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When the FDA approved bempedoic acid, marketed under the brand name Nexletol, back in 2020, it was clear that the drug helped lower LDL – the “bad” one. ugly football The drug is intended for people who cannot tolerate statin drugs because of muscle pain, a side effect reported by up to 29% of people who take statins.
What is still unknown is whether bempedoic acid also reduced the risk of cardiovascular events. Now, the results of the uncertain fact of the trial have been published The New England Journal of Medicine show a significant benefit. The study included approximately 14,000 people, all of whom were statin intolerant.
“A big effect on heart attacks,” says the study’s author, Dr. Steven Nissen Cleveland Clinic.
People who took daily doses of bempedoic acid for more than three years had a 23% lower risk of heart attack during that time, compared to those on placebo. There was also a 19% reduction in coronary revascularizations, which are procedures that return blood to the heart, such as bypass surgery or stenting to open arteries.
With these discoveries, the benefits of the drug are now clearer, says Dr. John Alexander, a cardiologist and professor at Duke University. “Bempedoic acid has now entered the list based on statin evidence,” Alexander wrote in an editorial published alongside the study.
Jennifer Kluczynski, 55, of Lambertville, Mich., had tried several statins but had been experiencing lots of muscle aches and pains. “I felt like I had a fever,” he explains. For some days he just wanted to go to bed. Her doctor prescribed Nexletol two years ago, and she says she feels much better and is not “achy”.
And his cholesterol levels remain well controlled with medication.
“This works wonderfully for me and I have no side effects,” says Kluczynski.
Bempedoic acid is a prodrug that enters the body after the drug with the help of an enzyme. And, like statin drugs, bempedoic acid is mainly metabolized in the liver, not in peripheral tissues like muscle, so Alexander says it has “few, if any, muscle side effects.” In a clinical trial, myalgias, which are muscle aches or pains, were reported among people on placebo (6.8%), compared with those on bempedoic acid (5.6%).
The researchers say that bempedoic acid was generally tolerated by the people in the trial, but some risks were reported, including an increased incidence of gout, which was reported in 3% of the bempedoic acid group, compared to 2% of the placebo group. The study also showed a small increase in the number of people who developed gallstones (2% in the bempedoic group, 1% in the placebo group). But the benefits of taking the drug “far outweigh the small risks that we observed in the trial,” study author Nissen told NPR.
The study of the therapeutic drug Esperion was partially funded by the manufacturer, but Nissen reports on his work independently. “My statisticians generated all the numbers in the manuscript,” he says. “We do our analyzes and report adverse events very carefully because every drug has benefits and risks.”
It’s important to show that statins are well tolerated by millions of people, Nissen says, and “there’s an overwhelming amount of evidence that they reduce the risk of heart attack, stroke and death from cardiovascular causes.”
It is also relatively inexpensive, with many patients paying less than $10 a month, given many options, including generics. Kluczynski’s insurance plan covers the cost of Nexletol, but it can cost about $400 a month for people who aren’t covered by insurance. There is currently no generic for Nexletol.
Nissen says statins “continue to be a cornerstone of therapy to prevent cardiovascular events.” But for people who simply cannot bear the state, “from them,” he says, “change.”
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