Ann Marie Navar explains how enlicitide decanoate delivers LDL-C reductions comparable with injectable PCSK9 inhibitors, which could improve access to nonstatin therapy for patients not at goal.
In a Pharmacy Times® Explainer, Ann Marie Navar, MD, PhD, an associate professor of medicine (cardiology) at UT Southwestern Medical School and study investigator in CORALreef Lipids (NCT05952856), explains the significance of enlicitde decanoate’s (Merck & Co.)
While statins remain first-line, Navar notes that many patients still fail to reach LDL-C targets, creating a need for additional nonstatin options. An oral PCSK9 inhibitor may reduce clinical inertia and improve uptake among prescribers hesitant to use injectables. Pharmacists will play a key role in counseling patients on proper administration, including taking enlicitide first thing in the morning on an empty stomach, and in ensuring routine LDL-C monitoring to identify eligible patients. Ongoing outcomes research will further clarify enlicitide’s cardiovascular benefits.
Pharmacy Times: How should pharmacists interpret the LDL-C reductions observed in CORALreef Lipids in the context of current lipid-lowering strategies?
Ann Marie Navar, MD, PhD: Enlicitide provides LDL-C lowering efficacy comparable with what has been seen for injectable PCSK9 monoclonal antibodies (mAbs). Statins should still always come first, but we know many people still don’t get to their cholesterol goal even on a high-intensity statin. With a nearly 60% reduction in LDL-C when given on top of background therapy, this offers a great option for patients who are above goal and need additional nonstatin therapy.
Pharmacy Times: Oral PCSK9 inhibition represents a shift from the injectable PCSK9 inhibitors many clinicians currently prescribe. What advantages or challenges do you think this oral option might bring for pharmacists and patients in everyday practice?
Navar: The biggest advantage, I hope, is that clinicians will feel more comfortable prescribing this than they have the injectables. We have seen low uptake of the mAbs in primary care, and even a large minority of cardiologists have never prescribed one. I hope that an easy-to-use and easy-to-prescribe oral option helps overcome clinical inertia in the use of nonstatins.
Pharmacy Times: From a pharmacy perspective, what essential counseling points should pharmacists provide patients who may be candidates for an oral PCSK9 inhibitor like enlicitide?
Navar: For now, patients still have to wait for the drug to be approved and on the market. It will be great for patients who need additional lipid-lowering therapy now and do not want to use an injectable. Pharmacists will be critical once it’s available to help remind patients they need to take this first thing in the morning on an empty stomach, like we currently teach patients taking levothyroxine sodium (Synthroid; AbbVie). Importantly, in the CORALreef Lipids trial, participants could take enlicitide along with their statin and a small glass of water.
Pharmacy Times: Many patients on statins still do not reach LDL-C targets. How might the availability of an effective oral PCSK9 inhibitor change the treatment paradigm, and what role can pharmacists play in identifying appropriate patients for this therapy?
Navar: The most important step in LDL-C control is for patients to have their LDL-C levels routinely measured. We can’t fix what we don’t measure.
Pharmacy Times: Is there anything else that you would like to add or that I did not mention?
Navar: The ongoing CORALreef Outcomes trial will help provide data on the cardiovascular benefit of enlicitide. Based on its mechanism of action being so similar to alirocumab and evolocumab, I have no reason to believe this will not also prevent cardiovascular disease.
Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.
