Atorvastatin added to interferon β for relapsing multiple sclerosis: a randomized controlled trial

J Neurol. 2012 Nov;259(11):2401-13. doi: 10.1007/s00415-012-6513-7. Epub 2012 May 9.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Atorvastatin
  • Drug Therapy, Combination
  • Female
  • Heptanoic Acids / administration & dosage*
  • Humans
  • Interferon beta-1b
  • Interferon-beta / administration & dosage*
  • Male
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Multiple Sclerosis, Relapsing-Remitting / epidemiology
  • Multiple Sclerosis, Relapsing-Remitting / pathology*
  • Prospective Studies
  • Pyrroles / administration & dosage*
  • Single-Blind Method
  • Treatment Outcome
  • Young Adult

Substances

  • Heptanoic Acids
  • Pyrroles
  • Interferon beta-1b
  • Interferon-beta
  • Atorvastatin