Atorvastatin Combined with Interferon to Verify the Efficacy (ACTIVE) in relapsing-remitting active multiple sclerosis patients: a longitudinal controlled trial of combination therapy
Interferon beta (IFNb) is a first-line treatment for people with MS, but its efficacy may vary amongst different people. Statins are known to have anti-inflammatory properties. In this unicentre controlled clinical trial carried out with 45 participants, the authors aimed to assess safety, tolerability and efficacy of low-dose atorvastatin, which belongs to the group of statins, plus subcutaneous IFNb-1a (Rebif44®), given for 24 months, in people with MS responding poorly to interferon beta-1a. The people that received the combined therapy (atorvastatin plus IFNb-1a) had better outcome than those that received IFNb-1a alone, in terms of active inflammatory lesions in the MRI, relapses, and risk of increasing disability. The authors have concluded that low-dose atorvastatin may be beneficial, as add-on therapy, in poor responders to high-dose interferon beta-1a alone. Mult Scler. 2010 Feb 11
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A large body of evidence suggests that, besides their cholesterol-lowering effect, statins exert anti-inflammatory action. Consequently, statins may have therapeutic potential in immune-mediated disorders such as multiple sclerosis.
The objectives were to determine safety, tolerability and efficacy of low-dose atorvastatin plus high-dose interferon beta-1a in multiple sclerosis patients responding poorly to interferon beta-1a alone. Relapsing-remitting multiple sclerosis patients, aged 18-50 years, with contrast-enhanced lesions or relapses while on therapy with interferon beta-1a 44 microg (three times weekly) for 12 months, were randomized to combination therapy (interferon + atorvastatin 20 mg per day; group A) or interferon alone (group B) for 24 months. Patients underwent blood analysis and clinical assessment with the Expanded Disability Status Scale every 3 months, and brain gadolinium-enhanced magnetic resonance imaging at screening, and 12 and 24 months thereafter.
Primary outcome measure was contrast-enhanced lesion number. Secondary outcome measures were number of relapses, EDSS variation and safety laboratory data. Forty-five patients were randomized to group A (n = 21) or B (n = 24).
At 24 months, group A had significantly fewer contrast-enhanced lesions versus baseline (p = 0.007) and significantly fewer relapses versus the two pre-randomization years (p < 0.001). At survival analysis, the risk for a 1-point EDSS increase was slightly higher in group B than in group A (p = 0.053). Low-dose atorvastatin may be beneficial, as add-on therapy, in poor responders to high-dose interferon beta-1a alone.
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