Bempedoic acid lowers LDL regardless of glycemic status
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Researchers found that bempedoic acid significantly reduced LDL compared with placebo in patients with diabetes, prediabetes or normoglycemia and hypercholesterolemia.
Bempedoic acid (Nexletol, Esperion Therapeutics) is a first-in-class ATP-citrate lyase inhibitor, according to an abstract presented at the virtual American Diabetes Association Scientific Sessions.
“These data are reassuring for the use of bempedoic acid in patients with diabetes or prediabetes, populations at high risk for cardiovascular disease in whom intensive LDL-lowering is generally recommended,” Lawrence A. Leiter, MD, FRCPC, FACP, FACE, FAHA, professor of medicine and nutritional sciences at the University of Toronto, told Healio.
Phase 3 trials
Researchers analyzed data from 3,623 patients from four phase 3 trials who were already on stable lipid-lowering therapy. Patients were assigned 180 mg bempedoic acid or placebo once per day for 12 to 52 weeks.
“Meta-analyses of the large statin trials have shown about a 10% increased risk of new-onset diabetes in statin users, although the number needed to harm is large and clearly outweighed by the cardiovascular benefits,” Leiter said in an interview. “As a result, there is great interest in whether other lipid-lowering agents may show a similar signal. There is also interest as to whether the LDL-C-lowering efficacy of a lipid-lowering drug would vary based on a patients’ glycemic status.”
Studies included in this analysis were grouped by enrollment criteria: 52 weeks for patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia, or 12 or 24 weeks in patients who were statin intolerant.
The primary efficacy endpoint was defined as a percentage change in LDL from baseline to 12 weeks.
Studies in patients with atherosclerotic CVD or heterozygous familial hypercholesterolemia found that bempedoic acid significantly lowered LDL compared with placebo in patients regardless of they had diabetes (18.6% vs. 0.6%; mean difference, 19.2%; 95% CI, 22.2 to 16.2), had prediabetes (16.4% vs. 2.1%; mean difference, 18.5%; 95% CI, 20.9 to 16.1) or were normoglycemic (14% vs. 3.2%; mean difference, 17.2%; 95% CI, 21.4 to 13). This was also seen in studies with patients who were statin intolerant and had diabetes (20.9% vs. 1.9%; mean difference, 18.9%; 95% CI, 24.7 to 13.1), had prediabetes (25% vs. 4.7; mean difference, 29.7%; 95% CI, 34.6 to 24.7) or were normoglycemic (25.2% vs. 1.6%; mean difference, 23.6%; 95% CI, 29.7 to 17.4).
Compared with placebo, bempedoic acid reduced non-HDL, total cholesterol, high-sensitivity C-reactive protein and apolipoprotein B (P < .01 for all).
Both bempedoic acid and placebo had a similar safety profile that did not differ by glycemic status. Compared with placebo, bempedoic acid did not increase the occurrence of new-onset diabetes or worsen glycemic control measures.
“We do not yet know whether the LDL-C lowering will translate into cardiovascular risk reduction, but this is being looked at in a large cardiovascular outcome trial,” Leiter told Healio.
‘Lipid management for everybody’
“As we work toward lipid management for everybody, we now have additional useful information for these distinctive patients and their health care providers,” Tim Mayleben, president and CEO for Esperion, said in a company press release. “Importantly, this analysis adds to the growing body of information regarding the efficacy and safety of Nexletol for the millions of appropriate patients needing to lower their bad cholesterol.”
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Leiter LA, et al. 185-OR. Presented at: American Diabetes Association Scientific Sessions; June 12-16, 2020 (virtual meeting).
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