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Statins for primary prevention: at what coronary risk is safety assured?
P R Jackson1, E J Wallis, I U Haq
1Section of Clinical Pharmacology and Therapeutics, University of Sheffield, Floor L, Hallamshire Hospital, Sheffield S10 2JF. Peter.R.Jackson@shef.ac.uk
Insights
Statins may increase mortality by 1% over 10 years in low-risk patients, negating benefits for those with coronary heart disease (CHD) event risk below 13%. Absolute safety for primary prevention in low-risk individuals remains unproven.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Preventive Cardiology
Background:
- HMG CoA reductase inhibitors (statins) are increasingly prescribed for primary vascular disease prevention.
- Use is expanding to patients with elevated cholesterol but low absolute coronary heart disease (CHD) risk.
Purpose of the Study:
- To investigate the absolute safety limits of statin therapy in patients at low risk for CHD.
- To determine the threshold of CHD risk below which statin benefits may be negated by potential harms.
Main Methods:
- Systematic literature review of major placebo-controlled statin outcome trials.
- Abstraction of all-cause mortality and baseline coronary risk factors.
- Regression analysis of statin-induced mortality reduction against population CHD risk.
Main Results:
- A 1% increase in 10-year mortality associated with statin use was suggested by regression analysis.
- This potential mortality increase could offset CHD benefits in patients with <13% 10-year CHD event risk.
Conclusions:
- The absolute safety of statins for low-risk CHD patients is not established.
- Calculating individual CHD risk is crucial before initiating statin primary prevention.
- Further evidence on safety is needed before extending statin use to low-risk populations.
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.
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