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

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 effic... Full description

Journal Title: The Lancet (British edition) 2016, Vol.388 (10059), p.2532-2561
Main Author: Collins, Rory, Prof
Other Authors: Reith, Christina, FRCP (Glasg.) , Emberson, Jonathan, PhD , Armitage, Jane, Prof , Baigent, Colin, Prof , Blackwell, Lisa, BSc , Blumenthal, Roger, Prof , Danesh, John, Prof , Smith, George Davey, Prof , DeMets, David, Prof , Evans, Stephen, Prof , Law, Malcolm, Prof , MacMahon, Stephen, Prof , Martin, Seth, MD , Neal, Bruce, Prof , Poulter, Neil, Prof , Preiss, David, PhD , Ridker, Paul, Prof , Roberts, Ian, Prof , Rodgers, Anthony, Prof , Sandercock, Peter, Prof , Schulz, Kenneth, Prof , Sever, Peter, Prof , Simes, John, Prof , Smeeth, Liam, Prof , Wald, Nicholas, Prof , Yusuf, Salim, Prof , Peto, Richard, Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/27616593
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title: Interpretation of the evidence for the efficacy and safety of statin therapy
format: Article
creator:
  • Collins, Rory, Prof
  • Reith, Christina, FRCP (Glasg.)
  • Emberson, Jonathan, PhD
  • Armitage, Jane, Prof
  • Baigent, Colin, Prof
  • Blackwell, Lisa, BSc
  • Blumenthal, Roger, Prof
  • Danesh, John, Prof
  • Smith, George Davey, Prof
  • DeMets, David, Prof
  • Evans, Stephen, Prof
  • Law, Malcolm, Prof
  • MacMahon, Stephen, Prof
  • Martin, Seth, MD
  • Neal, Bruce, Prof
  • Poulter, Neil, Prof
  • Preiss, David, PhD
  • Ridker, Paul, Prof
  • Roberts, Ian, Prof
  • Rodgers, Anthony, Prof
  • Sandercock, Peter, Prof
  • Schulz, Kenneth, Prof
  • Sever, Peter, Prof
  • Simes, John, Prof
  • Smeeth, Liam, Prof
  • Wald, Nicholas, Prof
  • Yusuf, Salim, Prof
  • Peto, Richard, Prof
subjects:
  • Anticholesteremic Agents - therapeutic use
  • Cardiovascular agents
  • 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
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
  • Internal Medicine
  • Myocardial Infarction - drug therapy
  • Myocardial Infarction - prevention & control
  • Patient safety
  • Patients
  • Risk Assessment
  • Safety
  • Simvastatin - therapeutic use
  • Statins
  • Stroke - drug therapy
  • Stroke - prevention & control
  • Studies
ispartof: The Lancet (British edition), 2016, Vol.388 (10059), p.2532-2561
description: 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 int
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleInterpretation of the evidence for the efficacy and safety of statin therapy
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creatorCollins, Rory, Prof ; Reith, Christina, FRCP (Glasg.) ; Emberson, Jonathan, PhD ; Armitage, Jane, Prof ; Baigent, Colin, Prof ; Blackwell, Lisa, BSc ; Blumenthal, Roger, Prof ; Danesh, John, Prof ; Smith, George Davey, Prof ; DeMets, David, Prof ; Evans, Stephen, Prof ; Law, Malcolm, Prof ; MacMahon, Stephen, Prof ; Martin, Seth, MD ; Neal, Bruce, Prof ; Poulter, Neil, Prof ; Preiss, David, PhD ; Ridker, Paul, Prof ; Roberts, Ian, Prof ; Rodgers, Anthony, Prof ; Sandercock, Peter, Prof ; Schulz, Kenneth, Prof ; Sever, Peter, Prof ; Simes, John, Prof ; Smeeth, Liam, Prof ; Wald, Nicholas, Prof ; Yusuf, Salim, Prof ; Peto, Richard, Prof
creatorcontribCollins, Rory, Prof ; Reith, Christina, FRCP (Glasg.) ; Emberson, Jonathan, PhD ; Armitage, Jane, Prof ; Baigent, Colin, Prof ; Blackwell, Lisa, BSc ; Blumenthal, Roger, Prof ; Danesh, John, Prof ; Smith, George Davey, Prof ; DeMets, David, Prof ; Evans, Stephen, Prof ; Law, Malcolm, Prof ; MacMahon, Stephen, Prof ; Martin, Seth, MD ; Neal, Bruce, Prof ; Poulter, Neil, Prof ; Preiss, David, PhD ; Ridker, Paul, Prof ; Roberts, Ian, Prof ; Rodgers, Anthony, Prof ; Sandercock, Peter, Prof ; Schulz, Kenneth, Prof ; Sever, Peter, Prof ; Simes, John, Prof ; Smeeth, Liam, Prof ; Wald, Nicholas, Prof ; Yusuf, Salim, Prof ; Peto, Richard, Prof
descriptionSummary 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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1EISSN: 1474-547X
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3PMID: 27616593
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languageeng
publisherEngland: Elsevier Ltd
subjectAnticholesteremic Agents - therapeutic use ; Cardiovascular agents ; 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 ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Internal Medicine ; Myocardial Infarction - drug therapy ; Myocardial Infarction - prevention & control ; Patient safety ; Patients ; Risk Assessment ; Safety ; Simvastatin - therapeutic use ; Statins ; Stroke - drug therapy ; Stroke - prevention & control ; Studies
ispartofThe Lancet (British edition), 2016, Vol.388 (10059), p.2532-2561
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1Reith, Christina, FRCP (Glasg.)
2Emberson, Jonathan, PhD
3Armitage, Jane, Prof
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5Blackwell, Lisa, BSc
6Blumenthal, Roger, Prof
7Danesh, John, Prof
8Smith, George Davey, Prof
9DeMets, David, Prof
10Evans, Stephen, Prof
11Law, Malcolm, Prof
12MacMahon, Stephen, Prof
13Martin, Seth, MD
14Neal, Bruce, Prof
15Poulter, Neil, Prof
16Preiss, David, PhD
17Ridker, Paul, Prof
18Roberts, Ian, Prof
19Rodgers, Anthony, Prof
20Sandercock, Peter, Prof
21Schulz, Kenneth, Prof
22Sever, Peter, Prof
23Simes, John, Prof
24Smeeth, Liam, Prof
25Wald, Nicholas, Prof
26Yusuf, Salim, Prof
27Peto, Richard, Prof
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descriptionSummary 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.
subject
0Anticholesteremic Agents - therapeutic use
1Cardiovascular agents
2Cardiovascular disease
3Cholesterol
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5Clinical outcomes
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7Coronary Disease - drug therapy
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9Drug therapy
10Drug-Related Side Effects and Adverse Reactions
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12Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
13Internal Medicine
14Myocardial Infarction - drug therapy
15Myocardial Infarction - prevention & control
16Patient safety
17Patients
18Risk Assessment
19Safety
20Simvastatin - therapeutic use
21Statins
22Stroke - drug therapy
23Stroke - prevention & control
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7Danesh, John, Prof
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9DeMets, David, Prof
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13Martin, Seth, MD
14Neal, Bruce, Prof
15Poulter, Neil, Prof
16Preiss, David, PhD
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18Roberts, Ian, Prof
19Rodgers, Anthony, Prof
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titleInterpretation of the evidence for the efficacy and safety of statin therapy
authorCollins, Rory, Prof ; Reith, Christina, FRCP (Glasg.) ; Emberson, Jonathan, PhD ; Armitage, Jane, Prof ; Baigent, Colin, Prof ; Blackwell, Lisa, BSc ; Blumenthal, Roger, Prof ; Danesh, John, Prof ; Smith, George Davey, Prof ; DeMets, David, Prof ; Evans, Stephen, Prof ; Law, Malcolm, Prof ; MacMahon, Stephen, Prof ; Martin, Seth, MD ; Neal, Bruce, Prof ; Poulter, Neil, Prof ; Preiss, David, PhD ; Ridker, Paul, Prof ; Roberts, Ian, Prof ; Rodgers, Anthony, Prof ; Sandercock, Peter, Prof ; Schulz, Kenneth, Prof ; Sever, Peter, Prof ; Simes, John, Prof ; Smeeth, Liam, Prof ; Wald, Nicholas, Prof ; Yusuf, Salim, Prof ; Peto, Richard, Prof
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7Coronary Disease - drug therapy
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21Statins
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6Blumenthal, Roger, Prof
7Danesh, John, Prof
8Smith, George Davey, Prof
9DeMets, David, Prof
10Evans, Stephen, Prof
11Law, Malcolm, Prof
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13Martin, Seth, MD
14Neal, Bruce, Prof
15Poulter, Neil, Prof
16Preiss, David, PhD
17Ridker, Paul, Prof
18Roberts, Ian, Prof
19Rodgers, Anthony, Prof
20Sandercock, Peter, Prof
21Schulz, Kenneth, Prof
22Sever, Peter, Prof
23Simes, John, Prof
24Smeeth, Liam, Prof
25Wald, Nicholas, Prof
26Yusuf, Salim, Prof
27Peto, Richard, Prof
formatjournal
genrearticle
ristypeJOUR
atitleInterpretation of the evidence for the efficacy and safety of statin therapy
jtitleThe Lancet (British edition)
addtitleLancet
date2016
risdate2016
volume388
issue10059
spage2532
epage2561
pages2532-2561
issn0140-6736
eissn1474-547X
codenLANCAO
abstractSummary 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.
copEngland
pubElsevier Ltd
pmid27616593
doi10.1016/S0140-6736(16)31357-5
oafree_for_read