NEXLIZET provided significant LDL-C reduction regardless of patients’ maximally tolerated statin dose1,2
Significant 38% mean LDL-C reduction compared to placebo, for extra control on top of a statin1
LDL-C reductions from baseline (LS mean) for other drugs in the trial1:
- NEXLETOL: -17% (n=88); ezetimibe: -23% (n=86)
053 Trial (Study 1) was a 12-week, randomized, double-blind, Phase 3 trial in 301 patients randomized 2:2:2:1 to receive NEXLIZET (n=86), NEXLETOL (n=88), ezetimibe (n=86), or placebo (n=41). 053 Trial included patients aged ≥18 years with fasting LDL-C ≥100 mg/dL if they had ASCVD and/or HeFH, or ≥130 mg/dL if they had multiple cardiovascular risk factors. Therapies were added to whatever patient’s maximally tolerated statin dose was (including no statin at all), either alone or with other lipid-lowering therapies. Primary endpoint was % change from baseline to Week 12 in LDL-C. Secondary endpoint was % change from baseline to Week 12 in hsCRP, non-HDL-C, total C, apolipoprotein B, HDL-C, and TGs.1,2
LDL-C=low-density lipoprotein cholesterol; LS=least squares; ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; hsCRP=high-sensitivity C-reactive protein; non-HDL-C=non-high-density lipoprotein cholesterol; total C=total cholesterol; TGs=triglycerides.
References: 1. NEXLIZET. Prescribing information. ESPERION Therapeutics, Inc.; 2020. 2. Data on file. CSR 1002-053. January 2019.