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.

Aim: To evaluate antithrombotic treatment patterns in patients in Italy with nonvalvular atrial fibrillation (NVAF) before and after direct oral anticoagulants (DOACs) were approved. Methods: This analysis included patients with a discharge diagnosis of NVAF in 2010 and 2014, which constituted the pre- and post-DOACs populations, respectively. Results: Approximately 90% of patients were eligible for oral anticoagulant (OAC) therapy. Overall use of OACs increased from 38% in 2010 to 45% in 2014; use of antiplatelet therapy decreased from 36 to 25%. Approximately 14% of eligible patients remained untreated. Conclusion: Although an improvement in OAC prescription was observed post-DOACs launch, treatment patterns in Italy suggest that a proportion of patients with NVAF are still undertreated or do not receive appropriate therapy.

The study aims to estimate the number of patients affected by treatment-resistant depression (TRD) in Italy, and to analyse the therapeutic pathways and drug utilization in real-world settings. This retrospective study is based on administrative databases of Italian Entities. Data were re-proportioned on the Italian population. Adult patients were included from July 2011 to December 2017 if they underwent ≥2 antidepressant (AD) cycles matching the following criteria: i) duration of ≥4 weeks for each cycle; ii) presence of ≥1 prescription for each AD at the maximum dosage

To analyse the healthcare resource consumption and related costs for the Italian National Health System of patients estimated to be affected by treatment-resistant depression (TRD) in Italy. Patients and Methods: This was an observational retrospective study based on administrative databases, including those related to residential/semiresidential structures, of Veneto Region and the Local Health Unit of Bergamo in Italy (for a total of around 6 million healthassisted subjects). Between July 2011 and December 2017, all adult patients with a third antidepressant (AD) after ≥2 AD (each one with at least ≥4 weeks duration, ≥1 prescription at maximum dosage reported in datasheets, a grace period ≤30 days when switching AD and treatment maintained ≥9 months) were included. Overall and psychiatry-related healthcare resources consumption and related costs were estimated on a 12-months based analysis. Data were re-proportioned to the Italian population. Results: We have previously estimated a total of 101,455 patients with TRD in Italy (130,049 considering the mean maximum dosage of AD). Of them, 44.2% had at least a psychiatric hospitalization/visit or accessed a residential/semiresidential structure, and 31% added another AD or a mood stabilizer/antipsychotic drug. Patients with at least one psychiatryrelated hospitalization increased over the number of antidepressant lines from 12.0% during first line up to 24.5% during fourth line. Direct healthcare costs increased from €4,405 for first line to €9,251 from fifth line onwards. Psychiatry-related costs went from €1,817 (first line) to €4,606 (fifth line onwards) and were mainly driven by residential/semiresidential structures and hospitalizations. Conclusion:An upward trend with number of AD lines was observed for all healthcare resource utilization and consequently for all direct costs, thus indicating an increasing burden for patients as they move forward AD lines.

In the last decade, novel oral anticoagulants (NOACs) have emerged as prominent therapeutic options in non-valvular atrial fibrillation (NVAF). We analysed the clinical burden and the switching rate between all available NOACs, and their dosage change over a period of 5 years in a representative population of patients with NVAF aged between 70 and 75 years. Methods and Results: This is a retrospective observational study on administrative databases, covering approximately 6.2 million health-assisted individuals by the Italian National Health System (around 11% of the entire Italian residents). Out of 4640 NVAF patients treated with NOACs and aged 70–75 years in 2017, 3772 (81.3%) patients were still in treatment with NOAC up to 2021 and among them, 3389 (73.0%) patients remained in treatment with the same NOAC during 2017–2021. In fact, 10.2% of patients switched NOAC type and 10.3% changed the dose of the same NOAC. Overall, after switching, the dabigatran and rivaroxaban groups lost, respectively, 13.5% and 2.8% of patients, while apixaban and edoxaban resulted in a relative percentage increase of 6.8% and 44.6% of patients, respectively. By a logistic regression analysis, the treatment with rivaroxaban, apixaban, and edoxaban (respect to dabigatran) was associated with a significant risk reduction of switch of 57%, 68%, and 44%, respectively. On the other hand, several features of high risk were associated with dose reduction. Conclusions. In our 5-year analysis of a large administrative database, a switching among NOACs or a change in NOAC dosages occurred in around 20% of elderly patients with NVAF. The type of NOAC was associated with a high switching rate, while several characteristics of high risk resulted as predictors of dose reduction of NOACs. Moreover, a worsening trend of clinical conditions occurred in patients maintaining the same NOAC treatment across 2017–2021.