Results of the Pivotal Phase 3 Study of the Bempedoic Acid / Ezetimibe Combination Tablet Published in the European Journal of Preventative Cardiology Demonstrated Significant LDL-C Lowering
- Bempedoic acid / ezetimibe fixed dose combination (FDC) tablet is an oral, once-daily ATP citrate lyase (ACL) inhibitor that reduces cholesterol synthesis in the liver
- Bempedoic acid / ezetimibe FDC tablet lowered LDL-C by 38% (placebo-corrected) and reduced hsCRP by 35% (from baseline) in patients receiving maximally tolerated statin therapy[i]
- Bempedoic acid / ezetimibe FDC tablet was observed to have a favourable safety profile and was well tolerated
MUNICH, Germany, (July 31, 2019) – Daiichi Sankyo Europe GMbH (hereafter, ‘Daiichi Sankyo’) today 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.[ii] Furthermore, only 22-32% of very high risk patients are believed to be at their target LDL-C level.[iii],[iv]
“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.”
[i] Ballantyne CM. et al. Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination in Patients With Hypercholesterolemia and High CVD Risk Treated With Maximally Tolerated Statin Therapy. Eur J Prev Cardiol. 2019. Available at: https://doi.org/10.1177/2047487319864671. Last accessed July 2019.
[ii] Rainer Z. et al. Lipid lowering drug therapy in patients with coronary heart disease from 24 European countries – Findings from the EUROASPIRE IV survey. Atherosclerosis, 2016; 246:243-250.
[iii] De Backer G. et al. Lipid Management of Patients with Coronary Heart Disease in 27 Countries in Europe: Results of EUROASPIRE V Survey of the European Society of Cardiology. Presented at EAS 2018. Available at: https://www.eas-society.org/news/399857/EAS2018-Late-Breaking-Clinical-Trial-EUROASPIRE-V.htm Last accessed July 2019.
[iv] Gitt AK. et al. Low-density lipoprotein cholesterol in a global cohort of 57,885 statin-treated patients. Atherosclerosis, 2016; 255:200-209.