The non-statin, cholesterol-lowering drug bempedoic acid (Nexletol) has been found to lower the risk of adverse cardiovascular events and death in statin-intolerant patients.
Statins are a key tool in preventing major cardiac events. But some patients can’t tolerate the drugs, including older adults, who are more likely to experience severe side effects. Bempedoic acid is commonly given in tandem with statin treatments. The new trial, CLEAR Outcomes, is the first to examine the potential for bempedoic acid alone to reduce cardiovascular outcomes in these patients, according to the researchers.
Trial participants included more than 13,000 patients with an average age of 65 years, randomized to a bempedoic acid group and a placebo group. Average follow-up was approximately 41 months.
Cholesterol levels fall
The drug reduced the rate of major adverse cardiovascular events by 13%, the investigators reported. In addition, LDL cholesterol levels fell by about 20% to 25% on average over the course of the study, compared to about 10% in the placebo group.
This reduction in LDL cholesterol is less than the 40% to 50% fall in levels usually found with statins. But the degree of change is significant in the overall risk of cardiac events for the statin intolerant, the researchers noted.
Side effects related to the drug were also reported, although these did not appear to lead to drug discontinuation.
An effective alternative
The results show that bempedoic acid is an effective alternative to the standard of care for reducing unsafe cholesterol level, according to study lead Steven E. Nissen, MD, of the Cleveland Clinic.
“Statins are the cornerstone of risk reduction in patients with elevated LDL cholesterol,” Nissen said in a statement. “Most people can take statins, but some cannot. This is the first study that directly addressed the problem of statin-intolerant patients. We achieved what we hoped we would get — a very positive result in a population of people who just could not tolerate statins.”
Full findings were published in the New England Journal of Medicine.