ET. The difference between Nexletol and placebo in mean percent change in LDL-C from baseline to Week 12 was -18% (p < 0.001). with other lipid-lowering therapies4. NEXLETOL. All trademarks and trade names are the property of their respective Nexletol is associated with an increased risk of tendon rupture or injury. Contraindications: NEXLETOL has no contraindications. Nexletol Nexlizet. CSR 5. Nexletol (bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor. and/or HeFH primarily taking moderate- to high-intensity statins.1,4, NEXLETOL (n=522), placebo (n=257); 2:1 randomization1, Included patients aged ≥18 years with fasting LDL-C ≥70 mg/dL4, NEXLETOL was added to patients' maximally tolerated statin dose (including no statin at all) either 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. 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. signs, ESPERION Therapeutics, Inc.; 2020. Avoid NEXLETOL and NEXLIZET in patients who have a history of tendon disorders or tendon rupture. 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. 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. rights reserved. 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. Discontinue NEXLETOL or NEXLIZET when pregnancy is recognized, unless the benefits of therapy outweigh the potential risks to the fetus. In a study, it reduced LDL cholesterol by about 20 mg/dl compared to placebo and had no more side effects than placebo, although a higher percentage of drug receiving subjects dropped out of the study because of side effects (11% vs. 7% under placebo). References: 1. Effect of bempedoic The primary efficacy outcome measure of the study was the percent change from baseline to Week 12 in LDL-C. alone and/or HeFH primarily taking moderate- to high-intensity statins.1,2, NEXLETOL (n=1,488), placebo (n=742); 2:1 randomization1, Included patients aged ≥18 years with fasting LDL-C ≥70 mg/dL2, NEXLETOL added to patients' maximally tolerated statin dose, either alone or with other lipid-lowering The trial included 779 patients randomized 2:1 to receive either Nexletol (n = 522) or placebo (n = 257) as add-on to a maximally tolerated lipid lowering therapy. Limitations of Use: The effect of NEXLETOL and NEXLIZET on cardiovascular morbidity and mortality has not been determined. Two trials with over 3,000 patients requiring additional LDL-C Reactions reported less frequently, but still more often than with placebo, included benign prostatic hyperplasia and atrial fibrillation. JAMA. Administer NEXLIZET either at least 2 hours before, or at least 4 hours after, bile acid sequestrants. Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of low-density lipoprotein receptors. Know, See CLEAR 2019;322(18):1780-1788. 4. We use cookies to offer you a better online experience, analyze site traffic, and serve targeted Cyclosporine: Caution should be exercised when using NEXLIZET and cyclosporine concomitantly due to increased exposure to both ezetimibe and cyclosporine. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. The primary efficacy outcome measure of the study was the percent change from baseline to Week 12 in LDL-C. mg to 10 mg; Lactation and Pregnancy: It is not recommended that NEXLETOL or NEXLIZET be taken during breastfeeding. 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. The trial included 2,230 patients randomized 2:1 to receive either Nexletol (n = 1488) or placebo (n = 742) as add-on to a maximally tolerated lipid lowering therapy. NEXLETOL efficacy, General safety (including adverse events, clinical safety laboratories, physical examinations, vital The link you have selected will take you away from NEXLETOLHCP.com to an external website. 2. The recommended dosage of Nexletol, in combination with maximally tolerated statin therapy, is 180 mg administered orally once daily. Two-Thirds of Trial Subjects for Drug Approvals Are Outside the U.S. Rules of Vaccine Approval May Be Changing, But Statistical Analysis Tools Remain Constant, Ask the Experts: Trial Operations Adjustments in a Remote World. Your use of third-party websites is subject to the terms and conditions and the privacy policies of those individual sites. of times per week) and those unable to tolerate any statin at any dose. Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported with ezetimibe. 08/20 US-NXTL-2000453. Information, Study HeFH=heterozygous familial hypercholesterolemia; This may result in a reduction of efficacy. non-HDL-C=non-high-density lipoprotein cholesterol; total C=total cholesterol; hsCRP=high-sensitivity Clinical Trials. 3. January 2019. cookie and Privacy Policy. After initiation of Nexletol, analyze lipid levels within 8 to 12 weeks. 4 mg. ‡High-intensity statins: atorvastatin 40 mg to 80 mg; rosuvastatin protein. Prescribing information. Nexletol is specifically indicated as an adjunct 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. Nexletol is supplied as a tablet for oral administration. Harmony efficacy, See CLEAR 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. to Data on file. The Nexletol and placebo groups are comparable in terms of adverse events (TEAE) during treatment. Warnings and Precautions: Hyperuricemia: Bempedoic acid, a component of NEXLETOL and NEXLIZET, may increase blood uric acid levels. owners. ACSVL1 is expressed primarily in the liver. In clinical trials, tendon rupture occurred in 0.5% of patients treated with Nexletol versus 0% of placebo-treated patients and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to … 2019;380(11):1022-1032. Efficacy of Nexletol was evaluated at Week 12. CSR 1002-040. mg; pravastatin 40 mg to 80 mg; lovastatin 40 mg; fluvastatin XL 80 mg; fluvastatin 40 mg; pitavastatin 2 mg 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.