Primary Prevention of Cardiovascular Mortality and Events With Statin Treatments
Open accessAbstract
Objectives This study aimed to evaluate the effectiveness of 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors (statins) in primary prevention of cardiovascular events.Background The role of statins is well established for secondary prevention of cardiovascular disease (CVD) clinical events and mortality. Little is known of their role in primary cardiovascular event prevention.Methods We conducted comprehensive searches of 10 electronic databases from inception to May 2008. We contacted study investigators and maintained a comprehensive bibliography of statin studies. We included randomized trials of at least 12-month duration in predominantly primary prevention populations. Two reviewers independently extracted data in duplicate. We performed random-effects meta-analysis and meta-regression, calculated optimal information size, and conducted a mixed-treatment comparison analysis.Results We included 20 randomized clinical trials. We pooled 19 trials (n = 63,899) for all-cause mortality and found a relative risk (RR) of 0.93 (95% confidence interval [CI]: 0.87 to 0.99, p = 0.03 [I(2) = 5%, 95% CI: 0% to 51%]). Eighteen trials (n = 59,469) assessed cardiovascular deaths (RR: 0.89, 95% CI: 0.81 to 0.98, p = 0.01 [I(2) = 0%, 95% CI: 0% to 41%]). Seventeen trials (n = 53,371) found an RR of 0.85 (95% CI: 0.77 to 0.95, p = 0.004 [I(2) = 61%, 95% CI: 38% to 77%]) for major cardiovascular events, and 17 trials (n = 52,976) assessed myocardial infarctions (RR: 0.77, 95% CI: 0.63 to 0.95, p = 0.01 [I(2) = 59%, 95% CI: 24% to 74%]). Incidence of cancer was not elevated in 10 trials (n = 45,469) (RR: 1.02, 95% CI: 0.94 to 1.11, p = 0.59 [I(2) = 0%, 95% CI: 0% to 46%]), nor was rhabdomyolysis (RR: 0.97, 95% CI: 0.25 to 3.83, p = 0.96 [I(2) = 0%, 95% CI: 0% to 40%]). Our analysis included a sufficient sample to reliably answer our primary outcome of CVD mortality.Conclusions Statins have a clear role in primary prevention of CVD mortality and major events.
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The graded intervention approach in Table 5 is based on evidence from multiple meta-analyses and randomized controlled trials showing consistent and graded reduction in atherosclerotic cardiovascular disease risk with reductions in total cholesterol and LDL-C.
“This graded approach is based on evidence from multiple meta-analyses and individual randomized controlled trials (RCTs), which show a consistent and graded reduction in ASCVD risk in response to reductions in TC and LDL-C levels (see Recommendations for cardiovascular disease risk estimation below) [31-41].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [37]
Moderate triglyceride elevation between 2.0 and 10.0 mmol/L is caused by polygenic effects of multiple genes influencing VLDL production and removal.
“Moderate elevation of TG levels (between 2.0 and 10.0 mmoL/L) is caused by the polygenic effect of multiple genes influencing both VLDL production and removal.”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [37]
Large-scale clinical trials have shown that statins substantially reduce cardiovascular morbidity and mortality in both primary and secondary prevention.
“A number of large-scale clinical trials have demonstrated that statins substantially reduce CV morbidity and mortality in both primary and secondary prevention.15 -17”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [17]
Other meta-analyses of primary prevention reported efficacy and safety results generally consistent with the CTT conclusions.
“Other meta-analyses 16,17,41 addressed the issue of primary prevention, with results regarding efficacy and safety that are, in general, consistent with the conclusions from the CTT.15”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [17]
This graded approach is based on evidence from multiple meta-analyses and individual RCTs, which show a consistent and graded reduction in CVD risk in response to reductions in TC and LDL-C levels.
“This graded approach is based on evidence from multiple meta-analyses and individual RCTs, which show a consistent and graded reduction in CVD risk in response to reductions in TC and LDL-C levels. 61-71”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [68]
These trials are consistent in showing that the higher the initial LDL-C level, the greater the absolute reduction in risk, while the relative risk reduction remains constant at any given baseline LDL-C level.
“These trials are consistent in showing that the higher the initial LDL-C level, the greater the absolute reduction in risk, while the relative risk reduction remains constant at any given baseline LDL-C level.”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [68]
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Ray, K. K. (2010) · Archives of Internal Medicine · doi:10.1001/archinternmed.2010.182 · Cited by 446 · see citing works
Mills, E. J., WU, P., Chong, G., Ghement, I., Singh, S., Akl, E. A., Eyawo, O., Guyatt, G., Berwanger, O., & Briel, M. (2011) · QJM · doi:10.1093/qjmed/hcq165 · Cited by 338 · see citing works
Self-citationBenefits of Statins in Elderly Subjects Without Established Cardiovascular Disease
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Uncertainty in Treatment Rankings: Reanalysis of Network Meta-analyses of Randomized Trials
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ESC/EAS Guidelines for the management of dyslipidaemias
Catapano, A. L., Reiner, Ž., De Backer, G., Graham, I., Taskinen, M.-R., Wiklund, O., Agewall, S., Alegria, E., Chapman, M. J., Durrington, P., et al. (2011) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2011.06.012 · Cited by 192 · see citing works
Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention
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Unmet Needs in LDL-C Lowering: When Statins Won’t Do!
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- Authors
- Mills, E. J., Rachlis, B., Wu, P., Devereaux, P. J., Arora, P., & Perri, D.
- Affiliations
- McMaster University (CA)
- University of British Columbia (CA)
- London School of Hygiene & Tropical Medicine (GB)
- University of Toronto (CA)
- Corresponding author
- Mills, Edward J.
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2008-11
- Volume
- 52
- Issue
- 22
- Pages
- 1769-1781
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W120848922
- Cited by
- 423
- References
- 71
- Citations by year
- 2026: 4 · 2025: 6 · 2024: 9 · 2023: 12 · 2022: 10 · 2021: 19 · 2020: 10 · 2019: 19 · 2018: 18 · 2017: 25 · 2016: 34 · 2015: 29 · 2014: 32 · 2013: 48 · 2012: 40
- FWCI
- 37.23
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Pfizer
- London School of Hygiene and Tropical Medicine
- Pfizer UK
- Medical Research Council
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health Promotion and Cardiovascular Prevention
- Keywords
- statins, primary prevention, cardiovascular mortality, cardiovascular events, myocardial infarction, all-cause mortality, cancer incidence, lipid-lowering therapy, statin safety, cardiovascular risk reduction, meta-regression, treatment effect heterogeneity, risk-benefit assessment, cardiovascular disease prevention
- MeSH terms
- Atorvastatin, Fluvastatin, Anticholesteremic Agents, Cardiovascular Diseases, Fatty Acids, Monounsaturated, Heptanoic Acids, Humans, Indoles, Lovastatin, Pyrroles, Risk, Confidence Intervals, Randomized Controlled Trials as Topic, Pravastatin, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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.
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