Bempedoic Acid and Ezetimibe Fixed Dose Combo effectively lowers LDL C in diabetics not on statins

Bempedoic acid is the first class oral ATP-citrate lyase inhibitor. The combination of Bempedoic acid (BA) and ezetimibe fixed-dose combination (EZE FDC) are approved as subordinating to diet for patients with type 2 diabetes mellitus (T2DM) and hypercholesterolemia who are at high risk for atherosclerotic cardiovascular disease (ASCVD) and to treat elevated low density lipoprotein cholesterol (LDL-C) levels.

Researchers have found in a new study that the combination of Bempedoic acid and ezetimide fixed dose combination essentially brought down LDL-C levels and is by and large well tolerated among patients with T2DM and hypercholesterolemia who were not receiving statins or other lipid lowering drugs.

The study has been  published in American Journal of Preventive Cardiology.

Statins are well known first line therapy for the treatment of elevated LDL-C levels albeit they are also to be linked with increased rates of new onset diabetes and worsening of glycemic control in patients with T2DM. Having said that adding non statins is needed for achieving risk based LDL-C lowering goals.

The study led by researchers, with an aim of assessing the efficacy and safety of BA 180mg + EZE 10mg FDC in patients with T2DM and hypercholesterolemia, enrolled patients with T2DM and elevated LDL-C levels. Change in percentage value of LDL-C during 12 weeks, other lipid parameters, high sensitivity C-reactive protein (hsCRP), monitoring of safety and tolerability were used for the assessment tool.

Of 179 randomized patients, either BA + EZE FDC, EZE, or placebo randomly for 12 weeks randomly within the same washout period, keeping mean value of LDL-C levels at 142.6 mg/dL and glycated hemoglobin of 8.0%. Salient findings of the study are:

• BA + EZE FDC therapy lowered mean LDL-C levels by 38.8%, significantly more than ezetimibe alone or placebo.

• BA + EZE FDC significantly reduced hsCRP levels from baseline vs ezetimibe (29.2%; p = 0.005) and vs placebo (36.7%; p < 0.001).

• Patients treated with BA + EZE FDC did not experience any serious treatment-emergent adverse events (TEAEs). Two serious TEAEs were reported during the study, one in the ezetimibe group (duodenal ulcer) and one in the placebo group (angioedema).

• Adverse events of special interest (AESIs) higher in the BA + EZE FDC group (15.0% [n = 9]) compared with the ezetimibe (8.3% [n = 5]) or placebo (8.5% [n = 5]) groups.

Reference:

Bays HE, Baum SJ, Brinton EA, Plutzky J, Hanselman JC, Teng R, Ballantyne CM. Effect of bempedoic acid plus ezetimibe fixed-dose combination vs ezetimibe or placebo on low-density lipoprotein cholesterol in patients with type 2 diabetes and hypercholesterolemia not treated with statins. Am J Prev Cardiol. 2021 Oct 4;8:100278.

doi: 10.1016/j.ajpc.2021.100278. PMID: 34746903; PMCID: PMC8550983.