The FDA has approved label expansions for bempedoic acid (Nestretol) and bempedoic acid/ezetimibe (Nexlisette), allowing them to be more widely used as cardiovascular preventive drugs, Esperion announced on Friday.

Based on the CLEAR Outcomes trial, two adenosine triphosphate (ATP) citrate lyase inhibitors are currently available in adults with established atherosclerotic cardiovascular disease (CVD) or at increased risk of CVD events. It is indicated for reducing the risk of myocardial infarction (MI). Coronary artery revascularization. Approval does not require patients to be on existing statin therapy.

Bempedoic acid and bempedoic acid/ezetimibe have an indication for lowering low-density lipoprotein (LDL) cholesterol only in patients with heterozygous familial hypercholesterolemia or atherosclerotic CVD who require additional cholesterol lowering. and expanded to all adults with primary hyperlipidemia.

“We believe these approvals position Nestretol and Nexlisette as non-statins. selected first within the cardiovascular risk reduction treatment paradigm,” Esperion President and CEO Sheldon Koenig said in a press release.

These broad approvals may help interested patients and clinicians overcome the economic issues associated with bempedoic acid in clinical practice. Anecdotally, those who think the drug is too expensive, or whose insurance won’t pay for it, are fortunate to have access to LDL cholesterol-lowering non-statins such as PCKS9 inhibitors and inclisiran (Leqvio). I was able to get alternative medicine.

In any case, despite common reports of myalgia and other adverse events, statins are still considered the guideline-recommended front-line treatment for lipid lowering.

In the placebo-controlled CLEAR Outcomes trial, bempedoic acid was successful in providing primary and secondary cardiovascular prevention in statin-intolerant patients requiring cholesterol lowering. The drug reduced the risk of major adverse cardiovascular events, namely coronary revascularization and myocardial infarction, over 3 years of follow-up (11.7% vs. 13.3% in the placebo group, HR 0.87, 95% CI 0.79-0.96).

In total, nearly 14,000 participants participated in CLEAR Outcomes. Of note, primary prevention patients appeared to derive greater clinical benefit from bempedoic acid than the secondary prevention cohort.

Bempedoic acid and bempedoic acid/ezetimibe are taken as a once-daily oral tablet. There are safety risks, including hyperuricemia and tendon rupture, and this drug is not recommended for pregnant or breastfeeding women.