The Integrated Multidisciplinary Pathway for Large-Scale Management of Dyslipidemia in High-Risk Patients (ENNA) Project: Rationale and Project Design.

Atherosclerotic cardiovascular disease is a leading cause of morbidity and mortality globally, significantly influenced by modifiable risk factors, particularly hypercholesterolemia. Despite the availability of effective lipid-reducing drugs, achieving the low-density lipoprotein cholesterol (LDL-C) target levels remains a significant challenge in clinical practice, contributing to persistently high rates of cardiovascular events. The intEgrated multidiscipliNary pathway for large-scale maNagement of dyslipidemiA in high-risk patients (ENNA) Project was designed to address the alarming rates of suboptimal lipid management in patients at great and very great risk in the province of Enna, Sicily.

Real-World Data Analysis of Patients Affected by Immune-Mediated Thrombotic Thrombocytopenic Purpura in Italy.

The therapeutic management of immune-mediated thrombotic thrombocytopenic purpura (iTTP) has recently benefited from the introduction of caplacizumab, an agent directed at the inhibition of platelet aggregation. This real-world analysis investigated the epidemiology and the demographic and clinical characteristics of iTTP patients in Italy before and after caplacizumab introduction in 2020. Hospitalized adults with iTTP were included using the administrative databases of healthcare entities covering 17 million residents.

Estimation of patients affected by inflammatory bowel disease potentially eligible for biological treatment in a real-world setting.

Background/aims: This analysis estimated the number of inflammatory bowel disease (IBD) patients presenting criteria of eligibility for biological therapies in an Italian real-world setting.

Methods: An observational analysis was performed on administrative databases of a sample of Local Health Units, covering 11.3% of the national population.

Healthcare resource utilization and costs of nonalcoholic steatohepatitis patients with advanced liver disease in Italy.

Background And Aims: Nonalcoholic steatohepatitis (NASH) may progress to advanced liver disease (AdvLD). This study characterized comorbidities, healthcare resource utilization (HCRU) and associated costs among hospitalized patients with AdvLD due to NASH in Italy.

Methods And Results: Adult nonalcoholic fatty liver disease (NAFLD)/NASH patients from 2011 to 2017 were identified from administrative databases of Italian local health units using ICD-9-CM codes.

Insulin Glargine U100 Utilization in Patients with Type 2 Diabetes in an Italian Real-World Setting: A Retrospective Study.

Background: This study is aimed at estimating the proportion of type 2 diabetes mellitus (T2DM) patients treated with basal insulin (insulin glargine U100) and at evaluating daily insulin dose, treatment pattern, and adherence to treatment of these patients.

Methods: Data from administrative and laboratory databases of 3 Italian Local Health Units were retrospectively collected and analyzed. All patients with a diagnosis of T2DM between 01/01/2012 and 31/12/2012 were considered, and those with at least a prescription of insulin glargine between 01/01/2013 and 31/12/2014 were included and followed up for one year.

[Pharmaco-utilization and outcomes in patients treated with oral anticoagulants from 2014 to 2015: evidences from administrative databases of the Romagna Local Health Unit].

Background: The present study aimed at describing (i) the characteristics of non-valvular atrial fibrillation (NVAF) patients newly treated with oral anticoagulants (vitamin K antagonists [VKA] or new oral anticoagulants [NOAC]), and (ii) their persistence to treatment assigned, clinical outcomes (bleeding and thromboembolic events) and mortality.

Methods: This study was conducted using administrative databases of an Italian Local Health Unit. All adult patients (aged ≥18 years) with NVAF and naïve to VKA (warfarin) or NOAC (rivaroxaban, apixaban, dabigatran) were included between January 1, 2014 and June 30, 2015.

Use of antiosteoporotic drugs and calcium/vitamin D in patients with fragility fractures: impact on re-fracture and mortality risk.

Purpose: To evaluate the impact of pharmacological treatment in osteoporosis patients with recent fracture and to assess the incidence of subsequent fracture and all-cause mortality.

Methods: This observational retrospective study was based on data from administrative databases of five Italian Local Health Units. Osteoporosis patients aged ≥ 50 years with hospitalization for vertebral or hip fracture occurring between 01/01/2011 and 31/12/2015 were included.

Patient characteristics and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban or vitamin K antagonists: real-world evidence from Italian administrative databases.

Aim: This study aimed to evaluate the risk of major bleeding among two cohorts of nonvalvular atrial fibrillation patients newly initiating a vitamin K antagonist (VKA) or apixaban in a real-world setting in Italy.

Patients & Methods: A retrospective study using a large administrative database of Italian local health units was performed, using data from ten local health units and patients were included from the date of new initiation of apixaban or VKAs from January 2012 to June 2015.

Results: Risk of major bleeding was calculated using an adjusted Cox regression model.

Intraclass differences in the risk of hospitalization for heart failure among patients with type 2 diabetes initiating a dipeptidyl peptidase-4 inhibitor or a sulphonylurea: Results from the OsMed Health-DB registry.

Aims: To re-analyse data from a previous retrospective study on 127 555 patients, in which we showed that dipeptidyl peptidase-4 (DPP-4) inhibitor therapy was associated with a lower risk of hospitalization for HF (HHF) than sulphonylurea (SU) therapy, in order to evaluate intraclass differences among DPP-4 inhibitors and SUs.

Methods: We included patients with type 2 diabetes (T2D) initiating DPP-4 inhibitor or SU therapy, alone or in combination with metformin. Patients undergoing intraclass switch, those with a previous HHF, those receiving insulin treatment, and those with <6 months observation were excluded.

Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimilars.

Aim: The purpose of this study was to assess the prescription of epoetins and consumption of health care resources (in terms of drug treatments) in naïve patients with hematological malignancies in a real-world setting; in particular, we compared the results between reference product and biosimilar products.

Methods: An observational retrospective study based on administrative and laboratory databases of three local health units was conducted. All adults diagnosed with hematological malignancies and who had received at least one epoetin (either reference product or biosimilars) prescription for the first time between 1 January 2010 and 30 April 2012 (enrollment period) were included.

Risk of hospitalization for heart failure in patients with type 2 diabetes newly treated with DPP-4 inhibitors or other oral glucose-lowering medications: a retrospective registry study on 127,555 patients from the Nationwide OsMed Health-DB Database.

Aims: Oral glucose-lowering medications are associated with excess risk of heart failure (HF). Given the absence of comparative data among drug classes, we performed a retrospective study in 32 Health Services of 16 Italian regions accounting for a population of 18 million individuals, to assess the association between HF risk and use of sulphonylureas, DPP-4i, and glitazones.

Methods And Results: We extracted data on patients with type 2 diabetes who initiated treatment with DPP-4i, thiazolidinediones, or sulphonylureas alone or in combination with metformin during an accrual time of 2 years.

Clinical outcomes and health care costs combining metformin with sitagliptin or sulphonylureas or thiazolidinediones in uncontrolled type 2 diabetes patients.

Objectives: TO COMPARE CLINICAL OUTCOMES AND HEALTH CARE COSTS ACROSS THREE COHORTS OF UNCONTROLLED DIABETIC PATIENTS WHO INITIATED TREATMENT WITH ONE OF THE FOLLOWING: sulphonylureas (SU), thiazolidinediones (TZD) or sitagliptin (SITA).

Materials And Methods: We performed a retrospective study based on a linkage between administrative and laboratory databases maintained by three Italian local health units. The index period ranged from July 2008-June 2010.

Drug adherence to olmesartan/amlodipine fixed combination in an Italian clinical practice setting.

Objective: To investigate the criteria for prescribing a combination pill for hypertensive patients, and whether the combination pill improves medication adherence.

Materials And Methods: This was a retrospective cohort study, performed in three Italian local health units. We selected all adult subjects who received at least one prescription of antihypertensive drugs between September 1, 2011 and December 31, 2011 (the enrollment period).

Rate of control of LDL cholesterol and incident hypertension requiring antihypertensive treatment in hypercholesterolemic subjects in daily clinical practice.

Introduction: Preliminary evidence suggests that hypercholesterolemia is associated to an increased risk to develop hypertension. We aimed at evaluating the association between low-density lipoprotein cholesterol (LDL-C) level and incidence of new onset of hypertension in a large population sample.

Materials And Methods: A population-based cohort of 20,074 subjects with at least one LDL-C measurement between July 2006 and June 2007 and free of antihypertensive treatment (AHT) at baseline was followed from the LDL-C date until death or 31 December 2009.

Glycemic control and diabetes-related health care costs in type 2 diabetes; retrospective analysis based on clinical and administrative databases.

Background: Diabetes is one of the most prevalent chronic diseases, and its prevalence is predicted to increase in the next two decades. Diabetes imposes a staggering financial burden on the health care system, so information about the costs and experiences of collecting and reporting quality measures of data is vital for practices deciding whether to adopt quality improvements or monitor existing initiatives. The aim of this study was to quantify the association between health care costs and level of glycemic control in patients with type 2 diabetes using clinical and administrative databases.

Adherence to statin treatment and health outcomes in an Italian cohort of newly treated patients: results from an administrative database analysis.

Background: Adherence to statin treatment is expected to be associated with health outcomes. Much of the available evidence is derived from studies conducted on selected populations (eg, Medicaid population), on specific cohorts of patients (eg, patients with diabetes mellitus or those who have experienced acute myocardial infarction [AMI]), or with respect to a single outcome (eg, only death or only AMI).

Objective: The aim of this study was to evaluate the association between adherence to statin therapy and all-cause mortality and cardiovascular morbidity (AMI and stroke) in an unselected cohort of newly treated patients.

Adherence to antihypertensive medications and health outcomes among newly treated hypertensive patients.

Objective: To evaluate adherence to antihypertensive therapy (AHT) and the association between adherence to AHT, all-cause mortality, and cardiovascular (CV) morbidity in a large cohort of patients newly treated with antihypertensives in a clinical practice setting.

Methods: An administrative database kept by the Local Health Unit of Florence (Italy) listing patient baseline characteristics, drug prescription, and hospital admission information was used to perform a population-based retrospective study including patients newly treated with antihypertensives, ≥18 years of age, with a first prescription between January 1, 2004 and December 31, 2006. Patients using antihypertensives for secondary prevention of CV disease, occasional spot users, and patients with early CV events, were excluded from the study cohort.

Awareness of albuminuria in an Italian population-based cohort of patients treated with hypoglycemic drugs.

Background: Albuminuria is a powerful predictor of renal and cardiovascular outcomes in type 2 diabetes and a good indicator of the evolution of renal disease. Our aim was to obtain information concerning the identification of albuminuria as well as the utilization of antihypertensive, lipid-lowering and antiplatelet drugs in patients with diabetes.

Methods: Subjects were enrolled from individuals registered with 3 Italian local health units by querying the drugs reimbursable, hospital laboratory investigation and hospital discharge databases.

Antihypertensive therapy among newly treated patients: An analysis of adherence and cost of treatment over years.

Objective: To perform a time-trend analysis of adherence and cost of antihypertensive treatment over four years.

Methods: A population-based retrospective cohort study was conducted. We included subjects ≥18 years, and newly treated for hypertension with diuretics, beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers between 01 January 2004 and 31 December 2007.

Cost offset of lipid-lowering drugs for primary and secondary prevention of cardiovascular disease.

This review aims to perform an adherence-based pharmacoeconomic evaluation of patients receiving statin therapy. A population-based study was performed. All patients receiving statins between January 1996 and December 1999 were included in the study.

Effects of introducing a clinical guideline on the cost of treating dyspeptic syndrome.

This review highlights the effects incurred on pharmacoutilization and the total expenses for dyspeptic syndrome by the introduction of a clinical guideline. A retrospective method of reading an administrative billing database in the Ravenna (Italy) local health unit was performed for all subjects who were health-assisted by ten general practitioners. They had previously developed and agreed to a clinical guideline to manage dyspeptic syndrome patients (study group) and a group of 30 self-regulating general practitioners patients (control group).

Pharmacoutilization of statin therapy after acute myocardial infarction. A real practice analysis based on administrative data.

Background: Despite randomized and controlled trials indicating continuous treatment with statin therapy as a factor in reducing morbidity and mortality after acute myocardial infarction, records reveal a high percentage of patients at risk who are either not receiving treatment or being treated inadequately.

Methods: An administrative database kept by the Local Health Unit of Ravenna and listing patient baseline characteristics, drug prescriptions and hospital admissions was used to perform: 1) an analysis of patients discharged alive from hospital each year between 1996 and 2000 with a diagnosis of acute myocardial infarction, and 2) a retrospective cohort study of drug utilization, and particularly the use of statins, year by year. All prescriptions for statins filled in the 6 months after hospital discharge were considered and used to classify patients in terms of their exposure to statin therapy and of their pharmacoutilization.

Pharmacoeconomics of antihypertensive drug treatment: an analysis of how long patients remain on various antihypertensive therapies.

The objective of the research was to perform a clinical practice-based analysis of how long patients remain on various antihypertensive drugs. An administrative database listing of patient baseline characteristics, drug prescriptions, and hospital admissions was used. All new users of antihypertensive drugs, > or =20 years of age, receiving a first prescription for diuretics, beta blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor antagonists between January 1, 2000, and December 31, 2000, were included and observed for 365 days.

Bayesian cost-effectiveness analysis based on the persistence with antihypertensive treatment.

An observational study was performed to compare five compounds as initial therapy to evaluate the persistence with antihypertensive treatment and drug cost. Over a 1-year follow-up period on the entire population (approximately 360,000 residents) of the Ravenna Local Health Unit. The presence of five major antihypertensive agents between January 1st, and December 31st, 1997 was investigated.

A retrospective, population-based analysis of persistence with antihypertensive drug therapy in primary care practice in Italy.

Background: Many hypertensive patients discontinue drug therapy despite the increased cardiovascular risk associated with inadequately controlled hypertension. However, most experiments do not address this premature discontinuation of therapy, making it difficult to project the appropriateness of antihypertensive drugs in real-world use.

Objective: The goal of this study was to assess patients' persistence with antihypertensive drug therapy in a nonexperimental setting.