In 2017, CV disease was listed as the underlying cause of death in approximately 859,125 US patients. Select one or more newsletters to continue. -Lipid levels should be checked within 8 to 12 weeks of treatment initiation. Subscribe to FierceBiotech to get industry news and updates delivered to your inbox. The short timeline made it highly unlikely that those events were caused by bempedoic acid, Sasiela said. also assessed the efficacy and safety of bempedoic acid in statin-intolerant patients with hypercholesterolemia over a period of 24 weeks. In the bempedoic acid group, there were five deaths that appeared to be related to cardiovascular disease, five due to cancer, two caused by gastrointestinal problems such … Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. A re-engineered adenovirus prolonged survival in mouse models of metastatic lung cancer and cleared tumors in about 35% of the animals. The company’s initial press release categorized the adverse events as unrelated to the treatment, with deaths listed in a separate chart (much to the chagrin of Bio-Twitter), but did not offer an immediate explanation. Available for Android and iOS devices. The phase 3 trial met its endpoints in safety and efficacy, including a 22% reduction in high-sensitivity C-reactive protein, and Esperion expects to submit applications to the FDA in the first quarter of 2019, and in Europe by the second quarter. However, many risk factors contribute to ASCVD including smoking, hypertension, obesity, physical inactivity, poor nutrition, and other clinical conditions (e.g., diabetes, metabolic syndrome). Version: 1.01. Pfizer's former R&D executive and Forbes columnist John LaMattina said on Twitter this morning: "My guess is that the FDA will require the results of Esperion's CV outcomes study before approval. These number worked out to mortality rates of 0.3% and 0.9% respectively; not good news for a drug with the overarching aim of preserving and … Polyphor is developing an inhaled version of murepavadin, which targets Pseudomonas aeruginosa infections, but is currently given intravenously. Zetia, atorvastatin, simvastatin, rosuvastatin, Lipitor, Crestor. You should not breastfeed while using bempedoic acid. Register Today. In CLEAR Harmony, new-onset or worsening diabetes occurred in 3.3% of patients who received bempedoic acid vs 5.4% of patients who received placebo. Patients who cannot tolerate a statin‐based treatment regimen present a particular challenge for lipid management and cardiovascular event risk reduction.1, 2 Registries and observational studies have reported statin intolerance prevalence rates of 7% to 29%, with the predominant symptoms being muscle‐related side effects.3 Statin‐associated muscle symptoms account for >90% of side effects attributed to statins4 and contribute to the high rate of nonadherence and discontinuation frequently ob… Bempedoic acid side effects (in more detail). Bempedoic acid is also used to lower LDL cholesterol in adults with coronary artery disease (clogged arteries). Generic Name: bempedoic acid (BEM pe DOE ik AS id)Brand Name: Nexletol, Medically reviewed by Drugs.com on Mar 25, 2020 – Written by Cerner Multum. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. RELATED: Esperion’s LDL drug flies through phase 2 as add-on treatment. kidney disease (or if you are on dialysis); Bempedoic acid may harm an unborn baby. Esperion unveiled top-line results from a yearlong phase 3 trial of bempedoic acid, showing it can lower LDL cholesterol levels by an additional 20% over 12 weeks in high-risk patients taking statins. (Arek Socha), From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx. Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. Follow your doctor's instructions about any restrictions on food, beverages, or activity. Participants were randomized 2:1 versus placebo, which saw two total deaths, or 0.3%, with one being labeled as CV-related following adjudication by an independent committee. Esperion CEO Tim Mayleben described the study’s population as more rigorous than the intent-to-treat population, with maximally tolerated statins and advanced disease, with about 80% diagnosed with hypertension and 28% with diabetes. Bempedoic acid may also be used for purposes not listed in this medication guide. Astellas has you covered, Virus escapes immune destruction and fights lung cancer in mice.

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