Cited by 292Lipoproteins and Cardiovascular HealthCancer, Lipids, and MetabolismPharmacovigilance and Adverse Drug Reactions

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Comparative Tolerability and Harms of Individual Statins: A Study-Level Network Meta-Analysis of 246 955 Participants From 135 Randomized, Controlled Trials

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Naci, Huseyin, Brugts, Jasper, Ades, Tony·2013·Circulation: Cardiovascular Quality and Outcomes

DOI 10.1161/circoutcomes.111.000071

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Abstract

Background—: Our objective was to estimate the comparative harms of individual statins using both placebo-controlled and active-comparator trials. Methods and Results—: We systematically reviewed randomized trials evaluating different statins in participants with and without cardiovascular disease. We performed random-effects pairwise and network meta-analyses to quantify the relative harms of individual statins. We included 55 two-armed placebo-controlled and 80 two- or multiarmed active-comparator trials including 246 955 individuals. According to pairwise meta-analyses, individual statins were not different than control in terms of myalgia, creatine kinase elevation, cancer, and discontinuations because of adverse events. Statins as a class resulted in significantly higher odds of diabetes mellitus (odds ratio, 1.09; 95% confidence interval, 1.02–1.16) and transaminase elevations (odds ratio, 1.51; 95% confidence interval, 1.24–1.84) compared with control. When individual statins were compared in network meta-analyses, there were numerous statistically detectable differences, favoring simvastatin and pravastatin. According to dose-level comparisons, individual statins resulted in higher odds of discontinuations with higher doses of atorvastatin and rosuvastatin. Similarly, higher doses of atorvasatin, fluvastatin, lovastatin, and simvastatin were associated with higher odds of transaminase elevations. Simvastatin at its highest doses was associated with creatine kinase elevations (odds ratio, 4.14; 95% credible interval, 1.08–16.24). Meta-regression analyses adjusting for study-level age at baseline, low-density lipoprotein cholesterol level, and publication year did not explain heterogeneity. There was no detectable inconsistency in the network. Conclusions—: As a class, adverse events associated with statin therapy are not common. Statins are not associated with cancer risk but do result in a higher odds of diabetes mellitus. Among individual statins, simvastatin and pravastatin seem safer and more tolerable than other statins.

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Naci H Brugts J Fleurence R Ades AE. Comparative efficacy and safety of statins: a systematic review and mixed treatment comparison—final protocol. 2009; www2.lse.ac.uk/LSEHealthAndSocialCare/pdf/HNaciProtocol.pdf. Accessed April 5 2013.

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Authors: Naci, H., Brugts, J., & Ades, T.
Affiliations: Erasmus MC (NL)
From the LSE Health, London School of Economics and Political Science, London, United Kingdom (H.N.); Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands (J.B.); and .School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom (T.A.).
ORCID: Naci, Huseyin
Brugts, Jasper
Venue: Circulation: Cardiovascular Quality and Outcomes
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2013-07
Volume: 6
Issue: 4
Pages: 390-399
ISSN: 1941-7705 (ISSN-L)
1941-7713
DOI: 10.1161/circoutcomes.111.000071
OpenAlex: W2160313369
Cited by: 292
References: 52
Citations by year: 2026: 10 · 2025: 8 · 2024: 17 · 2023: 14 · 2022: 15 · 2021: 20 · 2020: 26 · 2019: 31 · 2018: 23 · 2017: 21 · 2016: 36 · 2015: 24 · 2014: 38 · 2013: 8
FWCI: 34.80
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Circulation Cardiovascular Quality and Outcomes (publishedVersion)
PubMed (publishedVersion)
London School of Economics and Political Science Research Online (London School of Economics and Political Science) (acceptedVersion)
London School of Economics and Political Science Research Online (London School of Economics and Political Science) (submittedVersion)
Funders: McMaster University
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, statin safety, tolerability, diabetes mellitus, transaminase elevation, creatine kinase elevation, myalgia, cancer risk, simvastatin, pravastatin, dose-response relationship, cardiovascular disease
MeSH terms: Cardiovascular Diseases, Dose-Response Relationship, Drug, Humans, Lipids, Risk Factors, Biomarkers, Odds Ratio, Randomized Controlled Trials as Topic, Treatment Outcome, Risk Assessment, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Evidence-Based Medicine, Dyslipidemias

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Comparative Tolerability and Harms of Individual Statins: A Study-Level Network Meta-Analysis of 246 955 Participants From 135 Randomized, Controlled Trials

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