The 3rd Cardiovascular Outcome Trial Summit of the Diabetes & Cardiovascular Disease EASD Study Group was held on the 26-27 October 2017 in Munich. As in 2015 and 2016, this summit was organised in light of recently completed and published CVOTs on diabetes, aiming to serve as a reference meeting for in-depth discussions on the topic. Amongst others, the CVOTs EXSCEL, DEVOTE, the CANVAS program and the ACE-trial, which released primary outcome results in 2017, were discussed. Trial implications for diabetes management and recent perspectives of diabetologists, cardiologists, endocrinologists, nephrologists and general practitioners were highlighted. The clinical relevance of cardiovascular outcome trials and its implications regarding reimbursement were compared with real-world studies. The 4th Cardiovascular Outcome Trial Summit will be held in Munich 25-26 October 2018 ( http://www.dcvd.org ).
- MeSH
- Biomedical Research methods MeSH
- Diabetes Mellitus diagnosis epidemiology therapy MeSH
- Cardiology methods MeSH
- Cardiovascular Diseases diagnosis epidemiology therapy MeSH
- Clinical Trials as Topic * MeSH
- Cooperative Behavior MeSH
- Humans MeSH
- Interdisciplinary Communication MeSH
- Patient Care Team MeSH
- Check Tag
- Humans MeSH
- Publication type
- Congress MeSH
PURPOSE OF REVIEW: Familial hypercholesterolemia (FH) is often perceived and described as underdiagnosed and undertreated, though effective treatment of FH is available. Owing to the mentioned facts, it is ever more imperative to screen and treat FH patients. Subsequent to the identification of patients, the project focuses on the improvement of their prognoses. The ScreenPro FH project was established as a functional international network for the diagnosis, screening, and treatment of FH. Individual countries were assigned goals, e.g., to define the actual situation and available treatment. With "central support," more centers and countries participated in the project. Subsequently, individual countries reported the results at the beginning and end of the project. Collected data were statistically evaluated. RECENT FINDINGS: The increasing number of patients in databases, from 7500 in 2014 to 25,347 in 2018, demonstrates the improvement in overall effectiveness, as well as an increase in the number of centers from 70 to 252. Before all, LDL-C decreased by 41.5% and total cholesterol by 32.3%. As data from all countries and patients were not available at the time of the analysis, only those results from 10 countries and 5585 patients at the beginning of the project and at the time of writing are included. Our data are quite positive. However, our results have only limited validity. Our patients are far from the target levels of LDL-C. The situation can be improved with the introduction of new therapy, PCSK9-i, evolocumab, and alirocumab. International cooperation improved the screening of FH and finally led to an improvement in cardiovascular risk.
- MeSH
- Anticholesteremic Agents therapeutic use MeSH
- Antibodies, Monoclonal, Humanized therapeutic use MeSH
- Hyperlipoproteinemia Type II diagnosis drug therapy epidemiology MeSH
- Incidence MeSH
- Humans MeSH
- International Cooperation * MeSH
- PCSK9 Inhibitors MeSH
- Mass Screening methods MeSH
- Delivery of Health Care standards MeSH
- Proprotein Convertase 9 immunology MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Review MeSH
- Geographicals
- Europe MeSH
Therapeutic apheresis (TA) is prescribed to patients that suffer from a severe progressive disease that is not sufficiently treated by conventional medications. A way to gain more knowledge about this treatment is usually by the local analysis of data. However, the use of large quality assessment registries enables analyses of even rare findings. Here, we report some of the recent data from the World Apheresis Association (WAA) registry. Data from >104,000 procedures were documented, and TA was performed on >15,000 patients. The main indication for TA was the collection of autologous stem cells (45% of patients) as part of therapy for therapy. Collection of stem cells from donors for allogeneic transplantation was performed in 11% of patients. Patients with indications such as neurological diseases underwent plasma exchange (28%). Extracorporeal photochemotherapy, lipid apheresis, and antibody removal were other indications. Side effects recorded in the registry have decreased significantly over the years, with approximately only 10/10,000 procedures being interrupted for medical reasons.Conclusion: Collection of data from TA procedures within a multinational and multicenter concept facilitates the improvement of treatment by enabling the analysis of and feedback on indications, procedures, effects, and side effects.
- Publication type
- Journal Article MeSH
- Review MeSH
BACKGROUND: For patients with type 2 diabetes (T2D), cardiovascular disease (CVD) is the single most common cause of mortality. In 2008 and 2012, the Federal Drug Administration (FDA) and the European Medicines Agency (EMA) respectively mandated cardiovascular outcomes trials (CVOTs) on all new anti-diabetic agents, as prospective trials statistically powered to rule out excess cardiovascular risk in patients with T2D. Unexpectedly, some of these CVOTs have demonstrated not only cardiovascular safety, but also cardioprotective effects, as was first shown for the SGLT2 inhibitor empagliflozin in EMPA-REG OUTCOME. EXPERT OPINION: To debate newly available CVOT data and to put them into context, we convened as a group of medical experts from the Central and Eastern European Region. Here we describe our discussions, focusing on the conclusions we can draw from EMPA-REG OUTCOME and other SGLT2 inhibitor CVOTs, including when considered alongside real-world evidence. CONCLUSION: CVOTs investigating SGLT2 inhibitors have suggested benefits beyond glucose lowering that have been confirmed in real-world evidence studies.
EMPA-REG OUTCOME is recognised by international guidelines as a landmark study that showed a significant cardioprotective benefit with empagliflozin in patients with type 2 diabetes (T2D) and cardiovascular disease. To assess the impact of empagliflozin in routine clinical practice, the ongoing EMPRISE study is collecting real-world evidence to compare effectiveness, safety and health economic outcomes between empagliflozin and DPP-4 inhibitors. A planned interim analysis of EMPRISE was recently published, confirming a substantial reduction in hospitalisation for heart failure with empagliflozin across a diverse patient population. In this commentary article, we discuss the new data in the context of current evidence and clinical guidelines, as clinicians experienced in managing cardiovascular risk in patients with T2D. We also look forward to what future insights EMPRISE may offer, as evidence is accumulated over the next years to complement the important findings of EMPA-REG OUTCOME.
- MeSH
- Benzhydryl Compounds adverse effects therapeutic use MeSH
- Diabetes Mellitus, Type 2 diagnosis drug therapy mortality MeSH
- Sodium-Glucose Transporter 2 Inhibitors adverse effects therapeutic use MeSH
- Glucosides adverse effects therapeutic use MeSH
- Risk Assessment MeSH
- Hospitalization MeSH
- Cardiovascular Diseases diagnosis mortality therapy MeSH
- Clinical Decision-Making MeSH
- Clinical Trials as Topic methods MeSH
- Practice Patterns, Physicians' MeSH
- Humans MeSH
- Evidence-Based Medicine * MeSH
- Protective Factors MeSH
- Risk Factors MeSH
- Practice Guidelines as Topic MeSH
- Treatment Outcome MeSH
- Research Design * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
BACKGROUND AND AIMS: Management of familial hypercholesterolaemia (FH) may vary across different settings due to factors related to population characteristics, practice, resources and/or policies. We conducted a survey among the worldwide network of EAS FHSC Lead Investigators to provide an overview of FH status in different countries. METHODS: Lead Investigators from countries formally involved in the EAS FHSC by mid-May 2018 were invited to provide a brief report on FH status in their countries, including available information, programmes, initiatives, and management. RESULTS: 63 countries provided reports. Data on FH prevalence are lacking in most countries. Where available, data tend to align with recent estimates, suggesting a higher frequency than that traditionally considered. Low rates of FH detection are reported across all regions. National registries and education programmes to improve FH awareness/knowledge are a recognised priority, but funding is often lacking. In most countries, diagnosis primarily relies on the Dutch Lipid Clinics Network criteria. Although available in many countries, genetic testing is not widely implemented (frequent cost issues). There are only a few national official government programmes for FH. Under-treatment is an issue. FH therapy is not universally reimbursed. PCSK9-inhibitors are available in ∼2/3 countries. Lipoprotein-apheresis is offered in ∼60% countries, although access is limited. CONCLUSIONS: FH is a recognised public health concern. Management varies widely across countries, with overall suboptimal identification and under-treatment. Efforts and initiatives to improve FH knowledge and management are underway, including development of national registries, but support, particularly from health authorities, and better funding are greatly needed.
- MeSH
- Anticholesteremic Agents adverse effects therapeutic use MeSH
- Biomarkers blood MeSH
- Global Health * MeSH
- Healthcare Disparities MeSH
- Health Services Accessibility MeSH
- Phenotype MeSH
- Genetic Predisposition to Disease MeSH
- Hyperlipoproteinemia Type II blood diagnosis epidemiology therapy MeSH
- Cooperative Behavior MeSH
- Cholesterol, LDL blood MeSH
- Humans MeSH
- International Cooperation * MeSH
- Predictive Value of Tests MeSH
- Prevalence MeSH
- Health Care Surveys MeSH
- Risk Factors MeSH
- Blood Component Removal * adverse effects MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
