Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’)announced that results from the 12-week, pivotal Phase 3 bempedoic acid / ezetimibe FDC tablet study (also known as Study 053) were published in the European Journal of Preventative Cardiology. Bempedoic acid and its FDC tablet are currently undergoing regulatory review for marketing authorisation by the European Medicines Agency (EMA) and by the United States Food and Drug Administration (FDA).
Study 053 evaluated the efficacy, safety, and tolerability of the bempedoic acid / ezetimibe FDC tablet in patients with hypercholesterolemia and a history of atherosclerotic cardiovascular disease or at high risk for atherosclerotic cardiovascular disease receiving maximally tolerated statin therapy (including potentially no statin).
The European Journal of Preventative Cardiology publication highlights that the primary endpoint (LDL-C lowering) and key secondary endpoint outcomes following 12 weeks of treatment were met, namely, that the bempedoic acid / ezetimibe FDC tablet: (1)
significantly lowered LDL-cholesterol by 38% (placebo-corrected) on background maximally tolerated statin therapy;
significantly reduced high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, by 35% from baseline;
was observed to have a favourable safety profile and was well tolerated when added to maximally tolerated statin therapy;
had a similar number of adverse events, including muscle related adverse events, as well as serious adverse events and discontinuations due to an adverse event, to those seen the other active treatment groups.
"The results of this study show that the bempedoic acid / ezetimibe FDC tablet provided significant additional LDL-C lowering and hsCRP reductions when added to maximally tolerated statin therapy," said Christie M. Ballantyne MD, Professor of Medicine at the Baylor College of Medicine, Houston, Texas and lead study author. "For patients who are not at their goal levels despite currently accessible therapies, the LDL-C lowering and hsCRP reductions seen with the bempedoic acid / ezetimibe FDC tablet support that this could be a very important treatment option."
The use of statins to manage hypercholesterolemia is well established, but there remains a large number of patients in Europe at high risk of CVD who are unable to reach their target LDL‑C level due to, in many cases, insufficient statin efficacy at maximally tolerated doses.(2) Furthermore, only 22-32% of very high risk patients are believed to be at their target LDL-C level. (3) (4)
"We are pleased to report the superior LDL-C and hsCRP lowering benefits versus placebo that the FDC of bempedoic acid with ezetimibe brings to patients at high risk of CVD who do not reach their target for LDL-C despite being on maximally tolerated statin therapy. These results add to the growing body of evidence supporting bempedoic acid and the bempedoic acid / ezetimibe FDC tablet," said Wolfgang Zierhut, MD, Head of Antithrombotic and Cardiovascular Medical Affairs Department at Daiichi Sankyo Europe. "With its liver specific mode of action, bempedoic acid avoids the debilitating muscle-related side-effects that are often associated with statins and could serve as a valuable complementary treatment option to hypercholesterolemia patients who are not reaching their goals with existing treatment options."
Design of the Bempedoic Acid / Ezetimibe FDC Phase 3 trial (1002FDC-053)
This phase 3, double-blind clinical trial randomised 382 adult patients at high CVD risk due to atherosclerotic CVD, heterozygous familial hypercholesterolemia, or multiple CVD risk factors. Patients were randomised (2:2:2:1) to treatment with the FDC, bempedoic acid 180 mg, ezetimibe 10 mg, or placebo added to stable background statin therapy for 12 weeks. The primary efficacy endpoint was the percent change from baseline to week 12 in LDL-C. Among the 301 patients included in this analysis, the mean baseline LDL-C was 3.87 mmol/L (149.8 mg/dL). At week 12, the FDC lowered LDL-C (–36.2%) significantly more than placebo (1.8% [placebo-corrected difference, –38.0%]; P<0.001), ezetimibe alone or bempedoic acid alone. The FDC lowered LDL-C levels similarly across subgroups, including patients rec...
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