Abstract P242: Trending Positive Clinical Benefits & Significantly Lower Costs With Niacin Extended-Release Compared to Ezetimibe in Patients Receiving On-Going Statin Therapy

Abstract

Objective: To compare cardiovascular (CV) and economic outcomes among a community-based population initiating adjunct therapy with niacin extended-release (NER) for broader management of the lipid panel vs. ezetimibe (EZE) for continued LDL-C reductions. Methods: Statin-treated (simvastatin 20 mg/day or equivalent) patients aged ≥30 years initiating adjunct therapy with NER or EZE between 1/1/05-11/30-08 (index date) and ≥1 pre-index lipid panel (LDL-C <100 mg/dL and HDL-C <50 or <55 mg/dL for men and women, respectively) within the Healthcore Integrated Research Database were included. Patients with AST/ALT elevations or liver disease were excluded. Primary outcome was first occurrence of a major adverse CV event (MACE), defined as IHD, PVD, revascularization, or stroke; secondary outcomes were MACE+all-cause mortality and the total of MACE-related medical costs and pharmacy charges for anti-hyperlipidemic therapy. CV risk between NER and EZE were compared using Cox proportional hazards models with a pair-wise approach while generalized linear models with a log link function and gamma distribution were used to compare costs. Multivariate analyses controlled for age, gender, geographical region, co-morbidities, and baseline lipid values. Results: A total of the 452 patients initiated adjunct therapy with NER (n=186) and EZE (n=22). The NER cohort was younger (58.3±9.7 vs 60.4±9.7, P =0.0235), less likely to be female (17.7% vs 34.6%, P <0.0001), and had a shorter follow-up period (200.0 vs 363.2 days, P <0.0001). The NER cohort had a lower frequency of MACE (1.6%) vs EZE (4.5%), with an adjusted hazard ratio (aHR) of 0.39 (95%CI: 0.09-1.65). A similar trend was observed for the MACE+all-cause mortality with an aHR of 0.30 (95%CI: 0.08-1.27). These findings correspond to significantly lower adjusted costs for patients receiving NER ($2706; 95%CI: 2347-3119) vs EZE ($3489; 95%CI: 3101-3926) ( P <0.0001). Conclusions: The trend of positive clinical benefits from this real-world analysis are consistent with those of the ARBITER-6/HALTS study and suggest that treating beyond LDL-C with NER in secondary risk patients receiving simvastatin 20 mg/day or equivalent may reduce CV risk and associated costs.