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 ).
- Keywords
- ACE, CANVAS program, CVOT, CVOT Summit, Cardiovascular risk, D&CVD EASD Study Group, DEVOTE, Diabetes, EXSCEL,
- 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
The 1st Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes & Cardiovascular Disease (D&CVD) EASD Study Group was held during the annual meeting on 30 October 2015 in Munich. This summit was organized in light of recently published and numerous ongoing CVOTs on diabetes, which have emerged in response to the FDA and the EMA Guidelines. The CVOT Summit stands as a novel conference setup, with the aim of serving as a reference meeting for all topics related to CVOTs in diabetes. Members of the steering committee of the D&CVD EASD Study Group constitute the backbone of the summit. It included presentations of key results on DPP-4 inhibitors, GLP-1-Analogues, SGLT-2 inhibitors, acarbose and insulins. Diabetologists' and cardiologists' perspective on the potential need of new study designs were also highlighted. Furthermore, panel discussions on the design of CVOTs on diabetes were included in the program. The D&CVD EASD Study Group will continue its activity. In-depth discussions and presentations of new CVOTs like LEADER, will be resumed at the 2nd CVOT on diabetes of the D&CVD EASD Study Group, which will be held from 20-22 October 2016 in Munich ( http://www.dcvd.org).
- MeSH
- Diabetes Mellitus diagnosis drug therapy epidemiology MeSH
- Hypoglycemic Agents therapeutic use MeSH
- Cardiovascular Diseases diagnosis epidemiology prevention & control MeSH
- Clinical Trials as Topic methods MeSH
- Humans MeSH
- Risk Factors MeSH
- Research Design MeSH
- Check Tag
- Humans MeSH
- Publication type
- Congress MeSH
- Names of Substances
- Hypoglycemic Agents MeSH
The 2nd Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes and Cardiovascular Disease (D&CVD) EASD Study Group was held on the 20th-21st October 2016 in Munich. This second Summit was organized in light of recently published CVOTs on diabetes, with the aim of serving as a reference meeting for discussion on this topic. Along with presentations on the results of the most recently published CVOTs, panel discussions on trial implications for reimbursement and the perspective of cardiologists and/or nephrologists, as well as on CVOTs weaknesses and potentials constituted the heart of the program. Future activities of the D&CVD EASD Study Group in 2017 include an annual meeting in Milano and the 3rd CVOT Summit on Diabetes of the D&CVD EASD Study Group, in Munich ( http://www.dcvd.org ).
- MeSH
- Diabetes Mellitus, Type 2 complications drug therapy economics mortality MeSH
- Risk Assessment MeSH
- Hypoglycemic Agents adverse effects economics therapeutic use MeSH
- Cardiovascular Diseases economics etiology mortality prevention & control MeSH
- Clinical Trials as Topic MeSH
- Humans MeSH
- Evidence-Based Medicine MeSH
- Drug Costs MeSH
- Protective Factors MeSH
- Risk Factors MeSH
- Insurance, Health, Reimbursement MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Congress MeSH
- Editorial MeSH
- Names of Substances
- Hypoglycemic Agents MeSH
The 4th Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes & Cardiovascular Disease (D&CVD) EASD Study Group was held in Munich on 25-26 October 2018. As in previous years, this summit served as a reference meeting for in-depth discussions on the topic of recently completed and presented CVOTs. This year, focus was placed on the CVOTs CARMELINA, DECLARE-TIMI 58 and Harmony Outcomes. Trial implications for diabetes management and the impact of the new ADA/EASD consensus statement treatment algorithm were highlighted for diabetologists, cardiologists, endocrinologists, nephrologists and general practitioners. Discussions evolved from CVOTs to additional therapy options for heart failure (ARNI), knowledge gained for adjunct therapy of type 1 diabetes and, on the occasion of the 10 year anniversary of the FDA's "Guidance for Industry: "should CVOTs be continued and/or modified?" The 5th Cardiovascular Outcome Trial Summit will be held in Munich on 24-25 October 2019 ( http://www.cvot.org ).
- Keywords
- CARMELINA, CVOT, Cardiovascular risk, DECLARE-TIMI 58, Diabetes, Harmony Outcomes, ODYSSEY OUTCOMES,
- MeSH
- Biomedical Research methods standards MeSH
- Diabetes Mellitus diagnosis drug therapy epidemiology MeSH
- Endocrinology methods standards MeSH
- Hypoglycemic Agents adverse effects therapeutic use MeSH
- Cardiology methods standards MeSH
- Cardiovascular Diseases diagnosis epidemiology therapy MeSH
- Clinical Trials as Topic methods standards MeSH
- Cooperative Behavior MeSH
- Humans MeSH
- Interdisciplinary Communication MeSH
- Practice Guidelines as Topic MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Congress MeSH
- Names of Substances
- Hypoglycemic Agents MeSH
Following publication of the original article [1], author Antonio Ceriello requested that a correction be published in relation to his affiliations. His correct affiliations have been updated in this erratum. This correction is very important for the correct assignment of funds to his Institutions.
- Publication type
- Journal Article MeSH
- Published Erratum MeSH
People with diabetes compared with people without exhibit worse prognosis if affected by coronavirus disease 2019 (COVID-19) induced by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), particularly when compromising metabolic control and concomitant cardiovascular disorders are present. This Perspective seeks to explore newly occurring cardio-renal-pulmonary organ damage induced or aggravated by the disease process of COVID-19 and its implications for the cardiovascular risk management of people with diabetes, especially taking into account potential interactions with mechanisms of cellular intrusion of SARS-CoV-2. Severe infection with SARS-CoV-2 can precipitate myocardial infarction, myocarditis, heart failure, and arrhythmias as well as an acute respiratory distress syndrome and renal failure. They may evolve along with multiorgan failure directly due to SARS-CoV-2-infected endothelial cells and resulting endotheliitis. This complex pathology may bear challenges for the use of most diabetes medications in terms of emerging contraindications that need close monitoring of all people with diabetes diagnosed with SARS-CoV-2 infection. Whenever possible, continuous glucose monitoring should be implemented to ensure stable metabolic compensation. Patients in the intensive care unit requiring therapy for glycemic control should be handled solely by intravenous insulin using exact dosing with a perfusion device. Although not only ACE inhibitors and angiotensin 2 receptor blockers but also SGLT2 inhibitors, GLP-1 receptor agonists, pioglitazone, and probably insulin seem to increase the number of ACE2 receptors on the cells utilized by SARS-CoV-2 for penetration, no evidence presently exists that shows this might be harmful in terms of acquiring or worsening COVID-19. In conclusion, COVID-19 and related cardio-renal-pulmonary damage can profoundly affect cardiovascular risk management of people with diabetes.
- MeSH
- Betacoronavirus * MeSH
- Coronavirus drug effects MeSH
- COVID-19 MeSH
- Diabetes Mellitus drug therapy epidemiology MeSH
- COVID-19 Drug Treatment MeSH
- Angiotensin-Converting Enzyme Inhibitors therapeutic use MeSH
- Cardiovascular Diseases epidemiology therapy MeSH
- Comorbidity MeSH
- Coronavirus Infections drug therapy epidemiology MeSH
- Blood Glucose MeSH
- Humans MeSH
- Pandemics MeSH
- Risk Factors MeSH
- SARS-CoV-2 MeSH
- Blood Glucose Self-Monitoring MeSH
- Pneumonia, Viral epidemiology MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Angiotensin-Converting Enzyme Inhibitors MeSH
- Blood Glucose MeSH
In the pandemic "Corona Virus Disease 2019" (COVID-19) people with diabetes have a high risk to require ICU admission. The management of diabetes in Intensive Care Unit is always challenging, however, when diabetes is present in COVID-19 the situation seems even more complicated. An optimal glycemic control, avoiding acute hyperglycemia, hypoglycemia and glycemic variability may significantly improve the outcome. In this case, intravenous insulin infusion with continuous glucose monitoring should be the choice. No evidence suggests stopping angiotensin-converting-enzyme inhibitors, angiotensin-renin-blockers or statins, even it has been suggested that they may increase the expression of Angiotensin-Converting-Enzyme-2 (ACE2) receptor, which is used by "Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to penetrate into the cells. A real issue is the usefulness of several biomarkers, which have been suggested to be measured during the COVID-19. N-Terminal-pro-Brain Natriuretic-Peptide, D-dimer and hs-Troponin are often increased in diabetes. Their meaning in the case of diabetes and COVID-19 should be therefore very carefully evaluated. Even though we understand that in such a critical situation some of these requests are not so easy to implement, we believe that the best possible action to prevent a worse outcome is essential in any medical act.
- Keywords
- COVID-19, Cardiovascular complications, Diabetes, Intensive Care Unit,
- MeSH
- Antihypertensive Agents therapeutic use MeSH
- Betacoronavirus pathogenicity MeSH
- Biomarkers blood MeSH
- COVID-19 MeSH
- Diabetes Mellitus blood diagnosis drug therapy mortality MeSH
- Dyslipidemias drug therapy mortality MeSH
- Risk Assessment MeSH
- Hypertension drug therapy mortality MeSH
- Hypoglycemic Agents adverse effects therapeutic use MeSH
- Host-Pathogen Interactions MeSH
- Intensive Care Units * MeSH
- Coronavirus Infections diagnosis mortality therapy virology MeSH
- Blood Glucose drug effects metabolism MeSH
- Humans MeSH
- Pandemics MeSH
- Risk Factors MeSH
- SARS-CoV-2 MeSH
- Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use MeSH
- Pneumonia, Viral diagnosis mortality therapy virology MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Names of Substances
- Antihypertensive Agents MeSH
- Biomarkers MeSH
- Hypoglycemic Agents MeSH
- Blood Glucose MeSH
- Hydroxymethylglutaryl-CoA Reductase Inhibitors MeSH