FDA Expands Bempedoic Acid Label for Cardiovascular Risk Reduction

The U.S. Food and Drug Administration (FDA) has recently expanded the label for bempedoic acid, allowing its use for both primary and secondary cardiovascular risk reduction, whether taken alone or in combination with statins.

This decision comes after a comprehensive review of clinical trial data demonstrating the efficacy of bempedoic acid in reducing the risk of cardiovascular events in patients with established cardiovascular disease or those at high risk. Bempedoic acid works by inhibiting ATP citrate lyase, an enzyme involved in cholesterol biosynthesis, thereby lowering LDL cholesterol levels.

The expanded label provides healthcare providers with an additional option for managing cardiovascular risk in patients who may not tolerate or adequately respond to statin therapy alone. It also offers a potential alternative for patients who prefer a non-statin medication or those who require additional LDL cholesterol lowering despite being on statin therapy.

The FDA’s decision to broaden the indication for bempedoic acid reflects the agency’s commitment to addressing the unmet needs of patients at risk for cardiovascular events. However, it is important for healthcare providers to carefully evaluate each patient’s individual risk profile and treatment goals before initiating therapy with bempedoic acid or any other medication for cardiovascular risk reduction.

As with any prescription medication, patients should be counseled on the potential benefits and risks of bempedoic acid therapy, including possible side effects such as muscle pain and weakness. Close monitoring and regular follow-up are essential to ensure optimal treatment outcomes and patient safety.

The expanded label for bempedoic acid marks a significant development in the management of cardiovascular disease and underscores the importance of continued research and innovation in this area. Healthcare providers are encouraged to stay informed about updates to treatment guidelines and to collaborate with patients to develop individualized treatment plans that address their unique needs and preferences.