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Eur Heart J. 2018 Jul 14;39(27):2526-2539. doi: 10.1093/eurheartj/ehy182.

Adverse effects of statin therapy: perception vs. the evidence - focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract.

Author information

1
Division of Cardiology, Department of Medical Specialties, Foundation for Medical Researches, Geneva University Hospital, Rue Gabrielle-Perret-Gentil 4 1205 Geneva, Switzerland.
2
Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, UK.
3
Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.
4
Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
5
Department of Pharmacological and Biomolecular Sciences, University of Milan and IRCCS Multimedica, Milan, Italy.
6
National Institute for Health and Medical Research (INSERM) UMRS1166, Department of Endocrinology-Metabolism, ICAN-Institute of CardioMetabolism and Nutrition, AP-HP, Hôpital de la Pitié, Paris, France.
7
Department of Public Health, University Hospital Ghent, Ghent, Belgium.
8
Department of Medicine, Robarts Research Institute, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada.
9
Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.
10
Department of Medicine, Emory University, Atlanta, GA, USA.
11
Department of Atherosclerosis Research, Children's Hospital Oakland Research Institute, Oakland, CA, USA.
12
Department of Cardiology, University of Leipzig, Leipzig, Germany.
13
Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Toronto, ON, Canada.
14
Vth Department of Medicine (Nephrology, Hypertensiology, Endocrinology, Diabetology, Rheumatology), Medical Faculty of Mannheim, University of Heidelberg, Mannheim, Germany.
15
Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University Graz, Graz, Austria.
16
Department of Clinical Biochemistry and The Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Copenhagen, Denmark.
17
Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
18
The Copenhagen City Heart Study, Frederiksberg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.
19
Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
20
German Center for Diabetes Research (DZD), München-Neuherberg, Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research, Düsseldorf, Germany.
21
Department of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
22
Hospital Israelita Albert Einstein, São Paulo, Brazil.
23
Heart Institute (InCor), University of São Paulo Medical School Hospital, São Paulo, Brazil.
24
Metabolic and Atherosclerosis Research Center, Cincinnati, OH, USA.
25
Hartford Hospital, Hartford, CT, USA.
26
Department of Cardiology, Hacettepe University, Ankara, Turkey.
27
Jacobs School of Medicine & Biomedical Sciences, University at Buffalo, The State University of New York, New York, USA.
28
European Atherosclerosis Society, Gothenburg, Sweden.
29
Department of Medicine, Columbia University College of Physicians and Surgeons, New York, USA.
30
National Institute for Health and Medical Research (INSERM), and University of Pierre and Marie Curie-Paris 6, Pitié Salpêtrière, Paris, France.

Abstract

Aims:

To objectively appraise evidence for possible adverse effects of long-term statin therapy on glucose homeostasis, cognitive, renal and hepatic function, and risk for haemorrhagic stroke or cataract.

Methods and results:

A literature search covering 2000-2017 was performed. The Panel critically appraised the data and agreed by consensus on the categorization of reported adverse effects. Randomized controlled trials (RCTs) and genetic studies show that statin therapy is associated with a modest increase in the risk of new-onset diabetes mellitus (about one per thousand patient-years), generally defined by laboratory findings (glycated haemoglobin ≥6.5); this risk is significantly higher in the metabolic syndrome or prediabetes. Statin treatment does not adversely affect cognitive function, even at very low levels of low-density lipoprotein cholesterol and is not associated with clinically significant deterioration of renal function, or development of cataract. Transient increases in liver enzymes occur in 0.5-2% of patients taking statins but are not clinically relevant; idiosyncratic liver injury due to statins is very rare and causality difficult to prove. The evidence base does not support an increased risk of haemorrhagic stroke in individuals without cerebrovascular disease; a small increase in risk was suggested by the Stroke Prevention by Aggressive Reduction of Cholesterol Levels study in subjects with prior stroke but has not been confirmed in the substantive evidence base of RCTs, cohort studies and case-control studies.

Conclusion:

Long-term statin treatment is remarkably safe with a low risk of clinically relevant adverse effects as defined above; statin-associated muscle symptoms were discussed in a previous Consensus Statement. Importantly, the established cardiovascular benefits of statin therapy far outweigh the risk of adverse effects.

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