New Drug Reduces Risk of Major Cardiac Events by 13%
A new study published in the New England Journal of Medicine has shown that a newer drug called Nexletol, which contains the active ingredient bempedoic acid, can significantly reduce the risk of major cardiovascular events.[0]
The CLEAR Outcomes trial, which was funded by Esperion Therapeutics, enrolled 13,970 statin-intolerant patients between December 2016 and August 2019 across 32 countries.[1] Participants had to have LDL cholesterol levels of 100 mg/dL or higher, and either a previous cardiac event or other risk factors for heart disease.[2]
The primary outcome studied was a composite of cardiovascular death, heart attack, stroke or coronary revascularization (a procedure to open blocked arteries).[3] Those taking bempedoic acid experienced a greater occurrence of some side effects than those taking a placebo, such as renal impairment, gout, gallstones, and elevated hepatic enzymes, which is likely a result of the drug's activity in the liver.[4] The side effects, however, did not result in people ceasing use of the drug at a greater rate.[2]
Results showed that patients taking bempedoic acid had a combined 13% lower risk of death from cardiovascular disease, nonfatal strokes and nonfatal heart attacks.[5] When heart attacks alone were looked at, the risk reduction was 23%, and patients taking the daily tablet were 19% less likely to need a stent or heart bypass operation.[6]
The drug is activated only in the liver, so it is unlikely to cause muscle aches, which is a common side effect of statins.[1]
Esperion announced the full results from the trial at the American College of Cardiology's Annual Scientific Session & Expo together with the World Congress of Cardiology, and the company believes it would be entitled to receive $300 million in partner milestone payments for including certain required cardiovascular risk reduction data in the EU label, and up to $140 million in partner milestone payments for other regulatory milestones, including inclusion of certain required cardiovascular risk reduction data in the US label.[6]
0. “Bempedoic Acid, Approved to Treat LDL Cholesterol, Cuts Risk of Major CV Events by 13%” AJMC.com Managed Markets Network, 4 Mar. 2023, https://www.ajmc.com/view/bempedoic-acid-approved-to-treat-ldl-cholesterol-cuts-risk-of-major-cv-events-by-13-
1. “Bempedoic Acid Reduces Major Adverse Cardiovascular Events in Patients Who Cannot Tolerate Statins” Pharmacy Times, 4 Mar. 2023, https://www.pharmacytimes.com/view/bempedoic-acid-reduces-major-adverse-cardiovascular-events-in-patients-who-cannot-tolerate-statins
2. “CLEAR Trial Reported at ACC23 Finds Bempedoic Acid Lowers LDL Cholesterol, Reduces Risk of Serious …” Diagnostic and Interventional Cardiology, 4 Mar. 2023, https://www.dicardiology.com/content/clear-trial-reported-acc23-finds-bempedoic-acid-lowers-ldl-cholesterol-reduces-risk-serious
3. “Cleveland Clinic-Led Trial Shows That The First Drug Designed for Statin-Intolerant Patients Reduces Serious Cardiovascular Events” Cleveland Clinic Newsroom, 4 Mar. 2023, https://newsroom.clevelandclinic.org/2023/03/04/cleveland-clinic-led-trial-shows-that-the-first-drug-designed-for-statin-intolerant-patients-reduces-serious-cardiovascular-events/
4. “Bempedoic acid improved heart health in patients who can't tolerate statins, study finds” ABC17News.com, 4 Mar. 2023, https://abc17news.com/news/2023/03/04/bempedoic-acid-improved-heart-health-in-patients-who-cant-tolerate-statins-study-finds-2
5. “Here's an Alternative to Statins for Lowering Cholesterol” TIME, 4 Mar. 2023, https://time.com/6259864/cholesterol-statins-alternative-bempedoic-acid/
6. “Esperion Announces the Full Results from the landmark Cholesterol Lowering via Bempedoic Acid” Marketscreener.com, 3 Mar. 2023, https://www.marketscreener.com/quote/stock/ESPERION-THERAPEUTICS-IN-13479951/news/Esperion-Announces-the-Full-Results-from-the-landmark-Cholesterol-Lowering-via-Bempedoic-Acid-43165352/
