Long-Term Safety and Efficacy of Mipomersen in Patients with Familial Hypercholesterolemia Uncontrolled by Maximally Tolerated Lipid Lowering Therapy

Abstract

s 291 Apo B, P , .0001 for all; Table 1). Age $65 years, abdominal obesity, and lower baseline high-sensitivity C-reactive protein (hs-CRP) were significant predictors of greater reductions in LDL-C, non-HDL-C, Apo B, total C, VLDL-C, TGs, and all lipid-lipoprotein ratios but not for changes in HDL-C or ApoAI. Age $65 years was associated with significantly greater attainment of LDL-C (,70 mg/dL, ,100 mg/dL) and non-HDL-C (,100 mg/dL, ,130 mg/dL) targets; abdominal obesity predicted higher attainment of nonHDL-C ,130 mg/dL, and lower baseline hs-CRP was associated with greater attainment of LDL-C ,70 mg/ dL and non-HDL-C ,100 mg/dL. The number of MetS factors (1-5) did not predict LDL-C–lowering treatment efficacy. Effects of gender, race, baseline TGs, baseline HDL-C, and concomitant therapy were limited. MetS, diabetes, blood pressure, fasting glucose, and HOMA IR tertiles were not predictive of any treatment response. Conclusions: This post hoc study in MetS subjects with CHD risk identified age $65 years, abdominal obesity, and lower baseline hs-CRP as factors that significantly influence treatment effects of E/S and atorvastatin on changes in LDL-C, non-HDL-C and Apo B, the current treatment targets suggested for reduction of CMR. The clinical benefits of simvastatin and atorvastatin have been established; the effect of ezetimibe on cardiovascular outcomes awaits results from the Improved Reduction of Outcomes: Vytorin Efficacy International Trial.