John R Rinker1, Tiffany C Cossey2, Gary R Cutter3, William J Culpepper4. 1. Birmingham VA Medical Center, 700 19th Street South, Birmingham, AL 35233, USA; Department of Neurology, University of Alabama at Birmingham, 1720 7th Avenue South, SC 440, Birmingham, AL 35294, USA. Electronic address: rinkerj@uab.edu. 2. Birmingham VA Medical Center, 700 19th Street South, Birmingham, AL 35233, USA; Department of Internal Medicine, University of Alabama at Birmingham, 1808 7th Avenue South, BDB 420, Birmingham, AL 35294, USA. 3. Department of Biostatistics, University of Alabama at Birmingham, 1665 University Boulevard, Birmingham, AL 35294, USA. 4. VA Multiple Sclerosis Center of Excellence East, Baltimore VA Medical Center, 10 North Greene Street, Baltimore, MD 20201, USA.
Abstract
OBJECTIVE: Lithium (Li) reduces disease activity in animal models of multiple sclerosis (MS), but has not been previously studied in human MS. While developing a clinical trial to test the effects of Li in MS, we performed a retrospective chart review to determine the safety and tolerability of Li among US veterans with MS. METHODS: We identified all veterans with MS prescribed Li from 1998 to 2009 using the Department of Veterans Affairs Pharmacy Benefits Management. Charts were reviewed for Li-related adverse events and effects on the MS disease course. RESULTS: Among 21,847 veterans with MS, 101 met inclusion criteria and took Li ≥6 months. Eighteen percent of subjects experienced a Li-associated adverse event. Later age of MS onset was associated with increased risk of Li-related adverse events (p=0.004). Associations between Li use and MS disease activity were mixed: Li was not associated with increased risk of enhancing MRI lesions (p=0.655), but annualized relapse rates were higher on Li (0.34 vs. 0.20, p=0.044). In contrast, change in Expanded Disability Status Scale scores was greater in the off-Li period than the on-Li period (0.8 vs. 0.3, p=0.003). CONCLUSION: Adverse events occur in a minority of Li-treated MS patients. A consistent effect of Li on MS disease activity was not apparent. These findings indicate a clinical trial will be needed to ascertain Li's effects on the MS disease course. Published by Elsevier B.V.
OBJECTIVE:Lithium (Li) reduces disease activity in animal models of multiple sclerosis (MS), but has not been previously studied in human MS. While developing a clinical trial to test the effects of Li in MS, we performed a retrospective chart review to determine the safety and tolerability of Li among US veterans with MS. METHODS: We identified all veterans with MS prescribed Li from 1998 to 2009 using the Department of Veterans Affairs Pharmacy Benefits Management. Charts were reviewed for Li-related adverse events and effects on the MS disease course. RESULTS: Among 21,847 veterans with MS, 101 met inclusion criteria and took Li ≥6 months. Eighteen percent of subjects experienced a Li-associated adverse event. Later age of MS onset was associated with increased risk of Li-related adverse events (p=0.004). Associations between Li use and MS disease activity were mixed: Li was not associated with increased risk of enhancing MRI lesions (p=0.655), but annualized relapse rates were higher on Li (0.34 vs. 0.20, p=0.044). In contrast, change in Expanded Disability Status Scale scores was greater in the off-Li period than the on-Li period (0.8 vs. 0.3, p=0.003). CONCLUSION: Adverse events occur in a minority of Li-treated MS patients. A consistent effect of Li on MS disease activity was not apparent. These findings indicate a clinical trial will be needed to ascertain Li's effects on the MS disease course. Published by Elsevier B.V.
Entities:
Keywords:
Drug tolerance; Drug toxicity; Lithium; Multiple sclerosis; Retrospective study; Veteran