31 results on '"Fadini G.P."'
Search Results
2. Fibrate use is associated with a lower incidence of heart failure: A real-world study among people with type 2 diabetes
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Morieri, M.L., primary, Rigato, M., additional, Fagarazzi, C., additional, Avogaro, A., additional, and Fadini, G.P., additional
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- 2023
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3. Quantitative analysis on bioavailability of insulin in bags of parenteral nutrition
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Vitturi, N., primary, Francini-Pesenti, F., additional, Iori, E., additional, Lenzini, L., additional, Tresso, S., additional, Fadini, G.P., additional, and Avogaro, A., additional
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- 2021
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4. Improved Function of Circulating Angiogenic Cells Is Evident in Type 1 Diabetic Islet-Transplanted Patients
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Petrelli, A., Maestroni, A., Fadini, G.P., Belloni, D., Venturi, M., Albero, M., Kleffel, S., Mfarrej, B.G., Del Maschio, A., Maffi, P., Avogaro, A., Ferrero, E., Zerbini, G., Secchi, A., and Fiorina, P.
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- 2010
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5. The metabolic syndrome, diabetes and lung dysfunction
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Tiengo, A., Fadini, G.P., and Avogaro, A.
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- 2008
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6. A Multinational Real-World Study on the Clinical Characteristics of Patients with Type 2 Diabetes Initiating Dapagliflozin in Southern Europe
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Fadini, G.P. Tentolouris, N. Caballero Mateos, I. Bellido Castañeda, V. Morales Portillo, C.
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Introduction: A real-world study was performed to describe the clinical characteristics of patients who received dapagliflozin to better understand differences when initiating dapagliflozin in various countries and different prescribing settings. Methods: We assessed pooled data from observational studies carried out in Italy (n = 2484), Spain (n = 564) and Greece (n = 87). The primary objective was to compare the clinical profile of patients initiating dapagliflozin in the three countries. We also evaluated the percentage of patients who received dapagliflozin in clinical practice who satisfied DECLARE-TIMI 58 enrolment criteria. Results: In Italy and Spain, around 90% of patients were receiving metformin vs. 66% in Greece (p < 0.0001). Patients in Greece had lower levels of estimated glomerular filtration rate and lower prevalence rates of retinopathy, prior stroke, acute myocardial infarction, peripheral arterial disease and atherosclerotic cardiovascular disease. Grouping the cohorts by prescribing setting (primary vs. specialist care), baseline HbA1c was lower in primary care (8.4 ± 1.7 vs. 8.7 ± 1.5, respectively; p < 0.0001). Significantly more patients were receiving other medications for concomitant conditions in specialist care. A total of 1416 patients (48%) did not meet DECLARE inclusion criteria, while 1561 (52%) patients met the criteria (Greece 41.05%, Italy 53.19%, Spain 51.35%). Conclusions: Significant differences were seen among patients initiating dapagliflozin in southern Europe. Our results suggest that dapagliflozin was being initiated at different stages of the disease according to the country and prescribing settings. Such geographic heterogeneity may have an impact upon effectiveness of dapagliflozin on glucose lowering, as well as cardiovascular and renal outcomes. © 2019, The Author(s).
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- 2020
7. Positioning sulphonylureas in a modern treatment algorithm for patients with type 2 diabetes: Expert opinion from a European consensus panel
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Consoli, A., Czupryniak, L., Duarte, R., Jermendy, G., Kautzky-Willer, A., Mathieu, C., Melo, M., Mosenzon, O., Nobels, F., Papanas, N., Roman, G., Schnell, O., Sotiropoulos, A., Stehouwer, C.D.A., Tack, C.J.J., Woo, V., Fadini, G.P., Raz, I., Consoli, A., Czupryniak, L., Duarte, R., Jermendy, G., Kautzky-Willer, A., Mathieu, C., Melo, M., Mosenzon, O., Nobels, F., Papanas, N., Roman, G., Schnell, O., Sotiropoulos, A., Stehouwer, C.D.A., Tack, C.J.J., Woo, V., Fadini, G.P., and Raz, I.
- Abstract
Contains fulltext : 229476.pdf (Publisher’s version ) (Closed access), 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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- 2020
8. A survey of cholesterol lowering therapies and achievement of targets for cardiovascular prevention in type 2 diabetes in Italy
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Morieri, M.L., primary, Avogaro, A., additional, and Fadini, G.P., additional
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- 2020
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9. Hypoglycaemia, irrespective of the definition used, is reduced when switching to insulin degludec from other basal insulins in routine clinical care : The ReFLeCT study
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Feher, M., Fadini, G.P., Krarup Hansen, T., Jendle, Johan, Merchante, A., Koefoed, M.M., Rizi, E.P., Zimmermann, E., de Valk, H.W., Feher, M., Fadini, G.P., Krarup Hansen, T., Jendle, Johan, Merchante, A., Koefoed, M.M., Rizi, E.P., Zimmermann, E., and de Valk, H.W.
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Background and aims: ReFLeCT was a multicentre, prospective, observational study designed to investigate the safety and effectiveness of switching to insulin degludec (degludec) from other basal insulins in patients with type 1 (T1D) or type 2 diabetes (T2D). Few studies had prospectively collected hypoglycaemia data from patient diaries following a switch to degludec in everyday clinical practice. These additional analyses from the ReFLeCT study aimed to assess the effects of switching to degludec according to different hypoglycaemia definitions. Materials and methods: ReFLeCT comprised a 4-week baseline period (pre-switch basal insulin) and a 12-month follow-up period (degludec treatment). The primary endpoint of overall hypoglycaemia reported in patient diaries was reduced during follow-up vs baseline in T1D and T2D with improvement of glycaemic control, as previously reported. Here, hypoglycaemia data from ReFLeCT were analysed using pre-specified and updated (post hoc) American Diabetes Association (ADA) hypoglycaemia definitions. Definitions consisted of: documented asymptomatic and symptomatic, pseudo, probable symptomatic, and Level 1, 2 and 3 (severe) hypoglycaemia (Fig). Hypoglycaemic events were analysed using fully adjusted, negative binomial regression models. Results: In T1D (n=556) and T2D (n=611), estimated rate ratios across the previous and the updated ADA hypoglycaemia definitions were significantly lower during the 12-month follow-up vs the baseline period, except for asymptomatic hypoglycaemia in T1D and Level 3 hypoglycaemia in T2D (due to a low number of severe hypoglycaemic events, no comparable statistics were performed) (Fig). Event rates per patient year were also lower for all definitions during the 12-month follow-up vs the baseline period, except for Level 3 hypoglycaemia in T2D, which marginally increased, although this was likely due to the low number of events in this group. Conclusion: In patients with T1D and T2D, switching to degl
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- 2019
10. Switching to insulin degludec from other basal insulins reduces rates of hypoglycemia (according to different definitions) in routine clinical care : The ReFLeCT Study
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de Valk, H.W., Feher, M., Krarup Hansen, T., Jendle, Johan, Merchante, A., Koefoed, M.M., Rizi, E.P., Zimmermann, E., Fadini, G.P., de Valk, H.W., Feher, M., Krarup Hansen, T., Jendle, Johan, Merchante, A., Koefoed, M.M., Rizi, E.P., Zimmermann, E., and Fadini, G.P.
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- 2019
11. Switching to insulin degludec from other basal insulins reduces rates of hypoglycemia across patient subgroups in routine clinical care : The ReFleCT study
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de Valk, H.W., Feher, M., Krarup Hansen, T., Jendle, Johan, Merchante, A., Koefoed, M.M., Rizi, E.P., Zimmermann, E., Fadini, G.P., de Valk, H.W., Feher, M., Krarup Hansen, T., Jendle, Johan, Merchante, A., Koefoed, M.M., Rizi, E.P., Zimmermann, E., and Fadini, G.P.
- Abstract
ReFLeCT, a multicenter, prospective, observational study evaluated the safety and effectiveness of switching from other basal insulins to insulin degludec (degludec) in patients with type 1 (T1D) or type 2 diabetes (T2D) in routine clinical practice. ReFLeCT comprised a 4-week baseline period (pre-switch basal insulin) and 12-month follow-up period (degludec). The primary endpoint of overall hypoglycemia reported in patient diaries was reduced during the 12-month follow-up period vs. baseline, without compromising glycemic control. In pre-specified subgroup analyses of the primary endpoint, we assessed if the overall result was robust in different subgroups, characterized according to baseline A1C (<7.5, ≥7.5-<8.5, ≥8.5-<9.5, ≥9.5%), diabetes duration (quartiles) and physician’s reason for initiating degludec (hypoglycemia [Yes/No]). The estimated rate ratios of hypoglycemia were similar within subgroups (no significant interactions), and demonstrated overall lower rates (the majority significantly lower) during the 12-month follow-up periods vs. baseline in patients with T1D or T2D (Figure). Irrespective of baseline characteristics or physician’s reason for initiating degludec, switching to degludec from other basal insulins reduced rates of overall hypoglycemia in patients with T1D or T2D, in routine clinical practice.
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- 2019
12. Rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes)
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Fadini, G.P., primary, Zatti, G., additional, Consoli, A., additional, Bonora, E., additional, Sesti, G., additional, Avogaro, A., additional, Formoso, G., additional, Antenucci, D., additional, Grossi, G., additional, Pucci, A., additional, Andreozzi, F., additional, Indrieri, L., additional, Capobianco, G., additional, Gatti, A., additional, Bonadonna, R., additional, Zavaroni, I., additional, Dei Cas, A., additional, Felace, G., additional, Li Volsi, P., additional, Buzzetti, R., additional, Leto, G., additional, D'Angelo, F., additional, Morano, S., additional, Giaccari, A., additional, Sorice, G., additional, Orsi, E., additional, Carlo Bossi, A., additional, Querci, F., additional, Duratorre, E., additional, Malagola, C., additional, Franzetti, I., additional, Silvia Morpurgo, P., additional, Boemi, M., additional, Petrelli, M., additional, Aimaretti, G., additional, Karamouzis, I., additional, Cavalot, F., additional, Saglietti, G., additional, Gruden, G., additional, Devangelio, E., additional, Cazzetta, G., additional, Lamacchia, O., additional, Cervone, S., additional, Frittitta, L., additional, Arena, S., additional, Di Benedetto, A., additional, Piro, S., additional, Giordano, C., additional, Rizzo, M., additional, Chianetta, R., additional, Mannina, C., additional, Solini, A., additional, Natali, A., additional, Anichini, R., additional, Dotta, F., additional, Fattor, B., additional, Fadini, G.P., additional, Cigolini, M., additional, Simioni, N., additional, Frison, V., additional, Poli, M., additional, Lapolla, A., additional, Cristiano Chilelli, N., additional, and Vinci, C., additional
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- 2017
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13. Development of a multiphoton-multicolor and super-resolution STED microscope for in vivo experiments
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Gintoli, M., primary, Filippi, A., additional, Carli, M., additional, Scattolini, V., additional, Ciubotaru, C.D., additional, Nardin, C., additional, Leparulo, A., additional, Kaludercic, N., additional, Avogaro, A., additional, Fadini, G.P., additional, Bortolozzi, M., additional, Mammano, F., additional, and Romanato, F., additional
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- 2017
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14. Switching from twice-daily glargine or detemir to once-daily degludec improves glucose control in type 1 diabetes. An observational study
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Galasso, S., primary, Facchinetti, A., additional, Bonora, B.M., additional, Mariano, V., additional, Boscari, F., additional, Cipponeri, E., additional, Maran, A., additional, Avogaro, A., additional, Fadini, G.P., additional, and Bruttomesso, D., additional
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- 2016
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15. A perspective on NETosis in diabetes and cardiometabolic disorders
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Fadini, G.P., primary, Menegazzo, L., additional, Scattolini, V., additional, Gintoli, M., additional, Albiero, M., additional, and Avogaro, A., additional
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- 2016
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16. Pharmacologic targeting of the diabetic stem cell mobilopathy.
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Albiero, M. and Fadini, G.P.
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DIABETES , *HEMATOPOIETIC stem cells , *STEM cell transplantation , *LIFE expectancy , *HYPERGLYCEMIA - Abstract
Graphical abstract Abstract Diabetes is a chronic metabolic disease characterized by hyperglycemia and several associated biochemical abnormalities. Diabetes leads to multiorgan complications that collectively reduce life expectancy. Hematopoietic stem cells (HSCs) are nested within bone marrow (BM) niches whence they can be mobilized to the peripheral circulation. Clinically, this is done for HSC collection and autologous or allogenic transplantation. A great amount of data from basic and clinical studies support that diabetic patients are poor HSC mobilizers owing to BM remodeling. Dysfunction of the BM shares pathophysiological features and pathways with typical chronic diabetic complications that affect other issues (e.g. the retina and the kidney). From a clinical perspective, impaired HSC mobilization translates into the failure to collect a minimum number of CD34+ cells to achieve a safe engraftment after transplantation. Furthermore, blunted mobilization is associated with reduced steady-state levels of circulating HSCs, which have been consistently described in diabetic patients and associated with increased risk of adverse outcomes, including cardiovascular events and death. In this review, we discuss the most clinically relevant pharmacological options to overcome impaired HSC mobilization in diabetes. These therapeutic strategies may result in an improved outcome of diabetic patients undergoing HSC transplantation and restore circulating HSC levels, thereby protecting from adverse cardiovascular outcomes. [ABSTRACT FROM AUTHOR]
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- 2018
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17. Metformin improves putative longevity effectors in peripheral mononuclear cells from subjects with prediabetes. A randomized controlled trial
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Vigili de Kreutzenberg, S., primary, Ceolotto, G., additional, Cattelan, A., additional, Pagnin, E., additional, Mazzucato, M., additional, Garagnani, P., additional, Borelli, V., additional, Bacalini, M.G., additional, Franceschi, C., additional, Fadini, G.P., additional, and Avogaro, A., additional
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- 2015
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18. The great opportunity of the andrological patient: cardiovascular and metabolic risk assessment and prevention.
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Foresta, C., Ferlin, A., Lenzi, A., Montorsi, P., Corona, G., Esposito, K., Fadini, G.P., Isidori, A.M., La Vignera, S., Mannucci, E., Tona, F., and Zaninelli, A.
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CARDIOVASCULAR diseases risk factors ,METABOLIC syndrome risk factors ,IMPOTENCE ,BIOMARKERS ,ENDOTHELIUM diseases - Abstract
Andrologists, cardiologists and diabetologists (and general practitioners) have the great opportunity to collaborate and find shared clinical workup for the benefit of a large number of men. Several evidence established a link between erectile dysfunction ( ED), cardiovascular disease ( CVD), diabetes, and metabolic syndrome. Not only these conditions share many risk factors and pathophysiological mechanisms but also an emerging paradigm indicates that ED is, in fact, an independent marker of cardiovascular disease risk, CV events and CV mortality. However, there is no consensus on the best cardiologic investigation in men with ED with no known CVD and, on the contrary, on what is the clinical and prognostic role of detecting ED during cardiovascular investigation and CVD risk assessment. Only vasculogenic ED, which represents the most common type of organic ED, indeed represents a harbinger of CVD, especially for younger patients, and might be diagnosed by dynamic penile color doppler ultrasonography, which represents a real cardiovascular imaging technique that give evidence on the presence of systemic endothelial dysfunction and atherosclerosis. Furthermore, assessment of glucose and lipid metabolism is warranted as first step workup in all ED patients, and diabetologists should ask their patients for erectile function, address ED patients to andrologists, and consider vasculogenic ED in the context of the cardiovascular and metabolic workup and in the context of diabetic complications. Sexual symptoms (and testosterone levels) should sound as harbinger for cardiovascular and metabolic investigation and cardiologists and diabetologists have the opportunity to have a symptom (erectile dysfunction) and a vascular test (penile color doppler) that help them in better management of patients, their comorbidities and complications. [ABSTRACT FROM AUTHOR]
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- 2017
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19. Circulating endothelial progenitor cells are reduced in peripheral vascular complications of type 2 diabetes mellitus
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Fadini, G.P., Miorin, M., Facco, M., Bonamico, S., Baesso, I., Grego, F., Menegolo, M., de Kreutzenberg, S.V., Tiengo, A., Agostini, C., and Avogaro, A.
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Peripheral vascular diseases -- Diagnosis -- Care and treatment -- Research ,Type 2 diabetes -- Diagnosis -- Care and treatment -- Research ,Health ,Diagnosis ,Care and treatment ,Research - Abstract
Fadini GP, Miorin M, Facco M, Bonamico S, Baesso I, Grego F, Menegolo M, de Kreutzenberg SV, Tiengo A, Agostini C, Avogaro A: Circulating endothelial progenitor cells are reduced in [...]
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- 2005
20. Microangiopathy is independently associated with presence, severity and composition of carotid atherosclerosis in type 2 diabetes
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Vigili de Kreutzenberg, S., primary, Coracina, A., additional, Volpi, A., additional, Fadini, G.P., additional, Frigo, A.C., additional, Guarneri, G., additional, Tiengo, A., additional, and Avogaro, A., additional
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- 2010
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21. 44 ROSUVASTATIN PROMOTES EXPANSION OF HUMAN ENDOTHELIAL PROGENITOR CELLS. EVIDENCES FROM MULTIPLE CULTURE PROTOCOLS
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Fadini, G.P., primary, Albiero, M., additional, Piliego, T., additional, Boscaro, E., additional, Agostini, C., additional, and Avogaro, A., additional
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- 2008
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22. Microangiopathy is independently associated with presence, severity and composition of carotid atherosclerosis in type 2 diabetes.
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Vigili de Kreutzenberg, S., Coracina, A., Volpi, A., Fadini, G.P., Frigo, A.C., Guarneri, G., Tiengo, A., and Avogaro, A.
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Abstract: Background and aims: Common mechanisms for the development of micro- and macroangiopathic diabetic complications have been suggested. We aimed to cross-sectionally investigate strength and characteristics of the association between carotid atherosclerosis and microangiopathy in type 2 diabetic patients. Methods and results: Common carotid artery intima–media thickness (cIMT), carotid plaque (CP) type and degree of stenosis were evaluated by ultrasound, along with the determination of anthropometric parameters, HbA1c, lipid profile, assessment of diabetic retinopathy and nephropathy, in 662 consecutive patients with type 2 diabetes mellitus (T2DM). Patients were divided according to high/low cIMT, presence/absence of CP and of retinopathy and nephropathy. Patients with CP were older, more prevalently males, past smokers, had longer diabetes duration, significantly lower HDL cholesterol and more prevalent ischemic heart disease (all p <0.05) as compared to those with cIMT<1mm. Microangiopathies were more prevalent in patients with CP than in those without. At multivariate logistic regression, factors independently associated with the presence of CP were age, past smoke, HDL cholesterol, retinopathy and retinopathy plus nephropathy. A significant independent correlation of CP stenosis with stage of retinopathy and nephropathy was found. Finally, echolucent CPs were associated with a lower prevalence of proliferative retinopathy than CP containing calcium deposits. Conclusion: In T2DM, retinopathy, alone or in combination with nephropathy, is independently associated to CP, and severity of microangiopathy correlates with severity of carotid atherosclerosis. These observations, together with the different prevalence of proliferative retinopathy according to CP types, point to possible common pathogenic mechanisms in micro- and macrovascular complications. [Copyright &y& Elsevier]
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- 2011
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23. Initial treatment of diabetes in Italy. A nationwide population-based study from of the ARNO Diabetes Observatory
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Nello Martini, Olga Vaccaro, Salvatore Cataudella, G. P. Fadini, Elisa Rossi, Enzo Bonora, Giulio Marchesini, Roberto Miccoli, Bonora E., Cataudella S., Marchesini G., Miccoli R., Vaccaro O., Fadini G.P., Martini N., and Rossi E.
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Blood Glucose ,Male ,Time Factors ,Databases, Factual ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,Medicine (miscellaneous) ,Drug Prescription ,Insulin ,Practice Patterns, Physicians' ,Child ,media_common ,Aged, 80 and over ,Nutrition and Dietetics ,Drug Substitution ,Oral agent ,Middle Aged ,Metformin ,Sulfonylurea Compound ,Treatment Outcome ,Italy ,Child, Preschool ,Drug Therapy, Combination ,Female ,Cardiology and Cardiovascular Medicine ,Human ,medicine.drug ,Adult ,Drug ,Diabetes mellitu ,medicine.medical_specialty ,Time Factor ,Adolescent ,media_common.quotation_subject ,Drug Prescriptions ,Young Adult ,Internal medicine ,Diabetes mellitus ,medicine ,Hospital discharge ,Humans ,Hypoglycemic Agents ,Initial treatment ,Medical prescription ,Aged ,Hypoglycemic Agent ,business.industry ,Glucose lowering medication ,Infant, Newborn ,Infant ,Biomarker ,medicine.disease ,Drug Utilization ,Treatment ,Population based study ,Diabetes Mellitus, Type 1 ,Sulfonylurea Compounds ,Diabetes Mellitus, Type 2 ,business ,Biomarkers - Abstract
Background and aims To investigate diabetes treatment initiation and continuation in the next sixth months in newly diagnosed Italian subjects. Methods and results We analyzed administrative claims of 11,300,750 Italian residents. Subjects with incident diabetes were identified by glucose lowering drug prescriptions, disease-specific co-payment exemptions and hospital discharge codes occurring in 2018 but not in 2017. Incident cases were 65,932 of whom 91.4% received the prescription of a glucose lowering drug. Among the latter, those receiving a prescription of a noninsulin medication but no insulin were 84.8%, those receiving a prescription of insulin only were 9.4%, and those receiving prescriptions of both insulin and noninsulin drugs were 5.8%. Metformin was the most frequently drug initially prescribed in noninsulin treated subjects (~85%) and sulphonylurea receptor (SUR) agonists collectively ranked as second (~13%). Lispro (35%) and glargine (34%) were the most frequently prescribed molecules in subjects who were insulin treated. Differences in prescriptions were found in age categories, with increased use of SUR agonists across decades. In the first six months, as many as 50% of noninsulin treated patients continued with the initial drug, ~15% added a second agent, ~5% switched to another medication, and ~30% discontinued any glucose lowering treatment. Conclusions These data document that current guidelines are often neglected because prescriptions of SUR agonists as first agent are still quite common and insulin is prescribed more than expected. They point out the urgent need to improve the dissemination and implementations of guidelines in diabetes care.
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- 2021
24. Predictors of early discontinuation of dapagliflozin versus other glucose-lowering medications: a retrospective multicenter real-world study
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Fadini, G. P., Li Volsi, P., Devangelio, E., Poli, M., Cazzetta, G., Felace, G., Avogaro, A., Consoli, A., Formoso, G., Grossi, G., Pucci, A., Sesti, G., Andreozzi, F., Capobianco, G., Gatti, A., Bonadonna, R., Zavaroni, I., Cas, A. D., Buzzetti, R., Leto, G., Sorice, G. P., D'Angelo, P., Morano, S., Bossi, A. C., Duratorre, E., Franzetti, I., Morpurgo, P. S., Orsi, E., Querci, F., Boemi, M., D'Angelo, F., Petrelli, M., Aimaretti, G., Karamouzis, I., Cavalot, F., Saglietti, G., Cervone, S., Lamacchia, O., Arena, S., Di Benedetto, A., Frittitta, L., Giordano, C., Piro, S., Rizzo, M., Chianetta, R., Mannina, C., Anichini, R., Penno, G., Solini, A., Fattor, B., Bonora, E., Cigolini, M., Lapolla, A., Chilelli, N. C., Simioni, N., Frison, V., Vinci, C., Fadini G.P., Li Volsi P., Devangelio E., Poli M., Cazzetta G., Felace G., Avogaro A., Consoli A., Formoso G., Grossi G., Pucci A., Sesti G., Andreozzi F., Capobianco G., Gatti A., Bonadonna R., Zavaroni I., Cas A.D., Buzzetti R., Leto G., Sorice G.P., D'Angelo P., Morano S., Bossi A.C., Duratorre E., Franzetti I., Morpurgo P.S., Orsi E., Querci F., Boemi M., D'Angelo F., Petrelli M., Aimaretti G., Karamouzis I., Cavalot F., Saglietti G., Cervone S., Lamacchia O., Arena S., Di Benedetto A., Frittitta L., Giordano C., Piro S., Rizzo M., Chianetta R., Mannina C., Anichini R., Penno G., Solini A., Fattor B., Bonora E., Cigolini M., Lapolla A., Chilelli N.C., Simioni N., Frison V., and Vinci C.
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Blood Glucose ,Male ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,030209 endocrinology & metabolism ,Type 2 diabetes ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Endocrinology ,Glucosides ,Diabetes mellitus ,Internal medicine ,Adherence ,Observational ,Pharmacotherapy ,Real-world ,Aged ,Benzhydryl Compounds ,Diabetes Mellitus, Type 2 ,Dipeptidyl-Peptidase IV Inhibitors ,Female ,Humans ,Hypoglycemic Agents ,Middle Aged ,Retrospective Studies ,Withholding Treatment ,Diabetes Mellitus ,medicine ,Outpatient clinic ,Dapagliflozin ,business.industry ,Retrospective cohort study ,medicine.disease ,Metformin ,Discontinuation ,chemistry ,Tolerability ,030220 oncology & carcinogenesis ,business ,Type 2 ,medicine.drug - Abstract
Background and aims: In routine clinical practice, early discontinuation of newly initiated glucose-lowering medications (GLM) is relatively common. We herein evaluated if the clinical characteristics associated with early discontinuation of dapagliflozin were different from those associated with early discontinuation of other GLM. Methods: The DARWIN-T2D was a multicenter retrospective study conducted at diabetes specialist outpatient clinics in Italy. We included 2484 patients who were initiated on dapagliflozin in 2015–2016 and 14,801 patients who were initiated on other GLM (DPP-4 inhibitors, GLP-1 receptor agonists, or gliclazide) in the same period. After excluding patients who had not (yet) returned to follow-up, we compared the characteristics of patients who persisted on drug versus those who were no longer on drug at the first available follow-up after at least 3months. Results: As compared to those who persisted on drug, patients who discontinued dapagliflozin (51.7%) were more often female, had higher baseline fasting plasma glucose (FPG), HbA1c, and eGFR, and less common use of metformin. Upon multiple regression, higher HbA1c, higher eGFR, and lower metformin use remained independently associated with early discontinuation. Among patients who had been initiated on other GLM, 41.7% discontinued. Variables independently associated with discontinuation were older age, longer diabetes duration, higher HbA1c, eGFR, and albumin excretion, more common use of insulin and less metformin. Conclusion: In routine clinical practice, all variables associated with dapagliflozin discontinuation were also associated with discontinuation of other GLM. Thus, despite a distinctive mechanism of action and a peculiar tolerability profile, no specific predictor of dapagliflozin discontinuation was detected.
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- 2019
25. SGLT-2 inhibitors and atrial fibrillation in the Food and Drug Administration adverse event reporting system
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Gian Paolo Fadini, Angelo Avogaro, Emanuel Raschi, Benedetta Maria Bonora, Bonora B.M., Raschi E., Avogaro A., and Fadini G.P.
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United State ,lcsh:Diseases of the circulatory (Cardiovascular) system ,medicine.medical_specialty ,Time Factors ,Complications ,Databases, Factual ,Time Factor ,Epidemiology ,Endocrinology, Diabetes and Metabolism ,Disease ,Type 2 diabetes ,Clinical practice ,Risk Assessment ,Type 2 diabete ,Pharmacovigilance ,Adverse Event Reporting System ,Risk Factors ,Diabetes mellitus ,Internal medicine ,Atrial Fibrillation ,Adverse Drug Reaction Reporting Systems ,Humans ,Observational ,Medicine ,Adverse effect ,Sodium-Glucose Transporter 2 Inhibitors ,Protective Factor ,Original Investigation ,United States Food and Drug Administration ,business.industry ,Risk Factor ,Sodium-Glucose Transporter 2 Inhibitor ,Atrial fibrillation ,Protective Factors ,medicine.disease ,United States ,Treatment Outcome ,Diabetes Mellitus, Type 2 ,lcsh:RC666-701 ,Concomitant ,Adverse Drug Reaction Reporting System ,Cardiology and Cardiovascular Medicine ,business ,Complication ,Human - Abstract
Background Sodium glucose cotransporter-2 inhibitors (SGLT2i) reduce the risk of heart failure and new data show they can prevent atrial fibrillation (AF). We examined the association between SGLT2i and AF in the Food and Drug Administration adverse event reporting system (FAERS). Methods We mined the FAERS from 2014q1 to 2019q4 to compare AF reporting for SGLT-2 i versus reports for other glucose lowering medications (ATC10 class). Several exclusions were sequentially applied for: concomitant medications; diabetes, cardiovascular or renal disease indication; reports for competing adverse events (genitourinary tract infections, ketoacidosis, Fournier’s gangrene, amputation). We provide descriptive statistics and calculated proportional reporting ratios (PRR). Results There were 62,098 adverse event reports for SGLT2i and 642,031 reports for other ATC10 drugs. The reporting of AF was significantly lower with SGLT2i than with other ATC10 drugs (4.8 versus 8.7/1000; p Conclusions In a large pharmacovigilance database, AF was robustly and consistently reported more frequently for diabetes medications other than SGLT2i. This finding complements available evidence from trials supporting a protective role of SGLT2i against the occurrence of AF.
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- 2021
26. SGLT2 inhibitors for heart failure with reduced ejection fraction: a real EMPEROR?
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Gian Paolo Fadini, Emanuel Raschi, Igor Diemberger, Elisabetta Poluzzi, Fabrizio De Ponti, Raschi E., Fadini G.P., Diemberger I., Poluzzi E., and De Ponti F.
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medicine.medical_specialty ,Population ,Empagliflozin ,heart failure with reduced ejection fraction ,sodium-glucose co-transporter-2 inhibitors ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,medicine ,Humans ,Pharmacology (medical) ,Dapagliflozin ,Intensive care medicine ,education ,Sodium-Glucose Transporter 2 Inhibitors ,Pharmacology ,Heart Failure ,education.field_of_study ,Ejection fraction ,Clinical pharmacology ,business.industry ,Type 2 Diabetes Mellitus ,Stroke Volume ,General Medicine ,Hospitalization ,chemistry ,Diabetes Mellitus, Type 2 ,030220 oncology & carcinogenesis ,Observational study ,business ,030217 neurology & neurosurgery - Abstract
Introduction: In individuals with type 2 diabetes mellitus, sodium–glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and serious adverse renal events, both in randomized controlled trials and observational studies. Areas covered: In this paper, the authors critically discuss the rationale, results, and implications of the recent placebo-controlled EMPEROR-Reduced trial [NCT03057977], which evaluated empagliflozin in subjects with chronic heart failure and a reduced ejection fraction (HFrEF), with or without diabetes. A parallel with the DAPA-HF trial, investigating dapagliflozin in a similar albeit not fully overlapping population, is also provided. The authors finally provide the reader with their expert perspectives. Expert opinion: EMPEROR-Reduced confirmed and extended the findings from DAPA-HF, especially on renal outcomes, thus strengthening the rationale for considering SGLT2 inhibitors among established treatments in HFrEF. Forthcoming guidelines supported by the knowledge of the clinical pharmacology of SGLT2 inhibitors will hopefully assist cardiologists, nephrologists, and general practitioners in selecting the target population and promoting safe prescribing.
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- 2020
27. A view on the quality of diabetes care in Italy and the role of Diabetes Clinics from the 2018 ARNO Diabetes Observatory
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Roberto Miccoli, Gian Paolo Fadini, Salvatore Cataudella, Olga Vaccaro, Nello Martini, Elisa Rossi, Giulio Marchesini, Enzo Bonora, Bonora, E., Cataudella, S., Marchesini, G., Miccoli, R., Vaccaro, O., Fadini, G. P., Martini, N., Rossi, E., Bonora E., Cataudella S., Marchesini G., Miccoli R., Vaccaro O., Fadini G.P., Martini N., and Rossi E.
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Blood Glucose ,Male ,Glycated Hemoglobin A ,Time Factors ,Endocrinology, Diabetes and Metabolism ,Medicine (miscellaneous) ,Practice Patterns ,Disease ,030204 cardiovascular system & hematology ,Ambulatory Care Facilities ,0302 clinical medicine ,Adherence ,Anti-hyperglycemic agents ,Diabetes mellitus ,Monitoring ,Quality of care ,Aged ,Aged, 80 and over ,Biomarkers ,Diabetes Mellitus ,Female ,Glycemic Control ,Guideline Adherence ,Humans ,Hypoglycemic Agents ,Italy ,Middle Aged ,Practice Guidelines as Topic ,Practice Patterns, Physicians' ,Prevalence ,Quality Indicators, Health Care ,Treatment Outcome ,Health care ,80 and over ,Nutrition and Dietetics ,medicine.diagnostic_test ,Carotid ultrasonography ,Eye examination ,Cardiology and Cardiovascular Medicine ,Human ,medicine.medical_specialty ,Diabetes mellitu ,Time Factor ,030209 endocrinology & metabolism ,Anti-hyperglycemic agent ,03 medical and health sciences ,medicine ,Medical prescription ,Glycated Hemoglobin ,Physicians' ,Hypoglycemic Agent ,business.industry ,Biomarker ,medicine.disease ,Health Care ,Ambulatory Care Facilitie ,Emergency medicine ,Quality Indicators ,Microalbuminuria ,business ,Lipid profile - Abstract
Backgrounds and aims To investigate relevant indicators of quality of care in a large population-based sample of people with diabetes representative of clinical practice in Italy in 2018. Methods and results We analyzed data from 11,300,750 subjects. All administrative healthcare claims collected in 2018 were scrutinized to identify subjects with diabetes and investigate several indicators of quality of care. Subjects with diabetes were identified by anti-hyperglycemic drug prescriptions, disease-specific co-payment exemption and hospital discharge codes. Indicators of quality of care pertained to monitoring (HbA1c, creatinine, lipid profile, microalbuminuria, eye examination, ECG, ultrasonography of carotid and lower limb arteries) and diabetes treatment (anti-hyperglycemic agents in subjects with cardiovascular disease, CVD). Subjects attending and nonattending Diabetes Clinics were compared. We identified 697,208 individuals with diabetes. HbA1c was assessed at least once in the year in 62.7%, creatinine in 62.3%, total cholesterol in 59.6%, microalbuminuria in 34.3%. Frequency of eye examination was 8.2%, ECG 23.5%, carotid ultrasonography 14.3%, lower limb ultrasonography 7.6%. Among anti-hyperglycemic drugs, SGLT-2 inhibitors were prescribed to ~5% and GLP-1 receptor agonists to ~5% although the proportion of subjects with CVD was ~45%. Subjects attending Diabetes Clinics had higher figures for all these monitoring and treatment indicators. Conclusions The implementation of national and international guidelines regarding disease monitoring and treatment is far from being satisfactory, especially among subjects nonattending Diabetes Clinics. Further efforts and investments are needed for better disseminating guidelines, more efficaciously engaging healthcare professionals and more strongly empowering the healthcare system to improve diabetes care.
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- 2020
28. Clinical burden of diabetes in Italy in 2018: A look at a systemic disease from the ARNO Diabetes Observatory
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Salvatore Cataudella, Nello Martini, Olga Vaccaro, Giulio Marchesini, Enzo Bonora, Elisa Rossi, Roberto Miccoli, Gian Paolo Fadini, Bonora, E., Cataudella, S., Marchesini, G., Miccoli, R., Vaccaro, O., Fadini, G. P., Martini, N., Rossi, E., Bonora E., Cataudella S., Marchesini G., Miccoli R., Vaccaro O., Fadini G.P., Martini N., and Rossi E.
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Research design ,Male ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,Population ,Disease ,health care and epidemiology ,Diseases of the endocrine glands. Clinical endocrinology ,Ambulatory care ,administrative data ,Diabetes mellitus ,Health care ,medicine ,Diabetes Mellitus ,Humans ,Hypoglycemic Agents ,Medical prescription ,Epidemiology/Health Services Research ,education ,Copayment ,education.field_of_study ,business.industry ,Health Care Costs ,hospitalization ,resource use ,medicine.disease ,RC648-665 ,Italy ,Family medicine ,Female ,business - Abstract
IntroductionDiabetes is a highly prevalent disease worldwide and represents a challenge for patients and healthcare systems. This population-based study evaluated diabetes burden in Italy in 2018 by assessing all aspects of outpatient and hospital care.Research design and methodsWe investigated data of 11 300 750 residents in local health districts contributing to ARNO Diabetes Observatory (~20% of Italian inhabitants). All administrative healthcare claims were analyzed to gather information on access to medical resources. Subjects with diabetes, identified by antihyperglycemic drug prescriptions, disease-specific copayment exemption and hospital discharge codes, were compared with age, sex and residency-matched non-diabetic individuals.ResultsWe identified 697 208 subjects with ascertained diabetes, yielding a prevalence of 6.2% (6.5% in men vs 5.9% in women, p2-fold higher in subjects with diabetes, mainly driven by hospitalizations and outpatient care related to chronic complications rather than to glucose-lowering drugs, diabetes-specific devices, or metabolic monitoring.ConclusionsThe burden of diabetes in Italy is particularly heavy and, as a systemic disease, it includes all aspects of clinical medicine, with consequent high expenses in all areas of healthcare.
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- 2020
29. Similar effectiveness of dapagliflozin and GLP-1 receptor agonists concerning combined endpoints in routine clinical practice: A multicentre retrospective study
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Fadini, G. P., Sciannameo, V., Franzetti, I., Bottigliengo, D., D'Angelo, P., Vinci, C., Berchialla, P., Arena, S., Buzzetti, R., Avogaro, A., Consoli, A., Formoso, G., Grossi, G., Pucci, A., Sesti, G., Andreozzi, F., Capobianco, G., Gatti, A., Bonadonna, R., Zavaroni, I., Cas, A. D., Felace, G., Volsi, P. L., Leto, G., Sorice, G. P., Morano, S., Bossi, A. C., Duratorre, E., Morpurgo, P. S., Orsi, E., Querci, F., Boemi, M., D'Angelo, F., Petrelli, M., Aimaretti, G., Karamouzis, I., Cavalot, F., Saglietti, G., Cazzetta, G., Cervone, S., Devangelio, E., Lamacchia, O., Di Benedetto, A., Frittitta, L., Giordano, C., Piro, S., Rizzo, M., Chianetta, R., Mannina, C., Anichini, R., Penno, G., Solini, A., Fattor, B., Bonora, E., Cigolini, M., Lapolla, A., Chilelli, N. C., Poli, M., Simioni, N., Frison, V., Fadini G.P., Sciannameo V., Franzetti I., Bottigliengo D., D'Angelo P., Vinci C., Berchialla P., Arena S., Buzzetti R., Avogaro A., Consoli A., Formoso G., Grossi G., Pucci A., Sesti G., Andreozzi F., Capobianco G., Gatti A., Bonadonna R., Zavaroni I., Cas A.D., Felace G., Volsi P.L., Leto G., Sorice G.P., Morano S., Bossi A.C., Duratorre E., Morpurgo P.S., Orsi E., Querci F., Boemi M., D'Angelo F., Petrelli M., Aimaretti G., Karamouzis I., Cavalot F., Saglietti G., Cazzetta G., Cervone S., Devangelio E., Lamacchia O., Di Benedetto A., Frittitta L., Giordano C., Piro S., Rizzo M., Chianetta R., Mannina C., Anichini R., Penno G., Solini A., Fattor B., Bonora E., Cigolini M., Lapolla A., Chilelli N.C., Poli M., Simioni N., and Frison V.
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Blood Glucose ,Male ,Glycated Hemoglobin A ,Endocrinology, Diabetes and Metabolism ,Blood Pressure ,Type 2 diabetes ,030204 cardiovascular system & hematology ,Settore MED/13 - Endocrinologia ,chemistry.chemical_compound ,0302 clinical medicine ,Endocrinology ,Glucosides ,Clinical endpoint ,Medicine ,Dapagliflozin ,GLP-1 analogue ,Middle Aged ,Treatment Outcome ,glycaemic control ,antidiabetic drug ,dapagliflozin ,observational study ,Combination ,Original Article ,Drug Therapy, Combination ,Female ,Type 2 ,medicine.drug ,Adult ,medicine.medical_specialty ,030209 endocrinology & metabolism ,Glucagon-Like Peptide-1 Receptor ,03 medical and health sciences ,Drug Therapy ,GLP‐1 analogue ,Internal medicine ,Diabetes mellitus ,Internal Medicine ,Diabetes Mellitus ,Humans ,Hypoglycemic Agents ,Benzhydryl Compounds ,Aged ,Retrospective Studies ,Glycated Hemoglobin ,Body Weight ,Diabetes Mellitus, Type 2 ,Diabetic Angiopathies ,Exenatide ,Liraglutide ,business.industry ,Retrospective cohort study ,Original Articles ,medicine.disease ,Blood pressure ,chemistry ,Propensity score matching ,business ,Antidiabetic drug, dapagliflozin, GLP-1 analogue, glycaemic control, observational study - Abstract
Aims According to cardiovascular outcome trials, some sodium‐glucose contransporter‐2 inhibitors (SGLT2i) and glucagon‐like peptide‐1 receptor agonists (GLP‐1RA) are recommended for secondary cardiovascular prevention in type 2 diabetes (T2D). In this real‐world study, we compared the simultaneous reductions in HbA1c, body weight and systolic blood pressure after initiation of dapagliflozin or GLP‐1RA as second or a more advanced line of therapy. Materials and methods DARWIN‐T2D was a retrospective multi‐centre study conducted at diabetes specialist clinics in Italy that compared T2D patients who initiated dapagliflozin or GLP‐1RA (exenatide once weekly or liraglutide). Data were collected at baseline and at the first follow‐up visit after 3 to 12 months. The primary endpoint was the proportion of patients achieving a simultaneous reduction in HbA1c, body weight and systolic blood pressure. To reduce confounding, we used multivariable adjustment (MVA) or propensity score matching (PSM). Results Totals of 473 patients initiating dapagliflozin and 336 patients initiating GLP‐1RA were included. The two groups differed in age, diabetes duration, HbA1c, weight and concomitant medications. The median follow‐up was 6 months in both groups. Using MVA or PSM, the primary endpoint was observed in 30% to 32% of patients, with no difference between groups. Simultaneous reduction of HbA1c, BP and SBP by specific threshold, as well as achievement of final goals, did not differ between groups. GLP‐1RA reduced HbA1c by 0.3% more than the reduction achieved with dapagliflozin. Conclusion In routine specialist care, initiation of dapagliflozin can be as effective as initiation of a GLP‐1RA for attainment of combined risk factor goals.
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- 2019
30. Comparative Effectiveness of DPP-4 Inhibitors Versus Sulfonylurea for the Treatment of Type 2 Diabetes in Routine Clinical Practice: A Retrospective Multicenter Real-World Study
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Fadini, Gian Paolo, Bottigliengo, Daniele, D'Angelo, Federica, Cavalot, Franco, Bossi, Antonio Carlo, Zatti, Giancarlo, Baldi, Ileana, Avogaro, A, Consoli, A, Formoso, G, Grossi, G, Pucci, A, Sesti, G, Andreozzi, F, Capobianco, G, Gatti, A, Bonadonna, R, Zavaroni, I, Cas, Ad, Felace, G, Volsi, Pl, Buzzetti, R, Leto, G, Sorice, Gp, D'Angelo, P, Morano, S, Bossi, Ac, Duratorre, E, Franzetti, I, Morpurgo, Ps, Orsi, E, Querci, F, Boemi, M, D'Angelo, F, Petrelli, M, Aimaretti, G, Karamouzis, I, Cavalot, F, Saglietti, G, Cazzetta, G, Cervone, S, Devangelio, E, Lamacchia, O, Arena, S, Benedetto, Di, A, Frittitta, L, Giordano, C, Piro, S, Rizzo, M, Chianetta, R, Mannina, C, Anichini, R, Penno, G, Solini, A, Fattor, B, Bonora, E, Cigolini, M, Lapolla, A, Chilelli, Nc, Poli, M, Simioni, N, Frison, V, Vinci, C, Fadini G.P., Bottigliengo D., D'Angelo F., Cavalot F., Bossi A.C., Zatti G., Baldi I., Avogaro A., Consoli A., Formoso G., Grossi G., Pucci A., Sesti G., Andreozzi F., Capobianco G., Gatti A., Bonadonna R., Zavaroni I., Cas A.D., Felace G., Volsi P.L., Buzzetti R., Leto G., Sorice G.P., D'Angelo P., Morano S., Duratorre E., Franzetti I., Morpurgo P.S., Orsi E., Querci F., Boemi M., Petrelli M., Aimaretti G., Karamouzis I., Saglietti G., Cazzetta G., Cervone S., Devangelio E., Lamacchia O., Arena S., Di Benedetto A., Frittitta L., Giordano C., Piro S., Rizzo M., Chianetta R., Mannina C., Anichini R., Penno G., Solini A., Fattor B., Bonora E., Cigolini M., Lapolla A., Chilelli N.C., Poli M., Simioni N., Frison V., and Vinci C.
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endocrine system ,medicine.medical_specialty ,Epidemiology ,Endocrinology, Diabetes and Metabolism ,030209 endocrinology & metabolism ,Type 2 diabetes ,030204 cardiovascular system & hematology ,Database ,03 medical and health sciences ,0302 clinical medicine ,Endocrinology ,Diabetes mellitus ,Internal medicine ,medicine ,Clinical endpoint ,Pharmacotherapy ,Internal Medicine ,Outpatient clinic ,Gliclazide ,Original Research ,Glycemic ,business.industry ,nutritional and metabolic diseases ,Retrospective cohort study ,medicine.disease ,Metformin ,Diabetes and Metabolism ,business ,medicine.drug - Abstract
Introduction DPP-4 inhibitors (DPP4i) and sulfonylureas are popular second-line therapies for type 2 diabetes (T2D), but there is a paucity of real-world studies comparing their effectiveness in routine clinical practice. Methods This was a multicenter retrospective study on diabetes outpatient clinics comparing the effectiveness of DPP4i versus gliclazide extended release. The primary endpoint was change from baseline in HbA1c. Secondary endpoints were changes in fasting plasma glucose, body weight, and systolic blood pressure. Automated software extracted data from the same clinical electronic chart system at all centers. Propensity score matching (PSM) was used to generate comparable cohorts to perform outcome analysis. Results We included data on 2410 patients starting DPP4i and 1590 patients starting gliclazide (mainly 30–60 mg/day). At baseline, the two groups differed in disease duration, body weight, blood pressure, HbA1c, fasting glucose, HDL cholesterol, triglycerides, liver enzymes, eGFR, prevalence of microangiopathy, and use of metformin. Among DPP4i molecules, no difference in glycemic effectiveness was detected. In matched cohorts (n = 1316/group), patients starting DPP4i, as compared with patients starting gliclazide, experienced greater reductions in HbA1c (− 0.6% versus − 0.4%; p
- Published
- 2018
31. Metformin improves putative longevity effectors in peripheral mononuclear cells from subjects with prediabetes. A randomized controlled trial
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Giulio Ceolotto, S. Vigili de Kreutzenberg, Anna Maria Cattelan, Paolo Garagnani, Vincenzo Borelli, Marta Mazzucato, Angelo Avogaro, Elisa Pagnin, Maria Giulia Bacalini, Claudio Franceschi, Gian Paolo Fadini, Vigili de Kreutzenberg, S., Ceolotto, G., Cattelan, A., Pagnin, E., Mazzucato, M., Garagnani, P., Borelli, V., Bacalini, M.G., Franceschi, C., Fadini, G.P., and Avogaro, A.
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Blood Glucose ,Male ,medicine.medical_specialty ,Aging ,endocrine system diseases ,Endocrinology, Diabetes and Metabolism ,Medicine (miscellaneous) ,AMP-Activated Protein Kinases ,Placebo ,Peripheral blood mononuclear cell ,Dysmetabolism ,Monocytes ,Prediabetic State ,Sirtuin 1 ,Polysaccharides ,Internal medicine ,Gene expression ,medicine ,Humans ,Hypoglycemic Agents ,Prediabetes ,PI3K/AKT/mTOR pathway ,Telomere Shortening ,Inflammation ,Nutrition and Dietetics ,Cell Death ,business.industry ,TOR Serine-Threonine Kinases ,AMPK ,Middle Aged ,medicine.disease ,Longevity gene ,Metformin ,Endocrinology ,Ageing ,Female ,Insulin Resistance ,Cardiology and Cardiovascular Medicine ,business ,Biomarkers ,medicine.drug - Abstract
Background and aims: Prediabetes increases cardiovascular risk and is associated with excess mortality. In preclinical models, metformin has been shown to exert anti-ageing effects. In this study, we sought to assess whether metformin modulates putative effector longevity pro- grams in prediabetic subjects. Methods and results: In a randomized, single-blind, placebo-controlled trial, 38 prediabetic sub- jects received metformin (1500 mg/day) or placebo for 2 months. At baseline and after treat- ment, we collected anthropometric and metabolic parameters. Gene and protein levels of SIRT1, mTOR, p53, p66Shc, SIRT1 activity, AMPK activation, telomere length, and SIRT1 promoter chromatin accessibility were determined in peripheral blood mononuclear cells (PBMCs). Plasma N-glycans, non-invasive surrogate markers of ageing, were also analysed. Compared to baseline, metformin significantly improved metabolic parameters and insulin sensitivity, increased SIRT1 gene/protein expression and SIRT1 promoter chromatin accessibility, elevated mTOR gene expression with concomitant reduction in p70S6K phosphorylation in sub- jects' PBMCs, and modified the plasma N-glycan profile. Compared to placebo, metformin increased SIRT1 protein expression and reduced p70S6K phosphorylation (a proxy of mTOR ac- tivity). Plasma N-glycans were also favourably modified by metformin compared to placebo. Conclusion: In individuals with prediabetes, metformin ameliorated effector pathways that have been shown to regulate longevity in animal models. ClinicalTrials.gov Identifier: NCT01765946 e January 2013.
- Published
- 2015
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