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Published online before print June 4, 2008, doi:10.1212/01.wnl.0000319698.40024.1c)
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Volume 71, Number 18, October 28, 2008
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NEUROLOGY 2008;71:1390-1395
© 2008 American Academy of Neurology

Combining beta interferon and atorvastatin may increase disease activity in multiple sclerosis

G. Birnbaum, MD, B. Cree, MD, PhD, MCR, I. Altafullah, MD, M. Zinser, RN, BSN and A. T. Reder, MD

From the MS Treatment and Research Center (G.B., I.A.), Minneapolis Clinic of Neurology, MN; Department of Neurology (B.C.), University of California San Francisco; and Department of Neurology (A.T.R.), Pritzker School of Medicine, University of Chicago, IL.

Address correspondence and reprint requests to Dr. Gary Birnbaum, MS Treatment and Research Center, Minneapolis Clinic of Neurology, 4225 Golden Valley Road, Golden Valley, MN 55422 birnb001{at}tc.umn.edu

Objective: To explore whether high-dose atorvastatin can be administered safely to persons with relapsing-remitting multiple sclerosis (MS) taking thrice weekly, 44 µg dose subcutaneous interferon beta-1a.

Methods: Persons with clinically stable, relapsing-remitting MS, on standard high-dose subcutaneous interferon beta-1a, were randomized in a double-blind fashion to receive either placebo or atorvastatin at dosages of 40 or 80 mg/day for 6 months. Blinded neurologic examinations and brain MRI readings were obtained at months 0, 3, 6, and 9. Laboratory blood testing was performed monthly. Main outcome measures were the determination of drug toxicity using blood tests and ECG and determination of MS-related disease activity, either clinical relapses or new or contrast-enhancing lesions on MRI.

Results: Twenty-six subjects received at least one dose of study drug. Ten of 17 subjects on either 80 mg or 40 mg of atorvastatin per day had either new or enhancing T2 lesions on MRI or clinical relapses. One of the nine subjects on placebo had a relapse with active lesions on MRI. The subjects receiving atorvastatin were at greater risk for either clinical or MRI disease activity compared to placebo (p = 0.019). Significant changes in blood tests were noted only for lower cholesterol levels in subjects receiving atorvastatin.

Conclusion: The combination of 40 or 80 mg atorvastatin with thrice weekly, 44 µg interferon beta-1a in persons with multiple sclerosis resulted in increased MRI and clinical disease activity. Caution is suggested in administering this combination.

Abbreviations: ALT = alanine transaminase; ANOVA = analysis of variance; AST = aspartate transaminase; CK = creatinine kinase; EAE = experimental autoimmune encephalomyelitis; MS = multiple sclerosis; PBMC = peripheral blood mononuclear cells; TNF = tumor necrosis factor.


Editorial, page 1386

e-Pub ahead of print on June 4, 2008, at www.neurology.org.

{dagger}Deceased.

Supported by an investigator initiated, unrestricted research grant from EMD Serono, Inc. and Pfizer, Inc.

Disclosure: Author disclosures are provided at the end of the article.

Received August 13, 2007. Accepted in final form April 28, 2008.


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Correspondence:

Read all Correspondence

Combining beta interferon and atorvastatin may increase disease activity in multiple sclerosis
Silva Markovic-Plese, et al.
Neurology Online, 30 Sep 2008 [Full text]
Reply from the authors
Gary Birnbaum, MD, et al.
Neurology Online, 30 Sep 2008 [Full text]
Combining beta interferon and atorvastatin may increase disease activity in multiple sclerosis
Elena Salvatore, et al.
Neurology Online, 14 Dec 2008 [Full text]
Reply from the author
Gary Birnbaum, et al.
Neurology Online, 14 Dec 2008 [Full text]



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