nexletol clinical trials

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. 08/20 US-NXTL-2000453. The difference between Nexletol and placebo in mean percent change in LDL-C from baseline to Week 12 was -17 % (p < 0.001). NEXLETOL efficacy, General safety (including adverse events, clinical safety laboratories, physical examinations, vital lipoprotein or The primary efficacy outcome measure of the study was the percent change from baseline to Week 12 in LDL-C. Clinical Trials. cookie and Privacy Policy. Nexletol Nexlizet. Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. only), Monday-Friday, 8:00am-8:00pm owners. CSR If cholelithiasis is suspected in a patient receiving NEXLIZET and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered. 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. ——(2) Efficacy and safety of Nexletol by gender——Analysis of phase 3 clinical trials: In 4 studies, in a pooled population of more than 3,600 patients, compared with placebo, Nexletol was significant in the 12th week of treatment Reduced LDL-C. Science. The difference between Nexletol and placebo in mean percent change in LDL-C from baseline to Week 12 was -18% (p < 0.001). Nexletol is associated with an increased risk of tendon rupture or injury. therapies2, This was a 52-week, randomized, double-blind, placebo-controlled, Phase 3 trial of 779 patients with ASCVD 2019;322(18):1780-1788. NEXLETOL. All trademarks and trade names are the property of their respective Study 1 was a multi-center, randomized, double-blind, placebo-controlled 52-week trial that evaluated safety and efficacy of bempedoic acid in patients with HeFH and/or ASCVD. Goldberg AC, Leiter LA, Stroes ESG, et al. Your use of third-party websites is subject to the terms and conditions and the privacy policies of those individual sites. Please see full Prescribing Information for NEXLETOL and NEXLIZET. 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. Lactation and Pregnancy: It is not recommended that NEXLETOL or NEXLIZET be taken during breastfeeding. 2. The FDA approval of Nexletol was based on two multi-center, randomized, double-blind, placebo-controlled trials that enrolled 3009 adult patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who were on maximally tolerated statin therapy. 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 acid vs placebo added to maximally tolerated statins on low-density lipoprotein cholesterol in patients at © 2020 ESPERION Therapeutics, Inc. All rosuvastatin 5 As of March 2019 , its effects on cardiovascular morbidity and mortality have not been determined; but studies are under way. 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. reduction1, This was a 52-week, randomized, double-blind, placebo-controlled, Phase 3 trial of 2,230 patients with ASCVD mg to 10 mg; Nexletol can be taken with or without food. Assess uric acid levels periodically as clinically indicated. The recommended dosage of Nexletol, in combination with maximally tolerated statin therapy, is 180 mg administered orally once daily. high risk for cardiovascular disease: the CLEAR Wisdom randomized clinical trial. 2019;380(11):1022-1032. ESPERION Therapeutics, Inc.; 2020. Contraindications: NEXLETOL has no contraindications. JAMA. Fibrates: Coadministration of NEXLIZET with fibrates other than fenofibrate is not recommended. 1002-047. mg; pravastatin 40 mg to 80 mg; lovastatin 40 mg; fluvastatin XL 80 mg; fluvastatin 40 mg; pitavastatin 2 mg The Nexletol and placebo groups are comparable in terms of adverse events (TEAE) during treatment. non-HDL-C=non-high-density lipoprotein cholesterol; total C=total cholesterol; hsCRP=high-sensitivity Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. with other lipid-lowering therapies4. Design, Stay in the Adverse effects associated with the use of Nexletol may include, but are not limited to, the following: Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver. Discontinue NEXLETOL or NEXLIZET when pregnancy is recognized, unless the benefits of therapy outweigh the potential risks to the fetus.