Antonio Nicolucci

Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy · Diabetes and chronic diseases

Aim: To identify distinct glycated haemoglobin (HbA1c ) trajectories in people with type 2 diabetes (T2D) starting second-line glucose-lowering therapy. Materials and methods: DISCOVER was a 3-year observational study of individuals with T2D beginning second-line glucose-lowering therapy. Data were collected at initiation of second-line treatmen...

Background: Cardiovascular risk factors control is fluctuating, tends to change over time, and is potentially impacted by multifactorial interactions. Currently, the existence of risk factors, rather than their variability or interplay with one another, is used to define the population at risk. The association between variability of risk factors a...

Background: An "obesity paradox" for mortality has been shown in chronic disorders such as diabetes, and attributed to methodological bias, including the use of body mass index (BMI) for obesity definition. This analysis investigated the independent association of BMI versus surrogate measures of central adiposity with all-cause mortality in indiv...

Aims: In the Italian Diabetes and Exercise Study_2, a counselling intervention produced modest but sustained increments in moderate-to vigorous-intensity physical activity (MVPA), with reallocation of sedentary-time (SED-time) to light-intensity physical activity (LPA). This post hoc analysis evaluated the impact of intervention on estimated β-cel...

IntroductionPivotal trials documented glycemic benefits of fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi), with no weight gain and low hypoglycemia risk in type 2 diabetes (T2D). This study aimed at assessing effectiveness and patterns of use of iGlarLixi in a real-world setting.Methods This was a retrospective, m...

Aims Telemedicine is advocated as a fundamental tool in modern clinical management. However, data on the effects of telemedicine vs face-to-face consultation on clinical outcomes in type 2 diabetes (T2DM) are still uncertain. This paper describes the use of telemedicine during the 2020 COVID-19 emergency and compares volume activity and quality ind...

Aims To assess whether the presence and grade of diabetic retinopathy (DR) predict all-cause mortality, independent of risk factors for cardiovascular disease (CVD) and other complications, including diabetes-related kidney disease (DKD) and CVD, in individuals with type 2 diabetes mellitus. Methods Prospective cohort study that enrolled 15,773 pa...

Objective To develop and validate a model for predicting 5-year eGFR-loss in type 2 diabetes mellitus (T2DM) patients with preserved renal function at baseline Research Design And Methods: A cohort of 504.532 T2DM outpatients participating to the Medical Associations of Diabetologists (AMD) Annals Initiative was splitted into the Learning and Valid...

Background We sought to describe global patterns in achievement of risk factor control for primary prevention in patients with T2D and explore the association of country’s GNI/capita with risk factor control. Methods The DISCOVER study is a prospective, observational study of patients with T2D from 38 countries enrolled at initiation of second-lin...

Aims: To describe glucose-lowering treatment regimens and glycated haemoglobin (HbA1c) trajectories in individuals with type 2 diabetes (T2D) over 36 months of follow-up from the start of second-line therapy. Materials and methods: This data analysis from the 3-year, observational DISCOVER study programme included 14 687 participants from 37 cou...

Aims This study aims to evaluate the effectiveness and tolerability of once-weekly glucagon-like peptide receptor agonists (OW GLP-1RAs) and to assess the clinical benefits of switching from one GLP-1RA to another (switchers) in a routine clinical setting. Materials and Methods This is a retrospective, real-world cohort study, based on electronic...

Aim To construct predictive models of diabetes complications (DCs) by big data machine learning, based on electronic medical records. Methods Six groups of DCs were considered: eye complications, cardiovascular, cerebrovascular, and peripheral vascular disease, nephropathy, diabetic neuropathy. A supervised, tree-based learning approach (XGBoost)...

Aims This study assessed comparative effectiveness of glargine 300 U/mL (Gla-300) versus degludec 100 U/mL (Deg-100) in insulin-naïve patients with T2D. Methods This is a retrospective, multicenter, non-inferiority study based on electronic medical records. All patients initiating Gla-300 or Deg-100 were 1:1 propensity score-matched (PSM). Linear...

Background and aims: Data on second generation basal insulin (2BI) in people with type 2 diabetes (T2D) generated by clinical trials still need confirmation in real-world clinical settings. This study aimed at assessing the comparative effectiveness of 2BI [Glargine 300 U/mL (Gla-300) vs. Degludec 100 U/mL (Deg-100)] in T2D Italian patients switch...

Rationale: CRCs are known to be key determinants of patient outcomes in T2D; however, the burden of undiagnosed CRCs in unselected T2D population remains unclear, particularly in low-to-middle income countries (LMICs) . ‘Take CaRe of Me’ (TCOM) programme aims to determine the global burden and treatment patterns of CRCs in people with T2D without p...

Data on therapeutic approaches after GLP1-RA treatment failure are scant. Intensification strategies include addition of basal insulin to GLP1-RA, as free or fixed-ratio combination, as well as the switch to insulin therapy alone. Aim of the study was to assess treatment intensification approaches after GLP1-RA treatment and their effectiveness and...

Aims: To estimate the real-world change in weight over 3 years and the factors influencing it in participants who are overweight and live with type 2 diabetes. Materials & methods: DISCOVER is a multinational prospective observational study that enrolled participants with type 2 diabetes between December 2014 and June 2016 at the time of initiat...

DISCOVER is a 3-year observational study program of 15,983 people with type 2 diabetes initiating second-line glucose-lowering therapy in 38 countries. We investigated the association between socioeconomic status and both the availability of a baseline glycated hemoglobin (HbA1c) measurement and poor glycemic control (HbA1c level ≥ 9.0%) in partici...

Background Psychological well-being and quality of life (QoL) are important outcomes of lifestyle interventions, as a positive impact may favour long-term maintenance of behaviour change. Objective This study investigated the effect of a behavioural intervention for adopting and maintaining an active lifestyle on psychological well-being and healt...

Aims To assess changes in health-related quality of life (HRQoL) in DISCOVER, a 3-year, longitudinal, observational study of patients with type 2 diabetes initiating a second–line glucose-lowering therapy. Methods HRQoL was assessed using the physical and mental component summary (PCS and MCS) scores of the 36-item Short-Form Health Survey version...

Background HbA1c variability has emerged as risk factor for cardiovascular diseases in diabetes. However, the impact of HbA1c variability on cardiovascular diseases in subjects within the recommended HbA1c target has been relatively unexplored. Methods Using data from a large database, we studied 101,533 people with type 2 diabetes without cardiov...

Background: The key goals of management in patients with type 2 diabetes (T2D) are to prolong life and improve quality of life. Micro- and macrovascular complications of T2D not only increase the risk of morbidity and mortality, but cross-sectional studies indicate they may also worsen quality of life. We prospectively examined the association of...

Objective: In the Italian Diabetes and Exercise Study_2 (IDES_2), behavioral counseling promoted a sustained increase in physical activity (PA) volume (+3.3 MET h ⋅ week-1), moderate- to vigorous-intensity PA (MVPA) (+6.4 min ⋅ day-1), and light-intensity PA (LPA) (+0.8 h ⋅ day-1) and decrease in sedentary time (SED-time) (-0.8 h ⋅ day-1). Here, w...

Abstract OBJECTIVE In the Italian Diabetes and Exercise Study_2 (IDES_2), behavioral counseling promoted a sustained increase in physical activity (PA) volume (+3.3 MET h ⋅ week−1), moderate- to vigorous-intensity PA (MVPA) (+6.4 min ⋅ day−1), and light-intensity PA (LPA) (+0.8 h ⋅ day−1) and decrease in sedentary time (SED-time) (−0.8 h ⋅ day−1)....

Aims The European Society of Cardiology (ESC) recently defined cardiovascular risk classes for subjects with diabetes. Aim of this study was to explore the distribution of subjects with type 1 diabetes (T1D) by cardiovascular risk groups according to the ESC classification and to describe the quality indicators of care. Methods The study is based...

Aim The DISCOVER Global Registry (DGR) aims to provide insights into patient attributes and treatment patterns in patients with type 2 diabetes mellitus (T2DM) seen in clinical practice and understand the patterns and impact of treatment strategies on cardio-renal-metabolic multimorbidities. It aims to augment the real-world evidence base created b...

Background Micro- and macrovascular complications are a major cause of morbidity and mortality in people with type 2 diabetes (T2D). We sought to understand the global incidence rates and predictors of these complications. Methods We examined the incidence of vascular complications over 3 years of follow-up in the DISCOVER study—a global, observat...

Aims Clinical inertia negatively affects type 2 diabetes (T2DM) management. We evaluated changes in prescription patterns of hypoglycemic drugs during a 15 year-observation period in a large population of T2DM outpatients and their effect on metabolic control. Methods Data on all T2DM patients attending 258 Italian diabetes clinics between 2005 an...

Introduction. Gdue is a nutraceutical obtained from the association of two marine algae, Ascophyllum nodosum and Fucus vesiculosus, in addition to chromium picolinate, which could be useful for the treatment of dysglycemia, overweight, and the other components of the metabolic syndrome. The aim of the study was to assess the real-world effectivenes...

Aims Depression in type 2 diabetes may heavily affect the course of the disease. In this study, we investigated, among new cases with type 2 diabetes, the incidence and clinical predictors of depression and determined the extent to which depression constitutes a risk factor for acute and long-term diabetes complications and mortality. Methods In t...

Background There is a high incidence of cardiovascular disease in diabetes. Weight variability has been reported as independent risk factor for cardiovascular disease in the general population and preliminarily also in people with type 2 diabetes. Methods Using data from the Swedish National Diabetes Register the possible link between visit-to-vis...

Aim: To investigate factors associated with health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus (T2D) at initiation of second-line glucose-lowering therapy. Methods: DISCOVER is a 3-year, prospective observational study of patients with T2D initiating second-line glucose-lowering therapy, conducted in 38 countries. H...

Aims To assess the effects of glycated haemoglobin (HbA1c) levels at time of glucose-lowering treatment intensification in DISCOVER, a global observational study of patients with type 2 diabetes (T2D) initiating second-line therapy. Outcomes of interest were glycaemic control, hypoglycaemia, and need for further intensification during 3 years of fo...

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Second generation basal insulin (2BI) provide similar/improved efficacy with better safety compared to first generation BI. Real-world data on 2BI in patients with type 2 diabetes (T2D) are still limited. The study aimed at comparing effectiveness of 2BI (Gla-300 vs. iDeg-100) in insulin-naïve T2D. This was a retrospective, non-inferiority, multice...

Randomized clinical trials (RCT) showed benefits of FRC of basal insulin (BI) and GLP1-RAs in terms of glycemic target, no weight gain, low risk of hypoglycemia, and gastrointestinal side effects. Real-world evidence (RWE) complements RCT to assess effectiveness and safety of drugs in clinical practice. The study evaluated the impact of iGlarLixi [...

Introduction Although individualized target glycated hemoglobin (HbA 1c ) levels are recommended in older people with type 2 diabetes, studies report high levels of potential overtreatment. We aimed to investigate the proportion of older patients (aged ≥65 years) who potentially received an inappropriately intensive treatment (HbA 1c level <7.0% (5...

Aims Adults affected by obesity are at higher risk of premature mortality. Medications can help to lose weight and to maintain weight loss. Aim of this meta-analysis was to assess whether anti-obesity medications affect all-cause mortality, mortality due to cardiovascular events, cardiovascular risk factors and body weight. Data Synthesis A Medlin...

Background Familial hypercholesterolemia (FH) may arise from deleterious monogenic variants in FH‐causing genes as well as from a polygenic cause. We evaluated the relationships between monogenic FH and polygenic hypercholesterolemia in influencing the long‐term response to therapy and the risk of atherosclerosis. Methods and Results A cohort of 3...

Aims To assess the proportion of women with gestational diabetes (GDM) by performing postpartum Oral Glucose Tolerance Test (OGTT) and to identify GDM phenotypes at high-risk of postpartum dysglycemia (PPD). Methods Observational, retrospective, multicenter study involving consecutive GDM women. Recursive partitioning (RECPAM) analysis was used to...

Aims: Using data from DISCOVER, a 3-year, prospective, global observational study of patients with type 2 diabetes initiating second-line glucose-lowering therapy, we sought to explore the effects of second-line dual combinations therapies plus metformin on body weight, glycated haemoglobin (HbA1c ), health-related quality of life, and risks of hy...

We report the prevalence and change in severity of chronic kidney disease (CKD) in DISCOVER, a global, 3‐year, prospective, observational study of patients with type 2 diabetes (T2D) initiating second‐line glucose‐lowering therapy. CKD stages were defined according to estimated glomerular filtration rate (eGFR). Overall, 7843 patients from 35 count...

Background: Since 2010, more than half of World population lives in Urban Environments. Urban Diabetes has arisen as a novel nosological entity in Medicine. Urbanization leads to the accrual of a number of factors increasing the vulnerability to diabetes mellitus and related diseases. Herein we report clinical-epidemiological data of the Milano Me...

Background: It is unclear whether insulin resistance (IR) contributes to excess mortality in patients with type 2 diabetes independent of diabetic kidney disease (DKD), which is strongly associated with IR and is a major risk factor for cardiovascular disease (CVD), the main cause of death in these individuals. We tested this hypothesis in patient...

Background The European Society of Cardiology (ESC) recently defined cardiovascular risk classes for subjects with diabetes. Aim of this study was to explore the distribution of subjects with type 2 diabetes (T2D) by cardiovascular risk groups according to the ESC classification and to describe the quality indicators of care, with particular regard...

Background: There is growing evidence that digital patient-reported outcome (PRO) questionnaires and PRO-based decision support tools may help improve the active engagement of people with diabetes in self-care, thereby improving the quality of care. However, many barriers still exist for the real-world effectiveness and implementation of such PRO...

Aim: GLP-1 receptor agonists (GLP-1 RA) and SGLT-2 inhibitors (SGLT-2i) are recommended in type 2 diabetes subjects with established cardiovascular (CV) disease or at high CV risk. The efficacy and safety of GLP-1 RA and SGLT-2i compared with other anti-hyperglycemic agents (AHAs) was examined in large and unselected populations of Lombardy and Ap...

Aims: Heart failure (HF) is increasingly recognized as a major cause of morbidity and mortality in patients with type 2 diabetes (T2D), but the global epidemiology and treatment of HF in T2D are not well defined. This study aimed to examine the global prevalence of HF and the incidence of HF over 3 years of follow-up in patients with T2D [by prese...

Abstract Background Atherogenic dyslipidaemia has been implicated in the residual risk for cardiovascular morbidity and mortality, which remains despite attainment of LDL cholesterol goals especially in individuals with type 2 diabetes. However, its relationship with all-cause death has not been sufficiently explored. This analysis evaluated the in...

IntroductionFollowing pivotal trials, real-world evidence is important to assess the impact of new drugs in everyday clinical practice. The RESTORE-1 study aimed to compare effectiveness and safety of the second-generation basal insulins (2BI), i.e., insulin glargine 300 U/ml (Gla-300) vs. degludec 100 U/ml (IDeg-100), in type 1 diabetes (T1D).Meth...

Background Increased LDL cholesterol is a major risk factor for morbidity and mortality from cardiovascular disease, though this association is attenuated by the widespread use of statins. Moreover, despite attainment of LDL cholesterol goals, a residual cardiovascular risk remains, partly attributed to atherogenic dyslipidaemia, the relationship o...

Background. Atherogenic dyslipidaemia has been implicated in the residual risk for cardiovascular morbidity and mortality, which remains despite attainment of LDL cholesterol goals especially in individuals with type 2 diabetes. However, its relationship with all-cause death has not been sufficiently explored. This analysis evaluated the independen...

Objectives We evaluated how the Severe Acute Respiratory disease from Coronavirus 2 (SARS‐CoV‐2) epidemic impacted transfusion services, transfusion support required by Covid‐19 patients and their clinical outcome. Background In Italy, the first confirmed case of SARS‐CoV‐2 infection was registered on 21 February 2020. As of 20 April, about 250 00...

Background In patients with type 2 diabetes (T2D), optimal management of cardiovascular (CV) risk factors is critical for primary prevention of CV disease. Purpose To describe the association of country income and patient socioeconomic factors with risk factor control in patients with T2D. Methods DISCOVER is a 37-country, prospective, observatio...

Background Glucose variability has been associated with cardiovascular outcomes in type 2 diabetes, however, the interplay between glucose variability, empagliflozin and cardiovascular death has not been explored. In the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of cardiovascular death by 38%. We explore post-hoc the association betwee...

Background: GLP-1 receptor agonists (G LP-1 RA) and SGLT-2 inhibitors (SGLT-2i) are recommended in type 2 diabetes subjects with established cardiovascular (CV) disease or at high CV risk. The efficacy and safety of GLP-1 RA and SGLT-2i compared with other anti-hyperglycemic agents (AHAs) was examined in large unselected populations of Lombardy and...

Type 2 diabetes (T2DM) is a disease with heterogenous phenotypic manifestations.¹ Distinct subgroups, each with salient metabolic characteristics, risk of complications, and response to treatments, have been identified.²,³ An accurate phenotyping could improve outcome prediction and prevention strategies. However, which phenotyping parameters may e...

Issue The world is rapidly urbanizing, causing alarming health problems to their citizens. The Cities Changing Diabetes program aims to address the social factors and cultural determinants that can increase type 2 diabetes vulnerability among people living in cities. Rome joined the program in 2017, and a series of initiatives was launched with the...

IntroductionPrimary aim was to provide real-world evidence of the outcomes after the switch to glargine 300 U/ml (Gla-300) from other basal insulins (first or second generation) in Italy.Methods Multicenter, observational, retrospective study based on electronic medical records.ResultsOverall, 953 T2DM insulin ± OAD treated people switched to Gla-3...

Objectives To evaluate the extent to which patients with type 2 diabetes discontinue metformin therapy when initiating second-line treatment and factors associated with metformin discontinuation, using baseline data from the DISCOVER study programme. Design DISCOVER is a 3-year, prospective, observational study programme including data from 38 cou...

Background: Glucose variability has been associated with cardiovascular (CV) outcomes in type 2 diabetes, however, the interplay between glucose variability, empagliflozin and CV death has not been explored. In the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of CV death by 38%. We explore post-hoc the association between HbA1c variabilit...

Background: Glucose variability has been associated with cardiovascular outcomes in type 2 diabetes, however, the interplay between glucose variability, empagliflozin and cardiovascular death has not been explored. In the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of cardiovascular death by 38%. We explore post-hoc the association betwe...

The prediction of the risk profile related to the cardiopathy complication is a core research task that could support clinical decision making. However, the design and implementation of a clinical decision support system based on Electronic Health Record (EHR) temporal data comprise of several challenges. Several single task learning approaches con...

Introduction In addition to favoring renal disease progression, renal ‘hyperfiltration’ has been associated with an increased risk of death, though it is unclear whether and how excess mortality is related to increased renal function. We investigated whether renal hyperfiltration is an independent predictor of death in patients with type 2 diabetes...

Background: Symptom relief, prolonging survival and avoiding complications are key goals in treating type 2 diabetes (T2D), but health-related quality of life (HRQoL) may be as or more important to patients. We used DISCOVER, a global observational study of people with T2D initiating a second-line glucose-lowering therapy, to examine factors associ...

Background: We used DISCOVER, a 3-year observational study of people with T2D, to assess the effects of second-line metformin combination therapies on weight, HbA1c level and risk of hypoglycemia. Methods: Adjusted changes from baseline in weight and HbA1c level at 6, 12, 24 and 36 months were assessed using linear mixed models. An interval censore...

Background: Hepatitis B immunoglobulin (HBIG) therapy is available in intravenous (IV) or intra-muscular (IM) formulations. Recently, a subcutaneous (SC) formulation was introduced. This study evaluated changes in quality of life when liver transplant (LT) recipients were switched from IV or IM HBIG to the SC formulation. Methods: This multicent...