Maria Carla Roncaglioni

• MS
• Mario Negri Institute for Pharmacological Research

Peripheral artery disease (PAD) remains underdiagnosed in patients with coronary artery disease (CAD) and barriers persist to measure screening PAD in routine clinical practice. We assessed the prevalence of PAD in patients with CAD in Italian primary care setting using an easy automatic instrument to measure ankle brachial pressure index (ABI). A...

Objectives Current data on arterial and venous thrombotic events (ATE & VTE) and cardiovascular (CV) risk management in European systemic lupus erythematosus (SLE) population are limited. This study aimed to investigate the incidence and risk of thrombotic events and all-cause death in an Italian SLE cohort over the past decade, along with its phar...

The unfavorable effect of proton pump inhibitors (PPIs) on cardiovascular (CV) outcomes and mortality was reported in the general population. We investigated the impact of PPIs on CV outcomes and total mortality in older people with diabetes mellitus (DM) for whom evidence is missing. Using administrative health databases of the Lombardy Region, we...

Background Despite all the progress in the management of acute COVID-19, it is still not clear why some people continue to experience symptoms after recovery. Using data from a self-administered online survey, we assessed the prevalence and predictors of post-acute COVID-19 in an unselected population followed by GPs. Methods Patients ≥18 years wi...

Background COVID-19 has been associated with a higher risk of post-acute complications. Our aim was to analyze and compare post-acute cardiovascular complications of COVID-19 survivors of the first and second/third pandemic waves in Lombardy, in both hospitalized and non-hospitalized COVID-19 patients. Methods and results We included adults aged ≥...

Ursodeoxycholic acid (UDCA), an off‐patent drug used to treat liver disease, is able to block SARS‐CoV‐2 entry into the cells downregulating ACE2 expression, a promising strategy to protect against infection. In this light, John et al. have recently demonstrated that in patients with cirrhosis, UDCA exposure was associated with both a decrease in S...

Introduction Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking. Methods and anal...

Background: Cardiovascular (CV) disease is preventable through interventions targeting modifiable factors. Most algorithms based on modifiable CV risk factors (CV-rf) have been developed in US populations and do not account for the role of diet. We aimed to assess an algorithm based on modifiable CV-rf including diet, using data from an Italian po...

Aims: To describe glucose-lowering drugs prescribing pattern in a large population of older diabetics from 2010 to 2021. Methods: Using linkable administrative health databases, we included patients aged 65-90 years treated with glucose-lowering drugs. Prevalence rate of drugs was collected within each study year. A stratified analysis by gender...

Introduction: Cardiovascular (CV) disease, the leading cause of death globally, is largely preventable through targeting modifiable risk factors. Scores of modifiable CV risk factors able to collect the combined effect of all the included components were mainly developed in US populations, or do not include nutritional aspects. Hypothesis: We asses...

Background Glucagon-like peptide-1 receptor agonists (GLP-1 RA) and sodium glucose cotransporter-2 inhibitors (SGLT-2i) demonstrated cardiovascular and renal protection. Whether their benefits occur also during hospitalization for acute myocardial infarction (AMI) in patients with diabetes mellitus (DM) is not known. We evaluated in-hospital outcom...

Background Diabetes mellitus (DM) is associated with an increased mortality risk in patients hospitalized with acute myocardial infarction (AMI); however, no studies have investigated the impact of the duration of DM on in-hospital mortality. In this study, we evaluated in-hospital mortality in AMI patients according to DM status and its duration....

Background Diabetes is a major public health issue. Because lifetime risk, life expectancy, and years of life lost are meaningful metrics for clinical decision making, we aimed to estimate these measures for type 2 diabetes in the high-income setting. Methods For this multinational, population-based study, we sourced data from 24 databases for 23...

Background: A polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting-enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction. Methods: In this phase 3, randomized, controlled clin...

Abstract Background GLP-1 receptor agonists (GLP-1 RA) and SGLT-2 inhibitors (SGLT-2i) have shown to reduce the risk of major adverse cardiovascular events (MACE), death and worsening nephropathy when added to standard of care. However, these two dug classes differ in efficacy and safety. We compared the effectiveness and safety profile of GLP-1 RA...

Background Coexistent heart failure (HF) and diabetes mellitus (DM) are associated with marked morbidity and mortality. Optimizing treatment strategies can reduce the number and severity of events. Insulin is frequently used in these patients, but its benefit/risk ratio is still not clear, particularly since new antidiabetic drugs that reduce major...

Background Population-level trends in mortality among people with diabetes are inadequately described. We aimed to examine the magnitude and trends in excess all-cause mortality in people with diabetes. Methods In this retrospective, multicountry analysis, we collected aggregate data from 19 data sources in 16 high-income countries or jurisdiction...

Aims: We compared the association of metformin use and COVID-19 outcomes in a cohort of 31 966 patients with diabetes in Lombardy. Methods: We used a COVID-19 linkable administrative regional database to select diabetic patients over 40 years old. They had at least two prescriptions of antidiabetic drugs in 2019 and a positive test for SARS-CoV-...

High concentrations of ivermectin demonstrated antiviral activity against SARS-CoV-2 in vitro. Aim of this study was to assess safety and efficacy of high-dose ivermectin in reducing viral load in individuals with early SARS-CoV-2 infection. Randomised, double-blind, multicentre, phase II, dose-finding, proof-of-concept clinical trial. Participants...

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...

Background Diabetes prevalence is increasing in most places in the world, but prevalence is affected by both risk of developing diabetes and survival of those with diabetes. Diabetes incidence is a better metric to understand the trends in population risk of diabetes. Using a multicountry analysis, we aimed to ascertain whether the incidence of cli...

Although rheumatoid arthritis (RA) is associated with an increased risk of death and cardiovascular (CV) disease, the excess of these risks is expected to have diminished over time, in more recent incident cohorts with RA. We analysed the risk of all-cause death, stroke, and myocardial infarction as primary outcomes and all CV events as secondary o...

Aims Data on the impact of liver disease (LD) in patients with atrial fibrillation (AF) and the role of oral anticoagulant (OAC) drugs for stroke prevention, are limited. We analysed the impact of LD and OAC treatment in determining stroke, major bleeding, all-cause death and secondary bleeding outcomes. Methods A retrospective observational popul...

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...

Aim: Insulin is the preferred treatment for the control of diabetes in hospital, but it raises the risk of hypoglycaemia, because oral intake of carbohydrates in hospitalized persons is often lower than planned. Our aim was to assess the effect on the incidence of hypoglycaemia of giving prandial insulin immediately after a meal depending on the a...

Aims: Data on the impact of liver disease (LD) in patients with atrial fibrillation (AF) and the role of oral anticoagulant (OAC) drugs for stroke prevention, are limited. Methods: A retrospective observational population-based cohort study on the administrative health databases of Lombardy region Italy. All AF patients ≥40 years admitted to hos...

Background: In contrast with the abundance of global epidemiological descriptive data on cardiovascular diseases and their risk factors, information on the outcomes of real populations prospectively followed up in their life and care settings is much rarer, especially in low-income countries. Objectives: This study sought to evaluate the feasibi...

Objectives: To analyze the relationship between atrial fibrillation (AF) and Charlson comorbidity index (CCI) in a population-based cohort study over a long-term follow-up period, in relation to oral anticoagulant (OAC) prescriptions and outcomes. Patients and methods: We used data from the administrative health databases of Lombardy. All patien...

To analyze sex-related differences about AF prevalence, use of OAC and outcomes focusing on the older age classes. We used administrative data of the Lombardy Region, describing period prevalence, use of OAC and outcomes from 2002 to 2014 for all patients diagnosed with AF. AF prevalence over the 2002–2014 period was higher in males than in females...

Background: The clinical benefit of aspirin for the primary prevention of cardiovascular disease (CVD) in diabetes remains uncertain. To evaluate the efficacy and safety of aspirin for the primary prevention of cardiovascular outcomes and all-cause mortality events in people with diabetes, we conducted an updated meta-analysis of published randomi...

Background: Atrial fibrillation (AF) is the most commonly diagnosed arrhythmia, which is associated with an increased risk of stroke. Several studies have suggested that female AF patients could have a greater risk for stroke and thromboembolic events (TE). Methods: A systematic literature review update and meta-analysis was conducted using Pubm...

Background: A one-dose-fits-all approach to use of aspirin has yielded only modest benefits in long-term prevention of cardiovascular events, possibly due to underdosing in patients of large body size and excess dosing in patients of small body size, which might also affect other outcomes. Methods: Using individual patient data, we analysed the...

Background The aim of our study was to evaluate whether treatments for peripheral artery disease changed in two different cohorts identified in 2002 and 2008, and whether this had an impact on mortality and major clinical outcomes after six years of follow-up. Methods Using administrative health databases of the largest region in Northern Italy, w...

Aims: To describe the prevalence and management of diabetes among immigrants according to ethnic group and duration of stay, compared to Italian citizens. Methods: Diabetic immigrant and Italian residents aged 20-69 years in the administrative database of the Lombardy Region. Immigrants were classified by region of origin and as long-term reside...

Aims: To evaluate the association between diabetes mellitus (DM) and risk of seizures in a well-defined elderly population. Methods: The administrative databases of the Lombardy region (a 10 million population area in Northern Italy) were used to identify persons aged 65 years or older with DM (defined by prescription of antidiabetic drugs and/o...

Aims To assess the pattern of use of Emergency Departments (EDs), factors contributing to the visits, geographical distribution and outcomes in people aged 65 years or more living in the Italian Lombardy Region in 2012. Methods Based on an administrative database the study population was divided into groups according to the number of ED visits. A m...

AimsTo verify whether it is possible, in people with diabetes mellitus (DM) considered at very high cardiovascular (CV) risk, stratify this risk better and identify significant modifiable risk factor (including lifestyle habits) to help patients and clinicians improve CV prevention. Methods People with DM and microvascular diseases or one or more C...

Background and aims: In contrast to the well-documented global prevalence of diabetes, much less is known about the epidemiology of cardiovascular (CV) complications in recent years. We describe the incidence of major CV events, deaths and drug prescribing patterns from 2002 to 2012 in subjects with (DM) or without diabetes mellitus (No DM). Meth...

Background: Previous studies have stated that atrial fibrillation (AF) is associated with a higher risk of dementia. However, none have examined the competition between death and incident dementia in patients with AF. We evaluated the risk of incident dementia in patients with AF in comparison to people without this arrhythmia, considering of the...

Aims: Heart failure (HF) and chronic obstructive pulmonary disease (COPD) frequently co-exist, and each is a major public health issue. In a large cohort of hospitalized HF patients, we evaluated: (i) the impact of COPD on clinical outcomes; (ii) whether outcomes and treatments changed from 2002 to 2009; and (iii) the relationship between outcomes...

Background: Although high cardiovascular risk patients should be the main target of preventive strategies, modifiable risk factors are often inadequately controlled. Aim: To assess feasibility and results of a comprehensive personalized method for cardiovascular prevention in high risk patients followed by their general practitioner. Methods:...

To assess the prevalence, risk and management of hyperglycemia in patients with acute coronary syndrome (ACS). Design: a multicenter prospective observational study of a representative sample of patients with ACS consecutively admitted to intensive cardiac care units (ICCU). 31 out of 61 ICCUs in Lombardy, the most heavily populated Italian region....

Diabetes mellitus (DM) and atrial fibrillation (AF) are worldwide public health challenges and major causes of death and cardiovascular events. The association between DM and AF is controversial in literature and data on outcomes of individuals with both diseases have not been evaluated in population studies. We tested the hypothesis that DM is ind...

To describe the incidence of ischemic stroke, short-term mortality, recurrences, and prescription patterns. Data from administrative health databases of the Lombardy Region from 2002 to 2010 (about 4 million people) were analyzed for stroke incidence and recurrence, mortality, and drug prescriptions after an ischemic stroke. A total of 43,352 patie...

Background. Hypoglycemia due to inadequate carbohydrate intake is a frequent complication of insulin treatment of diabetic in-patients. Objective. To assess the effectiveness of a nurse-managed protocol to prevent hypoglycemia during subcutaneous insulin treatment. Design. Prospective pre-post-intervention study. Methods. In 350 consecutive diabet...

To assess the effectiveness, safety and feasibility of the revised, simplified nurse-managed version of our insulin infusion protocol, adapted to the new recommended glycaemic target of 140 to 180 mg/dL (Desio Diabetes Diagram i.v. 140-180). All clinical responses to the Desio Diabetes Diagram i.v. 140-180 in use for 3 years were recorded in patien...

To compare the utilization of health care resources (drug prescriptions, hospital admissions and health care services) by immigrant versus native elderly people (65 years or more), by using administrative database of the Lombardy Region. For each immigrant (an older people born out of Italy), one person born in Lombardy (native) was randomly select...

PREVALENCE AND DETERMINANTS OF DIABETES MELLITUS IN A REPRESENTATIVE SAMPLE OF ITALIAN ADULTSBackground: Diabetes mellitus is a dramatic epidemic worldwide. This study providea an updated estimate of itsprevalence and determinants among Italian adults.Methods: Data were derived from a face-to-face survey conducted in 2013 on 2901 individuals (1391...

Adherence to evidence-based cardiovascular (CV) medications after an acute myocardial infarction (AMI) is low after the first 6 months. The use of fixed-dose combinations (FDC) has been shown to improve treatment adherence and risk factor control. However, no previous randomized trial has analyzed the impact of an FDC strategy on adherence in post-...

To describe prescribing patterns in elderly Italian diabetic patients of the Lombardy Region in 2000 and 2010 using an administrative database. Hospital admissions and mortality were also recorded and compared in the two index years. Analyses were performed on the whole cohort of elderly diabetic patients and across age groups. Direct age standardi...

Background: The impact of diabetes on cardiovascular disease in both sexes is known, but the specifics have not been fully clarified. We investigated whether sex-related differences exist in terms of management and hospitalization in patients with newly diagnosed diabetes. Methods: We examined the rates of hospitalization for cardiovascular caus...

To investigate the incidence of major cardiovascular complications and mortality in the first years of follow-up in patients with newly diagnosed diabetes. We examined incidence rates of hospitalization for cardiovascular reasons and death among new patients with diabetes using the administrative health database of the nine million inhabitants of L...

Trials have shown a beneficial effect of n-3 polyunsaturated fatty acids in patients with a previous myocardial infarction or heart failure. We evaluated the potential benefit of such therapy in patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who had not had a myocardial infarction. In this double-blind, place...

Epidemiology of diabetes and its treatment in the Lombardy Region between 2000 and 2007: administrative database figures Diabetes is constantly increasing worldwide and is one of the most burdensome and costly chronic conditions. Administrative health databases are an important tool in public health surveillance for defining the burden of diseases,...

Daily aspirin reduces the long-term risk of death due to cancer. However, the short-term effect is less certain, especially in women, effects on cancer incidence are largely unknown, and the time course of risk and benefit in primary prevention is unclear. We studied cancer deaths in all trials of daily aspirin versus control and the time course of...

In spite of advances in prevention and treatment, the burden of cardiovascular diseases is increasing. A fixed-dose combination (FDC) pill, or "polypill," composed of evidence-based drugs has been proposed as a means of improving cardiovascular prevention by reducing cost and increasing patient adherence to treatment. The aim of the FOCUS project,...

To describe trends in diagnosed diabetes prevalence, incidence and mortality from 2000 to 2007 in the most heavily populated Italian region. We examined the prevalence and incidence rates of Type 1 and Type 2 diabetes and yearly mortality rates among individuals with diabetes from 2000 to 2007 using an administrative health database of prescription...

The study objectives were 1) to assess the effectiveness and safety of a standardized protocol for the transition to subcutaneous insulin and oral feeding in diabetic or hyperglycemic patients with acute coronary syndrome (ACS) who were receiving intravenous insulin and glucose at the time of the transfer from the intensive cardiac care unit to a g...

To investigate the prescribing patterns and the prevalence of polypharmacy in community-dwelling elderly people, and to analyze the association of chronic medications and number of drug prescriptions with age and sex. All prescriptions for people aged 65 years or older reimbursed by the Italian National Health Service (NHS) and dispensed by retail...

To assess the effectiveness of a nurse-led class with phone follow-up, to help patients achieve lifestyle changes after an acute coronary syndrome (ACS). Each patient < or = 75 years, admitted to a intensive cardiac care unit (ICCU) for ACS from September 2003 to December 2004, who attended the education class (case) was matched with two patients p...

Diabetic patients with acute coronary syndromes (ACS) might benefit from tight glycemic control by means of insulin infusion. Nurse-implemented insulin infusion protocols (IIP) are available but none validated in patients with ACS admitted to a coronary care unit (CCU). To assess feasibility, effectiveness and safety of a new nurse-managed IIP (Des...

Low-dose aspirin is of definite and substantial net benefit for many people who already have occlusive vascular disease. We have assessed the benefits and risks in primary prevention. We undertook meta-analyses of serious vascular events (myocardial infarction, stroke, or vascular death) and major bleeds in six primary prevention trials (95,000 ind...

Background Low-dose aspirin is of definite and substantial net benefit for many people who already have occlusive vascular disease. We have assessed the benefits and risks in primary prevention. Methods We undertook meta-analyses of serious vascular events (myocardial infarction, stroke, or vascular death) and major bleeds in six primary prevention...

Background: Diabetic patients with acute coronary syndromes (ACS) might benefit from tight glycemic control by means of insulin infusion. Nurse-implemented insulin infusion protocols (IIP) are available but none validated in patients with ACS admitted to a coronary care unit (CCU). Aims: To assess feasibility, effectiveness and safety of a new nurs...

To explore the predictive power of a risk stratification method for people with hypertension based on "essential" procedures (that is, available in economically less developed areas of the world), comparing it in the same population with the results given by the method suggested by the 1999 World Health Organization-International Society of Hyperte...

Objectives. To evaluate the drug prescribing profiles in the paediatric and elderly populations. ▶ Methods. The prescriptions processed in 2003 by Lecco's local health unit's pharmacies (which serve 326,130 people) were analysed. ▶ Results. In all, 58% of the residents served by the group of pharmacies received at least 1 drug prescription in 2003....

To assess the pharmacological treatment and the control of major modifiable cardiovascular risk factors in everyday practice according to the patients' cardiovascular risk level. In a cross-sectional study general practitioners (GPs) had to identify a random sample of their patients with cardiovascular risk factors or diseases and collect essential...

Aspirin therapy reduces the risk of cardiovascular disease in adults who are at increased risk. However, it is unclear if women derive the same benefit as men. To determine if the benefits and risks of aspirin treatment in the primary prevention of cardiovascular disease vary by sex. MEDLINE and the Cochrane Central Register of Controlled Trials da...

To evaluate the appropriate prescription of antiplatelets according to patients' global cardiovascular risk level in everyday practice. In a cross-sectional study, general practitioners (GPs) identified a random sample of 10% of patients at cardiovascular risk among all subjects coming to the surgery and collected data on cardiovascular risk factor...

The organization and conduction of the Rischio&Prevenzione trial, the first large-scale clinical trial in general practice since the Italian ministerial decree of 10 May 2001, offers an opportunity to reconsider the monitoring of large non-hospital trials. The interpretation we have given to the current rules implies a flexible approach, to guarant...

Although risk assessment charts have been proposed to identify patients at high cardiovascular risk, in everyday practice general practitioners (GPs) often use their knowledge of the patients to estimate the risk subjectively. A cross-sectional study aimed to describe how GPs perceive, qualify and grade cardiovascular risk in everyday practice. Gen...

The limitations of the Primary Prevention Program (PPP) diabetes substudy have been previously discussed in the original article (1) and in the accompanying editorial (2). Nevertheless, the comments of Dr. de Gaetano (3) require some important additional considerations. 1 ) The results of the substudy are not the outcome of a post hoc analysis, si...

Strategies to prevent cardiovascular diseases are still not widely applied. It is vital to involve people for effective prevention, and knowledge of their own coronary risk is a first step. Little is known about how people perceive their coronary risk. For this reason, we examined this perception in a sample of the general population and compared i...

We investigated in general practice the efficacy of antiplatelets and antioxidants in primary prevention of cardiovascular events in people with type 2 diabetes. The Primary Prevention Project (PPP) is a randomized, open trial with a two-by-two factorial design aimed to investigate low-dose aspirin (100 mg/day) and vitamin E (300 mg/day) in the pre...

Background Antioxidant supplementation with vitamin E had no effect in the prevention of cardiovascular diseases (CVD) in three recent large, randomized clinical trials. In order to reassess critically the role of vitamin E in CVD prevention, it is important to establish whether these results are related to a lack of antioxidant action. Methods We...