DETERMINANTS OF SMOKING CESSATION IN YOUNG WOMEN AND MEN AFTER ACUTE CORONARY SYNDROME

Abstract

s S295 For this mixed hyperlipidemia subset efficacy was evaluated in four phase 3 randomized studies (n1⁄41148) and safety, from the phase 2 and phase 3 studies (n1⁄42092) and their open label extension studies (n1⁄41485). Efficacy analyses were based on 12-week studies, while safety analyses included data from all available studies. Treatment differences were calculated vs. placebo and ezetimibe by evolocumab dose. RESULTS: Patients with mixed hyperlipidemia taking evolocumab had mean SD baseline LDL-C of 3.4 1.4 mmol/L, median (Q1, Q3) triglycerides of 2.0 (1.6, 2.5) mmol/L and mean SD HDL-C of 1.2 0.3 mmol/L. The mean treatment difference in percent change from baseline in LDL-C (mean of weeks 10 and 12) with evolocumab was approximately -67% vs. placebo and -42% vs. ezetimibe (all p<0.001) (figure) compared to -65% vs. placebo and -40% vs. ezetimibe in the entire study population. Treatment differences for evolocumab vs. placebo and ezetimibe followed a similar pattern for non-HDL-C, apolipoprotein B, and lipoprotein(a) (figure). Evolocumab was well tolerated, with balanced rates of serious adverse events or adverse events leading to discontinuation of the investigational product for evolocumab vs. placebo and ezetimibe (table). CONCLUSION: This analysis studied the effect of evolocumab in patients with mixed hyperlipidemia. LDL-C reduction with evolocumab in patients with mixed hyperlipidemia was similar to the LDL-C reduction seen in previous reports of the entire study population. Amgen Inc. 555 DETERMINANTS OF SMOKING CESSATION IN YOUNG WOMEN AND MEN AFTER ACUTE CORONARY SYNDROME