Cited by 218Lipoproteins and Cardiovascular HealthPharmacovigilance and Adverse Drug ReactionsAntiplatelet Therapy and Cardiovascular Diseases

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What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice

Finegold, Judith A, Manisty, Charlotte H, Goldacre, Ben, Barron, Anthony J, Francis, Darrel P·2014·European Journal of Preventive Cardiology

DOI 10.1177/2047487314525531

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Abstract

OBJECTIVE: Discussions about statin efficacy in cardiovascular prevention are always based on data from blinded randomized controlled trials (RCTs) comparing statin to placebo; however, discussion of side effects is not. Clinicians often assume symptoms occurring with statins are caused by statins, encouraging discontinuation. We test this assumption and calculate an evidence-based estimate of the probability of a symptom being genuinely attributable to the statin itself. METHODS: We identified RCTs comparing statin to placebo for cardiovascular prevention that reported side effects separately in the two arms. RESULTS: Among 14 primary prevention trials (46,262 participants), statin therapy increased diabetes by absolute risk of 0.5% (95% CI 0.1-1%, p = 0.012), meanwhile reducing death by a similar extent: -0.5% (-0.9 to -0.2%, p = 0.003). In the 15 secondary prevention RCTs (37,618 participants), statins decreased death by 1.4% (-2.1 to -0.7%, p < 0.001). There were no other statin-attributable symptoms, although asymptomatic liver transaminase elevation was 0.4% more frequent with statins across all trials. Serious adverse events and withdrawals were similar in both arms. CONCLUSIONS: Only a small minority of symptoms reported on statins are genuinely due to the statins: almost all would occur just as frequently on placebo. Only development of new-onset diabetes mellitus was significantly higher on statins than placebo; nevertheless only 1 in 5 of new cases were actually caused by statins. Higher statin doses produce a detectable effect, but even still the proportion attributable to statins is variable: for asymptomatic liver enzyme elevation, the majority are attributable to the higher dose; in contrast for muscle aches, the majority are not.

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Authors: Finegold, J. A., Manisty, C. H., Goldacre, B., Barron, A. J., & Francis, D. P.
Affiliations: Imperial College London (GB)
London School of Hygiene & Tropical Medicine (GB)
National Heart and Lung Institute, Imperial College, London, UK
Corresponding author: Finegold, Judith A
ORCID: Manisty, Charlotte H
Goldacre, Ben
Barron, Anthony J
Venue: European Journal of Preventive Cardiology
Publisher: Oxford University Press (OUP)
Published: 2014-03-12
Volume: 21
Issue: 4
Pages: 464-474
ISSN: 2047-4873 (ISSN-L)
2047-4881
DOI: 10.1177/2047487314525531
OpenAlex: W2105299596
Cited by: 214
References: 35
Citations by year: 2026: 9 · 2025: 8 · 2024: 9 · 2023: 9 · 2022: 16 · 2021: 12 · 2020: 13 · 2019: 17 · 2018: 14 · 2017: 19 · 2016: 30 · 2015: 30 · 2014: 28
FWCI: 6.73
Type: journal article
Language: en
Open access: closed
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: European Journal of Preventive Cardiology (publishedVersion)
PubMed (publishedVersion)
UCL Discovery (University College London) (submittedVersion)
Funders: Wellcome Trust
National Institute for Health and Care Research (FS/10/038)
British Heart Foundation (FS 10/038, PG/11/36/2883, FS/10/38/28268)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
Keywords: statins, adverse drug reactions, new-onset diabetes, liver transaminase elevation, muscle aches, cardiovascular disease prevention, primary prevention, secondary prevention, statin dose
MeSH terms: Diabetes Mellitus, Dose-Response Relationship, Drug, Humans, Liver, Muscular Diseases, Risk Factors, Biomarkers, Placebo Effect, Randomized Controlled Trials as Topic, Treatment Outcome, Risk Assessment, Hydroxymethylglutaryl-CoA Reductase Inhibitors

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What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice

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