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Background: Respiratory syncytial virus (RSV) is among the leading causes of hospitalization due to lower respiratory tract infections (LRTIs) in children younger than 5 years worldwide and the second cause of infant death after malaria. RSV infection occurs in almost all the infants before the second year of life with variable clinical severity, often requiring medical assistance. This analysis investigated patients aged 0–5 years with RSV infection focusing on epidemiology, clinical features, and economic burden of RSV-associated hospitalizations in a setting of Italian real clinical practice. Methods: An observational retrospective analysis was conducted on administrative databases of healthcare entities covering around 2.6 million residents of whom 120,000 health-assisted infants aged < 5 years. From 2010 to 2018, pediatric patients were included in the presence of hospitalization discharge diagnosis for RSV infections, and RSV-related acute bronchiolitis or pneumonia. Epidemiology, demographics, clinical picture and costs were evaluated in RSV-infected patients, overall and stratified by age ranges (0–1, 1–2, 2–5 years) and compared with an age-matched general population. Results: Overall 1378 RSV-infected children aged 0–5 years were included. Among them, the annual incidence rate of RSV-related hospitalizations was 175–195/100,000 people, with a peak in neonates aged < 1 year (689–806/100,000). While nearly 85% of infected infants were healthy, the remaining 15% presented previous hospitalization for known RSV risk factors, like preterm birth, or congenital heart, lung, and immune diseases. The economic analysis revealed that direct healthcare costs per patient/year were markedly higher in RSV patients than in the general population (3605€ vs 344€). Conclusions: These findings derived from the real clinical practice in Italy confirmed that RSV has an important epidemiological, clinical, and economic burden among children aged 0–5 years. While the complex management of at-risk infants was confirmed, our data also highlighted the significant impact of RSV infection in infants born at term or otherwise healthy, demonstrating that all infants need protection against RSV disease, reducing then the risk of medium and long-term complications, such as wheezing and asthma. [ABSTRACT FROM AUTHOR]

This real-world analysis investigated the characteristics and treatment patterns of patients with hereditary angioedema (HAE) in Italy using the administrative data of health units across Italy. Patients were identified via exemption code or HAE-specific treatments (thus, all known forms, type I, II and, III, were included). The index date was that of first prescription of HAE treatments within the inclusion period (01/2010–06/2021) or of the date of exemption. The number of HAE patients included was 148 (43.2% male, mean age 43.3 years). Gastrointestinal disorders affected 36.5% patients, hypertension affected 28.4%, hypercholesterolemia affected 11.5%, and depression affected 9.5%. The frequent gastrointestinal involvement was further confirmed by the use of antiemetics and systemic antihistamines that doubled after the index date. Among patients enrolled by treatment (n = 125), n = 105 (84%) were receiving a treatment for acute attacks. This analysis provided insights into the characterization of patients with HAE and their management in Italian clinical practice, suggesting that an unmet therapeutic need could be present for such patients in terms of the clinical burden. [ABSTRACT FROM AUTHOR]

Purpose: An Italian real-world retrospective study was conducted in patients with psoriasis (PSO) to evaluate their characteristics, treatment patterns, and biological/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) drug utilization. Patients and Methods: The retrospective analysis was carried out on real-world data collected from administrative databases of selected Italian health-departments; the dataset covered approximately 22% of the Italian population. PSO patients (identified by PSO hospitalization, and/or active exemption code and/or a topical anti-psoriatic medication prescription) were included. In prevalent patients identified during 2017– 2018-2019-2020, baseline characteristics and treatment patterns were investigated. Moreover, b/tsDMARD drug utilization (focusing on persistence, monthly dosage, and mean duration between prescriptions) was evaluated in bionaïve patients included during 2015 and 2018. Results: PSO was diagnosed in 241,552 (in 2017), 269,856 (in 2018), 293,905 (in 2019) and 301,639 (in 2020) patients. At the index date, almost 50% of patients had not received systemic medications, and 2% had received biological treatment. Among the b/tsDMARD-treated patients, a decrease in the use of tumour necrosis factor (TNF) inhibitors (60.0– 36.4%, from 2017 to 2020) and an increase in the use of interleukin (IL) inhibitors (36.3– 50.6%, from 2017 to 2020) were observed. In 2018, the persistence rates of TNF inhibitors and IL inhibitors in bionaïve patients ranged from 60.8– 79.7% and 83.3– 87.9%, respectively. Conclusion: This real-world study of PSO drug utilization in Italy showed that a significant number of patients were not treated with systemic medications and only 2% of patients were treated with biologics. An increase in the use of IL inhibitors and a decrease in the prescription of TNF inhibitors over years were found. Patients treated with biologics were highly persistent with treatment. These data provide insight into routine clinical practice for PSO patients in Italy, suggesting that the optimization of treatment for PSO still represents an unmet medical need. [ABSTRACT FROM AUTHOR]

This real-world analysis was performed on administrative databases to evaluate characteristics, therapies, and related economic burden of glaucoma in Italy. Adults with at least 1 prescription for ophthalmic drops (ATC class S01E: antiglaucoma preparations, miotics) during data availability period (January 2010−June 2021) were screened, then patients with glaucoma were included. First date of ophthalmic drops prescription was the index date. Included patients had at least 12 months of data availability before index-date and afterwards. Overall, 18,161 glaucoma-treated patients were identified. The most frequent comorbidities were hypertension (60.2%), dyslipidemia (29.7%) and diabetes (17%). During available period, 70% (N = 12,754) had a second-line therapy and 57% (N = 10,394) a third-line therapy, predominantly ophthalmic drugs. As first-line, besides 96.3% patients with ophthalmic drops, a small proportion reported trabeculectomy (3.5%) or trabeculoplasty (0.4%). Adherence to ophthalmic drops was found in 58.3% patients and therapy persistence reached 78.1%. Mean total annual cost per patient was €1,725, mostly due to all-cause drug expenditure (€800), all-cause hospitalizations (€567) and outpatient services (€359). In conclusion, glaucoma-treated patients were mostly in monotherapy ophthalmic medications, with an unsatisfying adherence and persistence (<80%). Drug expenditures were the weightiest item among healthcare costs. These real-life data suggest that further efforts are needed to optimize glaucoma management. [ABSTRACT FROM AUTHOR]

A real-world analysis among the Italian population has been carried out to estimate the number of atrial fibrillation (AF) patients undergoing catheter ablation and to evaluate their clinical outcome and economic burden. A retrospective analysis on administrative Italian databases has been performed. Between January 2011 and December 2019, all patients diagnosed with AF were considered and those undergoing catheter ablation were identified. Overall, 3084 (3.54%) of AF patients with at least one catheter ablation were included (mean age 63.2, 67.3% males). A significant decrease in the use of AF-related medications and in hospitalizations, mainly related to AF and heart failure, was observed during the 3-year post-ablation period. The average total cost per patient during the 1-year before ablation period was significantly higher compared to the 1-year post-ablation cost (EUR 5248 vs. 4008, respectively; p < 0.001). After propensity score matching, the overall mortality of patients who underwent ablation was significantly lower compared to that assessed in patients not treated with the procedure (9.386/1000 vs. 23.032/1000 person-year, respectively; p < 0.001). Moreover, the mean total costs were significantly higher in patients who did not undergo ablation compared to those who received ablation (EUR 5516 vs. 4008, respectively; p < 0.001). This real-world data analysis shows that in Italy, although catheter ablation is performed in a minority of AF patients, it is associated with significantly better post-procedure clinical outcomes and a significant reduction in healthcare-related costs. [ABSTRACT FROM AUTHOR]

Aims: The aims of this study were to evaluate if the risk of cardiovascular events and all-cause mortality was higher in the presence of hyperkalaemia (HK) in patients with heart failure (HF) treated with renin-angiotensin-aldosterone system inhibitors (RAASi), and to investigate in this cohort the increased risk of cardiovascular events and all-cause mortality among HK patients with non-optimal adherence to RAASi therapy.Methods and Results: In this retrospective cohort study based on administrative databases of five Italian Local Health Units, all adult patients with a HF diagnosis between January 2010 and December 2017 were included only if they were prescribed RAASi therapy during the first 3 months after the index date, that corresponded to the date of first HF diagnosis during the inclusion period. Patients were considered to have HK if serum potassium level was ≥5.5 mmol/L. A propensity score matching was applied before evaluation of hazard ratios. Patients with HK were 37% (P < 0.001) and 70% (P < 0.001), respectively, more at risk of cardiovascular events and of dying for all-cause mortality compared to non-HK patients. Among the HK group, patients non-adherent to RAASi therapy had a 39% (P = 0.105) higher risk of cardiovascular events and a twofold increased risk (P < 0.001) of all-cause death.Conclusion: Findings from this real-world study showed that in a cohort of HF patients under RAASi therapy, subjects with HK had an enhanced risk of cardiovascular events or death compared to patients without HK. Moreover, in HK patients, sub-optimal adherence to RAASi therapy was associated with an increased risk of all-cause mortality. [ABSTRACT FROM AUTHOR]

Objectives: Aim of the study was to describe the use and pharmacoutilization profiles of recommended drugs for HF patients, hospital re-admission rates, mortality rates and determine healthcare resource consumption and related costs for HF patients in an Italian region. Methods: We retrospectively analyzed data from the administrative database and included adult patients who were discharged alive with a primary or secondary HF diagnosis between 1 January 2010 and 31 December 2015. We assessed data on HF-related drug prescriptions at discharge and during a 12-month follow-up period, as well as treatment adherence and treatment modification. All-cause mortality, hospital HF re-admission, and mean direct cost per patient were also analyzed during the follow-up period. Results: A total of 69,164 patients were included. One in ten patients had discontinued all treatment initially prescribed by the end of follow-up. In total, 25.9% of patients were re-hospitalized with an HF diagnosis during the follow-up period; the mortality rate at 12 months was 24.3%. The mean annual cost per patient was €6,303.7, with nearly three-fourths attributable to hospitalizations. Conclusions: In our study, we observed an under-prescription of recommended drugs for the treatment of HF. Moreover, one out of four HF patients were re-hospitalized for HF-related causes and the healthcare costs related to hospitalization accounted for the great majority of the total healthcare resource costs. [ABSTRACT FROM AUTHOR]

Introduction: Polytherapy is often required to treat the comorbidity of hypertension and hyperlipidemia. Fixed-dose co-formulation, rather than free combinations, simplifies medication taking and also improves adherence to medication, which is the key for a successful management of these conditions. Aim: To determine the number of patients potentially eligible for treatment with triple fixed-dose atorvastatin/perindopril/amlodipine (CTAPA), and to estimate if an unmet medical need exists among CTAPA free combination treated patients. Methods: This observational retrospective study was based on administrative databases of 3 Italian Local Health Units. The cohort comprised adult patients with at least one prescription of amlodipine and perindopril (either as free combination or co-formulated) and atorvastatin during 2014. Follow-up period started on the date of prescription of the 3 molecules (index date) and lasted 1 year. Adherence to CTAPA was analyzed during follow-up, by using the proportion of days covered (PDC). Results: 2292 patients (9.1 per 10,000 beneficiaries) had a prescription for CTAPA as free combination. Only 1249 (54.5%) were adherent to the therapy (PDC ≥ 80%); among them, a small percentage required dosage modification. The number of patients with CTAPA increased during the study period. Discontinuation of drugs prescribed the year before interested 582 patients in 2014, and 522 in 2015. Considering the Italian national population (n = 60,782,668), it was estimated that 69,542 hypertensive patients could be eligible for fixed-dose CTAPA during 2014. Conclusions: Real-world analysis among patients with free combination therapy can be applied to estimate the eligible population for fixed combination, and to evaluate the appropriateness of their prescriptions. Moreover, fixed-dose CTAPA could effectively improve adherence, which was calculated to be low in the free combination cohort. [ABSTRACT FROM AUTHOR]

Objectives: The aim of the study was to assess all-cause mortality and cardiovascular (CV) events in patients after a period of 12 months of treatment with dual antiplatelet therapy (DAPT) after hospitalization for acute myocardial infarction (AMI) in a real-world setting. Health care costs for the management of patients post-AMI was also assessed.Methods: A retrospective analysis using data from the administrative databases of six local health units (LHUs) was performed. All beneficiaries of these LHUs hospitalized with AMI between January 01, 2010, and December 31, 2011, and exposed to a treatment period with DAPT up to 12 months after AMI discharge were included. All-cause mortality, CV hospitalizations, and health care costs occurring during the 36-month follow-up period from end of treatment with DAPT were considered. For the cost analysis, only patients still alive at the end of the follow-up period were included.Results: A total of 2,721 patients were included (mean ± SD age 63.6±17.3 years, 67.8% males). About 17% and 18% of all patients had CV events and died during the follow-up period, respectively. The annual mean cost per patient was €3,523.27. During the follow-up period, 63 patients had a second AMI event; for whom, the mean health care cost per patient was €19,570.70.Conclusion: In a real-world setting in Italy, considering a 36-month follow-up period, all-cause mortality, CV events, and related health care cost of patients hospitalized with an AMI undergoing a 12-month treatment period with DAPT remained relevant. This study suggests that increased efforts aimed at the prevention of recurrent AMI are warranted, as well as an accurate risk stratification in order to improve long-term outcome. [ABSTRACT FROM AUTHOR]

Objectives: The aims of this study were to assess the prevalence of diagnosed atrial fibrillation (AF), the drug use in patients with AF in terms of antithrombotic (AT) strategies used and the compliance with treatment, and to describe the characteristics of patients affected by AF in relation to treatment.Methods: The data collected were provided from databases of general practitioners (GPs) of the Local Health Unit of Bologna in Italy. From January 1, 2009, to December 31, 2012, all subjects aged ≥18 years followed by the 44 GPs enrolled in the study were evaluated, and the subjects with a diagnosis of AF were included in the analysis.Results: From 2009 to 2012, we identified 1,413 patients with a diagnosis of AF (2.09% of 67,517 patients of the 44 GPs). A total of 1,413 patients with a diagnosis of AF (2.09% of 67,517 patients of the 44 GPs) were enrolled in the study. During the study, 14% of the enrolled patients did not receive any prescription of ATs, 30% and 39.56% were treated only with antiplatelet (AP) agents and oral anticoagulants (OACs), respectively, and 16.28% of the patients received prescriptions for both an OAC and an AP agent; of the patients receiving prescriptions for both, only 4.17% received these therapies at the same time. Among the OAC users, the percentage of patients still on treatment with the index drug during the last 3 months of observation was 76.9%.Conclusion: Our findings emphasize that in an Italian real-world setting, the burden of AF in general population from a public health point of view underscores the need for improvement in utilization of appropriate ATs in patients with known AF. [ABSTRACT FROM AUTHOR]