A recent study published in JAMA suggests that bempedoic acid, an alternative therapy for individuals who cannot tolerate statins, may significantly reduce the risk of cardiovascular events like heart attacks or strokes in patients without a history of major cardiovascular events.
Statin is a type of medication that lowers cholesterol levels by inhibiting an enzyme involved in cholesterol production. It is commonly prescribed to reduce the risk of cardiovascular disease. Most cardiovascular outcome trials involving lipid-lowering treatments have traditionally focused on participants who have had a previous cardiovascular event.
Lowering “Bad Cholesterol”Levels with Bempedoic Acid
The research encompassed a randomized clinical trial that included 13,970 patients who were intolerant to statins, with 4,206 of them having no previous cardiovascular incidents. The average age of participants was 68 years, with 59% being female and 66% having diabetes. The results demonstrated that bempedoic acid effectively reduced low-density lipoprotein (LDL) cholesterol levels by approximately 21% or 30.2 mg/dL.
The Potential of Bempedoic Acid as an Exciting Alternative for Statins-Intolerant Primary Prevention Patients
Dr. Eugenia Gianos, the director of Women’s Heart Health at Northwell Lenox Hill Hospital, hailed this therapy as an exciting breakthrough for patients who are genuinely statin intolerant. Bempedoic acid improved cardiovascular outcomes in all patients, and this study subgroup had a significant representation of women, with over half of the study population being female.
Primary prevention patients, who have not yet experienced a cardiovascular event, represent a particularly exciting population for the use of bempedoic acid if they are statin intolerant. Additionally, it can also be considered as an add-on therapy for patients with heart disease who are unable to achieve target cholesterol levels with other treatments, explained Dr. Gianos.
Further Research Needed
Further research is needed despite the promising results and potential benefits of bempedoic acid. Dr. Nick West from Abbott’s vascular business, a statin manufacturer, highlighted that current evidence supports statin therapy for those who can tolerate it.
Before considering bempedoic acid as a primary option, trials with different statins and doses should be encouraged. Given the potential biases and the study’s secondary analysis status, additional research involving patients with adverse risk and varying cholesterol levels is necessary to establish bempedoic acid as a potential leading choice for primary prevention in patients unable to tolerate statins.
Recommendations for Statin-Intolerant Patients
Statins therapy will likely continue to be a cornerstone of cholesterol management to lower LDL cholesterol and reduce the risk of cardiovascular issues. However, other forms of cholesterol-lowering and risk-modifying therapies are available, including bile acid sequestering agents, fibrates, and PCSK-9 inhibitors, which have already demonstrated improved cardiovascular outcomes.
Moreover, it is crucial to emphasize that although the relative risk of cardiovascular health events is high in statin-intolerant patients, the absolute risk remains lower. Therefore, patients should focus on non-pharmacological measures to improve their LDL cholesterol and overall cardiovascular risk profile.
Lifestyle modifications such as maintaining a healthy body mass index, regular exercise, smoking cessation, and adopting a healthy, low-cholesterol diet are vital, advised Dr. West.
Risks Associated with Bempedoic Acid vs Statins
Before considering any new treatment or medication, it is essential to be aware of potential risks. Dr. Gianos stated that the safety profile of bempedoic acid was excellent overall. However, patients with gout should exercise caution as it may increase uric acid levels and potentially trigger gout attacks. Additionally, bempedoic acid might mildly increase the formation of gallstones, and although there were mild increases in liver and kidney markers, they are unlikely to be clinically significant.
Dr. West also cautioned that bempedoic acid carries several risks. Although the incidence of these events appears to be low, the use of bempedoic acid should be considered on a case-by-case basis, weighing the individual patient’s risk of these events against the potential cardiovascular benefits.
The recent research on bempedoic acid suggests that it may be a promising alternative for primary prevention patients who are unable to tolerate statins. However, experts agree that further research is necessary before making it a first-line treatment option.
In the meantime, statins remain the mainstay of cholesterol management, complemented by other cholesterol-lowering therapies and lifestyle modifications. Patients should consult with their healthcare providers to determine the most appropriate treatment approach based on their individual circumstances, taking into account the risks and benefits of each option.
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