Esperion’s heart drug significantly reduced the risk of major adverse cardiovascular events (MACE), such as heart attacks and strokes, according to results presented by the company at the American College of Cardiology (ACC).
The phase 3 CLEAR trial was designed to evaluate whether treatment with Nexletol (bempedoic acid) could reduce the risk of cardiovascular events in patients who are at high risk for cardiovascular disease with documented statin intolerance.
The results, which have also been published in the New England Journal of Medicine, showed the drug reduced the risk of hard MACE-4 and MACE-3 by 13% and 15%, respectively.
The impact of Nexletol was even more significant on specific event types, with the team finding relative risk reductions of 23% and 19% in heart attacks and bypass surgeries, respectively.
The company said it remains ‘on track’ to submit US and EU regulatory filings in the first half of this year to add a reduction in risk of cardiovascular events Nexletol’s prescribing information, a move it thinks could more than double the addressable treatment population for the drug.
Sheldon Koenig, president and chief executive officer of Esperion, said: “These results have the potential to bring significant benefits to the millions of primary and secondary prevention patients who are unable to reach their goals with current therapies.
“We expect applicable treatment guidelines to be updated quickly which will then lead to a paradigm shift in patient care.”
Cardiovascular diseases are the leading cause of death globally, according to the World Health Organization, resulting in an estimated 17.9 million deaths each year.
Those considered to be at a high risk of cardiovascular disease can be prescribed daily cholesterol-lowering statin pills. However, some patients are unable to take them for a variety of reasons, such as being at an increased risk of side effects.
JoAnne Foody, chief medical officer of Esperion, said: “We recognise that physicians and patients are eager for additional non-statin oral treatments that lower LDL cholesterol and high-sensitivity C-reactive protein, do not worsen glucose and reduce major adverse cardiovascular events.
“These results now position our products as the ‘go-to’ therapies for the large number of primary and secondary prevention patients unable to maximise or tolerate statins to reduce cardiovascular risk.”