Is there an alternative to statins for high cholesterol? Bempedoic acid just passed a key test
More than a quarter of Americans over 40 take medications to lower their cholesterol, most of them statins. But not everyone can tolerate statins or wants to.
Now a new study confirms that bempedoic acid, approved in 2020, not only lowers cholesterol but also reduces the risk for heart attack and stroke.
Statins will remain the first therapy patients are given to lower cholesterol. But the news means more people will likely be prescribed a once-daily pill of bempedoic acid.
Bempedoic acid is sold under the brand name Nexletol from Esperion Therapeutics of Ann Arbor, Michigan. It is sold with another drug, ezetimibe as Nexlizet.
Dr. Steven Nissen, the Cleveland Clinic cardiologist who led the study, said he often has patients in his office who won't or can't tolerate a statin.
"This establishes a therapy that for these really difficult-to-treat patients will be a major addition," he said.
What the study showed
The study, published Saturday in the New England Journal of Medicine, randomized nearly 14,000 patients, half to receive daily bempedoic acid and half a placebo. Both groups were followed for more than three years.
At six months, those who received the drug saw a 21% greater reduction in LDL cholesterol – the bad kind – than those who got the placebo.
At the end of three years, 9.5% of those in the placebo group had suffered a heart attack, stroke or died from a cardiovascular cause, compared with just over 8% of those who received the drug, a significant difference.
People who took the drug were more likely to develop gout, gallstones or some early signs of liver disease, but few had severe reactions.
They did not get type 2 diabetes, which is a known risk of statins.
In combination with ezetimibe, bempedoic acid lowers cholesterol by 35% to 40%, Nissen said, which is about as much as a moderate-intensity statin. The combination worked well in women and prevented first heart attacks and strokes, he said.
"I think there's a lot of plusses here," Nissen said. "We think this will be a pretty important addition to the armamentarium."
The importance of lowering cholesterol
High levels of LDL cholesterol drive heart attacks and strokes, and decades of data show that reducing it lowers the risk of cardiovascular events, said Dr. Sadiya Sana Khan, a cardiologist and assistant professor at Northwestern University's Feinberg School of Medicine, who was not involved in the new study.
"This is one of the most important factors we can modify," she said.
But huge numbers of people who might benefit from reducing their LDL levels aren't treated, she said. "Here's a new option, which I think is really exciting."
Statins and other cholesterol-lowering drugs essentially trick the liver into thinking it doesn't have enough cholesterol, so it pulls more from the bloodstream, said Dr. Joshua Knowles, a cardiologist at Stanford Health Care and an associate professor of medicine at Stanford University, who was not involved in the study.
So-called PCSK9-inhibitors, which lower LDL cholesterol by as much as 50%, can also work as statin substitutes or in combination with statins, but they are delivered by injection and cost about $12,000 a year. Bepoidic acid is available for about $425 a month or just over $5,100 a year. Generic statins can cost about $20 a month.
Statins and other drugs work slightly differently, so they can be used in combination for people who need extra help lowering their cholesterol, said Knowles, who specializes in caring for patients with genetic risk for high cholesterol.
Nissen and others said statins should remain the first treatment given to patients with high cholesterol, because they are inexpensive and proven to work well in hundreds of thousands of people over decades.
The challenge of statins
There's some debate over how many people can't take statins because of side effects, including uncomfortable and potentially serious muscle aches.
What really matters is whether patients will take a medication, said Dr. Eugene DePasquale, a cardiologist at the Keck School of Medicine of USC, who was not involved in the study.
Despite the drugs being prescribed widely, only about 60% of people take statins after a heart attack and fewer than 40% of those with diabetes but without heart disease take the drugs, according to a 2019 study.
"If they go home and don't take it, it's not doing any benefit," DePasquale said. "It's really important to have an alternative."
Although it has been on the market for several years, bempedoic acid has not been widely prescribed because of its cost and the lack of data showing it could prevent heart attack and stroke along with reducing cholesterol, Knowles said.
Now, with that data, insurance companies may be more likely to cover the drug and more doctors will be more willing to prescribe it.
"There are so many people in the United States that need lipid lowering," he said.
Contact Karen Weintraub at email@example.com.
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This article originally appeared on USA TODAY: Statin alternative passes key test: lowers stroke, heart attack risk