Bempedoic acid as treatment for subjects at cardiovascular risk who are statin-intolerant

ABSTRACT

Introduction

Atherosclerotic cardiovascular disease is the leading cause of death globally. LDL cholesterol is a key risk factor for cardiovascular disease.  The most common group of medicines for lowering LDL cholesterol are the statins, as they reduce the risk of cardiovascular events.  However, some subjects are statin-intolerant and remain at high risk.

Areas covered

CLEAR Outcomes; a phase 3 clinical trial of bempedoic acid, an ATP citrate lyase (ACL) inhibitor, in subjects who do not tolerate statins or are unable to take the recommended dose. It enrolled subjects with prior cardiovascular events (secondary prevention) and at high risk (primary prevention). The primary endpoint was a composite of major adverse cardiovascular events, and this occurred in less subjects in the bempedoic acid than the placebo group. 

Expert opinion

Bempedoic acid is suitable for use as monotherapy in the prevention of cardiovascular events in statin intolerant subjects, and it has a good safety profile in most subjects.

However, the effects of bempedoic acid in lowering LDL cholesterol and cardiovascular events are modest.  This suggests that more benefits may ensue ifbempedoic acid was used in combination with other lipid lowering agents to cause larger decreases in LDL cholesterol.

KEYWORDS:

• ATP citrate lyase (ACL) inhibitor
• bempedoic acid
• cardiovascular outcomes
• ezetimibe
• statin-intolerant

Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they have received honoraria for lectures from companies including Daiichi Sankyo. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.