Utilization of Statins: Guiding Principles and the New United States Guidelines

and coronary artery bypass grafts of 25% and coronary death of 22% [6] . In subsequent analyses of an additional 40,000 patients randomized to more or less intensive statin therapy, those assigned to more intensive statin therapy achieved greater benefits. A more recent subgroup analysis was conducted among the randomized subjects with a 5-year risk lower than 10%. Their mean risks were 2.6% for major coronary events plus 3% for other major vascular events, even in those with no previous history of vascular disease, diabetes mellitus, or chronic kidney disease. Thus, these low-risk subjects had a 10-year risk of vascular events of less than 20%, which corresponds to a 10-year risk of coronary events of less than 10%. The results in these lowrisk subjects were markedly consistent with secondary prevention patients and high-risk primary prevention subjects [7] . The hypothesis that statins are effective and safe for such subjects is being tested in a large-scale trial designed a priori to test the hypothesis [8] . Meanwhile, however, these findings add importantly relevant information to any individual judgment by the clinician as to whether to prescribe the drug to any such low-risk subjects [9] . In patients and subjects in every risk category, the size of the proportional reduction in major vascular events is directly proportional to the absolute reduction in lowdensity lipoprotein (LDL) cholesterol that is achieved. In addition, there is no threshold for LDL cholesterol below which there are no further benefits. These findings suggest that the primary goals for patients at high and moderate risk of occlusive vascular events should be to achieve the largest LDL cholesterol reduction possible. Further, the data show that this can be achieved without any material increases in the risk of myopathy. Finally, they also indicate that greater reductions in LDL cholesterol produce Despite remarkable declines in mortality, cardiovascular disease (CVD) will remain the major cause of premature death in the United States and is becoming the major cause of premature deaths worldwide [1] . The small-to-moderate net benefits of statins in the treatment and prevention of CVD are statistically significant and clinically important for this common and serious disease [2] . There is a large, robust, and consistent totality of evidence that includes cogent findings from basic research, descriptive and observational analytic epidemiological studies as well as large-scale randomized trials [3] . For the reliable detection of smallto-moderate effects, randomized evidence is crucial because the amount of uncontrolled and uncontrollable confounding inherent in all nonrandomized design strategies may be as big as the effect sizes [4] . Randomized evidence is necessary to develop guidelines which have recently been revised and widely disseminated throughout the USA [5] . We believe that such guidelines are necessary but not sufficient for astute clinical judgments. In this manuscript we prefer general guiding principles to further aid the clinician to making the best individual judgment after weighing the benefits and risks of a statin in light of the entire risk profile of the patient. The benefits and risks of statins have recently been updated in comprehensive worldwide meta-analyses of large-scale randomized trials designed a priori to test the hypothesis in secondary prevention patients as well as high-risk primary prevention subjects [6] . The meta-analyses include individual participant data from 26 randomized trials of about 170,000 secondary prevention patients and high-risk primary prevention subjects. Those assigned at random to a statin had statistically significant and clinically important reductions in myocardial infarction of about 30%, stroke of 15%, the need for stents Received: December 16, 2013 Accepted: December 16, 2013 Published online: February 8, 2014