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Daiichi Sankyo conferma il proprio impegno per una cura incentrata sul paziente con un’ampia presentazione di dati al Congresso EAS 2026

·Le presentazioni al 94° Congresso della European Atherosclerosis Society (EAS) mostrano la numerosità delle evidenze sull’acido bempedoico in diversi sottogruppi di pazienti e terapie di base.
·I dati di real-world dello studio MILOS, provenienti da molteplici coorti europee, dimostrano un’efficacia e un profilo di sicurezza coerenti nella pratica clinica.1,2,3,4
·L’analisi dello studio CLEAR Outcomes sottolinea l’impatto dell’acido bempedoico sulla riduzione del rischio cardiovascolare, inclusi ictus e tromboembolismo venoso (TEV).5,6
·L’impegno di Daiichi Sankyo nel “prendersi cura di ogni battito” è incentrato sull’offerta di opzioni terapeutiche orali accessibili, per fornire a ogni paziente la possibilità di raggiungere i propri obiettivi di LDL-C.

 Monaco di Baviera, Germania, 27 maggio 2026 – Daiichi Sankyo è lieta di annunciare la propria presenza al Congresso 2026 della European Atherosclerosis Society (EAS). La presentazione di 15 abstract, che comprendono sia analisi di studi clinici sia evidenze di real-world, sottolinea il costante investimento dell’azienda nella salute cardiovascolare e la sua missione di prendersi cura di ogni battito.

La presentazione dei 15 abstract offre una panoramica completa del ruolo dell’acido bempedoico nella gestione delle displipidemie. Questa include analisi post-hoc, in collaborazione con Esperion Therapeutics, dello studio di Fase 3 CLEAR Outcomes, che esplorano l’impatto sull’incidenza di ictus e tromboembolismo venoso (TEV).5,6 Sono stati  presentati anche risultati di real-world provenienti dal registro MILOS, inclusa una sotto-analisi dedicata alla valutazione dell’efficacia dell’acido bempedoico in associazione a diverse terapie di base.1,2,3,4 I risultati confermano un’efficacia e un profilo di sicurezza coerenti dell’acido bempedoico in diversi Paesi dell’UE, indipendentemente dai regimi terapeutici già in atto nei pazienti.7

L’impegno di Daiichi Sankyo nell’ampliare la base di evidenze sull’acido bempedoico è ulteriormente testimoniato dai nuovi dati presentati, sponsorizzati da Esperion, in pazienti pediatrici di età compresa tra 6 e 17 anni, affetti da ipercolesterolemia familiare8. Questo sottolinea anche il continuo impegno di Daiichi Sankyo nello studio dell’acido bempedoico in specifici gruppi poco rappresentati, per dare l’opportunità al maggior numero possibile di pazienti di raggiungere i propri obiettivi di LDL-C.9,10

“Ancora troppi pazienti in Europa non riescono a raggiungere i propri target di LDL-C, rimanendo inutilmente esposti al rischio cardiovascolare”, afferma il Prof. Maurizio Averna, Professore di Medicina Interna, Università di Palermo, Italia. “I dati real-world presentati a EAS 2026 forniscono evidenze fondamentali per aiutare i clinici a colmare questi gap terapeutici nella pratica clinica e a migliorare gli esiti per un’ampia varietà di pazienti”.

“In Daiichi Sankyo Europe, il nostro impegno va oltre i dati clinici: è radicato nel percorso individuale di ogni paziente”, ha dichiarato il Dr. Stefan Seyfried, Vice President e Head of Medical Affairs, Specialty Medicines, Daiichi Sankyo Europe. “L’ampio set di dati che presentiamo a EAS 2026 — testimonianza del nostro costante investimento nella salute cardiovascolare — rafforza la nostra missione di offrire a ogni paziente la possibilità di raggiungere i propri obiettivi terapeutici. Traducendo l’innovazione scientifica nella cura pratica e centrata sul paziente, ci assicuriamo di prenderci cura di ogni battito attraverso soluzioni innovative e accessibili”.

Ponendo l’accento sulla capacità dell’acido bempedoico di favorire migliori esiti cardiovascolari e la riduzione del colesterolo lipoproteico a bassa densità (LDL-C), indipendentemente dalla terapia di base e dal sottogruppo di pazienti, DS mira a fornire agli operatori sanitari le evidenze necessarie per supportare le decisioni terapeutiche nella gestione delle dislipidemie.

MILOS
MILOS (NCT04579367) è uno studio osservazionale europeo, multinazionale, in corso, condotto su pazienti adulti con diagnosi di ipercolesterolemia primaria o dislipidemia mista.11 L'obiettivo è quello di valutare l'uso, nella pratica clinica reale, di acido bempedoico e dell’associazione a dose fissa di acido bempedoico ed ezetimibe. Oltre alla Germania, lo studio MILOS comprende centri in Austria, Belgio, Italia, Paesi Bassi, Spagna, Svizzera e Regno Unito.11

CLEAR Outcomes
Lo studio CLEAR Outcomes è stato uno studio in doppio cieco, randomizzato, controllato con placebo, disegnato per valutare l’effetto dell’acido bempedoico sugli eventi cardiovascolari (CV) in pazienti intolleranti alle statine, per i quali era clinicamente indicata la prevenzione cardiovascolare primaria o secondaria.12 Lo studio ha arruolato 13.970 pazienti di età compresa tra 18 e 85 anni, con età media di 65,5 anni, quasi la metà dei quali donne; tutti presentavano malattia cardiovascolare accertata o erano ad alto rischio di malattia cardiovascolare, con LDL-C medio al basale pari a 139 mg/dL (3,59 mmol/L).12 Condotto in 1.250 centri in 32 Paesi, lo studio ha randomizzato i pazienti a ricevere acido bempedoico orale 180 mg una volta al giorno oppure placebo, con un follow-up mediano di 40,6 mesi.12 L’endpoint primario era un composito a quattro componenti di eventi cardiovascolari avversi maggiori (MACE-4): morte cardiovascolare, infarto miocardico non fatale, ictus non fatale o rivascolarizzazione coronarica; sono stati valutati anche molteplici endpoint cardiovascolari secondari chiave.12

Daiichi Sankyo
Daiichi Sankyo è una global healthcare company impegnata ad affermarsi come un punto di riferimento affidabile nell'innovazione in sanità, contribuendo a trasformare la vita delle persone attraverso la propria competenza scientifica e tecnologica. L'azienda scopre e sviluppa nuovi standard di cura per rispondere ai diversi bisogni medici con lo scopo di contribuire al miglioramento della qualità della vita in tutto il mondo. Con un focus strategico sull'oncologia, Daiichi Sankyo sta ampliando il portafoglio di anticorpi farmaco-coniugati leader nel settore, oltre a individuare nuove tecnologie rivoluzionarie per fornire farmaci in grado di cambiare la pratica clinica a pazienti, operatori sanitari e alla società. Per ulteriori informazioni, visita il sito www.daiichisankyo.it.


Contatti
Daiichi Sankyo                               
Elisa Porchetti
Corporate Communication & PR Manager
Tel.+39 366 6864549
elisa.porchetti@daiichisankyo.com                                        

Gianluca Trezzi
Tel: +39 340 8528584
g.trezzi@aimgroup.eu                                                        

                                                                                               

                                                 

Riferimenti

1. Averna M, et al. Real-world effectiveness and safety of bempedoic acid: Insights from the 1-year follow-up Italian cohort data of the MILOS study. Presented at European Atherosclerosis Society (EAS) Congress 2026.

2. Ray KK, et al. UK Real-World Experience with Bempedoic Acid in Dyslipidaemia: 1-Year Results from the MILOS Study. Presented at European Atherosclerosis Society (EAS) Congress 2026.

3. Stulnig T, et al. Real-World One-Year Data on the Use of Bempedoic Acid in Patients with Dyslipidemia: Insights from the MILOS Austria Study. Presented at European Atherosclerosis Society (EAS) Congress 2026.

4. Vanassche T, et al. Effectiveness and safety of bempedoic acid in routine clinical practice: 1-year follow-up data from MILOS Belgian cohort. Presented at European Atherosclerosis Society (EAS) Congress 2026.

5. Nicholls SJ, et al. Bempedoic acid and incidence of stroke among statin-intolerant patients: An analysis of the CLEAR Outcomes trial. Presented at European Atherosclerosis Society (EAS) Congress 2026.

6. Nicholls SJ, et al. The association between bempedoic acid and risk of venous thromboembolism: A post hoc analysis of the CLEAR Outcomes trial. Presented at European Atherosclerosis Society (EAS) Congress 2026.

7. Ray KK, et al. Bempedoic acid without background LLT, LDL cholesterol and cardiovascular events: a secondary analysis of the CLEAR Outcomes trial. Presented at European Atherosclerosis Society (EAS) Congress 2026.

8. Gidding SS, et al. Bempedoic Acid in Children aged 6-17 years with Heterozygous Familial Hypercholesterolaemia: A Phase 2 Study. Presented at European Atherosclerosis Society (EAS) Congress 2026.

9. European Medicines Agency. Nilemdo – summary of product characteristics (SmPC).  

10. European Medicines Agency. Nustendi – summary of product characteristics (SmPC).

11. Treatment with bempedoic acid and/​or its fixed-dose combination with ezetimibe in primary hypercholesterolemia or mixed dyslipidemia (MILOS). Available at: https://clinicaltrials.gov/study/NCT04579367?viewType=Card&term=NCT04579367&rank=1. Last accessed April 2026. 

12. Nissen SE, et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. 2023. 13;388(15):1353-1364.

13. Ballantyne CM, et al. Factors associated with enhanced LDL cholesterol lowering with bempedoic acid among statin-intolerant patients from CLEAR Outcomes. Presented at European Atherosclerosis Society (EAS) Congress 2026.

14. J.J. Gómez Doblas, et al. Real-World Use of Bempedoic Acid in Spain: 8-Week Results from the MILOS Study. Presented at European Atherosclerosis Society (EAS) Congress 2026.

15. K. Koskinas, et al. Swiss Real-World Experience with Bempedoic Acid in Dyslipidaemia: 8-Week Results from the Observational, Prospective MILOS Study. Presented at European Atherosclerosis Society (EAS) Congress 2026.

16. Vanassche T, et al. Comparable LDL-C reductions with bempedoic acid used alone or with background statin and/or ezetimibe therapy: real world evidence from the MILOS study. Presented at European Atherosclerosis Society (EAS) Congress 2026.