This site uses cookies to assist with navigation, analyse your use of our services, and provide content from third parties. The drug hasn't been shown to be better than statins and is unlikely to replace them – if licensed it would probably be used alongside. The US pharmaceutical company behind the drug, Esperion, is seeking a licence to market the drug this year in Europe and the US. There was no difference in reported side effects between this drug and the placebo over the course of 1 year. The trial has strengths in its large size and relatively long follow-up for safety. Doctors recruited 2,230 people with cardiovascular disease, hereditary high cholesterol or both, who had high LDL cholesterol (at least 70mg per decilitre) despite taking the maximum-tolerated dose of statin therapy for at least 1 year. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. After three months of treatment researchers found that bempedoic acid reduced patients' LDL cholesterol levels from baseline by an average of 18.1% compared to the placebo group. The researchers wanted to see if adding bempedoic acid to the treatment regime of people who had high LDL cholesterol, despite receiving the maximum dose of statins, would help reduce LDL levels in the blood. This was a randomised controlled trial (RCT) looking at a new treatment to lower LDL cholesterol. The study was published in the peer-reviewed medical journal the New England Journal of Medicine. Most people in this trial were white, so we can't be sure how people of other ethnicities respond to this treatment. Once converted to the active form the drug cannot leave the liver, so it can't enter muscles and hence could be of considerable advantage for some. Close menu. The dropout rate because of side effects was slightly higher in the bempedoic acid group (11%) compared with the placebo group (7%). 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Science X Daily and the Weekly Email Newsletter are free features that allow you to receive your favorite sci-tech news updates in your email inbox, Among heart attack survivors, drug reduces chances of second heart attack or stroke, 'Turncoat' macrophages in the tumor 'micro-environment' underlie breast cancer progression, Immune responses during embryo development could increase risk of schizophrenia, Using haptic feedback to improve enhanced force control of piano keystrokes in elite players, Stanford team creates cellular atlas of the human lung, Australian study suggests true COVID-19 infection rate is 6.2 times higher than official tallies (Update). the Louisville Metabolic and Atherosclerosis Research Center The treatment was also shown to be well-tolerated by patients, with some increased incidence of gout—due to slight increases in levels of uric acid in the blood—but no increased incidence of serious health conditions between the two groups. The trial also included a small proportion of patients with familial hypercholesterolemia (FH), an inherited condition which causes increased cholesterol levels and raises the risk of cardiovascular disease and strokes. Drug Name Active Ingredient Approval Date FDA-approved use … ... statins do a great job of lowering cholesterol. The safety of the drug needs to be confirmed before it is made available. Nexletol is a daily pill approved for people with a genetic predisposition for high cholesterol and for heart disease patients who need to further reduce their bad cholesterol. You can unsubscribe at any time and we'll never share your details to third parties. This document is subject to copyright. The drug reduced LDL cholesterol, but there was no difference in the number of heart attacks and strokes over 1 year; so we don't know for sure it will reduce risk of cardiovascular problems. List of innovative new products that never before have been used in clinical practice. The study took place across 14 different sites in 5 countries. They were split into 2 groups. The FDA has approved two new non-statin drugs that clinical trials indicated can help reduce high cholesterol. The research, published today in the New England Journal of Medicine, reports on findings from more than 2,200 patients and is the first to measure the safety and effectiveness of the new treatment against placebo in patients with increased risk of heart attack and stroke. This study adds to the research looking for new cholesterol-lowering treatments when statins either don't work or cause undesirable side effects. TRENTON, N.J. -- U.S. regulators on Friday approved a new type of cholesterol-lowering drug aimed at millions of people who can't tolerate — or don't get enough help from — widely used statin pills like Lipitor and Crestor. If approved, bempedoic acid is unlikely to replace statins but will most probably be used with them – as in this trial. Bempedoic acid has been shown to lower LDL cholesterol and appears safe over the course of 1 year. The main outcome of interest was whether the treatment was safe and did not cause any serious side effects. Researchers recruited over 2,000 people who were already taking statins to lower their cholesterol. New targets and cholesterol-lowering medication recommendations (statin therapy) for people with very high cholesterol or diabetes University of Minnesota Health has a 60-year legacy of heart care research and innovation, including the world’s first open-heart surgery. "Our latest study shows that bempedoic acid could be another addition to the arsenal of cholesterol-lowering treatments available to patients. Half of all people who are prescribed statins for the prevention of coronary heart disease fail to reach target cholesterol levels two years later, according to a new study. Almeda suggested a new treatment, specifically tailored for lowering elevated LDL cholesterol, called PCSK9 (proprotein covertase subtilisin/kexin tyoe 9) inhibitors. A new class of oral cholesterol-lowering drug could help patients unable to take statins due to side effects. The trial recruited people who were known to have cardiovascular disease due to the build-up of fatty material inside the arteries (atherosclerosis), or people with hereditary high cholesterol who are at higher risk of atherosclerosis. The drug is offered in two FDA-approved formulations to lower LDL cholesterol levels in patients who are intolerant of statins. In fact, though the drug lowered cholesterol, there was no difference in the rate of cardiovascular events between groups. However, this new drug could provide real benefit for the few people who can't ... on top of their usual medication. RCTs are the most reliable way of assessing the effect of an intervention. However, bempedoic acid is not currently a licensed treatment. Get weekly and/or daily updates delivered to your inbox. Click here to sign in with By using our site, you acknowledge that you have read and understand our Privacy Policy The researchers state that in this 52-week trial, bempedoic acid added to statin therapy did not lead to more side effects than placebo and led to significantly lower LDL cholesterol levels. The study was carried out by researchers from Imperial College London, the Louisville Metabolic and Atherosclerosis Research Center, the University of Milan, and the Baylor College of Medicine, Houston. Your feedback will go directly to Science X editors. Phys.org internet news portal provides the latest news on science, Tech Xplore covers the latest engineering, electronics and technology advances, Science X Network offers the most comprehensive sci-tech news coverage on the web. However, there are some important points to be aware of: Overall the results seem promising, but it remains to be seen whether bempedoic acid will become a licensed cholesterol-lowering treatment. They found that the effects of inhibiting the enzyme over longer time scale reduced the risk of cardiovascular disease with no obvious adverse effects of blocking this pathway. Cholesterol-lowering pill 'new option for statin users', Cholesterol-fighting drug which does not cause aching muscles could be alternative to statins, New fat-busting pill slashes heart attacks and strokes with no statin side-effects, researchers claim, Pill 'as good as statins' could benefit hundreds of thousands of patients - but it works without the same side effects, Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol, The New England Journal of Medicine. Neither your address nor the recipient's address will be used for any other purpose. The decision to treat cholesterol with medication depends on one’s overall risk for heart attacks and ... 2019. This … New cholesterol-lowering drug could be an alternative to statins However, the number of people experiencing side effects that led to them stopping the drug was slightly higher in the bempedoic acid group (10.9% compared with 7.1% in the placebo group). Like statins, bempedoic acid works by blocking a key enzyme used by the body to make cholesterol, in this case an enzyme called ATP-citrate lyase. and Terms of Use. Bempedoic acid might not have widespread use but be reserved for people who haven't responded to statins and are thought to be at high risk (with very high cholesterol or established heart disease). People were randomly assigned to take bempedoic acid (1,488 people) or matching placebo (742), in addition to their statin, for 52 weeks. 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