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. FDA Approves New Cholesterol-Lowering Drug. 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). 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. This reduces risk of bias. 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. The content is provided for information purposes only. It was funded by Esperion Therapeutics, a US pharmaceutical company. 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. 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.". 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. (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 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. Menu the Louisville Metabolic and Atherosclerosis Research Center The ongoing trial, called 'CLEAR OUTCOMES', is specially testing even longer-term safety and whether this approach reduces cardiovascular disease in addition to lowering cholesterol.". 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). 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. 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). However, bempedoic acid is not currently a licensed treatment. The average age of the people involved was 66. 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. The drug is offered in two FDA-approved formulations to lower LDL cholesterol levels in patients who are intolerant of statins. 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. Get weekly and/or daily updates delivered to your inbox. Share. A study has looked into the safety of a new treatment to lower low-density lipoprotein (LDL), commonly known as "bad" cholesterol. 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. Professor Ray added: "One of the key advantages of bempedoic acid is supposed to be that it shouldn't cause the muscle side effects reported by some statins users, as it taken up by the liver and needs to be converted into its active form via an enzyme only found in the liver. According to the group behind the study, the cholesterol-lowering treatment could be added to patients' existing drug regimens as well as providing an option for people who are unable to tolerate statins due to side effects such as muscle pain or bad interactions with other medications. and Terms of Use. "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. 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. 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. One group was given the new drug, bempedoic acid, alongside their statin for 1 year. 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. The most recent of these was CLEAR Wisdom, presented at the American College of Cardiology (ACC) 2019 Scientific Session, showing that the addition of bempedoic acid to maximally tolerated statin therapy significantly lowered LDL-C by 15.1% at 12 weeks; it also lowered total cholesterol, apolipoprotein B, non-HDL cholesterol, and C-reactive protein levels. 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. 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). There was no difference in reported side effects between this drug and the placebo over the course of 1 year. 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. 78% of people took either bempedoic acid or placebo as prescribed, though 95% completed all trial follow-ups to the final 52 week visit. Patients were drawn from the UK, Germany, Poland, Canada and the US, and were on varying intensities of cholesterol-lowering treatment regimens. This … We do not guarantee individual replies due to extremely high volume of correspondence. This study raises the prospect of a possible new treatment to reduce LDL cholesterol for people who have not responded well to statins alone. In the latest study, a total of 2,230 patients with high cholesterol levels (at least 1.8 mmol/L or 70 mg/dl) and taking cholesterol-lowering drugs (high or moderate intensity dose statins and/or ezetimibe) were randomly chosen to receive either the new treatment or placebo for one year. They were split into 2 groups. 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