It was no shock to attendees at the 2019 Directions in Pharmacy conference that 28.5 million adult Americans have cholesterol levels exceeding acceptable parameters. Joseph Saseen, PharmD, BCPS, BCACP, CLS, who is Professor and Vice Chair from the University of Colorado Anschutz Medical Campus, presented a concise and focused session that covered recent changes to cholesterol treatment guidelines and evidence-based recommendations.

Lifestyle modifications are an important treatment component, but medications are often necessary. A number of professional organizations, including the American Pharmacist Association, joined together to update the Guideline on the Management of Blood Cholesterol. This group of organizations found that certain populations benefit from statin use. For example, individuals who have clinical atherosclerotic cardiovascular disease (ASCVD) need to use statins for secondary prevention. Groups that benefit from primary prevention include those whose LDL-C is 190 mg/dL or higher, people with diabetes (type 1 or type 2) who are between the ages of 40 and 75 years, and individuals between the ages of 40 and 75 years whose 10-year ASCVD risk is elevated.

Dr. Saseen discussed statin intensity, differentiating highintensity therapy from moderate-intensity and low-intensity statin regimens. High-intensity statins can reduce LDL-C by 50% or more, while moderate-intensity statins will reduce LDL-C by 30% to 49%, and low-intensity statins will reduce LDL-C by less than 30%. He indicated that these reductions were identified in the VOYAGER database.

While health care providers have repeatedly turned to statins to help lower elevated cholesterol for many years, they have certain limitations. One of them is that clinicians may under-use these medications, failing to initiate or intensify treatment as indicated. In addition, some patients fail to achieve the desired effect even at maximum doses. Some patients have been unable to adhere to these medications, and research indicates that between 40% and 75% of patients discontinue statin therapy within 1 year. About 10% of patients report muscle pain or soreness, now referred to as statin-associated muscle symptoms (SAMS). These claims may be exaggerated and may also be a reason for clinical inertia.

Dr. Saseen covered proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, the focus of this session, in detail. Alirocumab and evolocumab are fully human monoclonal antibodies against PCSK9. Studies have found that in patients with clinical ASCVD, these biologics reduce LDL-C by 55% to 59%. Both of these biologics are dosed subcutaneously, and they have no clinically significant drug interactions. Alirocumab and evolocumab have been associated with some injection-site reactions. The 2018 guidelines discuss the appropriate role in therapy of the PCSK9 inhibitors. Both of these medications have been shown to reduce the risk of cardiovascular events when added to maximally tolerated statin therapy. The 2018 cholesterol guideline now recommends that clinicians consider the addition of a PCSK9 inhibitor in patients with very high risk ASCVD, in addition to maximally tolerated statin therapy and ezetimibe if LDL-C remains 70 mg/dL or higher.

For patients who have extremely elevated cholesterol, additional intervention may be needed. Ezetimibe is a reasonable addon medication in patients who are between 20 and 75 years and experience less than a 50% reduction in LDL-C despite maximum tolerated statin therapy. If after increasing the statin to its highest tolerated level and adding ezetimibe LDL-C remains high, clinicians may also consider bile acid sequestrants if triglycerides are not elevated, although this approach has more adverse effects. Clinicians can also consider the addition of a PCSK9 inhibitor to maximally tolerated statin therapy with ezetimibe, if additional LDL-C lowering is needed.

Recently, both PCSK9 inhibitors came down in price. Current pricing is below 00 annually, whereas their prices in mid- 2018 were approximately ,000 annually.

Pharmacists have a significant influence when it comes to selecting therapies for elevated cholesterol. They should follow the 2018 cholesterol guideline and each product’s FDA-approved prescribing information to ensure that patients have an FDA-approved indication and cholesterol levels that meet the guideline requirements. Pharmacists should note that both of the newer biologic products often require prior authorization, although the restrictions have been loosened since the 2018 guideline update and their prices were adjusted.

Key areas where pharmacists need to intervene are ensuring that patients are adherent and assisting with patient– clinician shared decision making. In the case of biologics, it is especially important to talk about handling possible injectionsite reactions, what to do if a patient misses a dose in a 2-week or 4-week schedule, and proper storage. Decision-driving conversations should cover risk reduction benefits, potential adverse effects, drug–drug interactions, and, most importantly, patient preferences.