Bempedoic acid is the active ingredient in NEXLETOL, as well as a component of NEXLIZET (in addition to ezetimibe), that has been shown to significantly reduce LDL-C levels when added to maximally tolerated statins. Bempedoic acid was studied in clinical trials of patients with ASCVD and/or HeFH who needed additional LDL-C lowering on top of diet and maximally tolerated statin therapy.1-3
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 cardiovascular risk factors. Therapies were added to whatever patient’s maximally tolerated statin dose was (including no statin at all). The primary endpoint was % change from baseline to Week 12 in LDL-C. A secondary endpoint was % change from baseline to Week 12 in hsCRP, non-HDL-C, total C, apolipoprotein B, HDL-C, and TGs.1,2
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. The primary endpoint was general safety, which included ARs, clinical safety laboratories, physical examinations, vital signs, and electrocardiogram. A secondary endpoint was % change from baseline to Week 12 in LDL-C.4,5
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. The 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.6,7
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In addition to NEXLIZET, patients receiving maximally tolerated statin therapy were included in the clinical trial. High-intensity statins included: atorvastatin 40 mg to 80 mg and rosuvastatin 20 mg to 40 mg.1,2
When NEXLIZET is coadministered with simvastatin, limit simvastatin dosage to 20-mg daily. When NEXLIZET is coadministered with pravastatin, limit pravastatin dosage to 40-mg daily.1
When NEXLIZET is coadministered with1:
In addition to NEXLETOL, patients receiving maximally tolerated statin therapy were included in the clinical trials. Low-intensity statins included: 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. Moderate-intensity statins included: 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. High-intensity statins included: atorvastatin 40 mg to 80 mg; rosuvastatin 20 mg to 40 mg.4.6
When NEXLETOL is coadministered with simvastatin, limit simvastatin dosage to 20-mg daily. When NEXLETOL is coadministered with pravastatin, limit pravastatin dosage to 40-mg daily.3
053 Trial results showed a significant 38% mean LDL-C reduction with NEXLIZET compared to placebo at 12 weeks (P<0.001), for extra control on top of a statin.1
In the primary analysis populations, CLEAR Harmony results showed a significant 18% mean LDL-C reduction with NEXLETOL compared to placebo at 12 weeks (P<0.001), and CLEAR Wisdom results showed a significant 17% mean LDL-C reduction with NEXLETOL compared to placebo at 12 weeks (P<0.001), for extra control on top of a statin. LDL-C reductions were also achieved in the subgroup populations: patients taking low to moderate and high-intensity statins.3-7
In the clinical trial for NEXLIZET, the most common ARs reported in ≥3% of patients in the NEXLIZET group were: urinary tract infection, nasopharyngitis, constipation, back pain, fatigue, upper respiratory tract infection, blood creatinine increased, blood uric acid increased, and bronchitis.1,8
To learn more about the incidence of ARs occurring in pivotal trials of bempedoic acid or ezetimibe that did not occur at a significant rate in the pivotal trial of NEXLIZET, please visit our NEXLIZET safety page.1
In the clinical trials for NEXLETOL, the most common ARs reported in ≥2% of patients with ASCVD and HeFH using NEXLETOL (and more frequently than with placebo) were: upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.3
NEXLIZET and NEXLETOL offer oral, once-daily dosing with the flexibility to be combined with existing lipid-lowering medications for appropriate patients.* They can be taken with or without food and no titration is necessary. NEXLIZET is dosed as one 180-mg bempedoic acid/10-mg ezetimibe tablet for all appropriate patients.† NEXLETOL is dosed as one 180-mg bempedoic acid tablet for all appropriate patients.1,3
NEXLIZET and NEXLETOL are appropriate for a range of patient types requiring added LDL-C lowering on top of diet and a maximally tolerated statin therapy, including a range of ASCVD patient types as well as HeFH patients.1,3
*Administer NEXLIZET either at least 2 hours before, or at least 4 hours after, bile acid sequestrants.1
†Concomitant use of simvastatin, pravastatin, cyclosporine, fibrates, or cholestyramine with NEXLIZET, or of simvastatin or pravastatin with NEXLETOL, may require adjustments for these medications. Please see "Drug Interactions" in the Important Safety Information below.1,3
Bempedoic acid is the active ingredient in NEXLETOL, as well as a component of NEXLIZET (in addition to ezetimibe).1,3,9-11
Bempedoic acid is the first and only ACL inhibitor, working complementary to statins to lower LDL-C. It works along the cholesterol biosynthesis pathway, 2 steps upstream from the primary target of statins. By inhibiting ACL, bempedoic acid decreases cholesterol biosynthesis, resulting in upregulation of LDL receptors and increased clearance of LDL-C from the bloodstream.1,3,9-11
NEXLIZET also contains ezetimibe, which reduces cholesterol absorption in the intestine. Ezetimibe decreases hepatic cholesterol stores, lowering circulating LDL-C.1,3,9-11
Broad coverage is offered for your patients with ASCVD and/or HeFH on both commercial and Medicare Part D plans. Use ASCVD and HeFH ICD-10-CM codes to start your appropriate patients on NEXLIZET today.
Prior authorization support is also available to streamline the process for your practice.
The NEXLIZET and NEXLETOL Co-Pay Savings Program can also help your patients save money once they are ready to pick up their prescription.
For additional information about savings and support for your patients and your practice, please visit our Coverage & Support page.
LDL-C=low-density lipoprotein cholesterol; 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; AR=adverse reaction; ACL=adenosine triphosphate-citrate lyase.
References: 1. NEXLIZET. Prescribing information. ESPERION Therapeutics, Inc.; 11/2020. 2. Data on file. CSR 1002-053. January 2019. 3. NEXLETOL. Prescribing information. ESPERION Therapeutics, Inc.; 2020. 4. Data on file. CSR 1002-040. October 2018. 5. 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. 6. Data on file. CSR 1002-047. January 2019. 7. 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. 8. Ballantyne CM, Laufs U, Ray KK, et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2020;27(6):593-603. 9. Pinkosky SL, Newton RS, Day EA, et al. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016;7(13457):1-13. 10. Pinkosky SL, Filippov S, Srivastava RA, et al. AMP-activated protein kinase and ATP-citrate lyase are two distinct molecular targets for ETC-1002, a novel small molecule regulator of lipid and carbohydrate metabolism. J Lipid Res. 2013;54(1):134-151. 11. Saeed A, Ballantyne CM. Bempedoic acid (ETC-1002): a current review. Cardiol Clin. 2018;36(2):257-264.
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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.
IMPORTANT SAFETY INFORMATION
Contraindications: NEXLETOL has no contraindications. NEXLIZET is contraindicated in patients with a known hypersensitivity to ezetimibe tablets. Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported with ezetimibe.
Warnings and Precautions: Hyperuricemia: Bempedoic acid, a component of NEXLETOL and NEXLIZET, may increase blood uric acid levels. Hyperuricemia may occur early in treatment and persist throughout treatment, and may lead to the development of gout, especially in patients with a history of gout. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. In clinical trials, tendon rupture occurred in 0.5% of patients treated with bempedoic acid versus 0% of patients treated with placebo, and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to months of starting bempedoic acid. Tendon rupture may occur more frequently in patients over 60 years of age, patients taking corticosteroid or fluoroquinolone drugs, patients with renal failure, and patients with previous tendon disorders. Discontinue NEXLETOL or NEXLIZET at the first sign of tendon rupture. Avoid NEXLETOL and NEXLIZET in patients who have a history of tendon disorders or tendon rupture.
Adverse Reactions: In NEXLETOL clinical trials, the most commonly reported adverse reactions were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. Reactions reported less frequently, but still more often than with placebo, included benign prostatic hyperplasia and atrial fibrillation.
In the NEXLIZET clinical trial, the most commonly reported adverse reactions observed with NEXLIZET, but not observed in clinical trials of bempedoic acid or ezetimibe, a component of NEXLIZET, and occurring more frequently than with placebo, were urinary tract infection, nasopharyngitis, and constipation.
Adverse reactions reported in clinical trials of ezetimibe, and occurring at an incidence greater than with placebo, included upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza. Other adverse reactions reported in postmarketing use of ezetimibe included hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria; erythema multiforme; myalgia; elevated creatine phosphokinase; myopathy/rhabdomyolysis; elevations in liver transaminases; hepatitis; abdominal pain; thrombocytopenia; pancreatitis; nausea; dizziness; paresthesia; depression; headache; cholelithiasis; cholecystitis.
Drug Interactions: Simvastatin and Pravastatin: Concomitant use with bempedoic acid results in increased concentrations and increased risk of simvastatin or pravastatin-related myopathy. Use of either NEXLETOL or NEXLIZET with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided.
Cyclosporine: Caution should be exercised when using NEXLIZET and cyclosporine concomitantly due to increased exposure to both ezetimibe and cyclosporine. Monitor cyclosporine concentrations in patients receiving NEXLIZET and cyclosporine. In patients treated with cyclosporine, the potential effects of the increased exposure to ezetimibe from concomitant use should be carefully weighed against the benefits of alterations in lipid levels provided by NEXLIZET.
Fibrates: Coadministration of NEXLIZET with fibrates other than fenofibrate is not recommended. Fenofibrate and ezetimibe may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected in a patient receiving NEXLIZET and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.
Cholestyramine: Concomitant use of NEXLIZET and cholestyramine decreases ezetimibe concentration. This may result in a reduction of efficacy. Administer NEXLIZET either at least 2 hours before, or at least 4 hours after, bile acid sequestrants.
Lactation and Pregnancy: It is not recommended that NEXLETOL or NEXLIZET be taken during breastfeeding. Discontinue NEXLETOL or NEXLIZET when pregnancy is recognized, unless the benefits of therapy outweigh the potential risks to the fetus. Based on the mechanism of action of bempedoic acid, NEXLETOL and NEXLIZET may cause fetal harm.
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
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A patient may be eligible for the NEXLETOL & NEXLIZET Co-Pay Card if they meet the
eligibility criteria below:
Should a patient have any change in insurance coverage or become enrolled in a Government Program during their enrollment in the NEXLETOL & NEXLIZET Co-Pay Card program, they must inform a NEXLETOL & NEXLIZET Co-Pay Card program representative and will no longer be eligible for the NEXLETOL & NEXLIZET Co-Pay Card program. Also, if a patient is enrolled in a Government Program, they may not use the NEXLETOL & NEXLIZET Co-Pay Card program even if they elect to be processed as a commercial or discount insurance plan patient.
To determine if a patient is eligible for the NEXLETOL & NEXLIZET Co-Pay Card program, the patient must enroll online at www.NexCopay.com, or call 855-699-8814, and opt-in to the NEXLETOL & NEXLIZET Co-Pay Card program. ESPERION will evaluate the patient’s eligibility and communicate an eligibility decision to the patient. Final patient eligibility determinations are provided by ESPERION and/or its program representatives.
Eligibility in the NEXLETOL & NEXLIZET Co-Pay Card program is for one year. Patients must reenroll for NEXLETOL & NEXLIZET Co-Pay assistance each year that they wish to participate in the program. If your card is lost or stolen, please visit www.NexCopay.com, or call 855-699-8814.
Eligible patients with commercial prescription drug insurance coverage for NEXLETOL or NEXLIZET may pay as little as $10 per fill for up to a 3-month supply. The NEXLETOL & NEXLIZET Co-Pay Card is not health insurance or a benefit plan. Distribution or use of the NEXLETOL & NEXLIZET Co-Pay Card does not obligate use or continuing use of any provider or continuing use of NEXLETOL or NEXLIZET. Patient is responsible for reporting the receipt of all NEXLETOL & NEXLIZET Co-Pay Card savings or reimbursement to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Co-Pay Card, as may be required.
The NEXLETOL & NEXLIZET Co-Pay Card is not valid for medications the patient receives for free or that are eligible to be reimbursed by other healthcare or pharmaceutical assistance programs that reimburse the patient in part or for the entire cost of his/her ESPERION medication. By using the NEXLETOL & NEXLIZET Co-Pay Card, the patient agrees not to seek reimbursement from health insurance or any third party for all or any part of the benefit received by the patient through the offer.
The NEXLETOL & NEXLIZET Co-Pay Card will be accepted by participating pharmacies in the United States. To qualify for use of this NEXLETOL & NEXLIZET Co-Pay Card, the patient may be required to pay out-of-pocket expenses for each prescription. The NEXLETOL & NEXLIZET Co-Pay Card program does not cover costs associated with a patient visit to a doctor’s office including prescriber, staff, administrative charges, labs, and other ancillary services. This NEXLETOL & NEXLIZET Co-Pay Card is only available with a valid prescription and cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. This offer is not conditioned on any past, present or future purchase, including refills.
Use of this NEXLETOL & NEXLIZET Co-Pay Card must be consistent with all relevant health insurance requirements and payer agreements. The NEXLETOL & NEXLIZET Co-Pay Card may not be sold, purchased, traded, or offered for sale, purchase, or trade. The NEXLETOL & NEXLIZET Co-Pay Card is limited to one per person during this offer period and is non-transferable. Void where prohibited or otherwise restricted by law.
ESPERION reserves the right to rescind, revoke, amend, or terminate the program without notice at any time.
If you have questions or need additional support, call 855-699-8814 (8:00 am-8:00 pm ET, Monday-Friday, excluding holidays).
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