Nejvíce citovaný článek - PubMed ID 23992602
The 9th Cardiovascular Outcome Trial (CVOT) Summit: Congress on Cardiovascular, Kidney, and Metabolic Outcomes was held virtually on November 30-December 1, 2023. This reference congress served as a platform for in-depth discussions and exchange on recently completed outcomes trials including dapagliflozin (DAPA-MI), semaglutide (SELECT and STEP-HFpEF) and bempedoic acid (CLEAR Outcomes), and the advances they represent in reducing the risk of major adverse cardiovascular events (MACE), improving metabolic outcomes, and treating obesity-related heart failure with preserved ejection fraction (HFpEF). A broad audience of endocrinologists, diabetologists, cardiologists, nephrologists and primary care physicians participated in online discussions on guideline updates for the management of cardiovascular disease (CVD) in diabetes, heart failure (HF) and chronic kidney disease (CKD); advances in the management of type 1 diabetes (T1D) and its comorbidities; advances in the management of CKD with SGLT2 inhibitors and non-steroidal mineralocorticoid receptor antagonists (nsMRAs); and advances in the treatment of obesity with GLP-1 and dual GIP/GLP-1 receptor agonists. The association of diabetes and obesity with nonalcoholic steatohepatitis (NASH; metabolic dysfunction-associated steatohepatitis, MASH) and cancer and possible treatments for these complications were also explored. It is generally assumed that treatment of chronic diseases is equally effective for all patients. However, as discussed at the Summit, this assumption may not be true. Therefore, it is important to enroll patients from diverse racial and ethnic groups in clinical trials and to analyze patient-reported outcomes to assess treatment efficacy, and to develop innovative approaches to tailor medications to those who benefit most with minimal side effects. Other keys to a successful management of diabetes and comorbidities, including dementia, entail the use of continuous glucose monitoring (CGM) technology and the implementation of appropriate patient-physician communication strategies. The 10th Cardiovascular Outcome Trial Summit will be held virtually on December 5-6, 2024 ( http://www.cvot.org ).
- Klíčová slova
- CGM, Cardiovascular disease, Chronic kidney disease, Diabetes, Finerenone, GLP-1 RA, Guidelines, Heart failure, MASLD, NAFLD, Obesity, SGLT2 inhibitor, Teplizumab,
- MeSH
- chronická renální insuficience * diagnóza epidemiologie terapie MeSH
- diabetes mellitus 2. typu * farmakoterapie MeSH
- diabetes mellitus * farmakoterapie MeSH
- kardiovaskulární nemoci * diagnóza epidemiologie prevence a kontrola MeSH
- krevní glukóza MeSH
- ledviny MeSH
- lidé MeSH
- obezita komplikace MeSH
- selfmonitoring glykemie MeSH
- srdeční selhání * komplikace MeSH
- tepový objem MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- dopisy MeSH
- Názvy látek
- krevní glukóza MeSH
The 8th Cardiovascular Outcome Trial (CVOT) Summit on Cardiovascular, Kidney, and Glycemic Outcomes was held virtually on November 10-12, 2022. Following the tradition of previous summits, this reference congress served as a platform for in-depth discussion and exchange on recently completed outcomes trials as well as key trials important to the cardiovascular (CV) field. This year's focus was on the results of the DELIVER, EMPA-KIDNEY and SURMOUNT-1 trials and their implications for the treatment of heart failure (HF) and chronic kidney disease (CKD) with sodium-glucose cotransporter-2 (SGLT2) inhibitors and obesity with glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists. A broad audience of primary care physicians, diabetologists, endocrinologists, cardiologists, and nephrologists participated online in discussions on new consensus recommendations and guideline updates on type 2 diabetes (T2D) and CKD management, overcoming clinical inertia, glycemic markers, continuous glucose monitoring (CGM), novel insulin preparations, combination therapy, and reclassification of T2D. The impact of cardiovascular outcomes on the design of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) trials, as well as the impact of real-world evidence (RWE) studies on the confirmation of CVOT outcomes and clinical trial design, were also intensively discussed. The 9th Cardiovascular Outcome Trial Summit will be held virtually on November 23-24, 2023 ( http://www.cvot.org ).
- Klíčová slova
- Cardiovascular disease, Chronic kidney disease, Diabetes, GIP/GLP-1 receptor agonist, Heart failure, Obesity, SGLT2 inhibitor,
- MeSH
- agonisté receptoru pro glukagonu podobný peptid 1 MeSH
- chronická renální insuficience * diagnóza farmakoterapie epidemiologie MeSH
- diabetes mellitus 2. typu * diagnóza farmakoterapie epidemiologie MeSH
- hypoglykemika terapeutické užití MeSH
- kardiovaskulární nemoci * diagnóza farmakoterapie epidemiologie MeSH
- krevní glukóza MeSH
- ledviny MeSH
- lidé MeSH
- selfmonitoring glykemie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- dopisy MeSH
- Názvy látek
- agonisté receptoru pro glukagonu podobný peptid 1 MeSH
- hypoglykemika MeSH
- krevní glukóza 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.
- Klíčová slova
- Canagliflozin, Cardiovascular disease, Dapagliflozin, Empagliflozin, SGLT2 inhibitor, Type 2 diabetes,
- MeSH
- diabetes mellitus 2. typu farmakoterapie MeSH
- glifloziny škodlivé účinky MeSH
- incidence MeSH
- kardiovaskulární nemoci epidemiologie etiologie MeSH
- komorbidita MeSH
- lidé MeSH
- prognóza MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- glifloziny MeSH
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 ).
- Klíčová slova
- ACE, CANVAS program, CVOT, CVOT Summit, Cardiovascular risk, D&CVD EASD Study Group, DEVOTE, Diabetes, EXSCEL,
- MeSH
- biomedicínský výzkum metody MeSH
- diabetes mellitus diagnóza epidemiologie terapie MeSH
- kardiologie metody MeSH
- kardiovaskulární nemoci diagnóza epidemiologie terapie MeSH
- klinické zkoušky jako téma * MeSH
- kooperační chování MeSH
- lidé MeSH
- mezioborová komunikace MeSH
- týmová péče o pacienty MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- kongresy MeSH
Type 2 diabetes (T2D) imposes a substantial disease burden, predominantly from cardiovascular disease (CVD), which accounts for >50% of deaths in this population and leads to a 12-year reduction in the life expectancy of a 60-year-old male patient with T2D and CVD compared with the general population. The results from mandatory cardiovascular outcome trials (CVOTs) are therefore of great interest in the field. The Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes meeting program aims to bring together experts from several associated disciplines to provide fair and balanced resources for those involved in the management of patients with T2D. This publication represents the opinions of the faculty on the key learnings from the meeting held in Vienna in the spring of 2017. In particular, we detail how data from the EMPA-REG OUTCOME® [cardiovascular outcomes trial of empagliflozin] and Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER®) (liraglutide) CVOTs can be practically interpreted across clinical specialities. It is hoped that this translation of CVOT data will achieve a dual treatment paradigm for the management of both raised glucose levels and CV risk in patients with T2D.
- Klíčová slova
- CVOT, DPP-4 inhibitors, GLP-1 agonists, SGLT2 inhibitors, cardiovascular disease, type 2 diabetes,
- Publikační typ
- časopisecké články MeSH
AIMS: These recommendations aim to improve care for patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk in Central and Eastern Europe. Cardiovascular disease (CVD) and/or chronic kidney disease (CKD) are major interdependent comorbidities in patients with T2D, accounting for 50% of mortality. Following recent CV outcomes trial (CVOT) results, including those from EMPA-REG OUTCOME®, LEADER®, SUSTAIN™-6 and, most recently, the CANVAS study, it is essential to develop regional expert consensus recommendations to aid physicians in interpreting these newest data to clinical practice. METHODS: The Central and Eastern European Diabetes Expert Group (CEEDEG) followed a Delphi method to develop treatment algorithms to aid physicians in the clinical management of patients with T2D at high CV risk. RESULTS: In light of the latest CVOT results, and in particular the EMPA-REG OUTCOME® and LEADER® trials, the diagnosis, assessment, treatment choice and monitoring of patients with T2D and established CVD and/or CKD have been considered together with existing guidelines and presented in two reference algorithms. In addition, adherence, special prescribing considerations and a proposed multidisciplinary management approach have been discussed and are presented with the proposed algorithms. CONCLUSIONS: The latest available high-level evidence on glucose-lowering drugs has enabled CEEDEG to develop practical consensus recommendations for patients with established CVD and/or CKD. These recommendations represent an update to international and country-level guidelines used for these patients, with the aim of providing a resource not only to endocrinologists, but to cardiologists, nephrologists and primary care physicians in the region.
- Klíčová slova
- Anti-glycaemic drugs, Cardiovascular disease, Renal disease, Type 2 diabetes,
- MeSH
- diabetes mellitus diagnóza epidemiologie terapie MeSH
- hypoglykemika terapeutické užití MeSH
- kardiovaskulární nemoci diagnóza epidemiologie terapie MeSH
- klinické zkoušky jako téma metody normy MeSH
- lidé MeSH
- směrnice pro lékařskou praxi jako téma normy MeSH
- translační biomedicínský výzkum metody normy MeSH
- výsledek terapie MeSH
- znalecký posudek metody normy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Geografické názvy
- Evropa epidemiologie MeSH
- východní Evropa epidemiologie MeSH
- Názvy látek
- hypoglykemika MeSH
PURPOSE OF REVIEW: There are currently over 40 different drugs in 12 distinct classes approved in the USA to treat patients with type 2 diabetes mellitus. This review summarizes our current knowledge about potential side effects of antidiabetic therapy and attempts to apply it to a clinical practice setting. RECENT FINDINGS: Given the heterogeneity of both the patients and the disease, it is mathematically impossible to test every available drug combination in long-term outcome, prospective, randomized blinded fashion before a clinician decides which agent(s) to prescribe to a specific patient in a given situation. To complicate the clinician's dilemma, there is lack of available tests to predict an individual's response or propensity to side effects. Further, the data available are derived from small, short-term registration trials and typically focus on relative rather than absolute risks of any given drug and do not address the potential adverse outcomes if a patient's diabetes remains untreated. Clinicians have to personalize their choice of antidiabetic therapy based both on the specific characteristics of the patient in front of them (stage of diabetes and its complications, overall health status, socioeconomic situation, other medications present, desire to improve control of diabetes, etc.) and the current knowledge about the relative and absolute balance of benefits and risks of any individual medication in that specific patient. It has to be recognized that this requires constant re-evaluation as database of our experience with antidiabetic therapy expands.
- Klíčová slova
- Antidiabetic medications, Drug side effects, Treatment of type 2 diabetes, Type 2 diabetes mellitus,
- MeSH
- agonisté receptoru pro glukagonu podobný peptid 1 MeSH
- biguanidy škodlivé účinky terapeutické užití MeSH
- diabetes mellitus 2. typu farmakoterapie MeSH
- hypoglykemika škodlivé účinky terapeutické užití MeSH
- lidé MeSH
- prospektivní studie MeSH
- sulfonylmočovinové sloučeniny škodlivé účinky terapeutické užití MeSH
- thiazolidindiony škodlivé účinky terapeutické užití MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Názvy látek
- agonisté receptoru pro glukagonu podobný peptid 1 MeSH
- biguanidy MeSH
- hypoglykemika MeSH
- sulfonylmočovinové sloučeniny MeSH
- thiazolidindiony MeSH
Diabetes is a global health emergency projected to affect 642 million people by 2040. Type 2 diabetes (T2D) represents 90% of diabetes cases and is associated with a range of cardiovascular (CV) risk factors that are more than double the incidence of CV disease and significantly increase mortality rates. Diabetes treatments have typically focused on improving glycemic control but their effect on CV outcomes has remained uncertain. In 2008, the US Food and Drug Administration (FDA) looked to address this knowledge gap and mandated CV outcome trials (CVOTs) for all new antidiabetic therapies. In 2015, EMPA-REG OUTCOME® became the first CVOT to present results for a sodium/glucose cotransporter 2 (SGLT2; also known as SLC5A2) inhibitor, empagliflozin. Subsequently, a regional meeting of the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes (ACROSS T2D) brought together a respected faculty of international experts and 150 physicians from 14 countries to discuss the current unmet medical needs of patients with T2D, the results from the EMPA-REG OUTCOME study and the implications of these results for clinical practice. This article summarizes the current scientific evidence and the discussions that took place at the ACROSS T2D regional meeting, which was held in Vienna, Austria, on May 30, 2016.
- Klíčová slova
- CVOTs, SGLT2 inhibitor, cardiovascular risk, empagliflozin, type 2 diabetes,
- Publikační typ
- časopisecké články MeSH
OBJECTIVE: As glucagon-like peptide-1 receptor agonists lower blood pressure (BP) in type 2 diabetes mellitus (T2DM), we examined BP control in relation to targets set by international bodies prior to randomization in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial. METHODS: We analyzed baseline data from LEADER (NCT01179048), an ongoing phase 3B, randomized, double-blind, placebo-controlled cardiovascular outcomes trial examining the cardiovascular safety of the glucagon-like peptide-1 receptor agonist liraglutide in 9340 people with T2DM from 32 countries [age (all mean ± SD) 64 ± 7.2 years, BMI 32.5 ± 6.3 kg/m, duration of diabetes 12.7 ± 8.0 years], all of whom were at high risk for cardiovascular disease (CVD). RESULTS: A total of 81% (n = 7592) of participants had prior CVD and 90% (n = 8408) had a prior history of hypertension. Despite prescription of multiple antihypertensive agents at baseline, only 51% were treated to a target BP of less than 140/85 mmHg and only 26% to the recommended baseline BP target of less than 130/80 mmHg. In univariate analyses, those with prior CVD were prescribed more agents (P < 0.001) and had lower BP than those without (137 ± 18.8/78 ± 10.6 mmHg versus 140 ± 17.7/80 ± 9.9 mmHg; P < 0.001). In logistic regression analyses, residency in North America (64% treated to <140/85 mmHg; 38% treated to <130/80 mmHg) was the strongest predictor of BP control. CONCLUSION: These contemporary data confirm that BP remains insufficiently controlled in a large proportion of individuals with T2DM at high cardiovascular risk, particularly outside North America. Longitudinal data from the LEADER trial may provide further insights into BP control in relation to cardiovascular outcomes in this condition.
- MeSH
- antihypertenziva terapeutické užití MeSH
- diabetes mellitus 2. typu komplikace farmakoterapie patofyziologie MeSH
- dvojitá slepá metoda MeSH
- hypertenze komplikace farmakoterapie patofyziologie MeSH
- hypoglykemika terapeutické užití MeSH
- krevní tlak MeSH
- lidé středního věku MeSH
- lidé MeSH
- liraglutid škodlivé účinky terapeutické užití MeSH
- receptor pro glukagonu podobný peptid 1 antagonisté a inhibitory MeSH
- rizikové faktory MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Severní Amerika MeSH
- Názvy látek
- antihypertenziva MeSH
- hypoglykemika MeSH
- liraglutid MeSH
- receptor pro glukagonu podobný peptid 1 MeSH
Incretin-based therapies either increase endogenous levels of glucagon-like peptide-1 by prolonging its half-life (DPP-4 inhibitors) or directly stimulate its receptor (glucagon-like peptide-1 analogues; GLP-1 RA). They are currently widely used for the treatment of patients with type 2 diabetes mellitus owing to good antidiabetic efficacy, low risk of hypoglycemia, and relatively few other side effects. They also offer potential additional benefits such as weight neutrality or weight loss, positive effects on blood pressure and lipid levels, and potential cardio- and neuroprotectivity. Some experimental and clinical studies have raised concerns with respect to potential cardiovascular and pancreatic side effects of these therapies such as increased risk of heart failure with DPP-4 inhibitors as well as acute pancreatitis and pancreatic cancer with both classes. The available data are at present not robust enough to enable firm conclusions regarding these potential associations. Nevertheless, some recent data suggest a possibility of slightly increased risk of acute pancreatitis with GLP-1 RAs while they do not indicate increased risk of pancreatic cancer. Ongoing cardiovascular outcome trials will shed more light on the possible cardioprotective effects of incretin-based therapies as well as on the possible interconnection of DPP-4 inhibitors and heart failure.
- MeSH
- diabetes mellitus 2. typu farmakoterapie MeSH
- hodnocení rizik MeSH
- hypoglykemika aplikace a dávkování škodlivé účinky MeSH
- inkretiny aplikace a dávkování škodlivé účinky MeSH
- kardiovaskulární nemoci chemicky indukované MeSH
- lidé MeSH
- nemoci slinivky břišní chemicky indukované MeSH
- nežádoucí účinky léčiv MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- hypoglykemika MeSH
- inkretiny MeSH