| アブストラクト | 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. |
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| ジャーナル名 | Drug safety |
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| Pubmed追加日 | 2018/2/11 |
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| 投稿者 | Golomb, Beatrice A; Verden, Abril; Messner, Alexis K; Koslik, Hayley J; Hoffman, Keith B |
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| 組織名 | Department of Medicine, University of California, San Diego, 9500 Gilman Drive #;0995, La Jolla, CA, 92093-0995, USA. bgolomb@ucsd.edu.;Advera Health Analytics, Inc., Santa Rosa, CA, USA.;0995, La Jolla, CA, 92093-0995, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/29427042/ |
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