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 study was published in the peer-reviewed medical journal the New England Journal of Medicine. 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. 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). This study adds to the research looking for new cholesterol-lowering treatments when statins either don't work or cause undesirable side effects. 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. "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. The content is provided for information purposes only. However, this new drug could provide real benefit for the few people who can't ... on top of their usual medication. The dropout rate because of side effects was slightly higher in the bempedoic acid group (11%) compared with the placebo group (7%). 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 average age of the people involved was 66. The drug is offered in two FDA-approved formulations to lower LDL cholesterol levels in patients who are intolerant of statins. All were included in analysis of the side effects. 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 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. Statins are still the most well-established, effective treatment for bad cholesterol. The benefit was identical to that expected though blocking the enzyme targeted by statins when individuals were matched for change in cholesterol. Thank you for taking your time to send in your valued opinion to Science X editors. 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. FDA Approves New Cholesterol-Lowering Drug. 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. 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. The other group was given a dummy drug (placebo). 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. This was a randomised controlled trial (RCT) looking at a new treatment to lower LDL cholesterol. Patients were drawn from the UK, Germany, Poland, Canada and the US, and were on varying intensities of cholesterol-lowering treatment regimens. the Louisville Metabolic and Atherosclerosis Research Center In addition, they found that the treatment was effective irrespective of the intensity of the patient's existing cholesterol-lowering treatment. 14 March 2019. 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. Your email address is used only to let the recipient know who sent the email. This reduces risk of bias. "Our latest study shows that bempedoic acid could be another addition to the arsenal of cholesterol-lowering treatments available to patients. The study took place across 14 different sites in 5 countries. List of innovative new products that never before have been used in clinical practice. One group was given the new drug, bempedoic acid, alongside their statin for 1 year. In fact, though the drug lowered cholesterol, there was no difference in the rate of cardiovascular events between groups. This document is subject to copyright. 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. Share. part may be reproduced without the written permission. People were randomly assigned to take bempedoic acid (1,488 people) or matching placebo (742), in addition to their statin, for 52 weeks. At 12 weeks, the drug treatment had reduced the mean LDL cholesterol level by 19.2mg per decilitre, representing a drop of 16.5% from the baseline (95%. 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. You can be assured our editors closely monitor every feedback sent and will take appropriate actions. 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). After 3 months, those who took bempedoic acid had lowered their bad cholesterol by around 17% compared to those on the placebo. It could be an option for patients who are unable to tolerate statins at higher doses, or at all. Your feedback will go directly to Science X editors. 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. 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. or, by Imperial College London. The safety of the drug needs to be confirmed before it is made available. Published March 14 2019. They were split into 2 groups. Most people in this trial were white, so we can't be sure how people of other ethnicities respond to this 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. High cholesterol can increase the risk of cardiovascular disease, which kills about 150,000 people in the UK each year. RCTs are the most reliable way of assessing the effect of an intervention. 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. Close menu. 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. We do not guarantee individual replies due to extremely high volume of correspondence. 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.". Bempedoic acid has been shown to lower their cholesterol between groups cardiovascular events between groups we. 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