Now, a new study confirms that bempedoic acid, approved in 2020, not only lowers cholesterol, but also reduces the risk of heart attack and stroke.
Statins will remain the first therapy patients receive to lower cholesterol. But the news means more people are likely to get a once-daily bempedoic acid pill.
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 are unwilling or unable to tolerate a statin.
“This establishes a therapy that will be an important addition for these really hard-to-treat patients,” he said.
What the study showed
The study, published Saturday in the New England Journal of Medicine, randomized nearly 14,000 patients, giving half a daily bempedoic acid and half a placebo. Both groups were followed for more than three years.
After six months, those given the drug saw a 21% greater reduction in LDL cholesterol – the bad kind – than those given the placebo.
After three years, 9.5% of those in the placebo group had had a heart attack, stroke or had died from a cardiovascular cause, compared to just over 8% of those given the drug, a significant difference.
People taking the drug were more likely to develop gout, gallstones or early signs of liver disease, but few showed serious reactions.
They did not develop type 2 diabetes, a known risk of statins.
In combination with ezetimibe, bempedoic acid lowers cholesterol by 35% to 40%, Nissen said, which is about the same amount as a moderate-intensity statin. The combination worked well in women and prevented the first heart attacks and strokes, he said.
“I think there are a lot of pluses here,” Nissen said. “We think this will be a pretty significant addition to the arsenal.”
The importance of lowering cholesterol
High levels of LDL cholesterol cause 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 change,” she said.
But huge numbers of people who could benefit from lowering their LDL levels go untreated, she said. “Here’s a new option, which I think is very 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 replacements or in combination with statins, but they are administered by injection and cost about $12,000 a year. Bepoic acid is available for about $425 per month or just over $5,100 per year. Generic statins can cost about $20 a month.
Statins and other medications 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 a 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 have been proven to work well in hundreds of thousands of people over decades.
The challenge of statins
There is some debate about how many people can’t take statins because of side effects, including uncomfortable and potentially serious muscle pain.
What really matters is whether patients will take a drug, said Dr. Eugene DePasquale, a cardiologist at USC’s Keck School of Medicine, who was not involved in the study.
Despite the drugs being widely prescribed, only about 60% of people take statins after a heart attack and less than 40% of people with diabetes but no heart disease take the drugs, according to a 2019 study.
“If they go home and don’t take it, there’s no benefit to it,” DePasquale said. “It’s very important to have an alternative.”
Although it’s been on the market for several years, bempedoic acid isn’t widely prescribed because of its cost and lack of data showing it can prevent heart attacks and strokes, along with lowering cholesterol, Knowles said.
Now, with that data, insurance companies are more likely to cover the drug and more doctors will be willing to prescribe it.
“There are so many people in the United States who need lipid lowering,” he said.
Please contact Karen Weintraub at [email protected]
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
This article originally appeared on USA TODAY: Alternative statin passes key test: Lowers risk of stroke and heart attack