Insights: Evolocumab in Primary Prevention? Key Takeaways From VESALIUS-CV

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 the clinical significance of the VESALIUS-CV (NCT03872401) trial and its potential to reshape lipid-lowering strategies for patients with elevated cardiovascular risk. Saseen described VESALIUS-CV as a pivotal, fully published, double-blind, randomized, placebo-controlled trial conducted by the Thrombolysis in Myocardial Infarction (TIMI) investigators that evaluated the impact of evolocumab (Repatha; Amgen) in a broader population than traditionally studied in proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor trials.

Unlike prior studies that focused primarily on very high-risk patients with recent acute coronary syndromes, VESALIUS-CV enrolled both secondary prevention patients with stable coronary, cerebrovascular, or peripheral arterial disease and high-risk primary prevention patients with diabetes. Importantly, the trial also included individuals with subclinical atherosclerotic cardiovascular disease identified by elevated coronary artery calcium scores, many of whom had never experienced a cardiovascular event. All participants were receiving maximally tolerated low-density lipoprotein (LDL)-lowering therapy, primarily statins, yet still had inadequately controlled atherogenic markers, including LDL cholesterol (LDL-C) of 90 mg/dL or higher, non–high-density lipoprotein cholesterol of 120 mg/dL or higher, or apolipoprotein B of 80 mg/dL or higher.

If you haven’t heard of the VESALIUS-CV study and you manage patients who have lipid disorders, you need to read it—it’s a game changer. - Joseph Saseen, PharmD, BCPS, BCACP, CLS

Over a median follow-up of 4.6 years, evolocumab produced substantial LDL-C reductions, with median LDL-C levels reaching approximately 45 mg/dL compared with 109 mg/dL in the placebo group. More importantly for clinical practice, these reductions translated into statistically significant decreases in both 3-point and 4-point major adverse cardiovascular events (MACE), demonstrating meaningful cardiovascular benefit across a less traditionally studied population. For pharmacists, these findings expand the evidence base supporting more aggressive LDL-lowering in selected high- and higher-risk patients, including those in primary prevention settings.

Saseen emphasized that PCSK9 inhibition should be viewed as an adjunct—not a replacement—to statin therapy, reinforcing the pharmacist’s role in optimizing combination lipid-lowering regimens to reduce long-term cardiovascular risk.

Watch part 1 of this video interview here.