The DOI matches its Crossref record; 201 of the 205 references it cites were found in a registry or an index.
Statin Safety: An Overview and Assessment of the Data—2005
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.
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“In a meta-analysis of 21 RCTs700) and in another meta-analysis of 30 RCTs701), the incidence rate of muscles-related adverse reactions with statin use was not found to be significantly different from that with a placebo.”
From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [701]
Citations
Cites
OLSSON, A. G., McMurray, J. J. V., Thorgeirsson, G., Spaulding, C. M., Slattery, J., Pyörälà, K., Færgeman, O., Wright, R. S., Berg, K. M., Wilhelmsen, L., et al. (1994) · The Lancet · Cited by 8,467
Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia
Shepherd, J., Cobbe, S. M., Ford, I., Isles, C. G., Lorimer, A. R., Macfarlane, P. W., McKillop, J. H., & Packard, C. J. (1995) · New England Journal of Medicine · doi:10.1056/nejm199511163332001 · Cited by 7,449
Sacks, F. M., Pfeffer, M. A., Moye, L. A., Rouleau, J. L., Rutherford, J. D., Cole, T. G., Brown, L., Warnica, J. W., Arnold, J. M. O., Wun, C.-C., et al. (1996) · New England Journal of Medicine · doi:10.1056/nejm199610033351401 · Cited by 7,439
(1998) · New England Journal of Medicine · doi:10.1056/nejm199811053391902 · Cited by 5,261
Downs, J. R., Clearfield, M., Weis, S., Whitney, E., Shapiro, D. R., Beere, P. A., Langendorfer, A., Stein, E. A., Kruyer, W., Gotto, Jr., et al. (1998) · JAMA · doi:10.1001/jama.279.20.1615 · Cited by 5,236
Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease
LaRosa, J. C., Grundy, S. M., Waters, D. D., Shear, C., Barter, P., Fruchart, J.-C., Gotto, A. M., Greten, H., Kastelein, J. J. P., Shepherd, J., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa050461 · Cited by 3,489
PREVENTION OF CORONARY HEART DISEASE WITH PRAVASTATIN IN MEN WITH HYPERCHOLESTEROLEMIA
Hepherd, J. A. S., Obbe, S. T. M. C., Ord, I. A. F., Sles, C. H. G. I., Orimer, A. R. O. L., Acfarlane, P. E. W. M., Illop, J. A. H. M. C. K., Ackard, C. H. J. P., & Roup, S. T. G. (1995) · Cited by 3,453
Shepherd, J., Blauw, G. J., Murphy, M. B., Bollen, E. L., Buckley, B. M., Cobbe, S. M., Ford, I., Gaw, A., Hyland, M., Jukema, J. W., et al. (2002) · The Lancet · doi:10.1016/s0140-6736(02)11600-x · Cited by 3,378
Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis
Wanner, C., Krane, V., März, W., Olschewski, M., Mann, J. F. E., Ruf, G., & Ritz, E. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa043545 · Cited by 2,614
Research works printed but not linked: 9
- Bottorff, 2004, Safety and statins, Am J Manag Care, 4, S27
- 2005, Position Statement, Diabetes Care, 28, S4
- Bays, 2003, Colesevelam HCl, Expert Opin Pharmacother, 4, 779
- Evans, 2004, Statin safety in perspective—maximising the risk:benefit, British Journal of Cardiology, 11, 449
- Bays, 2003, Comparison of once-daily, niacin extended-release/lovastatin with standard doses of atorvastatin and simvastatin (the ADvicor Versus Other Cholesterol-Modulating Agents Trial Evaluation [ADVOCATE]), Am J Cardiol, 91, 667, 10.1016/S0002-9149(03)00007-9 · DOI
- Omar, 2002, FDA adverse event reports on statin-associated rhabdomyolysis, Ann Pharmacother, 36, 288, 10.1345/aph.1A289 · DOI · Paper page
- Davidson, 2000, Lipid-altering efficacy and safety of simvastatin 80 mg/day, Nutr Metab Cardiovasc Dis, 10, 253
- 1994, Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease, Lancet, 344, 1383
- Eckernas, 1993, The effects of simvastatin and pravastatin on objective and subjective measures of nocturnal sleep, Br J Clin Pharmacol, 35, 284
Cited by
Sorted by citations
Items 201–262 of 262
Statin Muscle Toxicity and Genetic Risk Factors
Mombelli, G. G. (2013) · International Journal of Genomic Medicine · doi:10.4172/2332-0672.1000111 · Cited by 4
Shannon, J., John, S. M., Ferrara, J. J., Best, S., & Allen, S. N. (2012) · Digital Commons - PCOM (Philadelphia College of Osteopathic Medicine) · Cited by 3
Statinassoziierte Muskelsymptome und Statinmyopathie
Schneider, I., & Zierz, S. (2019) · Neurologie up2date · doi:10.1055/a-0794-9660 · Cited by 3
Statin intolerance: diagnosis, treatment and alternative therapies
Naderi, S., & Cho, L. (2014) · Clinical Lipidology · doi:10.2217/clp.14.23 · Cited by 3
Statin-induced muscular symptoms: a report of 3 cases.
Kumar, A., Wong, S. K., & Andrew, J. G. (2008) · PubMed · Cited by 3
Laparoscopic partial nephrectomy in a patient on simvastatin
El-Hakeem, E. E. A., Kaki, A. M., Almazlom, S. A., & Al-Sayyad, A. (2017) · Der Anaesthesist · doi:10.1007/s00101-017-0284-6 · Cited by 3
The Role of Drug Transporters in Statin-Induced Myopathy
Knauer, M. J. (2012) · Scholarship@Western (Western University) · Cited by 3
Simvastatin-related myopathy in shift workers: a report of two cases
Unzueta, S. F., Sosa‐Macías, M., Marchat, L. A., Lares-Assef, I., Carrasco, O. F., Correa‐Ramírez, M. M., Guerrero‐Romero, F., & Galavíz-Hernández, C. (2018) · Drug Metabolism and Personalized Therapy · doi:10.1515/dmpt-2018-0016 · Cited by 3
Statin use in carnitine palmitoyltransferase II deficiency
Saeed, A., Hadley, T. D., Jia, X., & Ballantyne, C. M. (2019) · Journal of clinical lipidology · doi:10.1016/j.jacl.2019.05.001 · Cited by 2
Sudano, I., Mach, F., Moccetti, T., Burkard, T., Fahe, C., Delabays, A., Rickli, H., Keller, P., Dopheide, J. F., Bodenmann, S., et al. (2022) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2022.953040 · Cited by 2
Jeffrey, M. P., & Whelan, B. (2025) · BMJ Case Reports · doi:10.1136/bcr-2024-263709 · Cited by 2
Statin treatment and muscle disorders
Ábel, T., & Fehér, J. (2009) · Orvosi Hetilap · doi:10.1556/oh.2009.28520 · Cited by 2
Managing the Risks of Cardiac Therapy in Cancer Patients
Chen, C. L., & Parameswaran, R. (2013) · Seminars in Oncology · doi:10.1053/j.seminoncol.2013.01.006 · Cited by 2
Cochrane Review: Statins for children with familial hypercholesterolemia
Vuorio, A. F., Kuoppala, J., Kovanen, P. T., Humphries, S. E., Strandberg, T. E., Tonstad, S., & Gylling, H. K. (2011) · Evidence-Based Child Health A Cochrane Review Journal · doi:10.1002/ebch.806 · Cited by 2
Is there is Need for Ubiquinone (CoQ10) Supplementation in Statin- Associated Myopathy?
Skripova, D., Pella, D., Kozlíková, K., & Rybár, R. (2010) · The Open Nutraceuticals Journal · doi:10.2174/1876396001003010242 · Cited by 2
Zarowitz, B. J. M. (2007) · Geriatric Nursing · doi:10.1016/j.gerinurse.2007.06.005 · Cited by 2
A Pharmacoepidemiological Network Model for Drug Safety Surveillance
Reis, B. Y., Olson, K. L., Tian, L., Bohn, R. L., Brownstein, J. S., Park, P. J., Cziraky, M. J., Wilson, M. D., & Mandl, K. D. (2012) · Drug Safety · doi:10.2165/11596610-000000000-00000 · Cited by 2
Statins versus placebo for people with chronic obstructive pulmonary disease (COPD)
Walsh, A., Perrem, L., Elshafi, M., Khashan, A. S., Henry, M. T., & Chróinín, M. N. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011959 · Cited by 2
Intestinal and hepatic drug transporters and their role in the disposition of lipid-lowering drugs
Schwarz, U. I. (2012) · Scholarship@Western (Western University) · Cited by 2
Investigational Agents Affecting Atherogenic Lipoproteins
Bays, H. E. (2009) · Elsevier eBooks · doi:10.1016/b978-141605469-6.50048-2 · Cited by 2
Self-citationFuture of Statins in Sepsis: A Review on Its Safety and Efficacy
eladwy, S., & Bazan, N. S. (2020) · Archives of Pharmaceutical Sciences Ain Shams University · doi:10.21608/aps.2020.2001.1022 · Cited by 2
When Technological Advance Meets Physician Learning in Drug Prescribing
Depalo, D., Bhattacharya, J., Atella, V., & Belotti, F. (2019) · National Bureau of Economic Research · doi:10.3386/w26202 · Cited by 2
The Impact of Statin Intolerance in Lipid Clinic Patients
Williams, K., & Mishra, V. (2015) · International Journal of Clinical Medicine · doi:10.4236/ijcm.2015.65040 · Cited by 1
Bays, H. E. (2023) · Contemporary diabetes · doi:10.1007/978-3-031-26681-2_26 · Cited by 1
Self-citationCombination Therapy with Statins
Singh, A., & Davidson, M. H. (2014) · Endocrinology and Metabolism Clinics of North America · doi:10.1016/j.ecl.2014.08.005 · Cited by 1
Statin-induced myopathy in the elderly: Part 1
Chew, S. T. H. (2009) · Adverse Drug Reaction Bulletin · doi:10.1097/fad.0b013e32832c0ce1 · Cited by 1
Mayo Clinic: management of patients with statin intolerance
Zysek, V., Spoon, J. N., & Kopecky, S. L. (2013) · Clinical Lipidology · doi:10.2217/clp.13.54 · Cited by 1
Clinical Quiz: An Old Lady with Oedema of All Four Limbs
Sia, J. (2009) · Hong Kong Journal of Emergency Medicine · doi:10.1177/102490790901600311 · Cited by 1
Aggarwal, M., Juneja, S., Goyal, M., & Khurana, T. (2018) · International Journal of Basic & Clinical Pharmacology · doi:10.18203/2319-2003.ijbcp20183496 · Cited by 1
Shek, B. B., Курбанов, Р. Д., Abduaeva, G. J., Nagay, A. V., Hoshimov, S. U., Nizamov, U. I., & Васиковна, З. А. (2017) · Siberian medical review · doi:10.20333/2500136-2017-2-35-41 · Cited by 1
Statin-Associated Muscle Symptoms Are Real
Toth, P. P. (2020) · Contemporary cardiology · doi:10.1007/978-3-030-33304-1_2 · Cited by 1
Differential Diagnosis of Statin-Associated Muscle Symptoms
Elam, M. B., & Childress, R. D. (2020) · Contemporary cardiology · doi:10.1007/978-3-030-33304-1_19 · Cited by 1
Molecular mechanisms of antiatherogenic drugs action
Lizunov, A. V., & Бычков, Э. Р. (2021) · Reviews on Clinical Pharmacology and Drug Therapy · doi:10.17816/rcf193291-301 · Cited by 1
Hyperlipidaemia and cardiovascular disease: statin update
Roberts, A. W., & Salim, M. (2007) · Current Opinion in Lipidology · doi:10.1097/mol.0b013e328157455f · Cited by 1
Comparison of three in vitro models expressing the membrane drug transporter OATP1B1
Ulvestad, M. (2007) · NORA - Norwegian Open Research Archives · Cited by 1
Lipoproteins in Diabetes: Risk and Opportunity
Guyton, J. R. (2008) · Humana Press eBooks · doi:10.1007/978-1-60327-043-4_17
Comparison of Red Yeast Rice With Placebo in Statin-Intolerant Adult Patients With Hyperlipidemia
Serrano, M. (2010) · CommonKnowledge Research Repository (Pacific University Oregon)
Bays, H. (2014) · Contemporary diabetes · doi:10.1007/978-1-4614-7554-5_22
Self-citationDetrimental effects of fluvastatin on plasma lipid metabolism in rat breast carcinoma model
Kapinová, A., Kubatka, P., Žihlavniková, K., Stollárová, N., Péč, M., Dobrota, D., Bojková, B., Kassayová, M., & Orendáš, P. (2013) · Acta veterinaria · doi:10.2298/avb1303137k
Statin therapy and skeletal muscle disorders
Ábel, T., & Fehér, J. (2009) · Clinical and Experimental Medical Journal · doi:10.1556/cemed.3.2009.28520
Blagojević, A. (2007) · eScholarship@McGill (McGill) · doi:10.82308/23952
Phenotype Standardization for Statin-Induced
Neely, D., Armitage, J., Chinoy, H., Cooper, R. G., Laaksonen, R., Bloch, K. M., Fahy, J., Hanson, A., Wadelius, M., & Pirmohamed, M. (2014)
Evaluation of Muscle Performance with Isokinetic Test in Patients Using Atorvastatin
Öztürk, G. T., Topal, S., Ozdemir, M., & Gogus, F. N. (2014) · Türkiye Fiziksel Tıp ve Rehabilitasyon Dergisi · doi:10.5152/tftrd.2014.46667
Islahudin, F. H., Salleh, N. H. M., & Kumolosasi, E. (2016) · Tropical Journal of Pharmaceutical Research · doi:10.4314/tjpr.v15i8.28
Banach, M. D., Juranek, J. K., & Antczak, J. M. (2015) · Family Medicine & Primary Care Review · doi:10.5114/fmpcr/60395
Wu, S. (2013) · ERA: Education and Research Archive (University of Alberta) · doi:10.7939/r3xk84x3b
Lobrigatte, M. F. P., Nogueira, G. D. M., Navarini, V. J., Crozatti, M. T. L., & Teixeira, J. J. V. (2018) · Saúde e Pesquisa · doi:10.17765/1983-1870.2018v11n1p99-106
Das, P. A. (2019) · Journal of Medical Science And clinical Research · doi:10.18535/jmscr/v7i12.22
Prevention of Stroke by Lowering Blood Cholesterol Concentrations
Paciaroni, M. (2020) · Cambridge University Press eBooks · doi:10.1017/9781316286234.017
Sanvee, G. M., Hitzfeld, L., Bouitbir, J., & Krähenbühl, S. (2021) · Research Square · doi:10.21203/rs.3.rs-565395/v1
(2006) · Current Opinion in Rheumatology · doi:10.1097/bor.0b013e32801437a8
Herbet, M., Gawrońska‐Grzywacz, M., Izdebska, M., & Jagiełło-Wójtowicz, E. (2013) · Current Issues in Pharmacy and Medical Sciences · doi:10.12923/j.2084-980x/26.3/a.04
Effect of Pregelatinized Brown Rice on Serum Cholesterol Levels in Obese Model Rats
Kobayashi, K., YAMAGISHI, A., NAKAGAWA, T., MAEDA, Y., Arisa, I. T. O. H., YAMADA, C., TOKUNAGA, K., Fujita, S., Suzuki, T., Tsujii, Y., et al. (2016) · food preservation science · doi:10.5891/jafps.42.3
Shek, A. B., Kurbanov, R. D., Abdullayeva, G. J., Nagai, A. V., Abdullaev, A. A., Ахмедова, Ш. С., Hoshimov, S. U., & Васиковна, З. А. (2017) · Eurasian heart journal · doi:10.38109/2225-1685-2017-1-24-31
Brown, A. L., Ramkumar, V., Patel, A., Kang, D., Lim, J., Shah, S., Ebrahim, H. Y., & Elmageed, Z. Y. A. (2024) · Cureus · doi:10.7759/cureus.73520
Difficulties of differential diagnosis of fibromyalgia
Karakulova, Y. V., Сергеевна, Ш. Е., & Александровна, Т. Л. (2025) · Meditsinskiy sovet = Medical Council · doi:10.21518/ms2025-114 · Cited by 1
Rheumatic Syndrome in Elderly Due to Treatment
Foocharoen, C. (2008) · ศรีนครินทร์เวชสาร (Srinagarind Medical Journal)
Serum Lipid Levels in Patients with Diabetic Retinopathy
Başdoğan, B., Şahinoğlu-Keşkek, N., Özilice, U., Raufoğlu, C., Özilice, Ö., & Keşkek, Ş. Ö. (2025) · Acta Medica Alanya · doi:10.30565/medalanya.1732116
Shin, W.-Y., Jang, H. Y., & Lee, K. C. (2026) · Frontiers in Pharmacology · doi:10.3389/fphar.2026.1752835
Wu, Y., Yeh, C., Hsu, C.-Y., Lin, C. Y., Huang, C., Tang, S., Huang, Y. T., Lin, C. Y., Yu, C.-H., Huang, C. Y., et al. (2026) · Journal of the Formosan Medical Association · doi:10.1016/j.jfma.2026.04.111
Zhang, H., & Feng, S. (2026) · Journal of Cardiothoracic Surgery · doi:10.1186/s13019-026-04499-7
Metadata
- 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)
- 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
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
