Evidence map›Paper›PMID 29427042›Full record

ArticleDrug safety2018

Amyotrophic Lateral Sclerosis Associated with Statin Use: A Disproportionality Analysis of the FDA's Adverse Event Reporting System.

Beatrice A Golomb, Abril Verden, Alexis K Messner, Hayley J Koslik, Keith B Hoffman

Abstract read
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In one paragraph

Article in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

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  17. Neuromuscular Complications of Statin Therapy.Current neurology and neuroscience reports · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Beatrice A GolombDepartment of Medicine, University of California, San Diego, 9500 Gilman Drive # 0995, La Jolla, CA, 92093-0995, USA. bgolomb@ucsd.edu.
Abril VerdenAdvera Health Analytics, Inc., Santa Rosa, CA, USA.
Alexis K MessnerDepartment of Medicine, University of California, San Diego, 9500 Gilman Drive # 0995, La Jolla, CA, 92093-0995, USA.
Hayley J KoslikDepartment of Medicine, University of California, San Diego, 9500 Gilman Drive # 0995, La Jolla, CA, 92093-0995, USA.
Keith B HoffmanAdvera Health Analytics, Inc., Santa Rosa, CA, USA.
University of California, San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionApparent 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.

objectiveThe 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.

methodsWe 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.

resultsRORs 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.

conclusionThese 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.

Indexed as

Adverse Drug Reaction Reporting SystemsAmyotrophic Lateral SclerosisDatabases, FactualHumansHydroxymethylglutaryl-CoA Reductase InhibitorsOdds RatioUnited StatesUnited States Food and Drug AdministrationHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID29427042
OpenAlexW2786977496

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.