Abstract P246: A Naturalistic Assessment of Lipid Treatment Strategies: Further LDL-C Reduction Versus Comprehensive Lipid Management

Abstract

Objective: To compare cardiovascular (CV) outcomes between patients initiating adjunct therapy with either niacin extended-release (NER) for broader lipid panel management or ezetimibe (EZE) for continued LDL-C reduction. Methods: Statin-treated patients aged ≥30 augmenting with NER or EZE between 1/1/05-11/30/09 (Index Date) were identified. Patients with ≥12 months of health plan eligibility before the Index Date (baseline) were included, and patients with secondary risk and ≥1 full lipid panel were retained. A propensity score (PPS) model was developed controlling for the following baseline factors: age, gender, geographic region, type of health coverage, baseline lipids, mode of therapy augmentation, potency of adjunct statin therapy, baseline statin adherence, comorbidities, and alternative CV medications. NER and EZE patients were matched based on PPS. Clinical outcomes included incidence of a major adverse cardiovascular event (MACE). MACE was defined as a composite of acute ischemic heart (IHD), peripheral vascular (PVD), and cerebrovascular disease (CVD) events. The economic outcome was annual CV disease-related costs. These outcomes were compared using univariate Cox proportional hazards and generalized linear models respectively. Results: A total of 15,195 patients initiated adjunct therapy with NER (n=3,098) and EZE (n=12,097) meeting all study criteria. Post-PPS match, 2,261 patients were identified in each cohort with no statistically significant differences in baseline or concurrent treatment characteristics. Frequency of MACE was lower among NER patients (3.5%) vs. EZE (5.4%), with a hazard ratio (HR) of 0.89 (95% CI: 0.67-1.20). Specifically, NER patients demonstrated a lower risk of IHD (HR: 0.90; 95% CI: 0.65-1.25) and CVD (HR: 0.69; 95% CI: 0.34-1.41) events vs. EZE patients. These findings correspond to significantly lower adjusted annual cost among NER patients ($8,168; 95% CI: $7,720 - $8,641) vs. EZE ($9,030; 95% CI: $8,535 - $9,553) ( P= 0.0136). Conclusions: Positive clinical benefits observed in this broader naturalistic population are consistent with results from recent clinical trials and suggest that treating beyond LDL-C with statin + NER in secondary risk patients may reduce CV risk and associated costs.