Cardiovascular primary prevention: how high should we set the bar?

Recent trials in cardiovascular medicine have contradicted current practice, and, accordingly, are medical reversals. Extended-release niacin and fenofibrate have failed to provide mortality benefit when added to statin therapy, though both drugs have been used for this purpose for years. Cardiovascular primary prevention is no small matter. Annual spending on statins exceeded $19 billion in 2005, ezetimibe cost over $5 billion in 2007, and fenofibrate costs passed $1 billion in 2009. Given the tremendous price of these medications, and recent trials that have undermined years of practice, we propose that the bar for cardiovascular primary prevention has been raised. Large studies must show improvements in overall mortality before novel agents are recommended and used. The implications of this proposal are considered.