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. Close menu. Many patients at higher risk, such as those with diabetes, inherited conditions or who have previously had heart attack or stroke, are prescribed cholesterol-lowering drugs, like statins, to reduce their risk. 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. Bempedoic acid has been shown to lower LDL cholesterol and appears safe 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. This RCT was also double blind, which means that the people receiving the treatment and the doctors administering the treatment are unaware of which treatment is being given. 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. "New fat-busting pill slashes heart attacks and strokes with no statin side-effects, researchers claim," reads The Sun's rather inaccurate headline. By using our site, you acknowledge that you have read and understand our Privacy Policy The other group was given a dummy drug (placebo). You can unsubscribe at any time and we'll never share your details to third parties. All were included in analysis of the 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. 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. 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 trial has strengths in its large size and relatively long follow-up for safety. FDA Approves New Cholesterol-Lowering Drug. Get weekly and/or daily updates delivered to your inbox. 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 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 difference in reported side effects between this drug and the placebo over the course of 1 year. 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). A study has looked into the safety of a new treatment to lower low-density lipoprotein (LDL), commonly known as "bad" cholesterol. 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. A new class of oral cholesterol-lowering drug could help patients unable to take statins due to side effects. This … 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.". RCTs are the most reliable way of assessing the effect of an intervention. 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. This site uses cookies to assist with navigation, analyse your use of our services, and provide content from third parties. 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. It was funded by Esperion Therapeutics, a US pharmaceutical company. 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. Click here to sign in with The US pharmaceutical company behind the drug, Esperion, is seeking a licence to market the drug this year in Europe and the US. Statins are still the most well-established, effective treatment for bad cholesterol. No. After 3 months, those who took bempedoic acid had lowered their bad cholesterol by around 17% compared to those on the placebo. 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. Menu One group was given the new drug, bempedoic acid, alongside their statin for 1 year. This document is subject to copyright. The average age of the people involved was 66. 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. New cholesterol-lowering drug could be an alternative to statins Share. 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. 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 FDA has approved two new non-statin drugs that clinical trials indicated can help reduce high cholesterol. 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). This study adds to the research looking for new cholesterol-lowering treatments when statins either don't work or cause undesirable side effects. ... statins do a great job of lowering cholesterol. However, bempedoic acid is not currently a licensed treatment. and Terms of Use. Neither your address nor the recipient's address will be used for any other purpose. Nexletol and Nexlizet can be used with statins that have moderate or … This was a randomised controlled trial (RCT) looking at a new treatment to lower LDL cholesterol. It could be an option for patients who are unable to tolerate statins at higher doses, or at all. 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. 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). 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. This study raises the prospect of a possible new treatment to reduce LDL cholesterol for people who have not responded well to statins alone. High cholesterol can increase the risk of cardiovascular disease, which kills about 150,000 people in the UK each year.
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