Clear cardiovascular benefit with bempedoic acid revealed in two studies
USA: Analysis of the CLEAR Outcomes trial results revealed the totality of the benefit of bempedoic acid on cardiovascular risk reduction, not just the first event.
Treatment with bempedoic acid is associated with a risk reduction of 20% in total MACE-4 events (composite of major adverse cardiovascular events including non-fatal myocardial infarction, non-fatal stroke, coronary revascularization and cardiovascular death), 17% in total MACE-3 events (composite of major adverse cardiovascular events including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death), 31% in total myocardial infarctions, and 22% in total coronary revascularizations.
Esperion today announced the presentation of results from two oral presentations at the Late-Breaking Science Session entitled, “Clinical trial updates on prevention and lipid-lowering” at the European Society of Cardiology (ESC) 2023 Congress, taking place August 25-28, 2023, in Amsterdam, Netherlands.
“We are pleased to share additional results from our landmark CLEAR Outcomes study in late-breaker presentations at ESC 2023,” said Sheldon Koenig, President and CEO of Esperion. “These prespecified analyses further reinforce the cardiovascular risk reduction benefits of bempedoic acid in high-risk patients, not only upon an initial cardiovascular event as described in the NEJM publication, but also in those who experience more than one cardiovascular event and in patients with diabetes. Importantly, bempedoic acid use was not associated with an increased rate of new onset diabetes, which is a key differentiating feature compared to statins. We continue to believe bempedoic acid will have an increasingly important place in the treatment paradigm to reduce cardiovascular risk in a broad range of high-risk patients.”
Stephen Nicholls, MBBS, PhD (Victorian Heart Institute, Monash University) presented a prespecified analysis in a late-breaker presentation titled, “Impact of bempedoic acid on total cardiovascular events in high-risk patients: analysis of the CLEAR Outcomes trial.
“High risk patients face the prospect of not just one clinical event in the future, but in many cases, patients experience multiple events in the future. This data reinforces the importance of cholesterol lowering in high risk patients with the potential to prevent multiple events moving forward,” said Dr. Stephen Nicholls.
A second late-breaker presentation, titled “Cardiovascular Benefits and Risk of New Onset Diabetes by Glycaemic Status with Bempedoic Acid: Prespecified Analyses of the CLEAR OUTCOMES trial,” was presented by Kausik K Ray, MD, FMedSci (Imperial College London). Of the 13,970 patients included in CLEAR Outcomes, 45.6% had diabetes, 41.5% were pre-diabetic, and 12.9% had normoglycemia. In this pre-specified analysis, bempedoic acid demonstrated a benefit in patients with diabetes at baseline, showing a 17% reduction in risk of MACE-4 and 20% reduction in risk of MACE-3. In addition, bempedoic acid did not increase rates of new onset diabetes in patients without diabetes, and was generally comparable to placebo (11.1% vs 11.5%, respectively). Finally, bempedoic acid did not result in increased HbA1c levels at 12 months or at end of study in patients considered to have pre-diabetes or normoglycemia.
“Patients with diabetes have twice the risk of cardiovascular disease and lose on average half a decade of life compared to those without and when cardiovascular disease also co exists this loss of life years is a decade and a half” said Dr. Kausik K Ray. “Lowering LDL-C with statins is beneficial in people with diabetes and reduces cardiovascular disease. To date most treatments have been as add on to statins in people with diabetes so the present findings with bempedoic acid are noteworthy for several reasons. Firstly, these analyses show that when statins cannot be tolerated, bempedoic acid used as monotherapy can provide clinically meaningful reductions in cardiovascular disease in people with diabetes. Secondly, we know statins can increase the risk of diabetes. Although bempedoic acid works in the same pathway as statins no signal for increased risk of diabetes was noted, providing assurance for the use of bempedoic acid in people without diabetes that cardiovascular benefits do not come at the cost of worsening glucose control.”
INDICATION
Bempedoic acid is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Limitations of Use: The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined.
