No Benefit of Simvastatin

Discussion of statins (Lipitor, Zocor, etc.) in the treatment of MS.
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No Benefit of Simvastatin

Post by scorpion » Sat Oct 23, 2010 5:17 am

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Post by dignan » Sat Oct 23, 2010 9:25 am


I guess they were doing a trial, so they wanted to see it through, but a similar trial had negative results, reported at the AAN meeting back in 2007:

A Double Blind, Placebo Controlled Trial of Atorvastatin in Combination with Subcutaneous Interferon Beta 1a in Persons with Multiple Sclerosis

Gary Birnbaum, Irfan Altafullah, Golden Valley, MN, Anthony Reder, Chicago, IL

OBJECTIVE: To determine if treatment with atorvastatin, in combination with subcutaneous interferon beta 1a, was safe, and had a salutary effect on the course of MS.

BACKGROUND: Preliminary data suggest statins may modify MS disease activity. We hypothesized that treatment with a beta interferon and a statin could be tolerated and would result in increased therapeutic benefits.

DESIGN/METHODS: Subjects with clinically definite, stable MS, ages 18-56, on subcutaneous interferon beta 1a for at least 6 months, with no drug toxicity, were randomized into 3 groups, and treated for six months with either placebo, atorvastatin, 40 mg per day, or atorvastatin, 80 mg per day, with follow-up 3 months after stopping oral drug. Subjects had monthly blood and urine tests, blinded neurologic exams and brain MRIs at Months 0, 3, 6, and 9. MS relapses were treated as needed. Primary outcome measures were safety parameters with secondary outcomes of new or worsening MRI lesions and/or clinical relapses. Data were analyzed with Chi-square and Student t-test analyses.

RESULTS: 29 subjects were enrolled. Data could be analyzed for 24 subjects, 18 females and 6 males, ages 28 to 56. EDSS ranged from 1 to 5.5. Two subjects on high dose atorvastatin withdrew due to myalgias and elevated liver enzymes. New and enhancing MRI lesions and/or relapses were noted in 9 of 13 subjects on atorvastatin, either 40 mg or 80 mg per day, and in 1 of 9 subjects on placebo (p=0.004 for differences between the two groups). New lesions occurred as early as 12 weeks following atorvastatin and continued up to 12 weeks after stopping the drug.

CONCLUSIONS/RELEVANCE: Combination treatment of MS with subcutaneous interferon beta 1a and atorvastatin, while well tolerated, resulted in increased MRI and clinical disease activity. ... 7L_S32.005

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