Esperion (ESPR) continues to showcase their positive CLEAR data with two oral presentations at the European Society of Cardiology (ESC) 2023 Congress, notes John McCamant, editor of The Medical Technology Stock Letter.
The company highlighted three specific positive aspects of CLEAR;
– In total cardiovascular event analysis, bempedoic acid shows 20% risk reduction in MACE-4 and 17% risk reduction in MACE-3.
– In an analysis of patients with diabetes, bempedoic acid shows 17% risk reduction in MACE-4 and 20% risk reduction in MACE-3.
– No increase in development of new onset diabetes in patients randomized to bempedoic acid compared to placebo.
The CLEAR data 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 New England Journal of Medicine 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.
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.
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.
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 come at the cost of worsening glucose control. Espriorn is a buy under $10 with a target price of $25.
