Expanded Indication for Bempedoic Acid Includes Cardiovascular Risk Reduction in Primary and Secondary Prevention Patients

The bempedoic acid U.S. approvals for cardiovascular risk reduction in patients unable to take recommended statin therapy, including no statin, also include LDL-C lowering for primary hyperlipidemia in patients taking a statin.

The cardiovascular risk reduction indication was based on data from the Clear Outcomes trial that included 13,970 patients with, or at high risk, of CVD. The median follow-up duration was 3.4 years.

Clear Outcomes Primary Results ↗︎

Bempedoic Acid Research News at ACC 2024 ↗︎

The Science Behind the Indication^1,2

The study achieved it’s primary composite endpoint of major adverse cardiac events, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization with a relative risk reduction of 13% with bempedoic acid compared to placebo.

Bemepodic acid reduced risk of myocardial infraction by 27% compared to placebo

Bempedoic acid reduced risk of coronary revascularization by 19% compared to placebo

30% of patients in the CLEAR OUTCOMES trial were enrolled for primary prevention

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Studied in adults who are unable to take recommended statin therapy, including those not taking a statin¹

At start of CVOT, 23% of patients were on less than low-intensity statin dosages.

References

NEXLETOL® (bempedoic acid) US Full Prescribing Information.
Nissen SE, Menon V, Nicholls SJ, et al. Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients. JAMA. 2023 Jul 11;330(2):131-140.