- New research shows primary prevention patients who were unable to tolerate statins demonstrated reduced cardiovascular events after taking bempedoic acid.
- Doctors say that while these results are promising and there are benefits of bempedoic acid, further research is needed.
- Lifestyle therapy is recommended to improve heart health, including a well-balanced diet and exercise.
Most cardiovascular outcome trials involving lipid-lowering treatments have only examined participants who had a previous cardiovascular event. As a result, researchers wanted to explore how bempedoic acid affects cardiovascular outcomes among people who are statin-intolerant and have never had a major cardiovascular event such as a heart attack.
According to a new study published in
This randomized clinical trial involved 13,970 statin-intolerant patients, which included 4,206 patients who have not had a cardiovascular event.
The average age of participants was 68 years, with 59% female and 66% with diabetes.
“This is an exciting new therapy in patients who are truly statin intolerant,” said Dr. Eugenia Gianos, the director of Women’s Heart Health at Northwell Lenox Hill Hospital. “It improved cardiovascular outcomes in all patients, and unlike other trials, this subgroup had a great representation of women, with more than half of the study population being female.”
Primary prevention patients who have not suffered a cardiovascular event, probably represent the most exciting population for use of this medication if they are statin intolerant, however, it can also be considered as add-on therapy in patients with heart disease not able to get their cholesterol down with other therapies, Gianos explained.
Doctors say that while these results are promising and there are benefits of bempedoic acid, further research is needed.
“From these data and the overall CLEAR study analysis, bempedoic acid reduces both systemic inflammation (measured by high-sensitivity C-reactive protein) and LDL cholesterol significantly, translating into favorable reductions in hard cardiovascular endpoints,” said Nick West, M.D., chief medical officer and divisional vice president of global medical affairs at pharmaceutical company Abbott’s vascular business. “However, the bulk of current evidence in this space supports statin therapy, where individuals can tolerate it – therefore trials of different statins at different doses should be encouraged strongly before defaulting to a therapy that is relatively novel, with only one high-quality study (to date) to support it.”
Abbott makes statins and gives consulting fees to one of the study authors Kausik K. Ray, MD of Imperial College London, London, United Kingdom.
Further, it should be noted that this is a secondary analysis of a larger trial, and should be viewed as hypothesis-generating: further studies enrolling patients with adverse risk, statin intolerance, and perhaps both elevated and ‘normal’ LDL-cholesterol are required before this agent becomes a first-line option for primary prevention in statin-intolerant patients, West added.
Statins are likely to remain a mainstay of cholesterol management in order to lower LDL cholesterol and help people reduce their risk of cardiovascular issues.
Additionally, other forms of cholesterol and risk-modifying therapy are also available, including bile acid sequestering agents, fibrates and PCSK-9 inhibitors, which have also already been shown to improve cardiovascular outcomes.
It is also important to emphasize that while the relative risk of cardiovascular events is high in these patients, absolute risk remains lower, and patients should also focus on non-pharmacological measures to favorably improve their LDL-cholesterol and overall cardiovascular risk profile – including maintaining a healthy body mass index, taking regular exercise, abstention from smoking and eating a healthy and low-cholesterol diet, West noted.
“Lifestyle therapy, such as optimal diet and exercise, should be used across-the-board, because not only does it lower cholesterol, it also provides so many other health benefits,” said Gianos.
Before trying any new treatment or medication, it’s important to be aware of potential risks.
“The safety profile for bempedoic acid was excellent overall. It should be considered that it may increase uric acid and perhaps be avoided in patients with gout and may mildly increase gallstones. The mild increases in liver and kidney markers are not likely to be clinically meaningful,” Gianos stated.
West also advised that bempedoic acid comes with several risks.
“Bempedoic acid, though not associated with myalgia/muscle cramps that are commonly reported with statins, can cause an elevation in uric acid levels leading to attacks of gout, and also elevation of liver enzymes – sometimes associated with gallstone formation,” said West. “Although the incidence of these events appears to be low, use of the drug should be considered on a case-by-case basis, weighing individual patients’ risk of these events against the cardiovascular possible benefits that may accrue.”
According to new research, primary prevention patients who were unable to tolerate statins showed reduced cardiovascular events after taking bempedoic acid.
Although these findings are promising, experts agree that further research is needed.
To improve heart health, making lifestyle changes, such as a nutritious diet and regular exercise, is recommended.