The trial has strengths in its large size and relatively long follow-up for safety. Too much LDL cholesterol (commonly called "bad cholesterol") in the blood can lead to plaques which clog blood vessels and increase the chance of heart attack and stroke. (UPDATED) The US Food and Drug Administration has approved bempedoic acid (Nexletol) an oral, once-daily, non-statin LDL cholesterol (LDL-C)-lowering medicine for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C, the drug’s maker, Esperion, announced on February … The dropout rate because of side effects was slightly higher in the bempedoic acid group (11%) compared with the placebo group (7%). However, bempedoic acid is not currently a licensed treatment. Bempedoic acid has been shown to lower LDL cholesterol and appears safe over the course of 1 year. Most people in this trial were white, so we can't be sure how people of other ethnicities respond to this treatment. Menu 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. What we have is a new class of drug that could be given to patients who are already taking statins and could help them to further reduce their cholesterol levels and thus potentially cut their risk of heart attacks and strokes.". New cholesterol-lowering drug could be an alternative to statins 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. 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. It could be an option for patients who are unable to tolerate statins at higher doses, or at all. List of innovative new products that never before have been used in clinical practice. Your opinions are important to us. The benefit was identical to that expected though blocking the enzyme targeted by statins when individuals were matched for change in cholesterol. In a second study, also published in the NEJM, the team looked at data from more than half a million people and used genetic markers to model the likely effects of the treatment (blocking the action of the key enzyme ATP citrate) over a longer period and comparing the likely effects to the key enzyme blocked by statins. The drug is offered in two FDA-approved formulations to lower LDL cholesterol levels in patients who are intolerant of statins. Citation: New cholesterol-lowering drug could help patients unable to take statins (2019, March 13) retrieved 24 November 2020 This document is subject to copyright. On Friday, Dec. 13, 2019, U.S. regulators approved expanded use of the medication for preventing serious heart complications in high-risk patients already taking cholesterol-lowering pills. The average age of the people involved was 66. 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. Thank you for taking your time to send in your valued opinion to Science X editors. This reduces risk of bias. 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 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 findings come from the largest study to date to test the effectiveness and safety of bempedoic acid, an oral medication—yet to be approved in Europe—which inhibits the body's ability to create the building blocks of cholesterol. Statins are still the most well-established, effective treatment for bad cholesterol. This … 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. Published March 14 2019. This study raises the prospect of a possible new treatment to reduce LDL cholesterol for people who have not responded well to statins alone. There was no significant difference between groups in the rate of overall side effects (78.5% receiving bempedoic acid and 78.7% receiving placebo) or serious side effects (14.5% bempedoic acid and 14.0% placebo). "Our latest study shows that bempedoic acid could be another addition to the arsenal of cholesterol-lowering treatments available to patients. It was funded by Esperion Therapeutics, a US pharmaceutical company. 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 information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. The other group was given a dummy drug (placebo). 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. There was no difference in reported side effects between this drug and the placebo over the course of 1 year. the Louisville Metabolic and Atherosclerosis Research Center Share. Click here to sign in with 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. "Overall, these latest studies show that not only is the treatment generally well-tolerated being comparable with placebo, and potentially safe over longer periods, but that when added to high intensity statin treatment it can help to further reduce LDL cholesterol levels. 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. THURSDAY, March 14, 2019 (HealthDay News) -- People whose high cholesterol is resistant to treatment with statin drugs may soon have a new treatment option. The safety of the drug needs to be confirmed before it is made available. This document is subject to copyright. 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. There was also no significant difference in the rate of major cardiovascular events like heart attack or stroke (4.6% in the bempedoic acid group and 5.7% in the placebo group). Patients were drawn from the UK, Germany, Poland, Canada and the US, and were on varying intensities of cholesterol-lowering treatment regimens. Nexletol and Nexlizet can be used with statins that have moderate or …