Amyotrophic Lateral Sclerosis Associated with Statin Use: A Disproportionality Analysis of the FDA's Adverse Event Reporting System
- PMID: 29427042
- DOI: 10.1007/s40264-017-0620-4
Amyotrophic Lateral Sclerosis Associated with Statin Use: A Disproportionality Analysis of the FDA's Adverse Event Reporting System
Abstract
Introduction: Apparent elevations in reporting of amyotrophic lateral sclerosis (ALS)-like conditions associated with statin use have been previously described from data obtained via US and European databases.
Objective: The aim of this study was to examine US FDA Adverse Event Reporting System (FAERS) data to compare reporting odds ratios (RORs) of ALS and ALS-like conditions between statins and other drugs, for each statin agent.
Methods: We assessed for disproportional rates of reported ALS and ALS-related conditions for each statin agent separately by using the ROR formula. FAERS data were analyzed through September 2015.
Results: RORs for ALS were elevated for all statins, with elevations possibly stronger for lipophilic statins. RORs ranged from 9.09 (6.57-12.6) and 16.2 (9.56-27.5) for rosuvastatin and pravastatin (hydrophilic) to 17.0 (14.1-20.4), 23.0 (18.3-29.1), and 107 (68.5-167) for atorvastatin, simvastatin, and lovastatin (lipophilic), respectively. For simvastatin, an ROR of 57.1 (39.5-82.7) was separately present for motor neuron disease.
Conclusion: These findings extend previous evidence showing that significantly elevated ALS reporting extends to individual statin agents, and add to concerns about potential elevated occurrence of ALS-like conditions in association with statin usage.
Similar articles
-
An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system.Pharmacoepidemiol Drug Saf. 2008 Nov;17(11):1068-76. doi: 10.1002/pds.1643. Pharmacoepidemiol Drug Saf. 2008. PMID: 18821724
-
Statins, neuromuscular degenerative disease and an amyotrophic lateral sclerosis-like syndrome: an analysis of individual case safety reports from vigibase.Drug Saf. 2007;30(6):515-25. doi: 10.2165/00002018-200730060-00005. Drug Saf. 2007. PMID: 17536877
-
Statin-associated lower urinary tract symptoms: data mining of the public version of the FDA adverse event reporting system, FAERS.Int J Clin Pharmacol Ther. 2014 Apr;52(4):259-66. doi: 10.5414/CP202033. Int J Clin Pharmacol Ther. 2014. PMID: 24472404
-
Statins and amyotrophic lateral sclerosis--the level of evidence for an association.J Intern Med. 2009 Dec;266(6):520-6. doi: 10.1111/j.1365-2796.2009.02173.x. J Intern Med. 2009. PMID: 19930099 Review.
-
Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors.Drug Saf. 2018 Apr;41(4):357-361. doi: 10.1007/s40264-017-0622-2. Drug Saf. 2018. PMID: 29196988 Review.
Cited by
-
Discovery and Exploration of Lipid-Modifying Drug Targets for ALS by Mendelian Randomization.Mol Neurobiol. 2024 Feb 7. doi: 10.1007/s12035-024-04007-9. Online ahead of print. Mol Neurobiol. 2024. PMID: 38324182
-
Association between genetically proxied lipid-lowering drug targets, lipid traits, and amyotrophic lateral sclerosis: a mendelian randomization study.Acta Neurol Belg. 2024 Apr;124(2):485-494. doi: 10.1007/s13760-023-02393-w. Epub 2023 Oct 27. Acta Neurol Belg. 2024. PMID: 37889424
-
Mendelian Randomization Analysis Reveals Statins Potentially Increase Amyotrophic Lateral Sclerosis Risk Independent of Peripheral Cholesterol-Lowering Effects.Biomedicines. 2023 May 4;11(5):1359. doi: 10.3390/biomedicines11051359. Biomedicines. 2023. PMID: 37239030 Free PMC article.
-
Historical Review of the Use of Relative Risk Statistics in the Portrayal of the Purported Hazards of High LDL Cholesterol and the Benefits of Lipid-Lowering Therapy.Cureus. 2023 May 1;15(5):e38391. doi: 10.7759/cureus.38391. eCollection 2023 May. Cureus. 2023. PMID: 37143855 Free PMC article. Review.
-
Amyotrophic Lateral Sclerosis as an Adverse Drug Reaction: A Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System.Drug Saf. 2022 Jun;45(6):663-673. doi: 10.1007/s40264-022-01184-1. Epub 2022 May 24. Drug Saf. 2022. PMID: 35610460
References
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical
Miscellaneous
