Impact of the New ACC/AHA Guidelines on the Treatment of High Blood Cholesterol in a Managed Care Setting

In November 2013, the American College of Cardiology (ACC) and the American Heart Association (AHA) released together new clinical guidelines for the treatment of patients with high blood cholesterol.1 The 2013 guidelines provide a new paradigm for cholesterol management in the primary and secondary prevention of coronary artery disease (CAD); these recommendations are based on clinical evidence from randomized controlled trials of cholesterol-lowering therapies rather than on expert consensus as in previous guidelines.2,3 Before the 2013 guidelines, the Adult Treatment Panel (ATP) III report of the National Cholesterol Education Program was the main clinical guideline for the primary and secondary prevention of CAD.4 The ATP III recommends statin therapy in patients with established cardiovascular (CV) disease or diabetes whose low-density lipoprotein cholesterol (LDL-C) levels are ≥100 mg/dL, or in patients with a combination of elevated LDL-C levels and a 10-year risk for CAD based on the Framingham risk calculator.4 The primary focus of the ATP III guideline was on a treat-to-target strategy, in which lipid-modifying medications were titrated to achieve specific LDL-C levels. Based on clinical trials that have shown that LDL-C–lowering therapy reduces the risk for CAD, the ATP III guideline used LDL-C as the target of cholesterol-lowering therapy.4 This recommendation diverges from current clinical evidence, because there are no major randomized clinical trials that have tested the benefits of treating patients to LDL-C targets. The 2013 ACC/AHA clinical guidelines no longer recommend the treat-to-target strategy for the management of cholesterol levels in patients with CAD, and instead recommend the use of fixed-dose, high-intensity and fixed-dose, moderate-intensity statin therapies to treat high-risk populations. These high-risk groups include patients with clinical atherosclerotic CV disease (ASCVD), patients with primary LDL-C elevations of ≥190 mg/dL, patients with diabetes who are aged 40 to 75 years, or patients aged 40 to 75 years without diabetes or ASCVD but with LDL-C levels between 70 mg/dL and 189 mg/dL whose estimated 10-year ASCVD risk is ≥7.5% based on a new risk calculator.1 Overall, with a focus on treating high-risk groups with cholesterol-lowering therapies that have been shown in randomized clinical trials to reduce the risk for ASCVD, the 2013 ACC/AHA guidelines recommend the use of statins for ASCVD risk reduction. The guidelines no longer recommend the use of nonstatin cholesterol-lowering therapies for ASCVD risk reduction, and they expand statin therapy for the primary prevention of ASCVD in patients with lower LDL-C levels who are at an increased risk for ASCVD. Recently, Pencina and colleagues projected that the 2013 guidelines would increase the number of US adults who would be eligible for statin therapy, with the greatest increase expected to be in adults aged 60 to 75 years.5 However, the potential impact of the 2013 cholesterol treatment guidelines on the pharmacy utilization of statin and nonstatin cholesterol-lowering medications in a managed care organization remains unknown. In this present study, therefore, we sought to estimate the impact of the 2013 guidelines on the pharmacy utilization of cholesterol-lowering medications in various risk groups in a managed care setting.