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New AHA/ACC cholesterol guideline recommends use of statins, new drugs

Loren Bonner















































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The American Heart Association (AHA) and the American College of Cardiology (ACC) released a new guideline that emphasizes a more patient-centered approach to cholesterol management. The guideline, which was published in the November 2018 issue of the Journal of the American College of Cardiology, updates the 2013 AHA/ACC cholesterol guideline and incorporates all recent evidence relevant to the treatment of hypercholesterolemia .

Even though statins continue to be the cornerstone of therapy in the new guideline, health care practitioners—includ ing pharmacists—should know that just starting a statin is not sufficient, according to Joseph Saseen, PharmD, BCPS, BCACP, who was a part of the writing committee for the guideline, serving as APhA’s representative.

“Patients need to be evaluated after implementing therapy to ensure they are adherent, and to also ensure that an adequate response is achieved,” said Saseen, who is vice chair of the department of clinical pharmacy at University of Colorado Skaggs School of Pharmacy.

The updated guideline not only calls for a more personalized assessment of risk for patients, but also recommends nonstatin cholesterol lowering medications, including ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, for patients who are at the greatest risk.

Maximally tolerated statin use is recommended to reduce LDL-C levels by at least 50% in patients who have atherosclerotic cardiovascular disease (ASCVD). But when statins are not working and the patient is very high risk, the guideline endorses the use of new drugs, PCSK9 inhibitors, that have been developed since the 2013 cholesterol guideline—but after starting ezetimibe. The guideline stresses a healthy diet and exercise as the primary intervention for patients who do not fall into these categories.

APhA is listed in the AHA/ACC guideline report as an official partner organization that endorsed the new guideline.





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Individualized treatment decisions


The new guideline, like the 2013 version, still strongly recommends statin therapy for patients who are at an increased risk of ASCVD. It’s recommended that patients use a maximally tolerated statin to reduce LDL-C.

“However, there is now strong emphasis on evaluating the response to therapy by evaluating the LDL-C lowering while on therapy,” said Saseen. “It’s all about the LDL-C lowering achieved—if it’s not acceptable, then it’s recommended to intensify therapy,” he said.

If the threshold LDL-C value is not reached, the guideline recommends enhancing statin therapy and then adding ezetimibe. In some patients, then adding a PCSK9 inhibitor may also be an option.

However, it’s noted in the guideline that PCSK9 inhibitors are likely cost-prohibitive to patients, based on mid-2018 pricing. Evolocumab (Repatha—Amgen) and alirocumab (Praluent—Sanofi-Aventis) both launched in 2015 with a list price of more than $14,000 a year. One manufacturer announced a price reduction this past October to less than $6,000 a year, with the other one expected to do the same.

Karen McConnell, PharmD, FCCP, BCPS-AQ Cardiology, ASH-CHC, system director of Clinical Pharmacy Services at Catholic Health Initiatives in Colorado, found it interesting that the guideline incorporated the cost of PCSK9 inhibitors in the recommendations.

“They used cost considerations to add a value statement on high-cost therapies. I think more guidelines should incorporate this information so clinicians understand the overall cost for medications,” said McConnell, who was appointed by APhA as an expert reviewer of the guideline.

Tools for personalized assessment of risk for patients are included in the guideline. Also emphasized is the need for health care practitioners to have a clinical discussion with their patients, which they can use to guide their choice of therapy.

Assessing an individual’s other risk factors can help further determine risk and allow a patient and clinician to discuss treatment options on the basis of the patient’s specific risk factors. These include metabolic syndrome, a family history of premature ASCVD, kidney disease, chronic inflammatory conditions, HIV, race and ethnicities at a higher risk, elevated lipoprotein(a), or elevated high-sensitivity C-reactive protein.

“It is allowing for more individualized treatment decisions,” said Janelle Ruisinger, PharmD, FAPhA, clinical professor of pharmacy at the University of Kansas School of Pharmacy. She said pharmacists can aid in risk assessment and discussion with patients about treatment decisions.

“Physicians are already pushed to see more patients in less time, so this is an area where pharmacists can assist by engaging in the clinician–patient risk discussion, help patients understand their CV risk, and determine the appropriate treatment route based on the patient’s preferences,” said Ruisinger, who also served as an APhA-appointed expert reviewer of the guideline.

She said the same is true for conversations about lifestyle modifications that the guideline calls for. Pharmacists are fully equipped to educate patients about the importance of diet, exercise, and more.

Separate sections in the guideline discuss recommendations for special populations, such as older adults, and for patients with certain conditions, such as heart failure.




Pharmacists influence adherence


The guideline specifically mentions the important role of pharmacists on the health care team when treating patients with hypercholesterolemia .

“The 2018 version recognizes that pharmacists can have a positive impact on adherence, which is a constant struggle with lipid-lowering medications,” said Ruisinger.

McConnell said pharmacists in all settings can contribute. Those working in ambulatory care can make sure their chronic care patients are on appropriately dosed statins, are adherent to their medications, and have had an appropriate response to therapy. Pharmacists working in inpatient settings need to ensure patients are discharged on an appropriate secondary prevention medication, including those for lipids. In the community setting, a pharmacist can play a role in making sure patients are adherent to their medications, McConnell said, and if they are complaining about adverse reactions, pharmacists can work with their provider to find alternatives.

In addition to the AHA/ACC guideline, other guidelines exist for managing patients’ cholesterol: The National Lipid Association (NLA) Recommendations for Patient-Centered Management of Dyslipidemia; the American Association of Clinical Endocrinologists and the American College of Endocrinology Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease; and the U.S. Preventive Services Task Force’s statement on Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication.

Ruisinger said she thinks it’s important to be aware of the other guidelines. However, pharmacists should ultimately follow whatever their health care team chooses.

“Most practitioners follow the AHA/ACC guidelines, and a few follow the NLA guidelines,” said Ruisinger. “If the pharmacist is working with a primary care practitioner group that prefers to follow the NLA guidelines, that is reasonable. I think it is important that the team is on the same page and following the same guidelines or recommendations.”

The 2018 AHA/ACC guideline is based on a few key studies that were published since the 2013 guideline, including HOPE-3 (Heart Outcomes Prevention Evaluation-3); IMPROVE-IT (The Improved Reduction of Outcomes: Vytorin Efficacy International Trial); FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk); and ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab).