When patients with ASCVD and/or HeFH need additional LDL-C lowering on top of diet and maximally tolerated statin therapy, adding NEXLIZET can get them significantly lower1
NEXLIZET: -36% (n=86)
placebo: +2% (n=41)
bempedoic acid: -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), bempedoic acid (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 CV risk factors. Therapies were added to whatever patient’s maximally tolerated statin dose was (including no statin at all). 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.1,3
ASCVD=atherosclerotic cardiovascular disease; CV=cardiovascular; HeFH=heterozygous familial hypercholesterolemia; hsCRP=high-sensitivity C-reactive protein; LDL-C=low-density lipoprotein cholesterol; LS=least squares; non-HDL-C=non-high-density lipoprotein cholesterol; TGs=triglycerides; total C=total cholesterol.
References: 1. NEXLIZET. Prescribing information. Esperion Therapeutics, Inc.; 09/2021. 2. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. 3. Data on file. CSR 1002-053. January 2019. 4. Data on file. Esperion 053 Ad-hoc Tables Excluding 3 Sites. March 2019.
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NEXLETOL and NEXLIZET are indicated as adjuncts to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
Limitations of Use:The effect of NEXLETOL and NEXLIZET on cardiovascular morbidity and mortality has not been determined.
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