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Translating results from the cardiovascular outcomes trials with glucagon-like peptide-1 receptor agonists into clinical practice: Recommendations from a Eastern and Southern Europe diabetes expert group.
Janez, A, Muzurovic, E, Stoian, AP, Haluzik, M, Guja, C, Czupryniak, L, Duvnjak, L, Lalic, N, Tankova, T, Bogdanski, P, et al
International journal of cardiology. 2022;:8-18
Abstract
Glucagon-like peptide-1 (GLP-1) receptor agonists mimic the action of the endogenous GLP-1 incretin hormone, improving glycaemic control in type 2 diabetes mellitus (T2DM) by increasing insulin secretion and decreasing glucagon secretion in a glucose-dependent manner. However, as cardiovascular (CV) morbidity and mortality is common in patients with T2DM, several trials with the use of GLP-1 receptor agonists (RAs) have been performed focusing on endpoints related to cardiovascular disease rather than metabolic control of T2DM. Following the positive cardiovascular effects of liraglutide, dulaglutide and semaglutide observed in these trials, major changes in T2DM management guidelines have occurred. This document from a Eastern and Southern European Diabetes Expert Group discusses the results of GLP-1 RA CV outcomes trials, their impact on recent clinical guidelines for the management of T2DM, and some selected combination regimens utilising GLP-1 RAs. We also propose an algorithm for guiding GLP-1 RA-based treatment according to patients' characteristics, which can be easily applied in every day clinical practice.
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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.
Giorgino, F, Bhana, S, Czupryniak, L, Dagdelen, S, Galstyan, GR, Janež, A, Lalić, N, Nouri, N, Rahelić, D, Stoian, AP, et al
Diabetes research and clinical practice. 2021;:108617
Abstract
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.
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Blood glucose levels should be considered as a new vital sign indicative of prognosis during hospitalization.
Kesavadev, J, Misra, A, Saboo, B, Aravind, SR, Hussain, A, Czupryniak, L, Raz, I
Diabetes & metabolic syndrome. 2021;(1):221-227
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BACKGROUND AND AIMS The measurement of vital signs is an important part of clinical work up. Presently, measurement of blood glucose is a factor for concern mostly when treating individuals with diabetes. Significance of blood glucose measurement in prognosis of non-diabetic and hospitalized patients is not clear. METHODS A systematic search of literature published in the Electronic databases, PubMed and Google Scholar was performed using following keywords; blood glucose, hospital admissions, critical illness, hospitalizations, cardiovascular disease (CVD), morbidity, and mortality. This literature search was largely restricted to non-diabetic individuals. RESULTS Blood glucose level, even when in high normal range, or in slightly high range, is an important determinant of morbidity and mortality, especially in hospitalized patients. Further, even slight elevation of blood glucose may increase mortality in patients with COVID-19. Finally, blood glucose variability and hypoglycemia in critically ill individuals without diabetes causes excess in-hospital complications and mortality. CONCLUSION In view of these data, we emphasize the significance of blood glucose measurement in all patients admitted to the hospital regardless of presence of diabetes. We propose that blood glucose be included as the "fifth vital sign" for any hospitalized patient.
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Sirtuin 1, Visfatin and IL-27 Serum Levels of Type 1 Diabetic Females in Relation to Cardiovascular Parameters and Autoimmune Thyroid Disease.
Łukawska-Tatarczuk, M, Franek, E, Czupryniak, L, Joniec-Maciejak, I, Pawlak, A, Wojnar, E, Zieliński, J, Mirowska-Guzel, D, Mrozikiewicz-Rakowska, B
Biomolecules. 2021;(8)
Abstract
The loss of cardioprotection observed in premenopausal, diabetic women may result from the interplay between epigenetic, metabolic, and immunological factors. The aim of this study was to evaluate the concentration of sirtuin 1, visfatin, and IL-27 in relation to cardiovascular parameters and Hashimoto's disease (HD) in young, asymptomatic women with type 1 diabetes mellitus (T1DM). Thyroid ultrasound, carotid intima-media thickness (cIMT) measurement, electrocardiography, and echocardiography were performed in 50 euthyroid females with T1DM (28 with HD and 22 without concomitant diseases) and 30 controls. The concentrations of serum sirtuin 1, visfatin and IL-27 were assessed using ELISA. The T1DM and HD group had higher cIMT (p = 0.018) and lower left ventricular global longitudinal strain (p = 0.025) compared to females with T1DM exclusively. In women with a double diagnosis, the sirtuin 1 and IL-27 concentrations were non-significantly higher than in other groups and significantly positively correlated with each other (r = 0.445, p = 0.018) and thyroid volume (r = 0.511, p = 0.005; r = 0.482, p = 0.009, respectively) and negatively correlated with relative wall thickness (r = -0.451, p = 0.016; r = -0.387, p = 0.041, respectively). These relationships were not observed in the control group nor for the visfatin concentration. These results suggest that sirtuin 1 and IL-27 contribute to the pathogenesis of early cardiac dysfunction in women with T1DM and HD.
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Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review.
Janež, A, Guja, C, Mitrakou, A, Lalic, N, Tankova, T, Czupryniak, L, Tabák, AG, Prazny, M, Martinka, E, Smircic-Duvnjak, L
Diabetes therapy : research, treatment and education of diabetes and related disorders. 2020;(2):387-409
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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.
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Positioning sulphonylureas in a modern treatment algorithm for patients with type 2 diabetes: Expert opinion from a European consensus panel.
Consoli, A, Czupryniak, L, Duarte, R, Jermendy, G, Kautzky-Willer, A, Mathieu, C, Melo, M, Mosenzon, O, Nobels, F, Papanas, N, et al
Diabetes, obesity & metabolism. 2020;(10):1705-1713
Abstract
The large number of pharmacological agents available to treat type 2 diabetes (T2D) makes choosing the optimal drug for any given patient a complex task. Because newer agents offer several advantages, whether and when sulphonylureas (SUs) should still be used to treat T2D is controversial. Published treatment guidelines and recommendations should govern the general approach to diabetes management. However, expert opinions can aid in better understanding local practices and in formulating individual choices. The current consensus paper aims to provide additional guidance on the use of SUs in T2D. We summarize current local treatment guidelines in European countries, showing that SUs are still widely proposed as second-line treatment after metformin and are often ranked at the same level as newer glucose-lowering medications. Strong evidence now shows that sodium-glucose co-transporter-2 inhibitors (SGLT-2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) are associated with low hypoglycaemia risk, promote weight loss, and exert a positive impact on vascular, cardiac and renal endpoints. Thus, using SUs in place of SGLT-2is and GLP-1RAs may deprive patients of key advantages and potentially important cardiorenal benefits. In subjects with ascertained cardiovascular disease or at very high cardiovascular risk, SGLT-2is and/or GLP-1RAs should be used as part of diabetes management, in the absence of contraindications. Routine utilization of SUs as second-line agents continues to be acceptable in resource-constrained settings.
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BE-SMART (Basal Early Strategies to Maximize HbA1c Reduction with Oral Therapy): Expert Opinion.
Bajaj, S, Das, AK, Kalra, S, Sahay, R, Saboo, B, Das, S, Shunmugavelu, M, Jacob, J, Priya, G, Khandelwal, D, et al
Diabetes therapy : research, treatment and education of diabetes and related disorders. 2019;(4):1189-1204
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The past three decades have seen a quadruple rise in the number of people affected by diabetes mellitus worldwide, with the disease being the ninth major cause of mortality. Type 2 diabetes mellitus (T2DM) often remains undiagnosed for several years due to its asymptomatic nature during the initial stages. In India, 70% of diagnosed diabetes cases remain uncontrolled. Current guidelines endorse the initiation of insulin early in the course of the disease, specifically in patients with HbA1c > 10%, as the use of oral agents alone is unlikely to achieve glycemic targets. Early insulin initiation and optimization of glycemic control using insulin titration algorithms and patient empowerment can facilitate the effective management of uncontrolled diabetes. Early glucose control has sustained benefits in people with diabetes. However, insulin initiation, dose adjustment, and the need to repeatedly assess blood glucose levels are often perplexing for both physicians and patients, and there are misconceptions and concerns regarding its use. Hence, an early transition to insulin and ideal intensification of treatment may aid in delaying the onset of diabetes complications. This opinion statement was formulated by an expert panel on the basis of existing guidelines, clinical experience, and economic and cultural contexts. The statement stresses the timely and appropriate use of basal insulin in T2DM. It focuses on the seven vital Ts-treatment initiation, timing of administration, transportation and storage, technique of administration, targets for titration, tablets, and tools for monitoring.Funding: Sanofi.
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Perspectives of Patients with Insulin-Treated Type 1 and Type 2 Diabetes on Hypoglycemia: Results of the HAT Observational Study in Central and Eastern European Countries.
Haluzik, M, Kretowski, A, Strojek, K, Czupryniak, L, Janez, A, Kempler, P, Andel, M, Tankova, T, Boyanov, M, Smircic Duvnjak, L, et al
Diabetes therapy : research, treatment and education of diabetes and related disorders. 2018;(2):727-741
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INTRODUCTION The aim of this study was to determine the level of awareness of hypoglycemia, the level of fear for hypoglycemia, and the response to hypoglycemic events among insulin-treated diabetes patients from Central and Eastern Europe (CEE). The impact of hypoglycemia on the use of healthcare resources and patient productivity was also assessed. METHODS This was a multicenter, non-interventional, two-part, patient self-reported questionnaire study that comprised both a retrospective cross-sectional evaluation and a prospective observational evaluation. Study participants were insulin-treated adult patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) from CEE. RESULTS Most patients (85.4% T1DM and 83.6% T2DM) reported normal hypoglycemia awareness. The median hypoglycemia fear score was 5 out of 10 for T1DM and 4 out of 10 for T2DM patients. Patients increased glucose monitoring, consulted a doctor/nurse, and/or reduced the insulin dose in response to hypoglycemia. As a consequence of hypoglycemia, patients took leave from work/studies or arrived late and/or left early. Hospitalization was required for 31 (1.2%) patients with T1DM and 66 (2.1%) patients with T2DM. CONCLUSION Hypoglycemia impacts patients' personal and social functioning, reduces productivity, and results in additional costs, both direct (related to increased use of healthcare resources) and indirect (related to absenteeism. FUNDING Novo Nordisk.
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Effect of micronized fenofibrate on microvascular complications of type 2 diabetes: a systematic review.
Czupryniak, L, Joshi, SR, Gogtay, JA, Lopez, M
Expert opinion on pharmacotherapy. 2016;(11):1463-73
Abstract
OBJECTIVE Micronized fenofibrate prevents the progression of microvascular complications in type 2 diabetes, but no systematic review has summarized these effects. Therefore, we performed a systematic review to investigate the effects of micronized fenofibrate on type 2 diabetes-related microvascular complications. RESEARCH DESIGN AND METHODS The PubMed database was systematically searched for trials in English language published between January 1990 and November 2015 that examined the effects of fenofibrate on microvascular complications in patients with type 2 diabetes. RESULTS Thirteen trials of the 290 clinical studies reviewed met the inclusion criteria. Fenofibrate significantly slowed the progression of early diabetic retinopathy by 30 to 40% within 4 to 5 years in patients with type 2 diabetes mellitus and pre-existing retinopathy at baseline. Fenofibrate also consistently reduced the progression of urinary albumin excretion in the trials studied. One large study demonstrated a significant effect (47% reduction) of the drug on diabetes-related minor amputations. CONCLUSIONS The available evidence supports the adjunctive early use of fenofibrate in type 2 diabetes mellitus for the prevention of microvascular complications, particularly in individuals presenting with the first signs of the complication and during the initial stages of the disease.
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Plasma total homocysteine in the active stage of ulcerative colitis.
Drzewoski, J, Gasiorowska, A, Małecka-Panas, E, Bald, E, Czupryniak, L
Journal of gastroenterology and hepatology. 2006;(4):739-43
Abstract
BACKGROUND Homocysteine, an independent risk factor for thromboembolism, has been recently shown to be elevated in ulcerative colitis (UC). However, its relation to the activity of the disease remain unclear. METHODS Two groups were studied: group consisted of 1-30 patients with UC (17 men, 13 women, mean age 50.3 +/- 14.7 years), including 15 patients with active disease. Group 2 (controls) consisted of 21 age-, sex-, bodyweight-matched healthy persons (12 men, nine women, mean age 53.1 +/- 12.8 years). Total plasma homocysteine (tHcy) and serum folate and vitamin B12 as well as selected coagulation parameters were assessed. RESULTS Mean tHcy in UC patients was significantly higher than in healthy controls: 10.8 +/- 3.1 mmol/L versus 6.8 +/- 2.5 mmol/L (P < 0.001). Patients with active disease had higher tHcy than patients in remission: 11.2 +/- 3.5 mmol/L versus 9.0 +/- 2.3 mmol/L (P = 0.048). Patients with > or =4 recurrences of the disease had also higher tHcy than the others: 11.5 +/- 3.6 mmol/L versus 9.0 +/- 2.1 mmol/L (P = 0.035). The tHcy correlated with duration of disease: r = 0.6632 (P < 0.05). Folate and B12 levels were within their reference ranges in all subjects. However, in the patients with active disease the platelet count, fibrinogen and D-dimer were significantly higher than in the patients in remission and the controls. CONCLUSIONS Ulcerative colitis is associated with elevated tHcy concentration, particularly in the active stage, and in more recurrent types of the disease; this elevation does not seem to be prevented by a normal folate status and might have an enhancing effect on the procoagulation blood profile.