Interpretation of the evidence for the efficacy and safety of statin therapy

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...

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Published in:	The Lancet (British edition) Vol. 388; no. 10059; pp. 2532 - 2561
Main Authors:	Collins, Rory, Reith, Christina, Emberson, Jonathan, Armitage, Jane, Baigent, Colin, Blackwell, Lisa, Blumenthal, Roger, Danesh, John, Smith, George Davey, DeMets, David, Evans, Stephen, Law, Malcolm, MacMahon, Stephen, Martin, Seth, Neal, Bruce, Poulter, Neil, Preiss, David, Ridker, Paul, Roberts, Ian, Rodgers, Anthony, Sandercock, Peter, Schulz, Kenneth, Sever, Peter, Simes, John, Smeeth, Liam, Wald, Nicholas, Yusuf, Salim, Peto, Richard
Format:	Journal Article
Language:	English
Published:	England Elsevier Ltd 19.11.2016 Elsevier Limited
Subjects:	Anticholesteremic Agents - therapeutic use Cardiovascular disease Cholesterol Cholesterol, LDL - blood Clinical outcomes Clinical Trials as Topic Coronary Disease - drug therapy Coronary Disease - prevention & control Drug therapy Drug-Related Side Effects and Adverse Reactions Health risks Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Internal Medicine Myocardial Infarction - drug therapy Myocardial Infarction - prevention & control Pain Patient safety Patients Prevention Risk Assessment Safety Side effects Simvastatin - therapeutic use Statins Stroke - drug therapy Stroke - prevention & control Studies Vascular diseases
ISSN:	0140-6736, 1474-547X
Online Access:	Get full text
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Abstract	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.
AbstractList	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 foreachmmol/L reduction in LDL cholesterol duringeachyear (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, adverseeffectsof 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. 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. Summary 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.
Author	Armitage, Jane Sandercock, Peter Blumenthal, Roger Wald, Nicholas Schulz, Kenneth Emberson, Jonathan Poulter, Neil Sever, Peter MacMahon, Stephen Rodgers, Anthony Yusuf, Salim Danesh, John Blackwell, Lisa Evans, Stephen Preiss, David Martin, Seth DeMets, David Simes, John Neal, Bruce Peto, Richard Reith, Christina Smith, George Davey Baigent, Colin Roberts, Ian Smeeth, Liam Law, Malcolm Collins, Rory Ridker, Paul
Author_xml	– sequence: 1 givenname: Rory surname: Collins fullname: Collins, Rory email: rory.collins@ndph.ox.ac.uk organization: Clinical Trial Service Unit & Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK – sequence: 2 givenname: Christina surname: Reith fullname: Reith, Christina organization: Clinical Trial Service Unit & Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK – sequence: 3 givenname: Jonathan surname: Emberson fullname: Emberson, Jonathan organization: Clinical Trial Service Unit & Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK – sequence: 4 givenname: Jane surname: Armitage fullname: Armitage, Jane organization: Clinical Trial Service Unit & Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK – sequence: 5 givenname: Colin surname: Baigent fullname: Baigent, Colin organization: Clinical Trial Service Unit & Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK – sequence: 6 givenname: Lisa surname: Blackwell fullname: Blackwell, Lisa organization: Clinical Trial Service Unit & Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK – sequence: 7 givenname: Roger surname: Blumenthal fullname: Blumenthal, Roger organization: Ciccarone Center for the Prevention of Heart Disease, Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA – sequence: 8 givenname: John surname: Danesh fullname: Danesh, John organization: MRC/BHF Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK – sequence: 9 givenname: George Davey surname: Smith fullname: Smith, George Davey organization: MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK – sequence: 10 givenname: David surname: DeMets fullname: DeMets, David organization: Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA – sequence: 11 givenname: Stephen surname: Evans fullname: Evans, Stephen organization: Department of Medical Statistics, London School of Hygiene & Tropical Medicine, University of London, London, UK – sequence: 12 givenname: Malcolm surname: Law fullname: Law, Malcolm organization: Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK – sequence: 13 givenname: Stephen surname: MacMahon fullname: MacMahon, Stephen organization: The George Institute for Global Health, University of Sydney, Sydney, Australia – sequence: 14 givenname: Seth surname: Martin fullname: Martin, Seth organization: Ciccarone Center for the Prevention of Heart Disease, Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA – sequence: 15 givenname: Bruce surname: Neal fullname: Neal, Bruce organization: The George Institute for Global Health, University of Sydney, Sydney, Australia – sequence: 16 givenname: Neil surname: Poulter fullname: Poulter, Neil organization: International Centre for Circulatory Health & Imperial Clinical Trials Unit, Imperial College London, London, UK – sequence: 17 givenname: David surname: Preiss fullname: Preiss, David organization: Clinical Trial Service Unit & Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK – sequence: 18 givenname: Paul surname: Ridker fullname: Ridker, Paul organization: Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA – sequence: 19 givenname: Ian surname: Roberts fullname: Roberts, Ian organization: Clinical Trials Unit, London School of Hygiene & Tropical Medicine, University of London, London, UK – sequence: 20 givenname: Anthony surname: Rodgers fullname: Rodgers, Anthony organization: The George Institute for Global Health, University of Sydney, Sydney, Australia – sequence: 21 givenname: Peter surname: Sandercock fullname: Sandercock, Peter organization: Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK – sequence: 22 givenname: Kenneth surname: Schulz fullname: Schulz, Kenneth organization: FHI 360, University of North Carolina School of Medicine, University of North Carolina, Chapel Hill, NC, USA – sequence: 23 givenname: Peter surname: Sever fullname: Sever, Peter organization: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, UK – sequence: 24 givenname: John surname: Simes fullname: Simes, John organization: National Health and Medical Research Council Clinical Trial Centre, University of Sydney, Sydney, Australia – sequence: 25 givenname: Liam surname: Smeeth fullname: Smeeth, Liam organization: Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, University of London, London, UK – sequence: 26 givenname: Nicholas surname: Wald fullname: Wald, Nicholas organization: Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK – sequence: 27 givenname: Salim surname: Yusuf fullname: Yusuf, Salim organization: Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada – sequence: 28 givenname: Richard surname: Peto fullname: Peto, Richard organization: Clinical Trial Service Unit & Epidemiological Studies Unit and MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/27616593$$D View this record in MEDLINE/PubMed
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Snippet	This Review is intended to help clinicians, patients, and the public make informed decisions about statin therapy for the prevention of heart attacks and... Summary This Review is intended to help clinicians, patients, and the public make informed decisions about statin therapy for the prevention of heart attacks...
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SubjectTerms	Anticholesteremic Agents - therapeutic use Cardiovascular disease Cholesterol Cholesterol, LDL - blood Clinical outcomes Clinical Trials as Topic Coronary Disease - drug therapy Coronary Disease - prevention & control Drug therapy Drug-Related Side Effects and Adverse Reactions Health risks Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Internal Medicine Myocardial Infarction - drug therapy Myocardial Infarction - prevention & control Pain Patient safety Patients Prevention Risk Assessment Safety Side effects Simvastatin - therapeutic use Statins Stroke - drug therapy Stroke - prevention & control Studies Vascular diseases
Title	Interpretation of the evidence for the efficacy and safety of statin therapy
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