When the FDA authorized bempedoic acid, commercialized as Nexletol, in 2020, it was evident that the medicine reduced LDL — “bad” cholesterol. The medicine was designed for patients who are unable to tolerate statin prescriptions owing to muscular soreness, which has been reported by up to 29% of statin users.
It was previously unknown if bempedoic acid lowered the risk of cardiovascular events. The findings of a randomized, controlled trial published in The New England Journal of Medicine indicate a considerable improvement. The trial involved around 14,000 participants, all of whom were statin intolerant.
“The main effect was on heart attacks,” says Cleveland Clinic researcher Dr. Steven Nissen.
Individuals who took bempedoic acid on a daily basis for more than three years had a 23% decreased chance of suffering a heart attack during that time than those who took a placebo. In addition, there was a 19% decrease in coronary revascularizations, which are treatments that restore blood flow to the heart, such as a bypass operation or stenting to open arteries.
According to Dr. John Alexander, a cardiologist and professor at Duke University, the medication’s advantages are now clearer as a result of these discoveries. “Bempedoic acid has now joined the list of evidence-based alternatives to statins,” Alexander wrote in an accompanying editorial.
Jennifer Kluczynski, 55, of Lambertville, Mich., had tried many statins but was still experiencing muscle aches and pains. “I felt like I had the flu,” she says, without the temperature. Some days, all she wanted to do was go back to bed. Her doctor prescribed Nexletol approximately two years ago, and she claims she feels much better and hasn’t “been achy” since then.
Her cholesterol levels are still nicely under control thanks to the medication.
“This is working beautifully for me, and I’m not experiencing any adverse effects,” Kluczynski
Bempedoic acid is a prodrug, which implies that it is activated by an enzyme after entering the body. Yet, unlike statin medicines, bempedoic acid is mostly processed in the liver rather than in peripheral tissues such as muscle, thus it “has minimal, if any, muscle-related adverse effects,” according to Alexander. Myalgias, or muscular aches and pains, were reported more frequently in the placebo group (6.8%) than in the bempedoic acid group (5.6%) in the clinical trial.
According to the researchers, bempedoic acid was generally well-tolerated by participants in the experiment, although there were some documented hazards, including an increased incidence of gout in 3% of the bemepedoic acid group compared to 2% of the placebo group. The study also discovered a little rise in the frequency of persons developing gallstones (2% in the bempedoic group, 1% in the placebo group). Yet, the advantages of taking the medicine “much exceed the modest hazards that we identified in the experiment,” according to study author Nissen.
The study was partially supported by the drug’s manufacturer, Esperion Therapeutics, but Nissen says his team operates independently. “All of the numbers in the paper were created by my statisticians,” he claims. “We do our own assessments and carefully record adverse occurrences because every medicine has advantages and hazards.”
Nissen emphasizes that statins are well tolerated by millions of individuals and that there is “enormous evidence that they lower the risk of heart attack, stroke, and death from cardiovascular causes.”
With the numerous alternatives, including generics, statins are also quite affordable, with many patients spending less than $10 per month. Nexletol is covered by Kluczynski’s insurance, but it can cost up to $400 per month for persons who do not have insurance. Nexletol presently does not have a generic.
Statins, according to Nissen, will “remain to be the cornerstone of therapy to avoid cardiovascular events.” “We have an option for them,” he explains, for folks who just cannot stomach a statin.
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