Taking Zetia alone does not lower your cholesterol that much, only 15% to 20%. “Nexletol is the first oral, once-daily, non-statin treatment option for indicated patients in nearly 2 decades.” Nexletol will be available on March 30, 2020 in 180mg strength tablets. According to a press release from Esperion, a phase III clinical trial of Nexletol “provided an average of 18 percent placebo corrected LDL-C lowering” in people who also took a statin. Their Achilles’ heel: Anywhere from 5% to 20% of people taking them cannot tolerate the medication, as the main side effect of muscle aching can be severe. The last time the Food and Drug Administration (FDA) approved a new non-statin cholesterol drug, Saddam Hussein still ran Iraq and ’N Sync remained a pop culture powerhouse. This was an expensive lesson for Pfizer, the company invested more than $800 million on a drug called torcetrapib, which harmed people even though it raised HDL levels. Healthline Media does not provide medical advice, diagnosis, or treatment. Last month, a new kind of medication called bempedoic acid (Nexletol) was approved for use by the FDA as a novel way to lower cholesterol. CLEAR Harmony (Study 1) Evaluated the safety and efficacy of NEXLETOL as add-on to patients’ maximally tolerated statin dose 1-3. Screening for heart disease: Which tests are worth your money? Adding Nexletol to that statin during the study cut his bad cholesterol even more. The pharmaceutical industry has been relatively slow in giving medical professionals and consumers new tools to fight high cholesterol, which can lead to heart disease and other serious health conditions. The medication comes in 180-mg tablets taken once per day with or without food. “Cholesterol medications have worked their way into significance for treatment outside of cholesterol therapy alone, yet development has not expanded,” he said. Nexlizet can be taken with ezetimibe, the last non-statin pill the FDA approved in 2002. “While statins have been available for decades and used to treat millions of people, bempedoic acid is a new chemical entity drug that has been tested in only several thousand people to date,” he added. Following a careful diet, exercising regularly, and dealing with stress are key components to lowering cholesterol, but sometimes medication in needed. It does not lower cholesterol much when taken alone — only by 17%. For two statins, simvastatin and pravastatin, your doctor may change the dose if you also take NEXLETOL. NEXLETOL and NEXLIZET are indicated as adjuncts to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. “The difference between Nexletol and Nexlizet is the latter contains ezetimibe — a cholesterol-lowering agent that has been available for many years that works by preventing the absorption of cholesterol from foods,” Dr. Richard C. Becker, a professor of cardiovascular health and diseases at University of Cincinnati in Ohio, told Healthline. The same is true of niacin, which raises HDL but is unsafe when taken with a statin. There has been minimal muscle aching reported. We have learned that lowering LDL cholesterol (so-called bad cholesterol) to levels that were previously thought to be too low is both safe and effective. Nexletol and Nexlizet are recommended to be taken with statins, if possible, based on the user’s statin tolerance. Nexletol was approved specifically as an adjunct treatment to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of … Statins, which are now generic and inexpensive, are usually the best way to lower cholesterol if you need a medication. They’re produced by Michigan-based Esperion Therapeutics. Humans also get cholesterol from food, which is why doctors recommend people with high cholesterol exercise, abstain from smoking, and follow a healthy diet. Stuck in a cycle of diet, exercise, and a statin without the results you need? Zu Beginn sowie nach Beendigung der gleichzeitigen Einnahmen sollten Sie deshalb die Blutgerinnung häufiger als sonst selbst kontrollieren oder vom Arzt kontrollieren lassen … The painful lesson: The best way to raise HDL is diet and exercise, and medications don’t work. “While (the two new drugs) wouldn’t likely be used together, both work to accomplish the LDL-C lowering goals,” an Esperion representative told Healthline. Pharmaceutical companies recognized an unmet need, both for statin intolerance and for cholesterol levels that remained too high despite being on statins, and the research has produced some fascinating results. In "Efficacy and Safety of Bempedoic Acid in Patients Who Cannot Tolerate Any Dose of a Statin: Pooled Analysis from Phase 3 Clinical Trials," (Abstract #P2139) data from a subgroup of more than 580 patients not receiving any dose of a statin showed a significant mean reduction of 26.5% (p< 0.001) in LDL-C by week 12 with NEXLETOL vs. placebo. But these new drugs also have some side effects of their own. In other words, statins don’t work for everyone. “Despite the measure, many patients will still have high LDL cholesterol,” Dr. Allan Stewart, the medical director for HCA East Florida’s Miami-Dade cardiovascular surgery program, told Healthline. Bempedoic acid is presently approved to take with a statin to further lower cholesterol, mainly for people with genetically high cholesterol. harmed people even though it raised HDL levels, California residents do not sell my data request. Does this new medication add something special? The FDA has approved two new non-statin drugs that clinical trials indicated can help reduce high cholesterol. Hopefully, further research will change this, but statin intolerance remains a problem in search of a solution. Unfortunately, they have a high incidence of side effects that limit long-term compliance with the treatment, including headaches, difficulty sleeping, flushing of the skin, and muscle cramps,” he explained. “It definitely made a difference,” Valant said. Now they have an option.”. “While the recipe for cholesterol medication therapy is often straightforward, some patients are left out due to intolerance,” Goetz said. Esperion notched major back-to-back FDA wins in February with its cholesterol-busting duo Nexletol and Nexlizet. For years, the medical community’s response was to suggest trying another statin, or recommend that patients just put up with their discomfort. © 2020 The Philadelphia Inquirer, LLC Terms of Use/Privacy Policy/California Notice California residents do not sell my data request. It should be taken with statin medications, but there are dosage limitations if taken with simvastatin or pravastatin. 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