The FDA approved it for use with a healthy diet and the maximum dose of statins a patient tolerates. The AP is solely responsible for all content. The American Heart Association explains the different cholesterol medications for lowering high cholesterol including Statins, HMG CoA reductase inhibitors, Selective cholesterol absorption inhibitors, Resins, bile acid sequestrant, bile acid-binding drugs, Lipid-Lowering Therapies. The Food and Drug Administration approved Esperion Therapeutics Inc.’s Nexletol for people genetically predisposed to have sky-high cholesterol and people who have heart disease and need to further lower their bad cholesterol. "Even with maximally tolerated statins, which may mean no statin at all, some of these patients can't achieve their LDL-C goals. Michael Valant, 71, of League City, Texas, took Nexletol for about 19 months in one study. Compared to a placebo, the drug reduced LDL cholesterol by an average of 18% in patients who were also on a statin, studies showed. The daily pill is to be taken in conjunction with a healthy diet and the highest statin dose patients can handle, the FDA said. Updated 1:55 AM ET, Mon February 24, 2020. The drug was generally well-tolerated in clinical studies, the company said, and label warnings and precautions include hyperuricemia, with the development of gout in some patients and an increased risk of tendon rupture or injury. High LDL, or bad cholesterol, is one of the top risks for heart attacks and other problems. Bempedoic acid is a once-a-day oral medication that will be commercially known as Nexletol. Nexletol works by inhibiting cholesterol production. Drugs.com provides accurate and independent information on more than 24,000 prescription … Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team. Follow Linda A. Johnson at https://twitter.com/LindaJ—onPharma. The availability of new drugs and biological products often means new treatment options for … "It's always important to remember," Blumenthal said, "good lifestyle habits are the cornerstone of prevention. "I definitely think it will be another tool that we have to utilize," said Blumenthal, director of Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease. Cholesterol is the waxy, fat-like substance found in many foods. “This is a nice alternative” to statins, but those medicines will still be the first choice, said Dr. Christie Ballantyne, Baylor College of Medicine's cardiology chief. ", Why losing weight might protect you from Covid-19, New diet can save lives and the planet, study says, Here's why you can't stop eating pizza, ice cream and chocolate chip cookies, These foods aren't as healthy as you think, Mediterranean diet named the best for 2019, Half of people prescribed statins don't reach cholesterol goals after two years, study says, Reduce cholesterol earlier in life to prevent heart problems later, study says. Insurers often restrict coverage of those medicines, which are shots patients give themselves once or twice a month. 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. Adding Nexletol to that statin during the study cut his bad cholesterol even more. Studies showed that Nexletol could lower LDL by about 25% when taken alone and by an additional 18% when combined with a statin. In studies, that combination reduced cholesterol between 38% to 44%, the company said. Patel, who was not involved in the research, estimated 10% to 15% of his patients might be eligible for Nexletol. The company has also applied for FDA approval to use the drug as a combination pill with ezetimibe, another non-statin. Esperion, based in Ann Arbor, Michigan, did not immediately disclose the drug's list price but previously said it planned a price of about $300 per month. Pa. high court denies another bid by Trump allies to halt election certification, Michigan restaurant leaves franchise over virus restrictions, Pennsylvania high court rejects lawsuit challenging election, Ex-Trump campaign aide sues over Russia probe surveillance, This undated photo provided by Esperion Inc. shows the cholesterol-lowering drug Nexletol made by Esperion Therapeutics Inc. “It definitely made a difference,” Valant said. In company-funded studies, common Nexletol side effects included high blood pressure and muscle and joint pain. Millions of people take cheap, generic statins, but the medicines don’t lower LDL cholesterol enough for many patients and others experience side effects such as muscle pain. Valant, a retired global supply chain manager, had a heart bypass operation more than a decade ago and then took a statin for years, but it wasn’t helping enough. Patel said that's likely just a random imbalance, not a big concern. Blumenthal said he could see doctors using the new drug if a statin doesn't lower cholesterol enough or if the statin isn't tolerated. Categories: Cholesterol | Tags: Cholesterol, Heart disease Statins also block cholesterol production in the liver, but in a different way, so the drugs together can reduce LDL more. Women who are pregnant or breast-feeding should not take Nexletol because of possible harm to the baby, the FDA said. The FDA has approved two new non-statin drugs that clinical trials indicated can help reduce high cholesterol. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The most common adverse reactions to the drug were upper respiratory infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes. Statins also block cholesterol production in the liver, but in a different way, so the drugs together can reduce LDL more. (CNN)The US Food and Drug Administration on Friday approved a drug to treat high cholesterol that works differently than statins, according to Esperion Therapeutics, the company that makes the drug. Other options include Zetia pills, also sold in generic form as ezetimibe for about $13 to $50 a month. The company estimates Nexletol could be appropriate for up to 18 million Americans and more than 100 million people in other countries. The Food and Drug Administration on Friday, Feb. 21, 2020 approved Esperion Therapeutics Inc.’s Nexletol for people genetically predisposed to have sky-high cholesterol and others who have heart disease and need to further lower their bad cholesterol. Nexletol, also known as bempedoic acid, should be available in late March, the company said. Your body needs it to function, but if your body makes too much, it can build up in the wall of your arteries. In one study of more than 2,200 patients, there were several more deaths from heart problems in the Nexletol group than among those given placebo pills. The US Food and Drug Administration on Friday approved a drug to treat high cholesterol that works differently than statins, according to Esperion Therapeutics, the company that makes the drug. Learn about alternatives such as new drugs … When arteries narrow, it restricts blood and oxygen from flowing to your heart and causes heart problems or stroke. The company has a large study underway to see whether Nexletol can lower the risk of heart attacks and other problems, not just cholesterol. He consults for Esperion and helped test the drug. Results are expected late in 2022. Turn on desktop notifications for breaking stories about interest? Statins are safe medications, and people with or at risk for heart disease and stroke should take them as directed, according to a new scientific statement from the American Heart Association. The new drug “would be valuable to add to treatment” for patients who can't get their LDL down enough with existing drugs or can't afford the injected ones, Duke Heart Center co-director Dr. Manesh Patel said. Serious side effects include tendon rupture. Far fewer patients use Repatha and Praluent, newer drugs that cost $6,000 or more a year. Today's approval provides them with a new medicine to go along with a healthy diet," said Tim Mayleben, president and chief executive officer of Esperion in a release. 24/7 coverage of breaking news and live events. The FDA approved this drug based on the fact that it can lower cholesterol, but it's still being studied to see if it will lower the risk of stroke and heart attack in patients who can't tolerate statins.
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