Abstract
Disclosure: J.R. Fredrick: None. S. Subramanian: None.
Introduction: Low-density lipoprotein cholesterol (LDL-C) has been established as the primary risk factor for atherosclerotic cardiovascular disease (ASCVD); hence, lowering LDL-C levels is critically important in primary and secondary ASCVD prevention. Statins have been the primary LDL-C lowering agents for decades, but intolerance is common, and patients often do not reach LDL-C goals. Bempedoic Acid (BA) is a novel oral agent approved in the US and Europe to reduce serum LDL-C levels by inhibiting the enzymatic activity of Adenosine triphosphate (ATP) citrate lyase in the cholesterol synthesis pathway. Recent data on real-life prescribing practices of BA in clinical practice since its approval in 2020 are not known. Hence, our objective was to evaluate its efficacy and safety in lowering LDL-C levels and analyze the prescribing practices and insurance coverage for BA. Methods: We conducted a retrospective cohort study using electronic medical records. We included adult patients over 18 years of age who were prescribed BA in all outpatient clinics within our academic practice in the year 2023. Results: Prescriptions were written for 72 patients; however, only 31 out of 72 started BA. Among those prescribed BA, 65% had a history of ASCVD, 84% had hyperlipidemia, 60% had hypertension, and 20% had type 2 diabetes. BA was most commonly prescribed for statin intolerance or LDL-C levels not at goal. BA was primarily prescribed by cardiologists or endocrinologists. BA significantly lowered LDL-C levels at 3 months (88mg/dl +/- 32) (p <0.001), 6 months (87mg/dl +/- 39) (p <0.001) and 1 year (92mg/dl +/- 29) (p<0.01) after initiation compared to baseline LDL-C levels (138mg/dl +/- 45)(paired t-test analysis). The most commonly reported adverse effect was myalgias, and there were few reports of headaches, nausea, and elevated liver enzymes. The majority of the patients who received BA were covered by Medicare (58%). The most common reasons for denial or lack of initiation of BA were 1) the need for a trial of either ezetimibe or PCSK-9 inhibitor, 2) substantial co-pay, or 3) conditional approval for a year. Conclusion: Our real-world study confirms that BA is effective in achieving a significant reduction in LDL-C levels for up to a year and minimal side effects, similar to the previous efficacy studies. However, significant challenges due to insurance coverage remain, such as need for use of other LDL-C lowering agents and high co-pays that continue to limit patients' access to this medication.
Presentation: Saturday, July 12, 2025