- The researchers are touting a study 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 may 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 the first option for treating high cholesterol levels.
Researchers are signaling they may be able to offer an alternative to statins for controlling cholesterol levels.
They’re 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 has not yet been published in a peer-reviewed journal, was presented this week at the ENDO 2023 conference, the annual meeting of the Endocrine Society.
The researchers analyzed data from the CLEAR Outcomes study, which included 13,970 people with or at high risk of cardiovascular disease who were intolerant to statins.
In that study, participants were given bempedoic acid for high levels of low-density lipoprotein (LDL) cholesterol.
Some of the findings from the CLEAR Outcomes study included:
- LDL levels were reduced by an average of 21%.
- Cardiovascular events (heart attack, stroke, blocked blood vessels) were reduced by 13%.
Scientists say they expect these results to improve with continued use.
It’s important to note that this isn’t a study in itself, 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 study and extracted data on bempedoic acid rather than statins, Ni explained to Medical News Today. The CLEAR Outcomes Study has also compiled several studies that have agreed to share their results. Current information is important and helpful, but it was not a controlled study.
The researchers compared bempedoic acid with the use of placebo. It’s unclear whether 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 Johns 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 the second tier drug, he said Medical News Today.
Esperion Therapeutics, the manufacturer of bempedoic acid, funded this study.
The researchers say the findings suggest that different cholesterol-lowering drugs may have similar benefits for cardiovascular health and may offer people, especially those intolerant to statins, a choice.
I am pleased that the CLEAR Outcomes study has once again demonstrated that there are not only cholesterol-lowering benefits, but also cardiovascular event reduction benefits in a non-statin drug, said Dr. Michael Wesley Milks, a cardiologist at 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 said. Medical News Today. While these data are encouraging, it is interesting to note that they are basing this conclusion on per-protocol (i.e., as treated) analysis, which is not considered rigorous to demonstrate benefit as an intention-to-treat methodology.
Statins are prescription drugs that work to reduce 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 for lowering cholesterol.
Statins have side effects that can keep people from taking them. The most common side effect is muscle pain.
Statins can cause body aches or pains, Weinberg said. It can sometimes slow the healing of muscle injuries. If you experience pain and discomfort every day, you may not want to take the drug. Bempedoic acid gives people a choice.
Bempedoic acid is a relatively new drug.
It can be taken alone or in combination with statins or ezetimibe. Typically, statins are the first line of medication used, and if they are ineffective or the patient is unable to tolerate the medicine, ezetimibe or bempedoic acid can be added or used alone.
[Bempedoic acid] it is a drug designed to lower cholesterol without being metabolized in the muscles, therefore reducing the potential for adverse effects on the muscles, said Dr. Jeffrey Tyler, an interventional cardiologist at Providence St. Joseph Hospital in California.
I think this is a reasonable drug for statin-intolerant patients as it reduces the risk of cardiovascular events, he said Medical News Today. This drug 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 doesn’t 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 some other longer established drugs, in particular PCSK9 inhibitors (e.g. evolocumab, alirocumab) which can lower C- About 60% LDL, though [they] they require the use of injections, he said. In the CLEAR OUTCOMES study of bemepdoic acid, LDL-C lowering was approximately 20%, which is similar to that of ezetimibe, an oral nonstatin drug that is available as a generic formulation and therefore remains more affordable for most of my patients who need cholesterol-lowering drugs that do not contain statins.
While statins will likely 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 may not be a magic bullet, Weinberg said. Some people may need a combination of medications to reach their goal. Bempedoic acid adds to the arsenal of cholesterol-lowering drugs.
I would be much more willing to try bempedoic acid than before the CLEAR Outcomes study came out and have used it ever since, he said. Based on this information, it appears to be a good second option. I’m interested in finding out how real-life data comes out as prescribed more often.
If someone has a history of heart attack, stroke or cardiovascular disease and finds statins aren’t working, they should talk to their doctor about add-ons 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 select cases yes, this drug would be helpful, he said Medical News Today. However, given the lack of long-term data and the impact on mortality, it should be used with caution.
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