Cited by 264Lipoproteins and Cardiovascular HealthCancer, Lipids, and MetabolismPharmacovigilance and Adverse Drug Reactions

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Statin Safety: An Overview and Assessment of the Data—2005

Bays, Harold·2006·The American Journal of Cardiology

DOI 10.1016/j.amjcard.2005.12.006

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Abstract

The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statin drugs, have been studied in numerous controlled human research trials involving hundreds of thousands of study participants. Statins have been prescribed for millions of patients. Based on this vast research and clinical experience, statins have been shown to improve lipid blood levels and reduce atherosclerotic coronary artery disease (CAD) risk, resulting in reduced CAD morbidity and mortality, and in several studies, reduced overall ("all-cause") mortality. From a safety perspective, both research trial evidence and clinical practice experience have demonstrated that statins are generally well tolerated. However, as with all pharmaceuticals, safety considerations exist with both monotherapy and combination statin therapy, mainly involving potential adverse effects on muscle, liver, kidney, and the nervous system. The evidence supporting statin-related potential adverse experiences on these organ systems is sometimes strong and based on clear clinical trial evidence (such as the increased risk of muscle enzyme elevation with higher statin doses). The evidence is at other times more speculative, being based on case reports and inconclusive clinical trial data (such as possible favorable or unfavorable effects of statins on cognition). Because the use of statins is so widespread, it is useful for the clinician to understand statin safety issues and the level of available evidence supporting the contention that various adverse effects are caused by statins. This review presents an assessment of statin safety based on an overview of the current statin safety data and their clinical implications.

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Authors: Bays, H.
Affiliations: Louisville Metabolic and Atherosclerosis Research Center (US)
Corresponding author: Bays, Harold
ORCID: Bays, Harold
Venue: The American Journal of Cardiology
Publisher: Elsevier BV
Published: 2006-04
Volume: 97
Issue: 8
Pages: S6-S26
ISSN: 0002-9149 (ISSN-L)
DOI: 10.1016/j.amjcard.2005.12.006
OpenAlex: W2011527537
Cited by: 264
References: 205
Citations by year: 2026: 3 · 2025: 3 · 2024: 3 · 2023: 3 · 2022: 7 · 2021: 6 · 2020: 10 · 2019: 10 · 2018: 12 · 2017: 19 · 2016: 17 · 2015: 11 · 2014: 17 · 2013: 15 · 2012: 12
FWCI: 5.20
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: The American Journal of Cardiology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords: statins, drug safety, adverse drug reactions, rhabdomyolysis, elevated liver enzymes, renal function, cognitive effects, lipid-lowering therapy, coronary artery disease, all-cause mortality
MeSH terms: Hypolipidemic Agents, Dementia, Dose-Response Relationship, Drug, Drug Therapy, Combination, Humans, Kidney Diseases, Liver, Muscular Diseases, Peripheral Nervous System Diseases, Proteinuria, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Evidence-Based Medicine, Stroke, Chemical and Drug Induced Liver Injury

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Statin Safety: An Overview and Assessment of the Data—2005

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