ArticlePloS one2011
Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system.
Article in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
40 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.
- A Meta-Analysis of the Incidence of Adverse Reactions of Statins in Various Diseases.Cardiovascular therapeutics · 2025Pooled it
- The effect of statins on muscle symptoms in primary care: the StatinWISE series of 200 N-of-1 RCTs.Health technology assessment (Winchester, England) · 2021Trial
- The Real-World Safety Profile of Immune Checkpoint Inhibitors in Melanoma: FAERS Pharmacovigilance Analysis Complemented by Randomized Trial Evidence.Health science reports · 2026Article
- Informative relational learning for adverse reaction prediction with enhanced generalization to novel drugs.Bioinformatics (Oxford, England) · 2026Article
- Evaluation of bone safety and antiseizure medications: a multi-source pharmacovigilance and Mendelian randomization analysis.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- From signal to significance: characterizing anthracycline-related hypercoagulable adverse events via pharmacovigilance, animal models, and clinical observation.Frontiers in pharmacology · 2026Article
- Pharmacovigilance analysis of neurological adverse events associated with GLP-1 receptor agonists based on the FDA Adverse Event Reporting System.Scientific reports · 2025Article
- Oxidative Stress-Induced Adverse Effects of Three Statins Following Single or Repetitive Treatments in Mice.Cureus · 2024Article
- Adverse events associated with immune checkpoint inhibitors in non-small cell lung cancer: a safety analysis of clinical trials and FDA pharmacovigilance system.Frontiers in immunology · 2024Article
- A pharmacovigilance study of the association between proton pump inhibitors and tumor adverse events based on the FDA adverse event reporting system database.Frontiers in pharmacology · 2024Article
- Association between coenzyme Q 10-related genetic polymorphisms and statin-associated myotoxicity in Korean stroke patients.Frontiers in pharmacology · 2024Article
- Psychiatric disorders associated with immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.EClinicalMedicine · 2023Article
- Rosuvastatin-Induced Rhabdomyolysis, Pancreatitis, Transaminitis, and Acute Kidney Injury.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2021Article
- Drug-drug-gene interactions as mediators of adverse drug reactions to diclofenac and statins: a case report and literature review.Arhiv za higijenu rada i toksikologiju · 2021Review
- Adverse event profiles of dipeptidyl peptidase-4 inhibitors: data mining of the public version of the FDA adverse event reporting system.BMC pharmacology & toxicology · 2020Article
- Long-term effects of various types of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors on changes in glomerular filtration rate in Korea.Frontiers of medicine · 2019Article
- Detecting Signals of Dietary Supplement Adverse Events from the CFSAN Adverse Event Reporting System (CAERS).AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2019Article
- Onset timing of statin-induced musculoskeletal adverse events and concomitant drug-associated shift in onset timing of MAEs.Pharmacology research & perspectives · 2018Article
- A Systematic Review on Healthcare Analytics: Application and Theoretical Perspective of Data Mining.Healthcare (Basel, Switzerland) · 2018Review
- Ontology-based systematical representation and drug class effect analysis of package insert-reported adverse events associated with cardiovascular drugs used in China.Scientific reports · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveAdverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) and to attempt to determine the rank-order of the association.
methodsAfter a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events.
resultsBased on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level.
conclusionsData mining of the FDA's adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events.
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Registered trials
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.