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Interpretation of the evidence for the efficacy and safety of statin therapy
Open accessAbstract
This Review is intended to help clinicians, patients, and the public make informed decisions about statin therapy for the prevention of heart attacks and strokes. It explains how the evidence that is available from randomised controlled trials yields reliable information about both the efficacy and safety of statin therapy. In addition, it discusses how claims that statins commonly cause adverse effects reflect a failure to recognise the limitations of other sources of evidence about the effects of treatment. Large-scale evidence from randomised trials shows that statin therapy reduces the risk of major vascular events (ie, coronary deaths or myocardial infarctions, strokes, and coronary revascularisation procedures) by about one-quarter for each mmol/L reduction in LDL cholesterol during each year (after the first) that it continues to be taken. The absolute benefits of statin therapy depend on an individual's absolute risk of occlusive vascular events and the absolute reduction in LDL cholesterol that is achieved. For example, lowering LDL cholesterol by 2 mmol/L (77 mg/dL) with an effective low-cost statin regimen (eg, atorvastatin 40 mg daily, costing about £2 per month) for 5 years in 10 000 patients would typically prevent major vascular events from occurring in about 1000 patients (ie, 10% absolute benefit) with pre-existing occlusive vascular disease (secondary prevention) and in 500 patients (ie, 5% absolute benefit) who are at increased risk but have not yet had a vascular event (primary prevention). Statin therapy has been shown to reduce vascular disease risk during each year it continues to be taken, so larger absolute benefits would accrue with more prolonged therapy, and these benefits persist long term. The only serious adverse events that have been shown to be caused by long-term statin therapy-ie, adverse effects of the statin-are myopathy (defined as muscle pain or weakness combined with large increases in blood concentrations of creatine kinase), new-onset diabetes mellitus, and, probably, haemorrhagic stroke. Typically, treatment of 10 000 patients for 5 years with an effective regimen (eg, atorvastatin 40 mg daily) would cause about 5 cases of myopathy (one of which might progress, if the statin therapy is not stopped, to the more severe condition of rhabdomyolysis), 50-100 new cases of diabetes, and 5-10 haemorrhagic strokes. However, any adverse impact of these side-effects on major vascular events has already been taken into account in the estimates of the absolute benefits. Statin therapy may cause symptomatic adverse events (eg, muscle pain or weakness) in up to about 50-100 patients (ie, 0·5-1·0% absolute harm) per 10 000 treated for 5 years. However, placebo-controlled randomised trials have shown definitively that almost all of the symptomatic adverse events that are attributed to statin therapy in routine practice are not actually caused by it (ie, they represent misattribution). The large-scale evidence available from randomised trials also indicates that it is unlikely that large absolute excesses in other serious adverse events still await discovery. Consequently, any further findings that emerge about the effects of statin therapy would not be expected to alter materially the balance of benefits and harms. It is, therefore, of concern that exaggerated claims about side-effect rates with statin therapy may be responsible for its under-use among individuals at increased risk of cardiovascular events. For, whereas the rare cases of myopathy and any muscle-related symptoms that are attributed to statin therapy generally resolve rapidly when treatment is stopped, the heart attacks or strokes that may occur if statin therapy is stopped unnecessarily can be devastating.
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In the citing paper
“Although LDL-lowering drugs have only moderate effects on TG levels, they reduce ASCVD risk in patients with and without HTG.42”
From Clinical review on triglycerides (2020) · cites this paper as [42]
Experimental — accuracy not yet measuredIn the citing paper
“Although LDL-lowering drugs have only moderate effects on TG levels, they reduce ASCVD risk in patients with and without HTG.42”
From Clinical review on triglycerides (2020) · cites this paper as [42]
In the citing paper
“Overall, statin therapy produced a 21% relative reduction in major vascular events (relative risk 0.79, 95% CI 0.77-0.81) per 1.0 mmoL/L reduction in LDL-C”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [217]
In the citing paper
“However, since the absolute risk of CAD is higher in older persons, the associated absolute increase in risk for a given increment in TC is larger with increasing age [217].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [217]
In the citing paper
“The relative reduction in major vascular events was similar, irrespective of age, among patients with pre-existing vascular disease, but appeared smaller among older individuals not known to have vascular disease.”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [217]
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Metadata
- Authors
- Collins, R., Reith, C., Emberson, J., Armitage, J., Baigent, C., Blackwell, L., Blumenthal, R., Danesh, J., Smith, G. D., DeMets, D., Evans, S., Law, M., MacMahon, S., Martin, S., Neal, B., Poulter, N., Preiss, D., Ridker, P., Roberts, I., Rodgers, A., Sandercock, P., Schulz, K., Sever, P., Simes, J., Smeeth, L., Wald, N., Yusuf, S., & Peto, R.
- Affiliations
- University of Oxford (GB)
- Johns Hopkins University (US)
- University of Cambridge (GB)
- University of Bristol (GB)
- University of Wisconsin–Madison (US)
- University of London (GB)
- The University of Sydney (AU)
- Imperial College London (GB)
- Brigham and Women's Hospital (US)
- University of Edinburgh (GB)
- University of North Carolina at Chapel Hill (US)
- Population Health Research Institute (CA)
- Corresponding author
- Collins, Rory
- ORCID
- Collins, Rory
- Reith, Christina
- Emberson, Jonathan
- Armitage, Jane
- Baigent, Colin
- Blumenthal, Roger
- Danesh, John
- Smith, George Davey
- DeMets, David
- Evans, Stephen
- MacMahon, Stephen
- Martin, Seth
- Neal, Bruce
- Poulter, Neil
- Preiss, David
- Ridker, Paul
- Roberts, Ian
- Rodgers, Anthony
- Sandercock, Peter
- Schulz, Kenneth
- Smeeth, Liam
- Wald, Nicholas
- Yusuf, Salim
- Peto, Richard
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2016-11
- Volume
- 388
- Issue
- 10059
- Pages
- 2532-2561
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2519634482
- Cited by
- 1,857
- References
- 299
- Citations by year
- 2026: 136 · 2025: 136 · 2024: 150 · 2023: 166 · 2022: 187 · 2021: 229 · 2020: 192 · 2019: 218 · 2018: 206 · 2017: 202 · 2016: 31
- FWCI
- 43.45
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Explore Bristol Research (publishedVersion, other-oa)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by-nc-nd)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion)
- Bristol Research (University of Bristol) (submittedVersion, other-oa)
- Spiral (Imperial College London) (submittedVersion, cc-by-nc-nd)
- Funders
- Cancer Research UK (16896)
- National Institute for Health and Care Research (NF-SI-0611-10057, HTA/14/49/159, 14/49/159, NF-SI-0513-10059)
- British Heart Foundation (SP/08/010/25939, SP/14/3/31114, RG/13/13/30194)
- Medical Research Council (MR/K006584/1, MR/L003120/1)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Keywords
- statin therapy, LDL cholesterol lowering, cardiovascular disease prevention, secondary prevention, primary prevention, absolute risk reduction, statin adverse effects, myopathy, rhabdomyolysis, new-onset diabetes, hemorrhagic stroke, atorvastatin, long-term treatment, evidence evaluation, cardiovascular risk assessment, cost-effectiveness, randomized controlled trials, meta-analysis
- MeSH terms
- Anticholesteremic Agents, Clinical Trials as Topic, Coronary Disease, Humans, Cholesterol, LDL, Myocardial Infarction, Safety, Risk Assessment, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Simvastatin, Stroke, Drug-Related Side Effects and Adverse Reactions
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