- Patients prescribed bempedoic acid and its fixed-dose
combination (FDC) with ezetimibe, with or without other lipid
lowering therapies, were associated with almost a one-third
relative reduction in low-density lipoprotein cholesterol (LDL-C)
from pre-treatment to 2-years in the MILOS study.1
- Real-world results demonstrated an approximately 7-fold
increase in the proportion of patients achieving their LDL-C goal
when treated with bempedoic acid or its FDC with ezetimibe.1
- Data from the MILOS German cohort showed that bempedoic acid,
alone or with ezetimibe, was effective and had a safety profile in
real-world settings consistent with the CLEAR clinical trial
programme.1,2,3,4
For EU media only
Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today
announced final 2-year follow-up data from the German cohort of the
multinational, European observational MILOS study.1 The study
evaluated the real-world use of bempedoic acid, marketed as
NILEMDO®▼ and its FDC with ezetimibe, NUSTENDI®▼, in patients with
primary hypercholesterolaemia or mixed dyslipidaemia.
The results, presented in Hamburg, Germany at DGK Hertztage
2024, demonstrated the effectiveness and safety profile of
bempedoic acid, both alone and in combination with other
lipid-lowering therapies (LLTs) in clinical practice.1 Raised LDL-C
is a key modifiable contributor to risk of major cardiovascular
events, with studies showing that every 1 mmol/L reduction in LDL-C
is associated with a 22% reduction in major cardiovascular events
after one year.5,6
The German cohort of MILOS study comprising 973 patients from
125 sites in Germany, is one of the most comprehensive assessments
of bempedoic acid in a real-world clinical setting to-date in
Germany.1 Patients were followed-up for two years, with LDL-C
levels assessed at pre-treatment, one year (1Y) and two years (2Y).
Overall, 638 of 973 patients (65.6%) completed 2Y follow up, with
LDL-C values at pre-treatment, 1Y and 2Y available for 451
patients. In these 451 patients, a mean reduction of LDL-C levels
from 3.1 mmol/L (121.4 mg/dL) at pre-treatment, to 2.0 mmol/L (77.2
mg/dL) was observed, representing an average relative reduction of
30.3% in the overall population.1
Additionally, the percentage of patients reaching their LDL-C
goals increased from 4.9% at pre-treatment to 35.3% at the 2Y
follow-up – an approximately 7-fold increase.1 The proportions of
high-risk and very high-risk patients reaching LDL-C goals
increased from 5.6% to 32.5%, and 3.6% to 35.2%, respectively.1
Overall, more than 80% of patients received bempedoic acid in
combination with other LLTs at pre-treatment and 2Y, including
statins and ezetimibe. The safety profile of bempedoic acid in this
real-world population was assessed at 1Y and 2Y and was consistent
with that observed in the CLEAR clinical trial programme. 2,3,4
“By significantly lowering LDL-C levels toward guideline goals,
we are taking a vital step in reducing the risk of cardiovascular
events, which can have a profound impact on a person’s long-term
health and quality of life,” said Professor Ioanna
Gouni-Berthold, University of Cologne, Center for Endocrinology,
Diabetes, and Preventive Medicine and Executive Board Member of the
International Atherosclerosis Society.
“Cardiovascular disease remains Europe’s leading cause of death,
yet the majority of premature CV events are preventable,”7,8 said
Dr. Stefan Seyfried, Vice President Medical Affairs, Specialty
Medicines, at Daiichi Sankyo Europe GmbH. “The findings from
this cohort reinforce the benefit provided by bempedoic acid for
reducing LDL-C levels. Our long-term goal is to empower the medical
community with real-world insights to improve CVD prevention and,
ultimately, improve patient care.”
-ENDS-
About MILOS
MILOS (NCT04579367) is an ongoing, multinational, European
observational study in adult patients diagnosed with primary
hypercholesterolaemia or mixed dyslipidaemia. The aim is to
evaluate the real-world use of bempedoic acid and bempedoic plus
ezetimibe FDC. Patients in the German cohort were recruited from
125 sites between January 2021 and January 2022 and were followed
up for 2 years after baseline measurements.1 Change in LDL-C levels
and the proportion of patients achieving LDL-C goal were assessed
in patients at pre-treatment, 1Y and 2Y visits. Analyses were
stratified by investigator-assessed CV risk, based on the ESC/EAS
dyslipidaemia guidelines.1 Beyond Germany, MILOS has sites in
Austria, Belgium, Italy, the Netherlands, Spain, Switzerland and
the UK.9
About Bempedoic Acid and its Fixed-Dose Combination with
Ezetimibe
Bempedoic acid (NILEMDO®) is a first-in-class, oral, once-daily
treatment to lower cholesterol, and can be combined with other oral
treatments to help lower cholesterol even further.10
Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which
is involved in the production of cholesterol in the liver.10
Bempedoic acid acts on the well-known cholesterol synthesis
pathway, upstream of the statin target in the liver, which allows
additional LDL-C lowering when added to statin or other
LDL-C-lowering therapies.11 Bempedoic acid is not activated in
skeletal muscle.10
Bempedoic acid is indicated in adults with primary
hypercholesterolaemia (heterozygous familial and nonfamilial) or
mixed dyslipidaemia, as an adjunct to diet:10
- in combination with a statin or statin with other
lipid-lowering therapies in patients unable to reach LDL-C goals
with the maximum tolerated dose of a statin or,10
- alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant, or for whom a statin is
contraindicated.10
Bempedoic acid is indicated in adults with established or at
high risk for atherosclerotic CV disease to reduce CV risk by
lowering LDL-C levels, as an adjunct to correction of other risk
factors:10
- in patients on a maximum tolerated dose of statin with or
without ezetimibe or,10
- alone or in combination with ezetimibe in patients who are
statin-intolerant, or for whom a statin in contraindicated.10
The bempedoic acid / ezetimibe FDC (NUSTENDI®) combines two
complementary ways of reducing cholesterol in a once-daily
tablet.
Bempedoic acid / ezetimibe FDC is indicated in adults with
primary hypercholesterolaemia (heterozygous familial and
nonfamilial) or mixed dyslipidaemia, as an adjunct to diet:12
- in combination with a statin in patients unable to reach LDL-C
goals with the maximum tolerated dose of a statin in addition to
ezetimibe,12
- alone in patients who are either statin-intolerant or for whom
a statin is contraindicated, and are unable to reach LDL-C goals
with ezetimibe alone,12
- in patients already being treated with the combination of
bempedoic acid and ezetimibe as separate tablets with or without
statin.12
Bempedoic acid / ezetimibe FDC is indicated in adults with
established or at high risk for atherosclerotic CV disease to
reduce CV risk by lowering LDL-C levels, as an adjunct to
correction of other risk factors:12
- in patients on a maximum tolerated dose of statin and not
adequately controlled with additional ezetimibe treatment
or,12
- in patients who are either statin-intolerant, or for whom a
statin in contraindicated, and not adequately controlled with
ezetimibe treatment or,12
- in patients already being treated with the combination of
bempedoic acid and ezetimibe as separate tablets.12
Daiichi Sankyo Europe has licensed exclusive commercialisation
rights to bempedoic acid and its FDC with ezetimibe (marketed as
NILEMDO® and NUSTENDI®) in the European Economic Area, UK,
Turkey and Switzerland from Esperion and is the full Marketing
Authorisation Holder in these territories.
About Daiichi Sankyo
Daiichi Sankyo is an innovative global healthcare company
contributing to the sustainable development of society that
discovers, develops, and delivers new standards of care to enrich
the quality of life around the world. With more than 120 years of
experience, Daiichi Sankyo leverages its world-class science and
technology to create new modalities and innovative medicines for
people with cancer, cardiovascular, and other diseases with high
unmet medical need.
For more information, please visit
https://www.daiichi-sankyo.eu/
▼ This medicinal product is subject to additional
monitoring.
References
1 DGK Hertztage 2024 Abstract. Real-world
effectiveness and safety of bempedoic acid in Europe: final 2-year
results from the MILOS German cohort. Gouni-Berthold, I et al.
2 Nissen SE, et al. Bempedoic Acid and
Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J
Med. 2023;388:1353–64
3 Ray KK, et al. Safety and Efficacy of
Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019;
380:1022–32
4 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. 2020; 27(6):
593–603
5 Cholesterol Treatment Trialists’ (CTT)
Collaboration. Efficacy and safety of more intensive lowering of
LDL cholesterol: a meta-analysis of data from 170 000 participants
in 26 randomised trials. Lancet. 2010. 376(9753): 1670–1681
6 NHS England. Improving lipid management
to reduce cardiovascular disease and save lives. Available at:
https://www.england.nhs.uk/long-read/improving-lipid-management-to-reduce-cardiovascular-disease-and-save-lives/#:~:text=Raised%20LDL%20cholesterol%20is%20one,vascular%20events%20after%201%20year.
Last accessed September 2024.
7 Eurostat. (2023) Causes of death
statistics. Available at:
https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Causes_of_death_statistics#Major_causes_of_death_in_the_EU_in_2020.
Last accessed September 2024.
8 World Heart Federation. Prevention.
Available at:
https://world-heart-federation.org/what-we-do/prevention/#:~:text=An%20estimated%2080%25%20of%20cardiovascular,and%20“knowing%20your%20numbers”.
Last accessed September 2024
9 ClinicalTrials.gov. 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#contacts-and-locations.
Last accessed September 2024.
10 European Medicines Agency. Nilemdo –
Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf.
Last accessed September 2024.
11 Pinkosky, S.L., et al. Liver-specific
ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and
attenuates atherosclerosis. Nat Commun. 2016. 7: 13457.
12 European Medicines Agency. Nustendi
–Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/en/documents/product-information/nustendi-epar-product-information_en.pdf.
Last accessed September 2024
HQ/BIL/09/24/0001
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Gillian D’Souza Daiichi Sankyo Europe GmbH Senior Manager,
Public Relations, Specialty Medicines +49 1515 5195599