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

Bays, Harold

doi:10.1016/j.amjcard.2005.12.006

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

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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In a meta-analysis of 21 RCTs and another meta-analysis of 30 RCTs, the incidence rate of muscle-related adverse reactions with statin use was not significantly different from that with placebo.
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From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [701]

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Self-citation
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Intolerance to Statins: Mechanisms and Management
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Toward “Pain-Free” Statin Prescribing: Clinical Algorithm for Diagnosis and Management of Myalgia
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Safety of Aggressive Lipid Management
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Statins: Adverse reactions, oxidative stress and metabolic interactions
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Statins in the Treatment of Dyslipidemia in the Presence of Elevated Liver Aminotransferase Levels: A Therapeutic Dilemma
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Banach, M., Rizzo, M., Toth, P. P., Farnier, M., Davidson, M. H., Al-Rasadi, K., Aronow, W. S., Athyros, V., Djuric, D. M., Ezhov, M. V., et al. (2015) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2015.1039980 · Cited by 162 · see citing works
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Clinical efficacy and safety of statins in managing cardiovascular risk
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Effectiveness and Tolerability of Every-Other-Day Rosuvastatin Dosing in Patients with Prior Statin Intolerance
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Drug-related Myopathies of Which the Clinician Should Be Aware
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Mechanisms and assessment of statin‐related muscular adverse effects
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Statins for children with familial hypercholesterolemia
Vuorio, A. F., Kuoppala, J., Kovanen, P. T., Humphries, S. E., Tonstad, S., Wiegman, A., Drogari, E., & Ramaswami, U. (2019) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006401.pub5 · Cited by 105 · see citing works
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Pharmacogenetics of Drug Transporters
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<i>N</i>-of-1 (Single-Patient) Trials for Statin-Related Myalgia
Joy, T. R., Monjed, A., Zou, G. Y., Hegele, R. A., McDonald, C. G., & Mahon, J. L. (2014) · Annals of Internal Medicine · doi:10.7326/m13-1921 · Cited by 130 · see citing works
Lowering low-density lipoprotein cholesterol: statins, ezetimibe, bile acid sequestrants, and combinations: comparative efficacy and safety.
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The prince and the pauper. A tale of anticancer targeted agents
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Use of Statins in Patients with Chronic Liver Disease and Cirrhosis: Current Views and Prospects
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Muscular effects of statins in the elderly female: a review
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Treatment options for the management of hypertriglyceridemia: strategies based on the best-available evidence
Maki, K. C., Bays, H. E., & Dicklin, M. R. (2012) · Journal of Clinical Lipidology · doi:10.1016/j.jacl.2012.04.003 · Cited by 83 · see citing works
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Safety of Rosuvastatin: Update on 16,876 Rosuvastatin-Treated Patients in a Multinational Clinical Trial Program
Shepherd, J., Vidt, D. G., Miller, E., Harris, S., & Blasetto, J. W. (2007) · Cardiology · doi:10.1159/000100908 · Cited by 84 · see citing works
The 'forgotten' bile acid sequestrants: is now a good time to remember?
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On the Inhibitor Effects of Bergamot Juice Flavonoids Binding to the 3-Hydroxy-3-methylglutaryl-CoA Reductase (HMGR) Enzyme
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Genetic predisposition to statin myopathy
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Benefit versus Risk in Statin Treatment
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Molecular mechanisms of statin intolerance
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A comprehensive review and meta-analysis of risk factors for statin-induced myopathy
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Lapaquistat Acetate
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Physiogenomic association of statin‐related myalgia to serotonin receptors
Ruaño, G., Thompson, P. D., Windemuth, A., Seip, R. L., Dande, A. S., Sorokin, A., Kocherla, M., Smith, A. P., Holford, T. R., & Wu, A. H. B. (2007) · Muscle & Nerve · doi:10.1002/mus.20871 · Cited by 70 · see citing works
Postprandial lipemia: An under-recognized atherogenic factor in patients with diabetes mellitus
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Chronic obstructive pulmonary disease: patho-physiology, current methods of treatment and the potential for simvastatin in disease management
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Statins and Stroke Prevention
Paciaroni, M., Hennerici, M. G., Agnelli, G., & Bogousslavsky, J. (2007) · Cerebrovascular Diseases · doi:10.1159/000104474 · Cited by 66 · see citing works
The Use of Statins in Pediatrics: Knowledge Base, Limitations, and Future Directions
Belay, B., Belamarich, P. F., & Tom-Revzon, C. (2007) · PEDIATRICS · doi:10.1542/peds.2006-0787 · Cited by 65 · see citing works
Safety of statins
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Association of statin use with peripheral neuropathy in the US population 40 years of age or older (美国40岁及以上人群的他汀使用情况与周围神经病变的关系)
Tierney, E. F., Thurman, D. J., Beckles, G. L., & Cadwell, B. L. (2012) · Journal of Diabetes · doi:10.1111/1753-0407.12013 · Cited by 57 · see citing works
Statins for children with familial hypercholesterolemia
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Lipid-lowering effects of colesevelam HCl in combination with ezetimibe
Bays, H. E., Rhyne, J. M., Abby, S. L., Lai, Y., & Jones, M. (2006) · Current Medical Research and Opinion · doi:10.1185/030079906x148436 · Cited by 58 · see citing works
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Statin-Induced Liver Injury Involves Cross-Talk between Cholesterol and Selenoprotein Biosynthetic Pathways
Kromer, A., & Moosmann, B. (2009) · Molecular Pharmacology · doi:10.1124/mol.108.053678 · Cited by 54 · see citing works
Statins for children with familial hypercholesterolemia
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Effects of Prescription Omega-3-Acid Ethyl Esters on Non—High-Density Lipoprotein Cholesterol When Coadministered With Escalating Doses of Atorvastatin
Bays, H. E., McKenney, J., Maki, K. C., Doyle, R. T., Carter, R. N., & Stein, E. (2010) · Mayo Clinic Proceedings · doi:10.4065/mcp.2009.0397 · Cited by 54 · see citing works
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Atorvastatin Glucuronidation Is Minimally and Nonselectively Inhibited by the Fibrates Gemfibrozil, Fenofibrate, and Fenofibric Acid
Goosen, T. C., Bauman, J. N., Davis, J. A., Yu, C., Hurst, S. I., Williams, J. A., & Loi, C. (2007) · Drug Metabolism and Disposition · doi:10.1124/dmd.107.015230 · Cited by 52 · see citing works
Biochemistry of Statins
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Statin-Associated Psychiatric Adverse Events
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Statins for Surgical Patients
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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 › Surgery › 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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