CLINICAL BENEFITS OF PROLONGED-RELEASE NICOTINIC ACID (NIASPAN®) AND EZETIMIBE IN STATIN-TREATED TYPE 2 DIABETES PATIENTS FAILING TO REACH TARGET CHOLESTEROL LEVELS

OBJECTIVES: To assess the clinical benefits of add-on treatment with Niaspan® (increases HDL-c) or ezetimibe (reduces LDL-c) on coronary heart disease (CHD) in type 2 diabetes patients failing to reach target cholesterol levels on statin monotherapy. METHODS: Two models were developed to project the clinical benefits of treatment over 10 years. The first model (Monte Carlo simulation) was used to evaluate the impact of simvastatin treatment on lipid levels and identify patients with low HDL-c or high LDL-c. Baseline cohort characteristics were taken from the diabetic sub-population of the 4S study. Patients with LDL-c <3mmol/L and HDL-c <1 mmol/L received add-on Niaspan®. Patients with LDL-c >3 mmol/L received add-on ezetimibe. Each add-on treatment was compared to statin monotherapy. Treatment effects for both drugs were taken from several clinical trials summarized in the European SPC. The second model (Markov model) was used to evaluate the cumulative incidence of CHD events. Transition probabilities were based on Framingham risk formulae. RESULTS: Over 10 years, in type 2 diabetes patients with controlled LDL-c and low HDL-c (<1 mmol/L), addition of Niaspan® (2g daily) to statin treatment was projected to reduce the absolute incidence of MI (3.2%), angina (0.7%) and CHD death (1.6%) compared to statin monotherapy. Relative risk reductions were 13.3%, 12.5% and 13.1% respectively. In patients with elevated LDL-c (>3 mmol/L), ezetimibe plus statin was associated with a reduced absolute incidence for MI (2.3%), angina (0.5%) and CHD death (1.1%) versus statin alone. Relative risk reductions were 7.7%, 7.4% and 7.9% respectively. CONCLUSIONS: Over 10 years, both Niaspan® and ezetimibe may lead to substantial reductions in the cumulative incidence of CHD events in type 2 diabetes patients failing to reach cholesterol targets with statin monotherapy. These findings highlight the potential long-term benefits of raising HDL-c in type 2 diabetes patients with controlled LDL-c.