011758:Pyrroles; D000068576:Interferon beta-1b; D016899:Interferon-beta; D000069059:Atorvastatin