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Guidelines versus trial-evidence for statin use in primary prevention: The Copenhagen General Population Study
Martin Bødtker Mortensen1, Børge Grønne Nordestgaard2
1Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; The Department of Clinical Biochemistry and The Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Insights
Most individuals recommended for statin therapy in primary prevention have direct randomized controlled trial (RCT) evidence. Guideline-based statin allocation is more efficient for preventing atherosclerotic cardiovascular disease (ASCVD) events than relying solely on RCT evidence.
Area of Science:
- Cardiovascular Medicine
- Preventive Cardiology
- Clinical Trial Evidence
Background:
- Risk calculators guide statin therapy for primary prevention, but their use lacks randomized controlled trial (RCT) validation.
- Current guidelines from major cardiovascular societies (ACC/AHA, CCS, NICE, ESC/EAS) recommend statin use based on risk assessment.
Purpose of the Study:
- To assess the extent to which guideline-based statin recommendations align with existing RCT evidence.
- To evaluate the efficiency of guideline-directed statin allocation versus RCT-based allocation for primary prevention of atherosclerotic cardiovascular disease (ASCVD).
Main Methods:
- Analysis of 79,171 individuals from the Copenhagen General Population Study, free of ASCVD and prior statin use.
- Assessment of direct RCT evidence supporting statin efficacy for individuals meeting guideline criteria.
- Calculation of the number needed to treat (NNT) to prevent one ASCVD event.
Main Results:
- A high percentage of individuals eligible for statin therapy under ACC/AHA (86%), CCS (88%), NICE (88%), and ESC/EAS (84%) guidelines had direct RCT evidence of efficacy.
- Individuals recommended for statins by guidelines represented 26-37% of the total cohort.
- The NNT to prevent one ASCVD event in 10 years ranged from 19-21 for guideline-recommended statin users with RCT support, increasing significantly for those without direct RCT evidence.
Conclusions:
- The majority of individuals recommended for primary prevention statin therapy by current guidelines are supported by direct RCT evidence.
- Guideline-based statin allocation demonstrates greater efficiency in preventing ASCVD events, indicated by lower NNT, compared to allocation based solely on RCT evidence.
Background And Aims:
Guideline-recommended use of risk calculators to select for statin therapy in primary prevention has never been tested in a randomized controlled trial (RCT). We determined the extent to which guideline-based statin recommendations from the American College of Cardiology/American Heart Association (ACC/AHA), Canadian Cardiovascular Society(CCS), UK National Institute for Health and Care Excellence (NICE), and European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) is supported by available evidence from RCTs.
Methods:
79,171 individuals from the Copenhagen General Population Study who were free of ASCVD and statin use at baseline were included. RCT evidence supporting guideline-recommended statin allocation and the estimated number needed to treat (NNT) to prevent one ASCVD event were assessed.
Results:
During 8.2 years of follow-up, 4031 ASCVD events occurred. Of individuals eligible for statin therapy with the ACC/AHA, CCS, NICE and ESC/EAS guidelines, 86%, 88%, 88% and 84% had direct RCT evidence of statin efficacy, respectively (guideline-positive&RCT-positive). This group represented 26-37% of all 79,171 individuals, while guideline-positive&RCT-negative individuals represented 5-7%, guideline-negative&RCT-positive individuals 28-39%, and guideline-negative&RCT-negative individuals represented 30-31%. The ASCVD events per 1000 person-years were 11.4-12.7 (guideline-positive&RCT-positive), 6.3-8.0 (guideline-positive&RCT-negative), 4.2-5.2 (guideline-negative&RCT-positive), and 2.3-2.5 (guideline-negative&RCT-negative), respectively, while the corresponding NNT to prevent one event in 10 years using high-intensity statin were 19-21, 30-32, 48-60, and 105-125, respectively.
Conclusions:
The far majority of individuals eligible for guideline-recommended primary prevention with statins have direct RCT evidence supporting statin use. Allocating statins based on guideline-criteria is more efficient with lower NNT for preventing ASCVD events than allocating statin therapy based solely on RCT evidence.
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