When patients with ASCVD and/or HeFH need additional LDL-C lowering on top of diet and maximally tolerated statin therapy, adding NEXLETOL can get them significantly lower1
LDL-C changes from baseline (LS mean) in CLEAR Harmony: NEXLETOL: -17% (n=1,488); placebo: +2% (n=742) (P<0.001).
LDL-C changes from baseline (LS mean) in CLEAR Wisdom: NEXLETOL: -15% (n=522); placebo: +2% (n=257) (P<0.001).
CLEAR Harmony (Study 1) was a 52-week, randomized, double-blind, Phase 3 trial in 2,230 patients randomized 2:1 to receive NEXLETOL (n=1,488) or placebo (n=742). CLEAR Harmony included patients aged ≥18 years with fasting LDL-C ≥70 mg/dL, and high-risk patients with ASCVD and/or HeFH. NEXLETOL was added to whatever patient’s maximally tolerated statin dose was, either alone or with other lipid-lowering therapies. Primary endpoint was general safety, which included ARs, clinical safety laboratories, physical examinations, vital signs, and electrocardiogram. Secondary endpoint was % change from baseline to Week 12 in LDL-C.2,3
CLEAR Wisdom (Study 2) was a 52-week, randomized, double-blind, Phase 3 trial in 779 patients randomized 2:1 to receive NEXLETOL (n=522) or placebo (n=257). CLEAR Wisdom included patients aged ≥18 years with fasting LDL-C ≥70 mg/dL, and high-risk patients with ASCVD and/or HeFH. NEXLETOL was 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 endpoints were % change from baseline to Week 24 in LDL-C, % change from baseline to Week 12 in non-HDL-C, total C, apolipoprotein B, and hsCRP, and absolute change from baseline to Weeks 12 and 24 in LDL-C.4,5
ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol; LS=least squares; AR=adverse reaction; non-HDL-C=non-high-density lipoprotein cholesterol; total C=total cholesterol; hsCRP=high-sensitivity C-reactive protein.
Mean LDL-C reductions vs placebo at 12 weeks across statin intensity subgroups2,4
*Low-intensity statins: simvastatin 10 mg; pravastatin 10 mg to 20 mg; lovastatin 20 mg; fluvastatin 20 mg to 40 mg; pitavastatin 1 mg. Low-intensity statins also included those patients taking low-dose statins using an alternate regimen (ie, every other day, or for a specified number of times per week) and those unable to tolerate any statin at any dose.2,4
†Moderate-intensity statins: atorvastatin 10 mg to 20 mg; rosuvastatin 5 mg to 10 mg; simvastatin 20 mg to 40 mg; pravastatin 40 mg to 80 mg; lovastatin 40 mg; fluvastatin XL 80 mg; fluvastatin 40 mg; pitavastatin 2 mg to 4 mg.2,4
‡Post hoc analysis.2
§High-intensity statins: atorvastatin 40 mg to 80 mg; rosuvastatin 20 mg to 40 mg.2,4
LDL-C=low-density lipoprotein cholesterol.
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52-week, randomized, double-blind, Phase 3 trials in patients with ASCVD
and/or HeFH primarily taking moderate- to high-intensity statins (N=3,009)1,2,4
ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol.
Based on a pooled analysis of 2 clinical studies of up to 52 weeks in duration.1
ARs occurring in ≥2% of patients with ASCVD and HeFH using NEXLETOL
(and more frequently than placebo)1
*Patients received NEXLETOL 180 mg orally once daily plus maximally tolerated statin therapy alone or in combination with other lipid-lowering therapies.1
†Included patients with hyperuricemia and patients with increased blood uric acid.1
‡Included patients with abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal discomfort.1
§Included patients with increased AST, increased ALT, increased hepatic enzyme, and increased liver function test.1
AR=adverse reaction; ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; AST=aspartate aminotransferase;
or without food
Does not need to be titrated*
Does not require
refrigeration for storage
Pill image is not actual size.
One 180-mg tablet for all appropriate patients1
*Concomitant use of simvastatin or pravastatin with NEXLETOL may require adjustments for these medications. Please see "Drug Interactions" in the Important Safety Information below.1
References: 1. NEXLETOL. Prescribing information. ESPERION Therapeutics, Inc.; 2020. 2. Data on file. CSR 1002-040. October 2018. 3. Ray KK, Bays HE, Catapano AL, et al. Safety and efficacy of bempedoic acid to reduce LDL cholesterol. N Engl J Med. 2019;380(11):1022-1032. 4. Data on file. CSR 1002-047. January 2019. 5. Goldberg AC, Leiter LA, Stroes ESG, et al. Effect of bempedoic acid vs placebo added to maximally tolerated statins on low-density lipoprotein cholesterol in patients at high risk for cardiovascular disease: the CLEAR Wisdom randomized clinical trial. JAMA. 2019;322(18):1780-1788. 6. NEXLIZET. Prescribing information. ESPERION Therapeutics, Inc. 11/2020.
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Find out about coverage for your patients and support for your practice
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.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
Lactation and Pregnancy:
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
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