Abstract Body (Do not enter title and authors here): Background: Early intervention with lipid lowering therapy (LLT) in patients with high cardiovascular (CV) risk before myocardial infarction or stroke may have substantial public health benefits, despite being perceived as less urgent. The effect of evolocumab in this population is being investigated in an ongoing clinical trial (NCT03872401: Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke [VESALIUS-CV]). The current ongoing observational study examines the global burden of a VESALIUS-CV-like population in the REAL-world (“VESALIUS-REAL") in eight regions. We present data here on baseline characteristics and LLT of VESALIUS-CV like patients in the US.

Methods: Using the eligibility criteria aligned with VESALIUS-CV (Figure), data were extracted from HealthVerity medical and pharmacy claims (2016-2023). A two-year observability period was required before index date; therefore, the first possible cohort entry was on January 1, 2018.

Results: There were 518,852 VESALIUS-CV like patients with median age of 72 years (Q1-Q3: 64-79 years) and 56% were female (Table). Overall, 43% had coronary artery disease and 34% had high-risk diabetes mellitus (DM). Median low density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol and apolipoprotein B were 114 (Q1-Q3: 97-138) mg/dL, 141 (122-168) mg/dL and 92 (181-110) mg/dL, respectively. About 22% were on background LLT of whom 87% were on statins alone. Patients on LLT vs. no LLT were younger (median age 65 [Q1-Q3: 59-72] vs. 73 [66-80] years), had higher prevalence of tobacco users (29% vs. 17%) and high-risk DM (45% vs. 31%).

Conclusions: In a large cohort of VESALIUS-CV like US patients, the majority had LDL-C sub-optimally managed with most not taking any LLT. This finding suggests an opportunity to reduce the treatment gap and improve lipid management in this population.