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BackgroundAlthough migraine is a disabling neurological condition that causes important disability, it remains an area of underdiagnosis and undertreatment worldwide. The aim of this study was to depict the burden of the unmet medical needs in migraine treated with triptans in a large Italian population.MethodsA 2-year longitudinal analysis of migraineurs with unmet medical needs on treatment with triptans was performed. The studied cohort consisted of subjects with ≥4 triptan dose units per month, selected from the general population These patients were stratified into: possible Low-Frequency Episodic Migraine (pLF-EM: 4–9 triptan dose units per month), possible High-Frequency Episodic Migraine (pHF-EM: 10–14 triptan dose units per month) and possible Chronic Migraine (pCM:> 14 triptan dose units per month). The first follow-up year was analysed to describe the use of preventive therapies, the second year to describe the ≥50% reduction in triptan use.ResultsOf 10,270,683 adults, 8.0 per 1000 were triptan users and, of these, 38.2% were migraineurs with unmet medical needs, corresponding to 3.1 per 1000 adults. By stratifying for the number of triptan dose units per month, 72.3% were affected by pLF-EM, 17.4% by pHF-EM, and 10.3% by pCM. In this cohort, 19.1% of individuals used oral preventive drugs and 0.1% botulinum toxin. Triptan use reduction was found in 22.3% individuals of the cohort, decreasing with the intensification of need levels (25.8% pLF-EM, 13.6% pHF-EM, 12.0% pCM).ConclusionsThis real-life analysis underlined that the unmet medical needs concern a large part of patients treated with triptans and there is an undertreatment with preventive therapies whose benefit is insufficient, which may be due to the lack of effective preventive strategies, probably still reserved to severe patients. This study allows forecasting the actual impact of newest therapeutic strategies aimed to fill this gap.

Objective To describe patients with severe asthma treated with or eligible for monoclonal antibodies, assessing the health and economic burden using the Italian National Healthcare Service (SSN) administrative data. Methods From 4.6 million inhabitants, among patients with asthma from 1 January to 31 December 2022, those with severe asthma were identified by monoclonal antibody dispensation (cohort A) and by eligibility for monoclonal antibodies, defined as continuous treatment with medium- or high-dose inhaled corticosteroids and long-acting beta agonists and the occurrence of exacerbations (cohort B-narrow and cohort B-broad according to “narrow” and” broad” definitions, respectively). One-year exacerbations, healthcare utilization, and direct costs were assessed. Results Of the 128,621 patients with asthma (51.8% women; mean age, 54 years), patients with severe asthma were identified as follows: cohort A (n = 3046; 2.4%), cohort B-narrow (n = 3517; 2.7%), and cohort B-broad (n = 7621; 5.6%). Compared with cohort A, patients in cohorts B-narrow and B-broad were older, had more comorbidities, experienced more moderate/severe exacerbations (70.9%–57.3% vs. 46.7%), and had higher hospitalization rates and greater drug use but fewer specialist visits. The annual SSN costs averaged €7512 for cohort A versus €2911–€2351 for cohorts B-narrow and B-broad. Cohort A incurred higher costs for asthma drugs, whereas cohorts B-narrow and B-broad incurred higher costs for concomitant drugs, hospitalizations, and specialist care. Conclusions A significant disease burden exists in patients with uncontrolled severe asthma who are potentially eligible for monoclonal antibodies in Italy.

Mechanical recycling of Fused Deposition Modeling 3D printing materials is very attractive for the circular economy. In this paper, the tensile properties of a virgin and a one-time-recycled short carbon fiber reinforced polyamide, coming from 3D printing scrap and failed parts, were evaluated. Anisotropy was taken into account properly by using characterization methods that are typical of composites. Rheological properties were obtained with a parallel plate rheometer in oscillatory mode, and thermal properties were investigated based on thermogravimetric analysis and differential scanning calorimetry. A decrease in the average molecular weight of the recycled material, indicated by the rheological measurements, induced brittleness. Nevertheless, the stiffness and yield strength of the 3D printed parts made with the recycled material were higher than those made with the virgin one. Since this behavior could not be explained based on an increase in crystallinity or a relevant decrease in the void content, a feasible explanation is proposed with an increase of the interlayer and intralayer adhesion quality. In any case, the recycled polyamide filament can be successfully reused in Fused Deposition Modeling 3D printing, even when significant mechanical properties are required, but attention must be paid to a certain decrease in ductility.

Background Chronic spontaneous urticaria (CSU) is a disorder of skin and mucosal tissues lasting at least 6 weeks. Treatments are primarily addressed to reduce symptoms; therefore, patients still experience poor living conditions and high unmet needs. This retrospective observational study was aimed to describe patients newly diagnosed with CSU, their healthcare resource utilization and related economic burden through Italian administrative healthcare data. Methods From a large Italian administrative healthcare database (˜5.5 million inhabitants/year), in- and outpatients newly diagnosed with CSU from January 1 st , 2016, to December 31 st , 2021 (index date) were identified through specific algorithms. Drug dispensations, overnight hospitalizations, emergency department (ED) accesses, local outpatient specialist care and direct costs charged to the Italian National Health Service (SSN) were described throughout the first follow-up year. Also, CSU exacerbations were assessed throughout the available follow-up/patient (variable based on the accrual year and up to December 31 st 2022). Results Patients newly diagnosed with CSU in Italy were 1,707. The median (IQR) age was 36 (18;55) years with twice as many females as males. Cardiometabolic diseases were the most common comorbidities. Throughout the first follow-up year: 72.9% patients were treated with second-generation H1-antihistamines (mainly cetirizine), 19.5% with omalizumab; concomitantly, 55.5% received oral corticosteroids (OCS), and 25.0% non-steroidal antiinflammatory drugs. At least one CSU exacerbation occurred in 81.2% patients; of them, only one third were treated with omalizumab on average 10.9 months following exacerbation. New users of omalizumab during the available follow-ups were 30.6% patients. On average, 1.6 overnight hospitalizations occurred to 16.8% of patients mainly because of urticaria and angioedema. At least one local outpatient specialist service was performed to 78.6% patients; 63.3% were examined by a specialist, on average 3 times during the first year. The mean per patient annual total expenditure was €1901, of which 45.4% was due to pharmaceuticals. Conclusions During the first year following the new CSU diagnosis, a lower than recommended antihistamines dispensation while an elevated use of OCS and a low and delayed omalizumab initiation after CSU exacerbation were observed, suggesting the urgent need to optimize treatment management to limit the burden on patients and healthcare systems.

Background Chronic obstructive pulmonary disease (COPD) represents an important health challenge, despite being preventable and manageable thanks to up-to-date recommendations. In Italy, the pharmaceutical care of COPD patients is still ill-timed and inaccurate. This study aimed to describe the treatment of COPD patients in Italy and possible switches following an exacerbation. Methods This observational retrospective analysis of Italian administrative healthcare data from the Fondazione Ricerca e Salute (ReS) database identified patients aged ≥ 45 years with COPD in 2019 and 2020. At least 6 years of look-back period and absence of concomitant asthma were required. COPD patients were categorized by treatment (SI–single/MI–multiple inhalers, TT–triple therapy, DT–dual therapy, other respiratory treatments, untreated) at index date (first dispensation during accrual period). Occurrence of moderate/severe exacerbation during one-year preceding index date and treatments during one-year preceding the exacerbation (possible switch) were evaluated. Results From ~ 4.7 million beneficiaries of the Italian National Health Service in 2019 and 2020, respectively, 105,828 and 103,729 (43 and 41 × 1,000 inhabitants aged ≥ 45 years) were identified as having COPD. Of 2019/2020 patients: 3.4%/5.2% received SI-TT, 20.7%/17.5% MI-TT, 35.9%/38.1% DT, 33.0%/33.1% other treatments, and 7.0%/6.0% were untreated. Males were prevalent and median age was > 73 years for all groups. Of 2019/2020 cohorts, heart failure and coronary artery disease affected 24/20%, 18/17%, and 11%/16% patients with SI-TT, MI-TT, DT, and other treatments, respectively. A previous moderate/severe exacerbation (2019/2020 patients) occurred to 60.5%/56.6%, 39.9%/37.4%, 30.8%/29.2% and 31.9%/29.7% patients treated with SI-TT, MI-TT, DT, and other treatments, respectively. Of 2019/2020 patients experiencing moderate/severe exacerbation: 6.0%/7.0% receiving DT, 5.1%/7.0% receiving other treatments and 4.5%/10.0% untreated, switched to SI-TT; 23.7%/16.9% receiving DT, 21.4%/17.7% receiving other treatments and 15.4%/12.0% untreated, switched to MI-TT. Conclusions COPD patients receiving TT were older and had more comorbidities, especially cardiovascular diseases, than patients receiving DT or other treatments. The limited number of patients switching after exacerbation suggests that many COPD patients may be inappropriately treated. Ensuring early and adequate treatment, combination of in-hospital and outpatient management, and integration of specialist and primary care is pivotal for the appropriate clinical management of COPD patients.

PurposeTo describe new users of atypical antipsychotics (APs) in terms of sociodemographic characteristics, cardio-metabolic risk profile, prescription patterns, healthcare costs and cardio-metabolic events over the 24 months after treatment initiation.MethodsAtypical AP new users were selected from the ReS database and grouped into three: patients already affected by cardio-metabolic diseases (group A), patients without these clinical conditions but with predisposing conditions (group B) and patients without cardio-metabolic diseases and predisposing conditions (group C). Annual prescription patterns and healthcare costs were analysed. Subjects of groups B and C were matched with controls to compare the occurrences of cardio-metabolic events over 24 months.ResultsThirty-two thousand thirty-four new users of atypical APs were selected (median age 69). The 22.3% had cardio-metabolic diseases, 14.8% had predisposing conditions and 62.9% had none of these. The 99.3% received monotherapy. The mean annual cost per patient was €2785, and the median cost was €1108. After 24 months, a cardio-metabolic event occurred in 11.5% of group B vs. 8.7% of the controls (p < .01), and in 5.0% of group C vs. 2.1% of the controls (p < .01).ConclusionPatients treated with atypical AP were on average old and, in a non-negligible amount, with cardio-metabolic disease or predisposing conditions. New users of atypical APs showed a significantly higher likelihood to develop a cardio-metabolic event early after treatment initiation.

Aims: To analyze the prevalence, comorbidities, outcomes and costs of type 2 diabetes mellitus (T2DM) patients with and without coronary artery disease (CAD) or stroke in a population of over 7 million inhabitants. Methods: T2DM patients were identified in 2015 (accrual period) from the Ricerca e Salute (ReS) database linking administrative records to demographics. Based on 2013–2015 information, four cohorts were considered: #1 with CAD and/or stroke; #2 without CAD and/or stroke; #3 with chronic CAD but no myocardial infarction or stroke; #4 with chronic CAD undergoing percutaneous coronary interventions (PCI). Hospitalizations, drugs and other outpatient care were assessed from 2015 to 2017. Results: The prevalence of T2DM was 6% (441,085/7,365,954). CAD and/or stroke in the previous 3 years affected 7.5% of T2DM patients (33,153); this cohort was generally older, of male sex, with more comorbidities, prescriptions, and hospital admissions (50.5% versus 13.4% during the first follow-up year) compared to cohort #2. Yearly costs were over three-fold for cohort #1 versus #2, main drivers being hospitalizations in the former and drugs in the latter. Two-year cardiovascular events were recorded significantly more commonly in cohort #4 compared to the other cohorts. Guideline-recommended lipid-lowering therapy was <80% in all but cohort #4. Conclusions: The present analysis points to three areas of potential improvement in T2DM management: (a) guideline-recommended treatment patterns of T2DM patients; (b) three-fold recurrences and costs in T2DM patients with, compared to those without, prior cardiovascular events; (c) high event rates associated with chronic CAD and PCI, warranting specific studies aimed at improved prevention.

Background and Objective Cardiovascular (CV) diseases represent a major cause of death and severe medical condition worldwide. Different therapeutic options are available to control low-density lipoprotein cholesterol (LDL-C) level in order to prevent CV events. In recent years, two new drugs were approved for patients who are unable to reduce circulating LDL-C with the current therapies: evolocumab and alirocumab (proprotein convertase subtilisin/kexin type nine [PCSK9] inhibitors). This study was aimed to characterise patients who started treatment with PCSK9 inhibitors in the Tuscany region of Italy during the first year of public healthcare service reimbursement and to describe the pattern of PCSK9 inhibitor use in the first 6 months of treatment. Methods Patients on PCSK9 inhibitor treatment in Tuscany (3.7 million inhabitants) from 07/2017 to 06/2018 were selected from regional healthcare administrative databases. Concomitant use of lipid-lowering therapies (LLTs), adherence and persistence during the 6 months preceding the first PCSK9 inhibitor dispensing, as well as comorbidities since 1996, were described. In the first 6 months of PCSK9 inhibitor treatment, adherence, persistence and concomitant LLTs were assessed. Results There were 269 (176 evolocumab, 93 alirocumab) new users of PCSK9 inhibitors. Patients (mean age of 59.1 years) were mainly male (71.0%) in secondary prevention (70.2%) and affected by familial hypercholesterolaemia (53.5%). Sixty-six patients (24.5%) had diabetes mellitus and 12 (4.5%) chronic renal failure. In the 6 months prior to the first PCSK9 inhibitor administration, 61.3% of patients received at least one prescription of ezetimibe or high-intensity statins and 45.7% were persistent to these drugs. During follow-up, 79.9% of patients were adherent to PCSK9 inhibitor and 73.3% were persistent. Conclusions During the first year of availability, the rate of prescription of PCSK9 inhibitors appears below expectations. Patients were mainly in secondary prevention and had been slightly persistent to previous LLTs. During follow-up, the PCSK9 inhibitor monotherapy showed high levels of adherence and persistence. This real-world study sets the stage for future longer-term investigations useful to improve our knowledge on the appropriateness, drug access and public healthcare sustainability of PCSK9 inhibitors.

Primary biliary cholangitis (PBC) is a rare, chronic, cholestatic, autoimmune, and disabling liver disease whose treatments are aimed at reducing its progression.The aim was to describe patients with PBC, their healthcare resource utilization (HCRU) and costs on the Italian National Health Service (SSN). From an Italian administrative healthcare database (~5.5 million inhabitants), called ReS Db, patients with PBC in 2021 (prevalent) were selected by specific codes and described by demographics, comorbidities, one-year HCRU, and health sector costs charged to the SSN. The 3-year treatment pattern was evaluated in a cohort of patients newly diagnosed in 2019 (incident). In 2021, 1375 patients with PBC were identified (prevalence: 28.2/100,000; females: 74.2%; mean age: 64 ± 15 years). During one-year follow-up of the prevalent cohort: 73.1% received ursodeoxycholic acid (UDCA); 3.0% obeticholic acid (OCA), and 3.4% off-label drugs; 19.9% were hospitalized, mainly for cirrhosis-related conditions; 61.2% were examined by a specialist. The annual mean cost was €4422/patient; drugs for PBC, concomitant drugs, and hospitalizations accounted for 12.1%, 31.7%, and 43.6% of total cost, respectively. Among the 40 incident patients, 38 (95%) received UDCA as first-line therapy. The study described the real-world impact of PBC in Italy from the perspective of the SSN and highlighted the burden and therapeutic needs of patients treated with UDCA.