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Published on: September 26, 2018
Cardiovascular primary prevention: how high should we set the bar?
Vinay Prasad1, Andrae Vandross
1Department of Medicine, Northwestern University, Chicago, IL 60611, USA. v-prasad@md.northwestern.edu
New cardiovascular drug trials show extended-release niacin and fenofibrate offer no mortality benefit alongside statins. The high cost of these medications necessitates higher evidence standards for cardiovascular primary prevention. Future recommendations require demonstrated improvements in overall mortality.
Area of Science:
- Cardiovascular Medicine
- Clinical Trials
- Pharmacoeconomics
Background:
- Extended-release niacin and fenofibrate have been commonly used as add-on therapies to statins for cardiovascular primary prevention.
- Recent clinical trials have yielded results that contradict established clinical practice regarding these medications.
Purpose of the Study:
- To evaluate the efficacy of extended-release niacin and fenofibrate in improving mortality when used with statin therapy.
- To propose revised standards for the recommendation and use of novel agents in cardiovascular primary prevention based on recent trial outcomes.
Main Methods:
- Review of recent large-scale clinical trials investigating the impact of extended-release niacin and fenofibrate on mortality in patients receiving statin therapy.
- Analysis of the cost-effectiveness and established practice surrounding cardiovascular primary prevention medications.
Main Results:
- Extended-release niacin and fenofibrate failed to demonstrate a mortality benefit when added to statin therapy.
- Significant financial investment in cardiovascular primary prevention drugs like statins, ezetimibe, and fenofibrate has been noted.
Conclusions:
- The efficacy of extended-release niacin and fenofibrate as add-on therapies to statins for cardiovascular primary prevention is not supported by recent evidence.
- A higher bar, requiring demonstrated improvements in overall mortality from large studies, should be established before recommending and utilizing novel agents in cardiovascular primary prevention.
- The findings necessitate a re-evaluation of current practices and the economic implications of cardiovascular drug spending.
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