G Birnbaum1, B Cree, I Altafullah, M Zinser, A T Reder. 1. MS Treatment and Research Center, Minneapolis Clinic of Neurology, 4225 Golden Valley Road, Golden Valley, MN 55422, USA. birnb001@tc.umn.edu
Abstract
OBJECTIVE: To explore whether high-dose atorvastatin can be administered safely to persons with relapsing-remitting multiple sclerosis (MS) taking thrice weekly, 44 microg 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 microg interferon beta-1a in persons with multiple sclerosis resulted in increased MRI and clinical disease activity. Caution is suggested in administering this combination.
RCT Entities:
OBJECTIVE: To explore whether high-dose atorvastatin can be administered safely to persons with relapsing-remitting multiple sclerosis (MS) taking thrice weekly, 44 microg 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 microg interferon beta-1a in persons with multiple sclerosis resulted in increased MRI and clinical disease activity. Caution is suggested in administering this combination.