- Researchers are touting a study that they say shows that the cardiovascular benefits of bempedoic acid are comparable to those obtained from statins.
- They say the findings indicate that bempedoic acid can be used as an alternative to statins for people who don’t tolerate those drugs well.
- Experts say more research is needed and, for now, statins should be considered as the first option for treating high cholesterol levels.
Researchers are reporting that they may be able to offer an alternative to statins to control cholesterol levels.
They are basing their conclusions on a study that concluded that bempedoic acid (Nexletol) reduces the risk of cardiac events as much as statins.
The research, which hasn’t been published yet in a peer-reviewed journal, was presented this week at the ENDO 2023 conference, the annual meeting of the Endocrine Society.
Researchers analyzed data from the CLEAR Outcomes trial, which included 13,970 people with or at high risk for cardiovascular disease who were intolerant to statins.
In that study, participants were given bempedoic acid for high low-density lipoprotein (LDL) cholesterol levels.
Some of the findings from the CLEAR Outcomes trial included:
- LDL levels were reduced by an average of 21%.
- Cardiovascular events (heart attack, stroke, blocked blood vessels) were reduced by 13%.
The scientists say they expect these results to improve with continued use.
“It is important to note that this is not a study per se,” said Dr. Yu-Ming Ni, a cardiologist at MemorialCare Heart and Vascular Institute at Orange Coast Medical Center in California.
“The researchers used data from the CLEAR Outcomes trial and pulled the data on bempedoic acid rather than statins,” Ni explained to Medical News Today. “The CLEAR Outcomes trial also compiled several studies that agreed to share their results. The current information is important and helpful but was not a controlled study.”
The researchers compared bempedoic acid to placebo use. It isn’t clear if the results are similar to the risk reduction from taking statins. However, compared to previous knowledge of statin use, they say the results are comparable.
“Benpedoic acid is like statins in that both are cholesterol-lowering drugs,” said Dr. Nicole Weinberg, a cardiologist at Providence Saint John’s Health Center in California.
“In my clinical experience, bempedoic acid is less effective than statins. I see statins as the first choice and bempedoic acid as a second-level drug,” she told Medical News Today.
Esperion Therapeutics, the manufacturer of bempedoic acid, funded this study.
The researchers say the results suggest that different cholesterol-lowering drugs can have similar benefits for cardiovascular health and can offer people, especially those who are intolerant to statins, a choice.
“I am pleased that the CLEAR Outcomes study has shown again that there are not only cholesterol-lowering but also cardiovascular event reduction benefits to a non-statin medication,” said Dr. Michael Wesley Milks, a cardiologist at The Ohio State University Wexner Medical Center.
“This particular analysis suggests that the degree of cardiovascular risk reduction is comparable to that of statins for a given amount of LDL cholesterol reduction,” he told Medical News Today. “While these data are encouraging, it is noteworthy that they are basing this conclusion on the per-protocol (ie, as-treated) analysis, which is not considered as rigorous for demonstrating benefit as an intention-to-treat methodology.”
Statins are prescription medications that work to decrease cholesterol levels.
They can prevent or reduce the risk of heart attack or stroke. The longer someone takes statins, the better they work. Statins are the most commonly prescribed drugs to lower cholesterol.
Statins do have side effects that can prevent people from taking them. The most common side effect is muscle aches.
“Statins can cause muscle soreness or aches,” Weinberg said. “Sometimes it can slow healing of muscle injury. If you experience pain and discomfort daily, you might not want to take the medication. Bempedoic acid offers people a choice.”
Bempedoic acid is a relatively new medication.
It can be taken alone or in combination with statins or ezetimibe. Typically, statins are the first line of drugs used, and if they are not effective or the patient is unable to tolerate the medicine, ezetimibe or bempedoic acid can be added or used alone.
“[Bempedoic acid] is a medication designed to lower cholesterol without being metabolized in the muscles, therefore reducing the potential for adverse effects on muscles,” said Dr. Jeffrey Tyler, an interventional cardiologist with Providence St. Joseph Hospital in California.
“I think this is a reasonable medication for statin-intolerant patients as it lowers the risk of cardiovascular events,” he told Medical News Today. “This medication has a slightly higher risk of gout, which may limit its use in some patients. I think statins will remain the cornerstone of cholesterol-lowering therapy given the large evidence base of their benefit for cardiovascular disease.”
Milks points out that there are limitations to bempedoic acid, particularly that it does not provide the same level of protection as other treatments.
“It is worth mentioning that the LDL-C lowering effect of bempedoic acid is less potent than certain other longer-established drugs, particularly PCSK9 inhibitors (e.g. evolocumab, alirocumab) which can lower LDL-C by approximately 60 percent, although [they] require use of injections,” he said. “In the CLEAR OUTCOMES trial of bemepdoic acid, LDL-C lowering was around 20 percent, which is similar to that of ezetimibe, a non-statin oral medication that is available as a generic formulation and thus remains more cost favorable for most of my patients who need non-statin cholesterol-lowering medications.”
Even though statins will probably remain the first line of treatment, having options benefits people with cardiovascular disease who are at high risk of heart attack or stroke.
“Like diabetes, there might not be one magic bullet,” Weinberg said. “Some people might need a combination of drugs to reach their goal. Bempedoic acid adds to the arsenal of drugs to lower cholesterol.”
Ni agrees.
“I would be much more willing to try bempedoic acid than before the CLEAR Outcomes trial came out and I have used it since then,” he said. “Based on this information, it appears to be a good second option. I am interested in discovering how real-life data comes out as prescribed more often.”
“If someone has a history of heart attack, stroke, or cardiovascular disease, and they find statins are not working, they should talk with their doctor about additions or alternatives, such as ezetimibe or bempedoic acid,” Ni added.
Dr. Aeshita Dwivedi, a cardiologist at Northwell Lenox Hill Hospital in New York, is also cautious about using bempedoic acid.
“In selected cases yes this drug would be helpful,” she told Medical News Today. “However given the lack of long term data and impact on mortality, it should be used in caution.”