Central and Eastern Europe Failing to Achieve LDL Treatment Targets: DA VINCI
Combination lipid-lowering therapy was virtually unused in these countries. Less than 9% of patients received two or more drugs.
There are substantial gaps in the treatment of LDL-cholesterol levels among primary and secondary prevention patients throughout Europe, a new analysis shows. But the gaps are particularly large in central and eastern European countries.
In the Czech Republic, Hungary, Poland, Romania, Slovakia, and Ukraine, less than one-quarter of all patients achieve the LDL-cholesterol target set out by the 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) dyslipidemia guidelines.
Michal Vrablik, MD, PhD (Charles University, Prague, Czech Republic), who presented results from a new analysis of the DA VINCI study at the EAS Congress 2021, said there were marked differences across central and eastern Europe. While no country fared particularly well, nearly one-third of patients in Poland and Romania achieved their LDL targets, while just one in 10 patients did so in Ukraine.
“To our surprise, not only were there differences within the regional groups of countries included in DA VINCI, but there are marked differences within the central and eastern European countries that led to a threefold difference in risk-based goal attainment with LDL as the primary goal of therapy,” said Vrablik during his presentation.
The DA VINCI study was an observational study of 5,888 patients prescribed lipid-lowering therapy for primary and secondary prevention throughout Europe. The main results, which were published in 2020, showed that 54% of patients treated achieved the LD- cholesterol target recommended in the 2016 ESC/EAS cholesterol guidelines. Just 33% of patients achieved the target recommended in the updated 2019 guidelines.
The ESC/EAS dyslipidemia guidelines outline a variety of LDL-cholesterol goals depending on patient risk. For those at low and moderate risk, the 2019 treatment targets are less than 3.0 mmol/L (115 mg/dL) and 2.6 mmol/L (100 mg/dL), respectively. For the high-risk and very-high-risk patients, the guidelines recommend a 50% reduction in LDL cholesterol and targets of less than 1.8 mmol/L (70 mg/dL) and 1.4 mmol/L (55 mg/dL), respectively.
The 2019 ESC/EAS targets are more aggressive than the older 2016 recommendations.
Fared Worse Than Rest of Europe
In the latest DA VINCI analysis, Vrablik and colleagues focused on 2,154 patients enrolled from the six central and eastern European countries. Overall, 53% of patients were treated with moderate-intensity statin monotherapy, a finding that was also observed in the overall DA VINCI cohort. Only 32% of patients received high-intensity statin therapy.
“When it comes to combination lipid-lowering therapy, the approach was really, really underrepresented,” said Vrablik. “Combination therapy with ezetimibe and other lipid-lowering therapy was well below 10% in the entire cohort. Also, at the time of the conduct of the DA VINCI, which was between 2017 and 2018, PCSK9 inhibitors were virtually not present in the central and eastern European regions.”
For the primary outcome, which was the percentage of patients who achieved LDL-cholesterol goal attainment, 44% of patients got to target based on the 2016 guidelines compared with 24% when measured against the 2019 ESC/EAS dyslipidemia guidelines. Comparatively, 34% and 40% of patients treated in northern and western European countries, respectively, achieved the LDL target set out in the 2019 dyslipidemia guidelines.
When stratified by CVD status, 37% of primary prevention patients in central and eastern Europe reached the 2019 LDL goal compared with just 13% of secondary prevention patients. In the northern European countries, 50% and 23% of primary and secondary patients, respectively, got to goal. In western Europe, 54% and 22% of primary and secondary prevention patients, respectively, achieved the 2019 ESC/EAS LDL targets.
“When you look into the very-high-risk cohorts, we are definitely in an unfavorable situation in terms of goal attainment,” said Vrablik. “Only 13% of the [central and eastern European cohort] in the very-high-risk stratum were achieving their LDL-cholesterol goals. Also, in primary prevention, we are less successful in goal attainment compared with northern and western Europe.”
Given the poorer results, Vrablik said the data support broader access to lipid-lowering therapies, particularly PCSK9 inhibitors, in areas that are “disadvantaged” when it comes to LDL goal attainment. They would like to use these data to further discussions with authorities, payers, and other stakeholders so that combination lipid-lowering therapy, which was extremely rare in these central and eastern European countries, can be more frequently adopted.
In terms of adherence to medical therapy, Vrablik said they have not yet done a formal analysis with standardized questionnaires but noted that only patients stabilized on lipid-lowering therapy for 1 year were included in the observational study. As such, he does not think that lack of adherence affected their findings.
Jeanine Roeters van Lennep, MD, PhD (Erasmus Medical Center, Rotterdam, the Netherlands), who moderated the discussion following the EAS presentation, said that she asks patients at their specialty dyslipidemia clinic if they are still taking their medication. “I have a questionnaire, and it’s really revealing, even if you as physician think your patients are very adherent.” Vrablik agreed, saying the questionnaire with one or two simple questions is often quite effective as a stimulus for adherence and is something that should be adopted widely into clinical practice.
Vrablik M, Seifert B, Parkhomenko A, et al. Are risk-based LDL-C goals achieved in primary and secondary care in Central and Eastern Europe? Comparison with other European regions from the DA VINCI study. Presented at: EAS 2021. June 2, 2021.
- Vrablik reports honoraria from Amgen, Boehringer Ingelheim, KRKA, Sanofi, MSD, Pfizer, Novartis, and Servier.