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Browsing by Author "Janež, Andrej (6603143804)"

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    Publication
    Evidence from routine clinical practice: EMPRISE provides a new perspective on CVOTs
    (2019)
    Schernthaner, Guntram (7101681229)
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    Karasik, Avraham (57202041431)
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    Abraitienė, Agne (55857059000)
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    Ametov, Alexander S. (7006386593)
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    Gaàl, Zsolt (35931929600)
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    Gumprecht, Janusz (7004895356)
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    Janež, Andrej (6603143804)
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    Kaser, Susanne (56363661500)
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    Lalić, Katarina (13702563300)
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    Mankovsky, Boris N. (58203878600)
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    Moshkovich, Evgeny (57199644535)
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    Past, Marju (57210889717)
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    Prázný, Martin (6701722128)
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    Radulian, Gabriela (24077138200)
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    Smirčić Duvnjak, Lea (57208387970)
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    Tkáč, Ivan (57202530921)
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    Trušinskis, Kārlis (8049349300)
    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. © 2019 The Author(s).
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    Publication
    Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review
    (2020)
    Janež, Andrej (6603143804)
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    Guja, Cristian (6603582360)
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    Mitrakou, Asimina (7004179428)
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    Lalic, Nebojsa (13702597500)
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    Tankova, Tsvetalina (8242458100)
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    Czupryniak, Leszek (7004014515)
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    Tabák, Adam G. (7003480687)
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    Prazny, Martin (6701722128)
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    Martinka, Emil (6701691301)
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    Smircic-Duvnjak, Lea (57208387970)
    Here, we review insulin management options and strategies in nonpregnant adult patients with type 1 diabetes mellitus (T1DM). Most patients with T1DM should follow a regimen of multiple daily injections of basal/bolus insulin, but those not meeting individual glycemic targets or those with frequent or severe hypoglycemia or pronounced dawn phenomenon should consider continuous subcutaneous insulin infusion. The latter treatment modality could also be an alternative based on patient preferences and availability of reimbursement. Continuous glucose monitoring may improve glycemic control irrespective of treatment regimen. A glycemic target of glycated hemoglobin < 7% (53 mmol/mol) is appropriate for most nonpregnant adults. Basal insulin analogues with a reduced peak profile and an extended duration of action with lower intraindividual variability relative to neutral protamine Hagedorn insulin are preferred. The clinical advantages of basal analogues compared with older basal insulins include reduced injection burden, better efficacy, lower risk of hypoglycemic episodes (especially nocturnal), and reduced weight gain. For prandial glycemic control, any rapid-acting prandial analogue (aspart, glulisine, lispro) is preferred over regular human insulin. Faster-acting insulin aspart is a relatively new option with the advantage of better postprandial glucose coverage. Frequent blood glucose measurements along with patient education on insulin dosing based on carbohydrate counting, premeal blood glucose, and anticipated physical activity is paramount, as is education on the management of blood glucose under different circumstances. Plain Language Summary: Plain language summary is available for this article. © 2020, The Author(s).
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    Management of patients with diabetes and obesity in the COVID-19 era: Experiences and learnings from South and East Europe, the Middle East, and Africa
    (2021)
    Giorgino, Francesco (7006329053)
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    Bhana, Sindeep (56523089600)
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    Czupryniak, Leszek (7004014515)
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    Dagdelen, Selcuk (6701599609)
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    Galstyan, Gagik R. (6701438348)
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    Janež, Andrej (6603143804)
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    Lalić, Nebojsa (13702597500)
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    Nouri, Nassim (57221476108)
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    Rahelić, Dario (6505508151)
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    Stoian, Anca Pantea (57200568822)
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    Raz, Itamar (7004953711)
    The COVID-19 pandemic has had a major effect on healthcare during 2020. Current evidence suggests that, while individuals with diabetes and obesity are no more prone to SARS-CoV-2 infection than those without, the risk of hospitalisation if someone has diabetes or obesity and then contracts COVID-19 is three times higher – and 4.5 times higher if they have diabetes and obesity. We assembled a panel of experts from South and East Europe, the Middle East, and Africa to discuss the challenges to management of diabetes and obesity during and post the COVID-19 pandemic. The experience and learnings of this panel cover a heterogeneous patient population, wide range of clinical settings, healthcare organisations, disease management strategies, and social factors. We discuss the importance of timely and effective disease management via telemedicine, providing reassurance and guidance for patients unable or unwilling to visit healthcare settings at this time. We address the use of novel therapies and their role in managing diabetes and obesity during the pandemic, as well as the importance of controlling hypoglycaemia and preventing cardiovascular complications, particularly in vulnerable people. Finally, we consider post-COVID-19 management of diabetes and obesity, and how these learnings and experiences should impact upon future clinical guidelines. © 2020 The Authors
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    Publication
    Management of patients with diabetes and obesity in the COVID-19 era: Experiences and learnings from South and East Europe, the Middle East, and Africa
    (2021)
    Giorgino, Francesco (7006329053)
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    Bhana, Sindeep (56523089600)
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    Czupryniak, Leszek (7004014515)
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    Dagdelen, Selcuk (6701599609)
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    Galstyan, Gagik R. (6701438348)
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    Janež, Andrej (6603143804)
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    Lalić, Nebojsa (13702597500)
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    Nouri, Nassim (57221476108)
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    Rahelić, Dario (6505508151)
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    Stoian, Anca Pantea (57200568822)
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    Raz, Itamar (7004953711)
    The COVID-19 pandemic has had a major effect on healthcare during 2020. Current evidence suggests that, while individuals with diabetes and obesity are no more prone to SARS-CoV-2 infection than those without, the risk of hospitalisation if someone has diabetes or obesity and then contracts COVID-19 is three times higher – and 4.5 times higher if they have diabetes and obesity. We assembled a panel of experts from South and East Europe, the Middle East, and Africa to discuss the challenges to management of diabetes and obesity during and post the COVID-19 pandemic. The experience and learnings of this panel cover a heterogeneous patient population, wide range of clinical settings, healthcare organisations, disease management strategies, and social factors. We discuss the importance of timely and effective disease management via telemedicine, providing reassurance and guidance for patients unable or unwilling to visit healthcare settings at this time. We address the use of novel therapies and their role in managing diabetes and obesity during the pandemic, as well as the importance of controlling hypoglycaemia and preventing cardiovascular complications, particularly in vulnerable people. Finally, we consider post-COVID-19 management of diabetes and obesity, and how these learnings and experiences should impact upon future clinical guidelines. © 2020 The Authors
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    Publication
    SGLT2 inhibitors in T2D and associated comorbidities - Differentiating within the class
    (2019)
    Schernthaner, Guntram (7101681229)
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    Drexel, Heinz (55162866700)
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    Moshkovich, Evgeny (57199644535)
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    Zilaitiene, Birute (6506600865)
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    Martinka, Emil (6701691301)
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    Czupryniak, Leszek (7004014515)
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    Várkonyi, Tamás (7005125975)
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    Janež, Andrej (6603143804)
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    Ducena, Kristine (36702447500)
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    Lalić, Katarina (13702563300)
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    Tankova, Tsvetalina (8242458100)
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    Prázný, Martin (6701722128)
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    Smirčić Duvnjak, Lea (57208387970)
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    Sukhareva, Olga (57151140700)
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    Sourij, Harald (6507809057)
    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. © 2019 The Author(s).
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    Unrecognised cardiovascular disease in type 2 diabetes: Is it time to act earlier?
    (2018)
    Schernthaner, Guntram (7101681229)
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    Lotan, Chaim (7005954879)
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    Baltadzhieva-Trendafilova, Elina (55396473400)
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    Ceponis, Jonas (23495190700)
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    Clodi, Martin (7003534674)
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    Ducena, Kristine (36702447500)
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    Goncalvesova, Eva (55940355200)
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    Guja, Cristian (6603582360)
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    Honka, Marek (24366583700)
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    Janež, Andrej (6603143804)
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    Lalić, Nebojša (13702597500)
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    Lehmann, Roger (14022858600)
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    Nyolczas, Noémi (24388812000)
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    Pauklin, Priit (57204737562)
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    Rynkiewicz, Andrzej (56261255000)
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    Sergienko, Igor (36440217900)
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    Duvnjak, Lea Smirčić (6508009486)
    Cardiovascular disease (CVD) is the most significant prognostic factor in individuals with type 2 diabetes (T2D). However, a significant number of individuals may develop CVD that does not present with the classic angina-related or heart failure symptoms. In these cases, CVD may seem to be 'silent' or 'asymptomatic', but may be more accurately characterised as unrecognised diabetic cardiac impairment. An initial step to raise awareness of unrecognised CVD in individuals with T2D would be to reach a consensus regarding the terminology used to describe this phenomenon. By standardising the terminologies, and agreeing on the implementation of an efficient screening program, it is anticipated that patients will receive an earlier diagnosis and appropriate and timely treatment. Given the availability of anti-diabetic medications that have been shown to concomitantly reduce CV risk and mortality, it is imperative to improve early identification and initiate treatment as soon as possible in order to enable as many patients with T2D as possible to benefit. © 2018 The Author(s).
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    Worldwide inertia to the use of cardiorenal protective glucose-lowering drugs (SGLT2i and GLP-1 RA) in high-risk patients with type 2 diabetes
    (2020)
    Schernthaner, Guntram (7101681229)
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    Shehadeh, Naim (7004178092)
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    Ametov, Alexander S. (7006386593)
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    Bazarova, Anna V. (6602259883)
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    Ebrahimi, Fahim (36570263600)
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    Fasching, Peter (59078005700)
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    Janež, Andrej (6603143804)
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    Kempler, Péter (35411093000)
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    Konrāde, Ilze (23397151000)
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    Lalić, Nebojša M. (13702597500)
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    Mankovsky, Boris (58203878600)
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    Martinka, Emil (6701691301)
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    Rahelić, Dario (6505508151)
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    Serafinceanu, Cristian (6506421865)
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    Škrha, Jan (57195093600)
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    Tankova, Tsvetalina (8242458100)
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    Visockienė, Žydrūnė (55560567200)
    The disclosure of proven cardiorenal benefits with certain antidiabetic agents was supposed to herald a new era in the management of type 2 diabetes (T2D), especially for the many patients with T2D who are at high risk for cardiovascular and renal events. However, as the evidence in favour of various sodium–glucose transporter-2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA) accumulates, prescriptions of these agents continue to stagnate, even among eligible, at-risk patients. By contrast, dipeptidyl peptidase-4 inhibitors (DPP-4i) DPP-4i remain more widely used than SGLT2i and GLP-1 RA in these patients, despite a similar cost to SGLT2i and a large body of evidence showing no clear benefit on cardiorenal outcomes. We are a group of diabetologists united by a shared concern that clinical inertia is preventing these patients from receiving life-saving treatments, as well as placing them at greater risk of hospitalisation for heart failure and progression of renal disease. We propose a manifesto for change, in order to increase uptake of SGLT2i and GLP-1 RA in appropriate patients as a matter of urgency, especially those who could be readily switched from an agent without proven cardiorenal benefit. Central to our manifesto is a shift from linear treatment algorithms based on HbA1c target setting to parallel, independent considerations of atherosclerotic cardiovascular disease, heart failure and renal risks, in accordance with newly updated guidelines. Finally, we call upon all colleagues to play their part in implementing our manifesto at a local level, ensuring that patients do not pay a heavy price for continued clinical inertia in T2D. © 2020, The Author(s).

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