People With ASCVD Often Not Treated Sufficiently in US

A new study has highlighted the significant clinical burden of those with or at risk for atherosclerotic cardiovascular disease (ASCVD), leading to substantial healthcare resource use and costs in the United States (US).¹

“Observational evidence suggests that despite the use of high-intensity statin monotherapy, as well as the availability of several adjunctive therapies for LDL-C lowering, achievement of LDL-C goals is suboptimal, and most patients remain at increased risk of ASCVD and recurrent events, leading to poor clinical and economic outcomes.² A comprehensive study of the extent of LDL-C goal attainment in the statin-treated US population with hypercholesterolemia, particularly stratified according to primary and secondary prevention settings, and its effects on clinical outcomes as well as healthcare utilization and costs was an important evidence gap,” study investigator Nancy Ortiz, PharmD, Global Head, Medical Strategy & Evidence Generation, New Amsterdam Pharma, Aventura, Florida, and colleagues wrote.¹

Ortiz and colleagues collected MarketScan administrative claims data from 2017–2021, which were linked to laboratory data, to identify patients with hypercholesterolemia followed for 2 years. They estimated the numbers of statin-treated hypercholesterolemia patients in primary prevention, very high-risk or not very high-risk secondary prevention, and their LDL-C goal achievement, and correlated these values to national estimates, along with annualized healthcare resource utilization and costs. They also evaluated cardiovascular events according to LDL-C goal attainment.

The investigators found that almost 125,000 statin-treated patients did not meet LDL-C goals, which, when applied to US national estimates. Inflating their data to national estimates demonstrated that approximately 72 million (M) patients have hypercholesterolemia, 43 M of which were classified as primary prevention (∼40% above goal), 9.8 M as very high-risk secondary prevention (∼78% above goal), and 9.1 M as not very high-risk secondary prevention (∼60% above goal) that are treated with statins, and 9.5 M that are untreated (∼84% above goal).

Importantly, the investigators found that managing LDL-C to goal was associated with a 50% reduction in the rate of patients that had a cardiovascular event. They found that the largest difference was for myocardial infarction (MI), with 14% of patients with LDL-C above goal experiencing a myocardial infarction compared to 5% of patients at their goal. Further benefits of LDL-C goal achievement were seen for stroke/transient ischemic attack (10% vs. 8%), percutaneous coronary intervention (4% vs. 1%), and coronary artery bypass graft (1% vs. 0%).¹

They also found that the rates of patients utilizing high-cost healthcare services and annualized healthcare costs increased as patients progressed from primary to secondary prevention, and from not very high- to very high-risk secondary prevention. Emergency department visits were over 45% more common in secondary prevention patients compared with those in primary prevention (63% vs. 43%). Inpatient stays occurred in 150% more patients (49% vs. 20%), and use of long-term care or skilled nursing facilities was 267% higher (11% vs. 3%). Among secondary prevention patients, those classified as very high risk had 34% more emergency department visits, 100% more inpatient stays, and 220% greater use of long-term care facilities compared with those not at very high risk.¹

Annualized healthcare costs were also higher in secondary prevention, with total yearly costs of $14,100 compared with $6300 in primary prevention. Secondary prevention patients incurred substantially greater medical and pharmacy expenses, with medical costs 158% higher and pharmacy costs approximately 60% higher. Similar differences were observed when comparing very high-risk and not very high-risk secondary prevention patients, with medical costs 101% higher and pharmacy costs 34% higher in the very high-risk group.¹

“Elevated LDL-C is highly prevalent in the US population, with over 30 million patients across primary ASCVD prevention and secondary prevention contexts. It is important to control LDL-C to reduce and manage transitions in the risk continuum. Among patients with ASCVD, most are considered at very high risk for a secondary cardiac event and accrue higher healthcare resource utilization and costs compared to ASCVD patients not at very high risk and primary prevention patients. Despite taking statins, residual cardiovascular risk remains, and patients above their LDL-C goals are exposed to more frequent healthcare utilization and high direct medical costs. Consequently, providers and patients need additional LDL-C lowering options to close this treatment gap,” Ortiz and colleagues concluded.¹

References

1. Ortiz N, Shehata J, Smart J, et al. Assessment of unmet clinical needs and healthcare resource use among statin-treated patients with or at risk of developing atherosclerotic cardiovascular disease. J Med Econ. 2025;28(1):1616-1625. doi:10.1080/13696998.2025.2558314

2. Navar AM, Shah NP, Shrader P, et al. Achievement of LDL-C <55 mg/dL among US adults: Findings from the cvMOBIUS2 registry. Am Heart J. 2025;279:107-117. doi:10.1016/j.ahj.2024.06.012