Pharmacotherapy Newsletter

Volume 1, Issue 13, 04/13/2009

Question

What data supports the use of statins (HMG-CoA Reductase inhibitors) for the primary prevention of cardiovascular (CVD) or coronary heart disease (CHD)?

Answer

Cardiovascular disease (CVD) is clearly one of the leading causes of mortality in the world.¹ It is estimated that 17 million deaths related to CVD occur every year.  As a result, the World Heart and Stroke Forum (WHSF) Guidelines Task Force of the World Heart Federation (WHF) recommended that each country develop a policy on CVD prevention.¹  This not only includes treating those with existing CVD (secondary prevention) but also includes developing strategies for identifying and treating patients at high risk for a primary event (e.g. myocardial infarction (MI) or stroke).  In the United States (U.S.), the National Heart Lung and Blood Institute of the National Institutes of Health have been publishing the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) recommendations for the prevention and treatment of CVD since 1993.²  The current report from 2001 provides treatment recommendations for patients who have risk factors for CVD but have yet to have an event (i.e. primary prevention).^2,3  In particular, ATP III recommends that the primary focus of evaluation and treatment be reducing LDL cholesterol (LDL-C) to specific goals.^2,3  This is because it has been well established that LDL-C concentrations have a direct effect on the rate of new-onset coronary heart disease (CHD) in men and women who are initially free of CHD.^4-7  This is especially true when the LDL-C is greater than 100 mg/dL, which appears to be atherogenic.  The class of drugs primarily used to target the LDL-C are the HMG CoA Reductase inhibitors (statins).^2,3,7  As with any set of guidelines available in a time where the standard is evidenced based medicine, the recommendations to treat primary prevention patients with CV risk factors should be based on data that demonstrates benefit for clinically relevant, patient-oriented outcomes (CV events, mortality, etc.), not just surrogate endpoints (such as LDL-C levels only).  So what data is available that support the use of statins for the primary prevention of CVD?