Expert: Debunking Cholesterol Myths and the Rise of Oral PCSK9 Inhibitors

In an interview with Pharmacy Times, Joseph Saseen, PharmD, BCPS, BCACP, CLS, professor and associate dean for clinical affairs in the Department of Clinical Pharmacy at the University of Colorado Anschutz Skaggs School of Pharmacy and Pharmaceutical Sciences, discussed persistent misconceptions surrounding cholesterol management and highlighted emerging lipid-lowering therapies that may significantly expand treatment options for patients struggling to reach low-density lipoprotein (LDL) cholesterol (LDL-C) goals.¹

Saseen emphasized that misinformation remains a major challenge in cardiovascular risk counseling, particularly the belief that elevated cholesterol is harmless or physiologically necessary. He stressed that robust evidence consistently demonstrates a clear association between high LDL-C levels and increased risk of atherosclerotic cardiovascular disease, including myocardial infarction, ischemic stroke, peripheral arterial disease, and cardiovascular mortality. Genetic conditions such as heterozygous and homozygous familial hypercholesterolemia, in which patients experience markedly elevated LDL-C from an early age, provide compelling proof of cholesterol’s causal role in cardiovascular disease.

Saseen also addressed misconceptions surrounding statin therapy, noting that despite being among the most extensively studied drug classes in medicine, statins are frequently viewed with skepticism due to concerns about adverse effects, particularly muscle-related symptoms. While acknowledging that intolerance can occur in a subset of patients, he reinforced that the overall benefit–risk profile of statins overwhelmingly favors their use in the majority of individuals at elevated cardiovascular risk.

If your cholesterol is elevated, there’s an increased risk of atherosclerotic cardiovascular disease—heart attacks, ischemic stroke, peripheral arterial disease, and cardiovascular death—and that’s based on proof and evidence. - Joseph Saseen, PharmD, BCPS, BCACP, CLS

Looking ahead, Saseen highlighted the significance of data presented at the 2025 American Heart Association Scientific Sessions on enlicitide decanoate (Merck & Co.), an investigational oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. Unlike currently available PCSK9-targeted therapies, which are administered by injection, the oral enlicitide decanoate demonstrated LDL-C reductions exceeding 50% in clinical studies, comparable to injectable monoclonal antibodies. For pharmacists, the potential availability of an oral PCSK9 inhibitor represents an important advancement, offering a more acceptable and scalable option for patients who are unable or unwilling to use injectable therapies. Saseen noted that as this therapeutic class continues to evolve, pharmacists will play a critical role in patient education, therapy selection, and optimizing long-term cardiovascular risk reduction.

REFERENCE

1. Directory—Skaggs School of Pharmacy and Pharmaceutical Sciences. University of Colorado Anschutz. Accessed February 3, 2026. https://pharmacy.cuanschutz.edu/about-us/profile/joseph-saseen