Esperion’s cholesterol-lowering pill works when statins fail

A cholesterol lowering daily pill from US pharma Esperion, which can be used when statins are not working in high-risk patients, is edging closer to the market after a phase 3 trial success.

The trial showed bempedoic acid significantly lowered “bad” LDL-cholesterol, and reduced the inflammation biomarker high-sensitivity C-reactive protein in high-risk patients with high LDL cholesterol levels, despite taking medication such as statins.

Esperion’s international Study 1 tested the drug versus placebo in 2,230 high-risk patients with atherosclerotic cardiovascular disease (ASCVD) that was inadequately controlled with lipid-modifying therapies, including maximum doses of statins.

The company has already filed bempedoic acid, and a combination pill with ezetimibe, with the FDA and European Medicines Agency.

If approved, the drug could be a strong competitor to Sanofi and Amgen, whose injected PCSK9 inhibitor drugs Praluent  and Repatha are used in patients with high cholesterol levels despite statin therapy.

The study involved patients with ASCVD or heterozygous familial hypercholesterolemia with high LDL-C levels, inadequately controlled with lipid-modifying therapies including maximum dose statins.

They were randomly selected in a 2:1 ratio to receive bempedoic acid or placebo, with the main goal being safety and tolerability after a year of therapy.

The secondary objective assessed efficacy of bempedoic acid at lowering cholesterol after 12 weeks versus placebo.

Tertiary objectives were to assess the effect of bempedoic acid on other lipid parameters and risk markers, including hsCRP.

Results published in the New England Journal of Medicine showed that after 12 weeks bempedoic acid significantly lowered LDL-cholesterol by 18% compared with background maximally tolerated statin therapy.

It significantly reduced high-sensitivity C-reactive protein by 22%, which is an important marker of underlying inflammation associated with cardiovascular disease.

The drug did not lead to higher overall adverse events compared with placebo (78.5% versus 78.7% with placebo) and the proportion of patients with serious adverse events was similar (14.5% versus placebo 14%).

There were fewer adjudicated major adverse cardiac events (4.6% vs placebo 5.7%), and lower rates of new onset or worsening of diabetes (3.3% versus 5.4% placebo).

Esperion is also waiting for results from the CLEAR OUTCOMES trial, which is testing longer-term safety and whether the treatment reduced cardiovascular disease risk in addition to lowering cholesterol.

Professor Kausik Ray, from the Imperial Centre for Cardiovascular Disease Prevention, at Imperial College London’s School of Public Health, said: “This latest study shows that bempedoic acid could be another addition to the arsenal of once-daily, oral cholesterol-lowering treatments available to patients.

“Overall, these recent studies show that not only is the treatment generally well-tolerated, being comparable with placebo, and potentially safe over longer periods, but that when added to high intensity statin treatment it can help to further reduce LDL-cholesterol levels.”

 

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