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Author Notes:

Corresponding author: Francois Mach; Tel: +41 22 3727192, Fax: +41 22 3727229, Email: francois.mach@hcuge.ch

Author Contributions: The Writing Group comprised F.M., K.K.R., O.W., A.C., A.L.C. and the Co-Chairs.

Acknowledgements: We acknowledge literature research support (Cognitive function subsection) from Ms Aliki Buhayer (Prism Scientific Sarl).

Disclosures: The following authors report disclosures outside the submitted work; F.M. has received research grants from Amgen, AstraZeneca and MSD, and honoraria for consultancy from Amgen, AstraZeneca, MSD and Pfizer.

K.K.R. has received research grants from Sanofi, Regeneron, Pfizer, Amgen and MSD, and honoraria for lectures, advisory boards and/or as a steering committee member from Sanofi, Amgen, Regeneron, Lilly, The Medicines Company, AstraZeneca, Pfizer, Kowa, IONIS, Esperion, Takeda, Boehringer Ingelheim.

O.W. has received honoraria for lectures from Sanofi, Amgen, MSD, and AstraZeneca.

See publication for full list of disclosures.

Subjects:

Research Funding:

The Panel met in London and Barcelona at meetings chaired by M.J.C. and H.N.G. to comprehensively and critically appraise and discuss the literature for this review.

Funding for attendance of the Panel members at these meetings was provided by unrestricted educational grants to the European Atherosclerosis Society from Amgen, AstraZeneca, Eli Lilly, Esperion, Merck, Pfizer, and Sanofi-Regeneron.

These companies were not present at the Consensus Panel meetings, had no role in the design or content of the manuscript, and had no right to approve or disapprove the final document.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • Statin
  • Adverse effects
  • Glucose homeostasis
  • Metabolic syndrome
  • Cognitive function
  • Renal function
  • Liver function
  • Haemorrhagic stroke
  • Cataract
  • CHRONIC KIDNEY-DISEASE
  • INDUCED LIVER-INJURY
  • PLACEBO-CONTROLLED TRIAL
  • DENSITY-LIPOPROTEIN CHOLESTEROL
  • RANDOMIZED CONTROLLED-TRIALS
  • RECEPTOR-MEDIATED ENDOCYTOSIS
  • PCSK9 INHIBITOR EVOLOCUMAB
  • MRC/BHF HEART PROTECTION
  • TYPE-2 DIABETES-MELLITUS
  • ALL-CAUSE MORTALITY

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

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Journal Title:

EHJ Cardiovascular Imaging / European Heart Journal - Cardiovascular Imaging

Volume:

Volume 39, Number 27

Publisher:

, Pages 2526-2539

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

VC The Author(s) 2018. Published by Oxford University Press on behalf of the European Society of Cardiology.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/).

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