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Aims: The 2019 and 2021 European Society of Cardiology (ESC) classifications stratified patients with type 2 diabetes into three categories according to the 10-year risk of death from atherosclerotic cardiovascular disease (ASCVD). The very high-risk category included individuals with established ASCVD, target organ damage (TOD), and/or, in the 2019 classification only, ≥ 3 additional ASCVD risk factors. We assessed risk of all-cause mortality according to the two ESC classifications in the Renal Insufficiency And Cardiovascular Events cohort. Methods: Participants (n = 15,773) were stratified based on the presence of ASCVD, TOD, and ASCVD risk factors at baseline (2006–2008). Vital status was retrieved in 2015. Results: Less than 1% of participants fell in the moderate-risk category. According to the 2019 classification, ~ 1/3 fell in the high-risk and ~ 2/3 in the very high-risk category, whereas the opposite occurred with the 2021 classification. Mortality risk increased across categories according to both classifications. Among very high-risk patients, mortality was much lower in those with ≥ 3 additional ASCVD risk factors and almost equal in those with TOD and ASCVD ± TOD, using the 2019 classification, whereas it was much higher in those with ASCVD + TOD and, to a lesser extent, TOD only than in those with ASCVD only, using the 2021 classification. Conclusions: The negligible number of moderate-risk patients suggests that these classifications might overestimate risk of ASCVD death. Downgrading patients with ≥ 3 additional ASCVD risk factors to the high-risk category is consistent with mortality data. Risk of death is very high in the presence of TOD irrespective of established ASCVD. Trial registration: ClinicalTrials.gov, NCT00715481. [ABSTRACT FROM AUTHOR]

Introduction: Recent guidelines for the treatment of type 2 diabetes mellitus (T2DM) provide evidence supporting limited use of sulphonylureas (SUs), especially in specific risk patient categories, yet data from national registries still suggest their widespread use. The aim of this study was to investigate characteristics of patients with diabetes treated with SUs and quantify the proportion of patients that met the recommendations for use of SUs by recent guidelines and of those presenting characteristics representing an inappropriate prescription risk (IPR). Methods: A multicenter, retrospective, cross-sectional, observational study in patients with T2DM receiving treatment with SUs (as monotherapy or in combination with another diabetes therapy) was conducted between 2017 and 2018 in 22 outpatient diabetes clinics across Italy. Exclusion criteria were type 1 diabetes, diabetes mellitus secondary to other conditions, and presence of severe/life-threatening diseases. Results: A total of 510 patients with T2DM (306 men, 204 women; mean age ± standard deviation 69.8 ± 9.3 years) who were receiving treatment with a SU (as monotherapy or in combination therapy) were assessed in the study. Overall, 70.6% [n = 360; 95% confidence interval (CI) 66.4%, 74.5%] were assessed to have an IPR. Of these, approximately half presented one factor for risk of inappropriate prescription, and 27 and 10.6% presented two and three factors, respectively. In terms of factors contributing to the total burden of risk of inappropriate treatment with SUs, 37.5% (95% CI 33.2%, 41.8%) of all patients were obese; 33.3% (95% CI 29.3%, 37.6%)] were aged ≥ 75 years; 18.6% (95% CI 15.3%, 22.3%) had a history of cardiovascular disease; 14.1% (95% CI 11.2%, 17.4%) had chronic renal insufficiency; 1.8% (95% CI 0.8%, 3.3%) had a history of severe hypoglycemia; 1.8% (95% CI 0.8%; 3.3%) had cognitive impairment; and 2.4% (95% CI 1.2%, 4.1%) had a risky occupation. Conclusions: The results of this study provide evidence of a high rate of inappropriate SU prescription risk among patients with T2DM, especially among those with overweight/obesity, older age, history of cardiovascular disease, and hypoglycemia. [ABSTRACT FROM AUTHOR]

Aims/hypothesis: Non-albuminuric renal impairment has become the prevailing diabetic kidney disease (DKD) phenotype in individuals with type 2 diabetes and an estimated GFR (eGFR) <60 ml min−1 1.73 m−2. In the present study, we compared the rate and determinants of all-cause death in individuals with this phenotype with those in individuals with albuminuric phenotypes.Methods: This observational prospective cohort study enrolled 15,773 individuals with type 2 diabetes in 2006-2008. Based on baseline albuminuria and eGFR, individuals were classified as having: no DKD (Alb−/eGFR−), albuminuria alone (Alb+/eGFR−), reduced eGFR alone (Alb−/eGFR+), or both albuminuria and reduced eGFR (Alb+/eGFR+). Vital status on 31 October 2015 was retrieved for 15,656 individuals (99.26%).Results: Mortality risk adjusted for confounders was lowest for Alb−/eGFR− (reference category) and highest for Alb+/eGFR+ (HR 2.08 [95% CI 1.88, 2.30]), with similar values for Alb+/eGFR− (1.45 [1.33, 1.58]) and Alb−/eGFR+ (1.58 [1.43, 1.75]). Similar results were obtained when individuals were stratified by sex, age (except in the lowest age category) and prior cardiovascular disease. In normoalbuminuric individuals with eGFR <45 ml min−1 1.73 m−2, especially with low albuminuria (10-29 mg/day), risk was higher than in microalbuminuric and similar to macroalbuminuric individuals with preserved eGFR. Using recursive partitioning and amalgamation analysis, prevalent cardiovascular disease and lower HDL-cholesterol were the most relevant correlates of mortality in all phenotypes. Higher albuminuria within the normoalbuminuric range was associated with death in non-albuminuric DKD, whereas the classic ‘microvascular signatures’, such as glycaemic exposure and retinopathy, were correlates of mortality only in individuals with albuminuric phenotypes.Conclusions/interpretation: Non-albuminuric renal impairment is a strong predictor of mortality, thus supporting a major prognostic impact of renal dysfunction irrespective of albuminuria. Correlates of death partly differ from the albuminuric forms, indicating that non-albuminuric DKD is a distinct phenotype.Trial registration:: ClinicalTrials.gov NCT00715481 [ABSTRACT FROM AUTHOR]

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 < 0.001), fasting glucose (− 14.1 mg/dl versus − 8.8 mg/dl; p = 0.007), and body weight (− 0.4 kg versus − 0.1 kg; p = 0.006) after an average 6 months follow-up. DPP4i improved glucose control more than gliclazide, especially in patients who had failed with other glucose-lowering medications or were on basal insulin.Conclusions: This large retrospective real-world study shows that, in routine clinical practice, starting a DPP4i allows better glycemic control than starting low-dose gliclazide.Funding: The Italian Diabetes Society, with external support from AstraZeneca. [ABSTRACT FROM AUTHOR]

Aims: To define the contribution of chronic kidney disease (CKD) to excess mortality in patients with type 2 diabetes and identify the baseline variables associated with all-cause death in those with and without CKD using the RECursive Partitioning and Amalgamation (RECPAM) method. Methods: This observational, longitudinal, cohort study enrolled 15,773 consecutive non-dialytic patients with type 2 diabetes in 19 Diabetes Clinics throughout Italy in 2006-2008. Based on the presence of albuminuria ≥ 30 mg day−1 and/or estimated glomerular filtration rate (eGFR) < 60 mL min−1·1.73 m−2 at baseline, patients were classified as having or not CKD. Vital status was verified on October 31, 2015 for 99.26% of patients.Results: Mortality increased with increasing albuminuria and eGFR category. Excess risk versus the general population was maximal in patients aged < 55 years in the worse albuminuria or eGFR category. Conversely, in subjects aged ≥ 75 years with albuminuria < 10 mg day−1 or eGFR ≥ 75 mL min−1·1.73 m−2, excess mortality was no longer detectable. At RECPAM analysis, the main correlates of death in the whole cohort were albuminuria > 44 mg day−1, prevalent CVD, and eGFR < ~ 75 mL min−1·1.73 m−2; gender, prevalent CVD, and higher albuminuria in the normoalbuminuric range, in patients without CKD; and CVD, eGFR ~ < 50 mL min−1·1.73 m−2, and albuminuria > 53 mg day−1, in those with CKD. Conclusions: CKD is a major contributor to excess mortality in type 2 diabetes, conferring a very high risk in younger patients and fully accounting for excess risk in the older ones. Higher albuminuria and lower eGFR, even in the normal range, identify individuals with increased mortality risk.Trial registration ClinicalTrials.gov (NCT00715481; https://clinicaltrials.gov/ct2/show/NCT00715481). [ABSTRACT FROM AUTHOR]

Aims: Within the normoalbuminuric range, low albuminuria (LA, 10-29 mg/24 h) is associated with higher adverse cardiovascular and renal outcomes than normal albuminuria (NA, <10 mg/24 h). This cross-sectional analysis of the cohort from the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicentre Study was aimed at assessing the independent correlates of LA versus NA in patients with type 2 diabetes. Methods: This analysis involved 11,538 normoalbuminuric patients (73.2 % of the entire RIACE cohort): 6023 (52.2 %) with NA and 5515 (47.8 %) with LA. Binary logistic regression analysis with backward conditional variable selection was applied to assess the independent correlates of LA versus NA. Results: Compared with NA subjects, LA patients were more frequently males, older and with family history of hypertension, had longer diabetes duration, lower HDL cholesterol, and higher haemoglobin (Hb) A, triglycerides, and blood pressure (BP), use of anti-hyperglycaemic and anti-hypertensive drugs, and prevalence of metabolic syndrome, retinopathy, chronic kidney disease, any cardiovascular disease, myocardial infarction, and coronary and peripheral events. Men with LA were also more frequently current or former smokers and had higher body mass index, waist circumference, and non-HDL cholesterol. Independent correlates of LA were age (OR 1.018), family history of hypertension (OR 1.321), smoking status (former, OR 1.158; current, OR 1.237), HbA (OR 1.062), waist circumference (OR 1.050), triglycerides (OR 1.001), and diastolic BP (OR 1.014), together with use of anti-hyperglycaemic and anti-hypertensive agents. Conclusions: Several risk factors are associated with increased albuminuria within the normoalbuminuric range. As most of these factors are potentially modifiable, treating them aggressively might reduce the excess risk associated with LA. Trial registration: NCT00715481; . [ABSTRACT FROM AUTHOR]

The present study has been performed in order to evaluate the usefulness of the artificial pancreas in the surgical management of previously not localized insulinomas. In the 4 patients studied, blood glucose was maintained both overnight and during surgery up to a preselected individualized level in order to avoid hypoglycemia. During surgery, only one patient required dextrose infusion. The continuous intrasurgical monitoring of blood glucose in the 4 cases examined showed that: (1) anesthesia induction, surgical incision and viscera mobilization were accompanied by a rise in blood glucose (10-30 mg/dl), reaching the highest levels 30-40 min after the start of the operation; (2) adenoma manipulation was followed by a drop in blood glucose (10-40 mg/dl), reaching the lowest level after 30-40 min; (3) adenoma resection was followed by a rise in blood glucose (25-40 mg/dl), particularly evident after 30-40 min. It is concluded that the artificial pancreas is certainly useful during surgery of insulin-producing tumors, allowing continuous monitoring of glycemia and avoiding dangerous blood glucose excursions: however, when the insulinoma is not identified during surgery, the periods elapsing between the surgical phases and the blood glucose changes observed can be too prolonged to ensure successful conservative serial pancreatectomy in all cases. [ABSTRACT FROM AUTHOR]