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A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
Published on: December 9, 2015
A retrospective review of lithium usage in veterans with multiple sclerosis
John R Rinker1, Tiffany C Cossey2, Gary R Cutter3
1Birmingham 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.
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.
Insights
Lithium (Li) use in multiple sclerosis (MS) patients showed a minority experienced adverse events. Its effect on MS disease activity was inconsistent, necessitating further clinical trials for definitive answers.
Area of Science:
- Neuroimmunology
- Pharmacology
- Clinical Neurology
Background:
- Lithium (Li) has demonstrated efficacy in reducing disease activity in animal models of multiple sclerosis (MS).
- Previous research has not investigated the effects of Li on human MS.
- Understanding Li's safety and tolerability is crucial before clinical trials in MS patients.
Purpose of the Study:
- To evaluate the safety and tolerability of Lithium (Li) in US veterans diagnosed with multiple sclerosis (MS).
- To explore potential associations between Li use and MS disease activity.
- To inform the design of future clinical trials investigating Li for MS treatment.
Main Methods:
- Retrospective chart review of US veterans with MS prescribed Li between 1998 and 2009.
- Identification of patients receiving Li for at least six months.
- Analysis of Li-related adverse events and impact on MS disease course markers (MRI lesions, relapse rates, disability progression).
Main Results:
- Of 101 eligible veterans with MS taking Li, 18% experienced Li-associated adverse events.
- Later age of MS onset correlated with a higher risk of Li-related adverse events (p=0.004).
- Li use showed mixed effects on MS disease activity: no increased risk of MRI lesions (p=0.655), but higher annualized relapse rates (0.34 vs. 0.20, p=0.044) and greater disability progression off Li (p=0.003).
Conclusions:
- Adverse events from Li treatment affect a minority of multiple sclerosis patients.
- The impact of Li on MS disease activity was not consistently demonstrated in this cohort.
- Further clinical trials are required to definitively ascertain the therapeutic effects of Li on the MS disease course.

