Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b
What it found
The main measure did not show a significant benefit.
“The primary end point, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.926; 95% CI 0.265-14.0007; p = 0.51).”Read by software from the paper's abstract
Proportion of patients with new lesions on T2-weighted images
odds ratio 1.926
p = 0.51
Total participants: 77
Read by software from the paper's abstract
What was tested
Treatment tested
- Interferon beta-1b
Interferon alpha/beta receptor agonist
Compared with
- Interferon beta-1b
Interferon alpha/beta receptor agonist
What it measured
Main measures
Proportion of patients with new lesions on T2-weighted images after 12 months of treatment
Month 0
MRI lesionsProportion of patients with new lesions on T2-weighted images after 12 months of treatment
Month 12
MRI lesions
Other measures (16)
Gd-enhancing lesions on T1-weighted images after 12 months of treatment.
Month 0
MRI lesionsTotal T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment.
Month 0
MRI lesionsCortical atrophy (changes in brain volume, changes in grey matter and white matter) on magnetic resonance imaging (MRI) after 12 months of treatment
Month 0
MRI lesionsBrain volume lossClinical disease progression (Expanded Disability Status Scale [EDSS], Multiple Sclerosis Functional Composite [MSFC] )
Month 0
Disability progressionFunctional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] )
Month 0
Disability progressionNumber of relapse-free patients after 12 months of treatment
Month 0
RelapsesRelapse rate after 12 months of treatment
Month 0
RelapsesTime to first relapse
Month 0
RelapsesGd-enhancing lesions on T1-weighted images after 12 months of treatment.
Month 12
MRI lesionsTotal T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment.
Month 12
MRI lesions
Who could take part
Relapsing MS · 18 to 67
Inclusion Criteria: * Successful completion of the SWABIMS study * Written informed consent Exclusion Criteria * Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms * Secondary progressive MS * Uncontrolled severe medical disorder * Participation in any other studies
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The "SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study" is the follow up study of the "SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS)" (see http://www.clinicaltrials.gov. Identifier: NCT00942591) SWABIMS evaluated the efficacy, safety and tolerability of atorvastatin 40 mg in addition to interferon-beta 1b compared to interferon-beta 1b monotherapy in patients with relapsing-remitting multiple sclerosis for 15 month. The SWABIMS Follow up study observes patients that finish the SWABIMS study for another 12 month with ongoing unchanged medication.
Papers
Results
Atorvastatin added to interferon beta for relapsing multiple sclerosis: 12-month treatment extension of the randomized multicenter SWABIMS trial.PLoS One · 2014
The primary end point, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.926; 95% CI 0.265-14.0007; p = 0.51).
Read by software from the paper's abstract
Background
Kamm CP, Mattle HP; SWABIMS Study Group. SWiss Atorvastatin and interferon Beta-1b trial In Multiple Sclerosis (SWABIMS)--rationale, design and methodology. Trials. 2009 Dec 14;10:115. doi: 10.1186/1745-6215-10-115.Background
Youssef S, Stuve O, Patarroyo JC, Ruiz PJ, Radosevich JL, Hur EM, Bravo M, Mitchell DJ, Sobel RA, Steinman L, Zamvil SS. The HMG-CoA reductase inhibitor, atorvastatin, promotes a Th2 bias and reverses paralysis in central nervous system autoimmune disease. Nature. 2002 Nov 7;420(6911):78-84. doi: 10.1038/nature01158.Background
Kwak B, Mulhaupt F, Myit S, Mach F. Statins as a newly recognized type of immunomodulator. Nat Med. 2000 Dec;6(12):1399-402. doi: 10.1038/82219.
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Linked trials
Extension of
SWABIMSPhase 2 · Completed
Links found where a registry record names another trial's registry number.
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History
Started
Mar 2007
Main results due
Apr 2010
Finished
Apr 2010
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