Fibrates: Coadministration of NEXLIZET with fibrates other than fenofibrate is not recommended. or Efficacy of Nexletol was evaluated at Week 12. Lactation and Pregnancy: It is not recommended that NEXLETOL or NEXLIZET be taken during breastfeeding. Bempedoic acid and its active metabolite, ESP15228, require coenzyme A (CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively. with other lipid-lowering therapies4. 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. HeFH=heterozygous familial hypercholesterolemia; C-reactive 5. Use of either NEXLETOL or NEXLIZET with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided. mg; pravastatin 40 mg to 80 mg; lovastatin 40 mg; fluvastatin XL 80 mg; fluvastatin 40 mg; pitavastatin 2 mg References: 1. therapies2, This was a 52-week, randomized, double-blind, placebo-controlled, Phase 3 trial of 779 patients with ASCVD This may result in a reduction of efficacy. Wisdom efficacy, View January 2019. 4 mg. ‡High-intensity statins: atorvastatin 40 mg to 80 mg; rosuvastatin The recommended dosage of Nexletol, in combination with maximally tolerated statin therapy, is 180 mg administered orally once daily. The Nexletol and placebo groups are comparable in terms of adverse events (TEAE) during treatment. 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. Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. Your use of third-party websites is subject to the terms and conditions and the privacy policies of those individual sites. Tendon rupture occurred within weeks to months of starting bempedoic acid. Medical Information Contact Center: 1-833-377-7633 (toll free, US 300 N. Washington St., Suite 200, Falls Church, VA 22046, USA, Phone 617.948.5100 – Toll free 866.219.3440, Copyright © 2020. Based on the mechanism of action of bempedoic acid, NEXLETOL and NEXLIZET may cause fetal harm. Efficacy of Nexletol was evaluated at Week 12. 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. 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. ESPERION Therapeutics, Inc.; 2020. Nexletol can be taken with or without food. The primary efficacy outcome measure of the study was the percent change from baseline to Week 12 in LDL-C. Design, CMS, Hosting & Web Development :: ePublishing, Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges, Clinical Trial Risk Management in the Post-COVID-19, All-Digital World: Predictive Transformation in Quality, Compliance and Risk Management, 2020 in Review: Celebrating the Successes of the Clinical Research Community After A Difficult Year, Medical Device Clinical Trials in China: Latest Regulatory Developments, Regenerative Medicine: Steps to Accelerate Development, Clinical Trial Agreements: A Guide to Key Words and Phrases, Simple Changes Can Make Trials More Patient Friendly. Data on file.
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