Statins for primary prevention: at what coronary risk is safety assured?

Aims  Increasingly HMG CoA reductase inhibitors (statins) are being used for primary prevention of vascular disease in patients with a raised cholesterol but at low absolute risk of coronary heart disease (CHD). This study uses clinical trial results to explore the limits of absolute safety for stat...

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Published inBritish journal of clinical pharmacology Vol. 52; no. 4; pp. 439 - 446
Main Authors Jackson, Peter R., Wallis, Erica J., Haq, Ifti U., Ramsay, Lawrence E.
Format Journal Article
LanguageEnglish
Published Oxford, UK Blackwell Science Ltd 01.10.2001
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Abstract Aims  Increasingly HMG CoA reductase inhibitors (statins) are being used for primary prevention of vascular disease in patients with a raised cholesterol but at low absolute risk of coronary heart disease (CHD). This study uses clinical trial results to explore the limits of absolute safety for statin use in such patients. Methods  The major placebo controlled statin outcome trials were identified by automated and manual literature searches. Principal results including all cause mortality in placebo and intervention groups and baseline values of standard coronary risk factors were ed for each trial. For the trials identified the reduction in overall mortality with statin treatment for each study was regressed against the underlying CHD risk of the population recruited into that trial using a statistically robust method. Results  The regression line describing the relationship between mortality benefit and risk suggests that statin use could be associated with an increase in mortality of 1% in 10 years. This would be sufficiently large to negate statin's beneficial effect on CHD mortality in patients with a CHD event risk less than 13% over 10 years. Conclusions  Absolute safety of statins has not been demonstrated for patients at low risk of CHD. Patients absolute risk of CHD should be calculated before starting statin treatment for primary prevention. Extensions of such treatment to low risk patients should await further evidence of safety.
AbstractList Aims  Increasingly HMG CoA reductase inhibitors (statins) are being used for primary prevention of vascular disease in patients with a raised cholesterol but at low absolute risk of coronary heart disease (CHD). This study uses clinical trial results to explore the limits of absolute safety for statin use in such patients. Methods  The major placebo controlled statin outcome trials were identified by automated and manual literature searches. Principal results including all cause mortality in placebo and intervention groups and baseline values of standard coronary risk factors were abstracted for each trial. For the trials identified the reduction in overall mortality with statin treatment for each study was regressed against the underlying CHD risk of the population recruited into that trial using a statistically robust method. Results  The regression line describing the relationship between mortality benefit and risk suggests that statin use could be associated with an increase in mortality of 1% in 10 years. This would be sufficiently large to negate statin's beneficial effect on CHD mortality in patients with a CHD event risk less than 13% over 10 years. Conclusions  Absolute safety of statins has not been demonstrated for patients at low risk of CHD. Patients absolute risk of CHD should be calculated before starting statin treatment for primary prevention. Extensions of such treatment to low risk patients should await further evidence of safety.
Aims  Increasingly HMG CoA reductase inhibitors (statins) are being used for primary prevention of vascular disease in patients with a raised cholesterol but at low absolute risk of coronary heart disease (CHD). This study uses clinical trial results to explore the limits of absolute safety for statin use in such patients. Methods  The major placebo controlled statin outcome trials were identified by automated and manual literature searches. Principal results including all cause mortality in placebo and intervention groups and baseline values of standard coronary risk factors were ed for each trial. For the trials identified the reduction in overall mortality with statin treatment for each study was regressed against the underlying CHD risk of the population recruited into that trial using a statistically robust method. Results  The regression line describing the relationship between mortality benefit and risk suggests that statin use could be associated with an increase in mortality of 1% in 10 years. This would be sufficiently large to negate statin's beneficial effect on CHD mortality in patients with a CHD event risk less than 13% over 10 years. Conclusions  Absolute safety of statins has not been demonstrated for patients at low risk of CHD. Patients absolute risk of CHD should be calculated before starting statin treatment for primary prevention. Extensions of such treatment to low risk patients should await further evidence of safety.
AIMSIncreasingly HMG CoA reductase inhibitors (statins) are being used for primary prevention of vascular disease in patients with a raised cholesterol but at low absolute risk of coronary heart disease (CHD). This study uses clinical trial results to explore the limits of absolute safety for statin use in such patients.METHODSThe major placebo controlled statin outcome trials were identified by automated and manual literature searches. Principal results including all cause mortality in placebo and intervention groups and baseline values of standard coronary risk factors were abstracted for each trial. For the trials identified the reduction in overall mortality with statin treatment for each study was regressed against the underlying CHD risk of the population recruited into that trial using a statistically robust method.RESULTSThe regression line describing the relationship between mortality benefit and risk suggests that statin use could be associated with an increase in mortality of 1% in 10 years. This would be sufficiently large to negate statin's beneficial effect on CHD mortality in patients with a CHD event risk less than 13% over 10 years.CONCLUSIONSAbsolute safety of statins has not been demonstrated for patients at low risk of CHD. Patients absolute risk of CHD should be calculated before starting statin treatment for primary prevention. Extensions of such treatment to low risk patients should await further evidence of safety.
Increasingly HMG CoA reductase inhibitors (statins) are being used for primary prevention of vascular disease in patients with a raised cholesterol but at low absolute risk of coronary heart disease (CHD). This study uses clinical trial results to explore the limits of absolute safety for statin use in such patients. The major placebo controlled statin outcome trials were identified by automated and manual literature searches. Principal results including all cause mortality in placebo and intervention groups and baseline values of standard coronary risk factors were abstracted for each trial. For the trials identified the reduction in overall mortality with statin treatment for each study was regressed against the underlying CHD risk of the population recruited into that trial using a statistically robust method. The regression line describing the relationship between mortality benefit and risk suggests that statin use could be associated with an increase in mortality of 1% in 10 years. This would be sufficiently large to negate statin's beneficial effect on CHD mortality in patients with a CHD event risk less than 13% over 10 years. Absolute safety of statins has not been demonstrated for patients at low risk of CHD. Patients absolute risk of CHD should be calculated before starting statin treatment for primary prevention. Extensions of such treatment to low risk patients should await further evidence of safety.
Author Haq, Ifti U.
Wallis, Erica J.
Jackson, Peter R.
Ramsay, Lawrence E.
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  surname: Jackson
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  givenname: Ifti U.
  surname: Haq
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  givenname: Lawrence E.
  surname: Ramsay
  fullname: Ramsay, Lawrence E.
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Issue 4
Keywords Human
Enzyme
Treatment efficiency
Coronary artery
Enzyme inhibitor
Cardiovascular disease
Controlled therapeutic trial
Coronary heart disease
Thrombosis
Metaanalysis
Arterial disease
Vascular disease
Prevention
Chemotherapy
Treatment
Placebo
Clinical trial
Hydroxymethylglutaryl-CoA reductase
Oxidoreductases
Comparative study
Bibliographic review
Antilipemic agent
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Snippet Aims  Increasingly HMG CoA reductase inhibitors (statins) are being used for primary prevention of vascular disease in patients with a raised cholesterol but...
Increasingly HMG CoA reductase inhibitors (statins) are being used for primary prevention of vascular disease in patients with a raised cholesterol but at low...
Aims  Increasingly HMG CoA reductase inhibitors (statins) are being used for primary prevention of vascular disease in patients with a raised cholesterol but...
AIMSIncreasingly HMG CoA reductase inhibitors (statins) are being used for primary prevention of vascular disease in patients with a raised cholesterol but at...
SourceID pubmedcentral
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StartPage 439
SubjectTerms Biological and medical sciences
Coronary Disease - etiology
Coronary Disease - mortality
Coronary Disease - prevention & control
drug safety
Female
General and cellular metabolism. Vitamins
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
hydroxymethylglutaryl‐Co A reductase inhibitors
hyperlipidaemia
Hyperlipidemias - complications
Hyperlipidemias - drug therapy
Male
Medical sciences
meta‐analysis
Middle Aged
Pharmacoepidemiology
Pharmacology. Drug treatments
Primary Prevention
Randomized Controlled Trials as Topic
Risk Factors
Title Statins for primary prevention: at what coronary risk is safety assured?
URI https://onlinelibrary.wiley.com/doi/abs/10.1046%2Fj.0306-5251.2001.01478.x
https://www.ncbi.nlm.nih.gov/pubmed/11678788
https://search.proquest.com/docview/72232708
https://pubmed.ncbi.nlm.nih.gov/PMC2014585
Volume 52
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