Evaluation of biochemical and economic outcomes in patients treated with PCSK9 inhibitors in a real clinical practice setting
BACKGRO UND : PCSK9 inhibitors (PCSK9i) in combination with high-dose statins can reduce LDL -cholesterol (LDL-C) levels by 50-60% over statin monotherapy. This analysis investigated biochemical (LDL-C reduction) and economic outcomes in Italian patients treated with PCSK9i or potentially eligible but untreated.METHOD S: Administrative databases of healthcare institutions covering around 5 million residents were used… Read More »Evaluation of biochemical and economic outcomes in patients treated with PCSK9 inhibitors in a real clinical practice setting
Healthcare Costs and Treatment Patterns of Triplet Therapies in Relapsed/Refractory Multiple Myeloma: Real World Evidence from Italy
Purpose: This analysis sought to characterize patients with relapsed or refractory multiple myeloma (RRMM) on triplet therapy with immunomodulatory agents/proteasome inhibitors/monoclonal antibodies combined with dexamethasone, describing their demographic and clinical features, therapeutic pathways and the related healthcare costs for the Italian National Health Service (NHS).Patients and Methods: A retrospective observational analysis was conducted on administrative… Read More »Healthcare Costs and Treatment Patterns of Triplet Therapies in Relapsed/Refractory Multiple Myeloma: Real World Evidence from Italy
A Real-World Analysis of Patientswith Triple Class Exposed Multiple Myeloma in Italy: Epidemiology Estimates, Treatment Pattern and Economic Burden
ABSTRACTOBJECTIVES: This research aimed to provide updated epidemiological estimates of multiple myeloma (MM) in Italy andto characterize the clinical journey, treatment patterns, and economic burden focusing specifically on the subset of patientswho have been exposed to all three major therapeutic classes: proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies (triple-class exposed, TCE).METHODS: A retrospective analysis… Read More »A Real-World Analysis of Patientswith Triple Class Exposed Multiple Myeloma in Italy: Epidemiology Estimates, Treatment Pattern and Economic Burden
Evoluzione dei trattamenti per l’angioedema ereditarioin Italia: utilizzo del lanadelumab nella pratica clinica
Introduction: Hereditary angioedema (HEA) is a rare genetic disorder characterised by recurrent episodes ofedema affecting various body districts. HEA therapy includes treatment of acute attacks and short- or long-termprophylaxis.Objective: To describe the main demographic and clinical characteristics of patients with HEA in real Italian clinicalpractice, as well as the use of pharmacological treatments, the use… Read More »Evoluzione dei trattamenti per l’angioedema ereditarioin Italia: utilizzo del lanadelumab nella pratica clinica
Treatment Pathways, Drug Utilization and Healthcare Resource Consumption in Patients with Metastatic Anaplastic Lymphoma Kinase-Positive Non-small Cell Lung Cancer: A Real-World Analysis with Administrative Databases in Italy
Background: Metastatic anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) is a rare but clinically distinct subtype of lung cancer with therapeutic sensitivity to ALK inhibitors (ALKi). Over the past decade, several ALKi have been introduced in Italy, yet real-world data on their utilization, patient characteristics, outcomes, and healthcare burden remain limited. Objectives: This… Read More »Treatment Pathways, Drug Utilization and Healthcare Resource Consumption in Patients with Metastatic Anaplastic Lymphoma Kinase-Positive Non-small Cell Lung Cancer: A Real-World Analysis with Administrative Databases in Italy
Real-World Evidence on Disease Burden and Economic Impact of Paroxysmal Nocturnal Haemoglobinuria in Italy
Background/Objectives: This analysis was conducted in Italy to estimate the epidemiology of paroxysmal nocturnal hemoglobinuria (PNH) and to describe the features and economic burden of PHN in the adult population considering the role of anti-complement therapy with C5/3-inhibitors (C5/3i). Methods: Administrative databases of healthcare entities covering approximately 12 million citizens were used to estimate the prevalence and incidence of PNH. Demographics, clinical characteristics and healthcare costs were analyzed among adults with PHN stratified by the presence/absence of C5/3i therapy. Results: The prevalence in Dec-2021 of PNH in adults was 17.6/1,000,000 people, and the incidence rate in the period 2011–2022 was 1.5/1,000,000/year. In 142 patients with at least 12 months of data available before and after inclusion (mean age: 50.7 years; 45.8% males), 27% received C5/3i therapy. The main baseline comorbidities were aplastic anemia and other bone marrow failure syndromes, found in 10.6% of patients and more common in C5/3i-treated than untreated patients (18.4% vs. 7.7%). Cost analysis showed that the average cost per patient per year (PPPY) was EUR 41,084, mainly driven by drug expenses (87% of total costs), especially anti-complement therapy (80%). RBC transfusions were the most impactive item among the hospitalization costs (EUR 1982 of EUR 4284 PPPY). The C5/3i-treated cohort was associated with higher total costs (EUR 133,472 vs. EUR 8089, p < 0.001), mainly due to drug expenses (EUR 127,180 vs. EUR 3217, p < 0.001). Conclusions: This real-world analysis confirmed a rising PNH prevalence in Italy, aligning with global data. Despite available therapies, many patients face a high disease burden, suggesting potential benefits from novel treatments targeting upstream complement components.
The role of sodium zirconium cyclosilicate drug utilization in managing hyperkalemia: impact on healthcare resource utilization and on maintenance of renin-angiotensin-aldosterone system inhibitor therapy in Italian clinical practice
Aims Hyperkalemia (HK) is prevalent in patients with chronic kidney disease (CKD) and heart failure, particularly those on renin-angiotensin-aldosterone system inhibitors (RAASi). However, HK treatment often necessitates RAASi discontinuation. Sodium zirconium cyclosilicate (SZC), reimbursed in Italy since 2021, offers a new treatment option for HK. This study aimed to assess real-world SZC use and resulting… Read More »The role of sodium zirconium cyclosilicate drug utilization in managing hyperkalemia: impact on healthcare resource utilization and on maintenance of renin-angiotensin-aldosterone system inhibitor therapy in Italian clinical practice
The Integrated Multidisciplinary Pathway for Large-Scale Management of Dyslipidemia in High-Risk Patients (ENNA) Project: Rationale and Project Design
Atherosclerotic cardiovasculardiseaseisaleadingcauseofmorbidityandmortalityglobally,significantlyinfluenced bymodifiable riskfactors,particularlyhypercholesterolemia.Despitetheavailabilityofeffectivelipid-reducing drugs,achievingthelow-densitylipoproteincholesterol(LDL-C)targetlevelsremainsasignif-icant challengeinclinicalpractice,contributingtopersistentlyhighratesofcardiovascularevents.TheintE-grated multidiscipliNarypathwayforlarge-scalemaNagementofdyslipidemiAinhigh-riskpatients(ENNA)Project wasdesignedtoaddressthealarmingratesofsuboptimallipidmanagementinpatientsathighandvery-high riskintheprovinceofEnna,Sicily.ThisprogramaimstooptimizeLDL-Ccontrolthroughaninte-grated caremodelthatfosterscollaborationamongpharmacists,generalpractitioners,andcardiologists,ulti-mately promotingapatient-centeredapproachtotherapy.Thepatientswhoareeligibleareidentified usingdata-driven methodsthroughprescriptionclaims,laboratoryresults,andhospitaldischargedata,facilitatedby localpharmacies.Generalpractitionersplayacrucialroleastheprimarycareprovidersforinitiatingoroptimizing lipid-reducingtherapy,whereascardiologistsareinvolvedinmanagingmorecomplexcasesrequiring specializedintervention.TheprimaryobjectiveoftheENNAProjectistoincreasethepercentageofpatients atgreatriskinwhomLDL-Ctargetsareachieved,improvingoveralllipidmanagementandthera-peutic adherence.
A Real-World Analysis of the Population with Hepatitis C Virus Infection Affected by Type 2 Diabetes in Italy: Patients’ Characteristics, Comorbidity Profiles and Treatment Patterns
Background and Objectives: HCV infection represents a main risk factor for type 2 diabetes (T2D). This real-world analysis investigated the HCV-positive (HCV+) population with a T2D co-diagnosis in Italy. Methods: From 2017 to 2021, HCV+ patients were identified from administrative databases and stratified into T2D-HCV+ and HCV+-only cohorts in the presence/absence of a T2D diagnosis. Both cohorts were further divided by treatment with direct-acting antivirals (DAAs). The subgroups were compared for demographic variables, comorbidity profiles, most frequent hospitalizations, and drug prescriptions before inclusion. A sensitivity analysis was performed on patients included after 2019, the year of widespread use of pangenotypic DAAs. Results: Considering HCV+ patients aged ≥55 years, T2D-HCV+ patients (N = 1277) were significantly (p < 0.001) older than HCV+-only (N = 6576) ones and burdened by a worse comorbidity profile (average Charlson index: 1.4 vs. 0.3, p < 0.05). Moreover, regardless of T2D presence, DAA-treated patients were older (p < 0.001) and had a worse Charlson index than the untreated ones. T2D-HCV+ patients showed tendentially higher hospitalization rates and co-medication prescriptions compared to the HCV+-only patients. After 2019, a trend towards reduced co-medication use in DAA-treated patients was noticed, especially antibiotics and cardiovascular drugs. Conclusions: The co-presence of T2D in HCV+ patients resulted in a worse clinical status, as confirmed by the more frequent requirement of hospitalizations and complex polypharmacy regimens
Demographics and Clinical Burden of Disease Among RSV-Hospitalized Older Adults in Italy: A Retrospective Cohort Study
Respiratory syncytial virus (RSV) is a leading cause of acute respiratory infection and can lead to severe disease in older adults or those with comorbidities. This analysis aims to evaluate the demographic and clinical burden of RSV hospitalizations among older adults in Italy and inform potential preventative strategies. Adults aged ≥50 years with ≥1 hospitalization discharge diagnosis for RSV from 2010 to 2021 were included. Demographic characteristics before the first RSV hospitalization and clinical outcomes during this hospitalization and the 12 months following are described. Of the 243 patients, mean (SD) age was 73.7 (13.1) years, 40.7% were male, and the most common comorbidities were chronic obstructive pulmonary disease (37.9%), diabetes (21.8%), and heart failure (15.2%). Mean length of index hospitalization was 17.0 days, during which 9.1% of patients died. At index or during the 12-month follow-up, 5.8% had an intensive care unit admission, 61.3% were prescribed antibiotics, 8.2% had a stroke, and 3.3% had an acute myocardial infarction. During the 12-month follow-up, approximately, half of patients experienced worsening of preexisting comorbidities, with notable rates of re-hospitalization and mortality (44.4% and 29.6%). This study shows a high clinical burden of RSV among older adults in Italy, emphasizing a need for improved RSV surveillance, and may guide policymakers and healthcare providers in making informed recommendations for, and implementation of, RSV vaccination in Italy.