Daiichi Sankyo Europe announced the initiation of the development of new oral triple combination tablets in Europe containing bempedoic acid, ezetimibe, and different doses of a statin (atorvastatin or rosuvastatin). The fixed-dose triple therapy is designed to simplify treatment, reduce pill burden, and improve adherence among patients managing elevated low-density lipoprotein cholesterol (LDL-C), a leading modifiable risk factor for cardiovascular disease (CVD).

The announcement coincides with the presentation of new findings from the MILOS and SANTORINI registries at the European Society of Cardiology (ESC) Congress 2025, which continue to underscore the challenges in achieving LDL-C treatment goals and accurately assessing cardiovascular risk.

“As bempedoic acid and ezetimibe are already approved as a single-dose therapy, the development of an oral triple combination tablet with different statin doses can make it easier for physicians to tailor treatment to each patient,” said Dr. Stefan Seyfried, Vice President and Head Medical Affairs Specialty Medicines, Daiichi Sankyo Europe. “This approach exemplifies our dedication to our motto: we care for every heartbeat.”

“Dyslipidaemia management is evolving just as hypertension therapy did—moving from multiple separate medications to fixed-dose combinations that improve adherence and outcomes,” added Prof. Yvonne Winhofer-Stöckl, Medical University of Vienna.

Data Driving the Development

• MILOS registry findings highlight frequent underestimation of CV risk in clinical practice, with up to 50% of high-risk and 70% of very high-risk patients incorrectly categorised at lower risk levels. Treatment disparities persist, with women less likely than men to receive intensive lipid-lowering therapy.

• Data from a four-country cohort of MILOS confirmed the real-world effectiveness and safety of bempedoic acid across both sexes, demonstrating LDL-C reduction without new safety concerns.

• SANTORINI registry data revealed that only 20% of high- and very high-risk patients received treatment intensification, with older patients particularly underserved. Alarmingly, nearly 75% of high/very high CV risk patients in Germany were not prescribed any lipid-lowering therapy.

• Simulation using SANTORINI data suggested that an optimised triple oral therapy pathway (statin, ezetimibe, bempedoic acid) could enable 6 in 10 patients to achieve LDL-C goals, significantly lowering their long-term CV risk.

These insights align with the 2025 Focused Update of the 2019 ESC/EAS Guidelines, which recognise the clinical value of triple oral combination therapies in addressing LDL-C management gaps.

Addressing a Global Health Challenge

CVD remains the leading cause of death in Europe, with elevated LDL-C being one of the most prevalent modifiable risk factors. Despite proven benefits of lipid-lowering therapies, inconsistent clinical practice, treatment inertia, and poor adherence due to polypharmacy continue to prevent many patients from reaching their recommended LDL-C targets.

Through the Specialty Medicines Unit, Daiichi Sankyo Europe is committed to advancing patient-centred solutions in cardiovascular medicine. The development of oral triple combination tablets reflects the company’s mission to ease the burden of treatment, protect people from CVD, and help patients enjoy healthier, longer lives.