OBJECTIVES: Atherosclerotic cardiovascular disease (ASCVD) leads to considerable clinical and economic burdens. Primary prevention and secondary prevention of cardiac events seek to control low-density lipoprotein cholesterol (LDL-C) to established goals, which vary based on prevention setting and patient factors. Statins aim to lower LDL-C and are first-line treatment. Many patients struggle controlling LDL-C, despite use of statins, leading to poor health outcomes. The study objective was to estimate US unmet clinical needs, healthcare utilization and costs in primary and secondary prevention settings, based on LDL-C goal attainment.

METHODS: This retrospective cohort study leveraged 2020-2021 MarketScan administrative claims linked to laboratory data, to assess the clinical and economic burden of statin-treated patients not at LDL-C goals. Patients taking statins were segmented into 6 groups based on the prevention setting, LDL-C goal attainment, and risk level (secondary prevention). The number of statin treated patients in each segment was estimated and inflated to national estimates, along with annualized healthcare resource utilization and all-cause healthcare costs.

RESULTS: Almost 125,000 statin treated patients did not meet LDL-C goals. The US national estimates suggest that 7.8 and 9.7 million patients in primary prevention were above and far above goal, respectively. In secondary prevention, 5 million and 8 million patients were above and far above goals. High healthcare utilization emerged in multiple settings of care (e.g., outpatient, inpatient, and emergency department) across prevention settings and risk levels. Mean annual costs for primary prevention above goal were approximately $9,000, while annualized costs for not high risk and very high-risk secondary prevention above goal were approximately $14,000 and $27,000, respectively.

CONCLUSIONS: Millions of patients on statins are not achieving their LDL-C goals, indicating a significant clinical burden among patients with, or at risk for ASCVD. This unmet treatment need results in substantial healthcare resource use and costs each year.