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Bempedoic acid (BA), an adenosine triphosphate-citrate lyase (ACL) inhibitor, has illustrated strong efficacy in minimizing low-density lipoprotein cholesterol (LDL-C) and cardiovascular (CV) risk in clinical trials. However, data on its real-world performance remains limited.
Treatment with bempedoic acid—alone or in fixed-dose combination with ezetimibe—leads to a significant 22.7% reduction in LDL-C levels and a six-fold rise in patients achieving LDL-C targets within 8 weeks, without new safety concerns.
Bempedoic acid (BA), an adenosine triphosphate-citrate lyase (ACL) inhibitor, has illustrated strong efficacy in minimizing low-density lipoprotein cholesterol (LDL-C) and cardiovascular (CV) risk in clinical trials. However, data on its real-world performance remains limited.
The European MILOS study sought to fill this gap by evaluating the effectiveness and safety of BA and its fixed-dose combination (FDC) with ezetimibe (BA/BA+EZE FDC) in everyday clinical settings among patients with hypercholesterolemia or mixed dyslipidemia. This report presents interim 8-week follow-up results from the Belgian cohort.
Between November 2022 and October 2023, 375 Belgian patients were recruited. Among them, 101 volunteers (BA=58; BA+EZE FDC=43) had LDL-C values available at baseline and at 8 weeks (8W). The mean (SD) age was 65.8 (10.0) years, and 65.3% were male. Nearly 8.3% had heterozygous familial hypercholesterolemia, 25.6% had diabetes, and 69.3% were receiving secondary CV prevention. Nearly 89.3% were classified as high or very high CV risk. Prior to initiating BA or BA+EZE therapy, 24% had not received any prior lipid-lowering treatment (LLT).
After a mean (standard deviation) treatment duration of 78.3 (66.6) days, the cohort illustrated a mean relative LDL-C reduction of 22.7% (32.5) and a median reduction of 25.6%. LDL-C levels dropped from 2.9 (1.3) mmol/L [112.5 mg/dL] to 2.1 (1.4) mmol/L [82.7 mg/dL] following BA or BA+EZE therapy, administered with or without background LLTs.
Importantly, the proportion of patients attaining LDL-C targets rose from 5.0% at baseline to 33.7% at week 8, reflecting an over 6-fold improvement, including an 18% rise among very high CV risk individuals. No novel safety concerns were reported during the follow-up period, aligning with prior clinical trial findings.
The Belgian interim findings from the MILOS real-world study confirm that BA, alone or in FDC with EZE, markedly improves LDL-C goal attainment within just 8 weeks, even among high and very high CV risk patients. These results reinforce BA’s value as a potent, well-tolerated non-statin therapy for tackling dyslipidemia in clinical practice.
Atherosclerosis
Usage of bempedoic acid and/or its fixed-dose combination with ezetimibe in Belgian patients with dyslipidaemia: Baseline characteristics and 8-week follow-up data from the MILOS study
Thomas Vanassche et al.
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