- Inequalities in cardiovascular disease (CVD) care have been
found, which impact clinical outcomes:
- Gender inequalities exist in CVD care, specifically with LDL-C
goal attainment where despite similar guideline recommendations,
23.9% of female patients weren’t prescribed lipid-lowering
therapies at baseline vs. only 20.7% of male patients.1
- Non-adherence to treatment for atrial fibrillation (AF)
patients can significantly increase the risk of stroke and was
influenced by factors including age, gender and body
weight.2,3
- Patient comorbidities and frailty may unnecessarily affect CVD
management.4,5,6
- Daiichi Sankyo remains committed to its promise to continue
expanding medical knowledge to support better CV care, including
exploring holistic approaches to improve outcomes.
Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today
announced its reinforced commitment to addressing key unmet needs
and barriers in cardiovascular (CV) care, by shining a light on
inequalities in treatment and outcomes experienced by various
patient groups. The announcement follows the presentation of data
from sub-analyses of the SANTORINI observational study and ETNA-AF
(Edoxaban Treatment in routiNe clinical prActice in patients with
nonvalvular Atrial Fibrillation) study programme, at the European
Society of Cardiology (ESC) Congress 2024.
Gender inequalities in CV disease treatment and LDL-C goal
attainment
Raised low-density lipoprotein cholesterol (LDL-C) is a key
modifiable contributor to risk of cardiovascular major events. It
has been shown that for every 1 mmol/L reduction in LDL-C, there is
a 22% reduction in major cardiovascular events after 1 year.7,8
Female patients in Europe who are at high or very high CV risk were
undertreated and less achieved guideline-recommended LDL-C levels,
according to data from the observational SANTORINI study.1
As part of its efforts to expand medical knowledge to help
protect people from CV disease (CVD), Daiichi Sankyo funds and
designs studies, such as SANTORINI, that investigate the underlying
causes behind the burden of CVD in Europe. Data from a new
sub-analysis of SANTORINI, based on 5,197 male patients with a mean
age of 65 years, and 2,013 females with a mean age of 66 years,
showed that female patients were undertreated compared to men as
fewer achieved guideline-recommended LDL-C levels within the
study.1
While the proportion of patients reaching LDL-C goals improved
from baseline to 1-year follow up, it was greater in males (22.9%
and 33.3%, respectively) than in females (16.9% and 24.6%,).1
Despite similar guideline recommendations, more females received no
lipid-lowering therapies at baseline and 1-year follow up (23.9% to
3.9%, respectively) than males (20.7% to 2.7%).1
“We know that the severity of cardiovascular disease for women
is as high as it is with men, and patients of both sexes remain
undertreated.9,10 But this new sub-analysis of the SANTORINI study
further suggests that in clinical practice, women as a group were
being disproportionally undertreated and do not always reach
recommended LDL-C level goals,” said Professor David Nanchen,
University of Lausanne, Center for Primary Care and Public Health
(Unisanté), Lausanne, Switzerland. “These findings underscore the
need for more widespread attention to better manage the risk of
cardiovascular disease in women.”
Treatment adherence and the impact of non-adherence on
patient outcomes
Treatment for atrial fibrillation with oral anticoagulation
relies on adherence and persistence to be effective.
Non-persistence to single non-vitamin K antagonist oral
anticoagulants (NOACs) has been associated with increased stroke
risk in atrial fibrillation (AF) patients.2
Daiichi Sankyo committed to ETNA-AF, which combines data from
distinct non-interventional studies in Europe, East Asia, and Japan
in a single database, to delve deeper into the global burden of
CVD. More than 28,000 patients were included in the ETNA-AF
registries and followed for four years in Europe and two years in
countries outside Europe.11
Results from a new post hoc sub-analysis of the ETNA-AF
programme showed that, of the 9,417 [13,164 enrolled] (71.5%)
patients who completed the 4-year study, 87.4% were persistent with
edoxaban treatment.3 Treatment discontinuation and non-persistence
were both associated with factors including increasing age, male
sex, body weight extremes, low renal function, heart failure,
vascular disease, chronic hepatic disease, alcohol use, perceived
frailty, chronic obstructive pulmonary disease, smoking, current AF
symptoms, and ablation.3
“The high number of patients who persisted with edoxaban
treatment for the duration of the 4-year study is good news for our
efforts to mitigate therapeutic non-adherence,2” said Professor
Raffaele De Caterina, MD, PhD, FESC, Director of Cardiology at Pisa
University Hospital. “We hope that the associated factors for
non-persistence observed in the study will also assist the
development of treatment strategies in clinical practice, for the
benefit of patient outcomes.”
Treatment for patients with frailty and comorbidities
Barriers to recommending anticoagulation to manage non-valvular
AF (NVAF), such as complex multimorbidities are significant in
frail patients.12 As such, the prescription of NOACs in the frail
patient population is <50%.12 Doctors are required to balance
stroke risk and bleeding risk when making prescribing
decisions.12
Frailty is a common reason to choose non recommended doses of
NOACs and so the four year follow up data from ETNA-AF were used to
assess clinical outcomes in such patients. Patients with
'perceived' or objective frailty who were treated with a reduced
(non-recommended) 30mg dose showed a higher rate of all-cause death
versus the 60mg dose (HR [95% CI]: 1.44[1.06,1.96]) with no
significant effect on major bleeding. This suggests that the
presence of frailty per se should not necessarily drive dose
reductions.5
In a separate sub analysis of the data, patients were divided
into low, middle and high tertiles based on body mass index (BMI),
body surface area (BSA) and lean body mass (LBM). Rates of
thromboembolic events were low (0.7-0.9%/100PY) and similar across
tertiles. However, higher rates of any haemorrhagic events were
observed in the low ([2.2–2.4%]) vs middle ([1.5–1.8%]) and high
([1.4–1.5%]) tertiles for BSA and LBM, suggesting that these
variables, more than BMI, should be considered when analysing
outcomes in patients treated with edoxaban.4,6
“At Daiichi Sankyo, we continue in our long-term commitment to
provide scientific evidence that can support the optimal treatment
of patients with cardiovascular disease, and to find solutions for
individuals who have previously been undertreated,” said Dr. Stefan
Seyfried, Vice President Medical Affairs, Specialty Medicines, at
Daiichi Sankyo Europe GmbH. “Our promise to patients is to continue
shining a light on treatment inequalities and unmet needs in
cardiovascular care, with the goal of reducing the burden on
patients and their loved ones.”
-ENDS-
About SANTORINI
The SANTORINI study is a multinational, prospective,
observational study that enrolled 9,602 patients with high and very
high CV risk from over 623 sites in 14 countries across Europe.
Patients were recruited between March 2020 and February 2021.10 The
primary objective was to document, in the real-world setting, the
effectiveness of current LDL-C management approaches in high- and
very high-cardiovascular-risk patients requiring lipid-lowering
therapies over a 1-year period.10 The study included both
previously diagnosed and treated patients and those newly diagnosed
and requiring treatment.10
Complete baseline data was included for 9,044 patients (mean
age: 65.3 ± 10.9 years; 72.6% male).10 Physicians used 2019 ESC/EAS
guidelines as a basis for CV risk classification in 52% of
patients; 29.2% of patients were classified as high risk and 70.8%
as very high risk.10 Central reassessment with the same guidelines
classified 6.5% as high risk and 91% as very high-risk.10 Overall,
21.8% of patients had no documented lipid lowering therapies
(LLTs), 54.2% were receiving monotherapy and 24% combination LLT.10
Median LDL-C was 2.1 mmol/L with 20.1% of patients achieving
risk-based LDL-C goals as per the 2019 ESC/EAS guidelines.10
About ETNA-AF
ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in
patients with nonvalvular Atrial Fibrillation) is a global
programme that combines data from distinct non-interventional
studies in Europe, East Asia, and Japan in a single database. A
total of more than 28,000 patients were included in the ETNA-AF
registries and followed for two years (patients in Europe were
followed for four years).11 The primary objective of ETNA-AF was to
collect information on the use of edoxaban in routine clinical
practice, including the safety and efficacy profile in
non-preselected patients with nonvalvular AF.13,14,15,16,17
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/
References
________________________________
1 Nanchen, D., et al. Contemporary LDL-cholesterol management in
male and female patients at high-cardiovascular risk: results from
the European observational SANTORINI study. Oral presentation, ESC
Congress 30 August 2024. 2 Vitolo, M., et al. The importance of
adherence and persistence with oral anticoagulation treatment in
patients with atrial fibrillation. European Heart Journal –
Cardiovascular Pharmacotherapy. 2021. 7;(FI1): f81–f83 3
Diemberger, I., et al. Persistence and predictors for
non-persistence to edoxaban therapy in patients with atrial
fibrillation: 4-year follow-up data from the ETNA-AF-Europe study.
ESC Congress 2024 4 Boriani, G., et al. Impact of differences in
body mass index, body surface area and lean body mass on clinical
outcomes in patients with atrial fibrillation receiving edoxaban:
4-year follow-up data from ETNA-AF-Europe. ESC 2024 5 Fumagalli,
S., et al. Edoxaban dose, frailty, and outcomes in patients with
atrial fibrillation: the ETNA-AF-Europe 4-year follow-up. ESC 2024
6 Boriani, G., et al. Impact of body weight and body mass index on
clinical outcomes of edoxaban therapy in atrial fibrillation
patients included in the ETNA-AF-Global registry. ESC 2024 7
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 8 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 August 2024. 9 ESC. Cardiovascular Disease in Women.
Available at:
https://www.escardio.org/The-ESC/Advocacy/women-and-cardiovascular-disease.
Last accessed August 2024. 10 Ray, K.K., et al. Treatment gaps in
the implementation of LDL cholesterol control among high- and very
high-risk patients in Europe between 2020 and 2021: the
multinational observational SANTORINI study. Lancet. 2023. 29:
100624. 11 Daiichi Sankyo Europe – ETNA-AF (UK). Available at:
https://www.daiichi-sankyo.eu/media/about-etna-af-uk/. Last
accessed August 2024. 12 Bul, M., et al. Frailty and oral
anticoagulant prescription in adults with atrial fibrillation: A
systematic review. Aging Medicine. 2022. 6(2): 195–206 13 Edoxaban
Treatment in Routine Clinical Practice for Patients With Non
Valvular Atrial Fibrillation (ETNA-AF-EU). Available at:
https://clinicaltrials.gov/ct2/show/NCT02944019. Last accessed
August 2024. 14 Edoxaban Treatment in Routine Clinical Practice for
Patients With Atrial Fibrillation in Korea and Taiwan
(ETNA-AF-KOR-TWN). Available at:
https://clinicaltrials.gov/ct2/show/NCT02951039. Last accessed
August 2024. 15 Edoxaban Treatment in Routine Clinical Practice for
Patients With Non-Valvular Atrial Fibrillation (ETNA-AF-Hong Kong).
Available at: https://clinicaltrials.gov/ct2/show/NCT03247582. Last
accessed August 2024. 16 Edoxaban Treatment in Routine Clinical
Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF).
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accessed August 2024. 17 ETNA-AF-Japan. Available at:
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019728.
Last accessed August 2024.
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Gillian D’Souza Daiichi Sankyo Europe GmbH Senior Manager,
Public Relations, Specialty Medicines +49 1515 5195599