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. Reproduction in whole or part is prohibited. Subscribe to FierceBiotech to get industry news and updates delivered to your inbox. On a later conference call with investors, Esperion’s senior vice president for clinical research, Bill Sasiela, said the deaths stemmed from an older, less-healthy study population, two-thirds of which were current or former smokers. Follow your doctor's instructions about any restrictions on food, beverages, or activity. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. However, a link in the press release took readers to a chart that contained some surprising and concerning data: deaths associated with placebo 2, deaths associated with bempedoic acid…13. Register Today. Usual Adult Dose for Cardiovascular Risk Reduction: Tell your doctor about all other cholesterol medicines you use, especially: This list is not complete. Bempedoic acid may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the arm, shoulder, or Achilles' tendon of the heel. 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 … This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. Shares tumbled by more than 20% before the market opened. In the current study, there were no deaths due to … Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Though the trial excluded patients who had had a significant cardiovascular event within three months of enrolling, the company said the safety results were as expected—and that previous trials covering that early timeline did not produce cause for alarm. Select one or more newsletters to continue. Five of the deaths in the treatment arm were related to lung cancer, with most seeing tumors discovered within the first three months of the study. With daily, oral bempedoic acid, Esperion hopes to offer a cheaper alternative, at about $4,000 annually, to lowering LDL in combination with a statin, compared to PCSK9 inhibitor infusions from Amgen and Regeneron with list prices that can reach $14,000 a year. The short timeline made it highly unlikely that those events were caused by bempedoic acid, Sasiela said. Follow all directions on your prescription label and read all medication guides or instruction sheets. In addition, the price that Esperion plans to charge for bempedoic acid is not much lower than the price that Express Scripts apparently is getting from Regeneron for Praluent. At least not in the text of the company’s press release. Version: 1.01. However, many risk factors contribute to ASCVD including smoking, hypertension, obesity, physical inactivity, poor nutrition, and other clinical conditions (e.g., diabetes, metabolic syndrome). Tendon problems may be more likely in certain people (older adults, people with kidney disease, or people who take steroid medicine or certain antibiotics. 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. The primary endpoint of the study is the effect of bempedoic acid on major adverse cardiovascular events (cardiovascular death, non-fatal myocardial … 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. The company characterized the adverse events as unrelated to treatment, with some linked to lung cancer, in a high-risk population of mostly current and former smokers. Usual Adult Dose for Heterozygous Familial Hypercholesterolemia: 180 mg orally once a day Comments:-This drug should be given with maximally tolerated statin therapy. Bempedoic acid is also used to lower LDL cholesterol in adults with coronary artery disease (clogged arteries). You should not breastfeed while using bempedoic acid. Other drugs may affect bempedoic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. In 2017, CV disease was listed as the underlying cause of death in approximately 859,125 US patients. Copyright 1996-2018 Cerner Multum, Inc. RELATED: Esperion’s LDL drug flies through phase 2 as add-on treatment. Bempedoic acid side effects (in more detail). The study, the company’s largest in bempedoic acid, enrolled 2,230 patients at high risk for cardiovascular events, requiring diagnoses of heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease. Comply with the packet or canister of moisture-absorbing preservative a history of cancer and! Dose if it is almost time for your next dose on food, beverages, or arms ; symptoms... Medication records issue that more patients died on bempedoic acid mechanism is n't locked down, the Serenity... 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