Angelini Pharma (Italy)

Sustained seizure freedom without intolerable adverse events is the main goal of epilepsy treatment, but may be challenging to achieve for some patients, particularly following the failure of multiple anti-seizure medications (ASMs). A majority of days without seizures is another important clinical outcome that can lead to meaningful improvement in quality of life. The objective of this post-hoc analysis was to evaluate the percentage of seizure-free days by responder groups during the open-label extension (OLE) of study C017 with a focus on patients who achieved near-seizure freedom that was sustained during the duration of the study (≥ 90%-< 100% responders group). The study also evaluated retention rates and the impact of concomitant antiseizure medications. Study C017 (NCT01866111) was a double-blind, randomized, placebo-controlled, dose-response trial evaluating adults 18-70years old who were taking 1-3 concomitant ASMs. Participants completed the 18-week double-blind treatment period and entered the OLE. This post-hoc analysis quantified the proportion of seizure-free days by responder category and by number and type of concomitant ASMs. The occurrence and severity of treatment-emergent adverse events during the OLE were also reported. Sixty (16.9%) of the 354 study participants were≥90%-< 100% responders (median age 42.5years, 46.7% [n=28] female, median number of concomitant ASMs at baseline was 2). The study population also included 91 (25.7%) patients who were≥50%-< 75% responders, 62 (17.5%) patients who were≥75%-< 90% responders, and 13 (3.7%) patients who were 100% responders. The median duration of cenobamate exposure was 5.6years for the≥90%-< 100% responders; 1.8years for the non-responders; 5.5years for the≥50%-< 75% responders; 5.5years for the≥75%-< 90% responders; and 5.6years for the 100% responders. The percentage of seizure-free days during the entire OLE was 97.9% in the≥90%-< 100% responder group, compared to 93.5% in the≥75%-< 90% group and 83.9% in the≥50%-< 75% group. The number and mechanism of action of concomitant ASMs did not meaningfully impact the proportion of days without seizures. The percentage of days with seizures in the≥90%-< 100% responder group declined from 33.2% at baseline to 1.2% at Year 5. At Year 5, the≥90%-< 100% responder group had a high retention rate (90%). The most commonly occurring adverse events were dizziness, somnolence, and headache. Participants taking cenobamate who achieved≥90%-< 100% responder rates were seizure-free for nearly 98% of days during the 5years of the OLE. These results suggest that a high reduction of seizure burden can be achieved and maintained by many people with epilepsy taking cenobamate.

Objectives: This study aimed to evaluate the effectiveness and safety of paracetamol 1000 mg/ibuprofen 300 mg administered three times daily (TID) in comparison with ibuprofen 600 mg TID in the management of patients with acute moderate/severe non-specific low back pain (LBP). Methods: This was a phase IV, randomized, open-label, parallel-group study conducted in adults with moderate/severe LBP (Visual Analogue Scale [VAS] score ≥ 40 mm). Results: A total of 171 patients were included in the modified intention-to-treat (m-ITT) population (paracetamol 1000 mg/ibuprofen 300 mg: 83 patients; ibuprofen 600 mg: 88 patients). No significant between-group difference on the primary endpoint (SPID 0-3 days) was found. Patients were mainly women (60.2% and 55.7%), with a mean age of 42.8 and 43.3 years, respectively. In the m-ITT population, the effectiveness, safety and tolerability were similar between groups. In the per-protocol population, clinical pain reduction was observed with paracetamol 1000 mg/ibuprofen 300 mg. At visit 1, significant differences in the Clinical Global Impression-Improvement scale (paracetamol 1000 mg/ibuprofen 300 mg: 63.9%; ibuprofen 600 mg: 45.5%; p = 0.0137) and a trend favouring paracetamol 1000 mg/ibuprofen 300 mg in Patients' Global Impression of Change (63.9% vs 44.4%; p = 0.0539) score were observed. Conclusions: Given the open-label design and the exploratory nature of study's secondary endpoints, no claims of superiority can be drawn; but our findings confirm that good management of acute moderate/severe LBP can be achieved with multimodal therapy with paracetamol 1000 mg/ibuprofen 300 mg. EudraCT Number: 2020-005278-86 (EudraCT Number 2020-005278-86-Clinical trial results-EU Clinical Trials Register; date of registration: 14 June 2021).

La presente investigación abordó la planificación financiera y la rentabilidad en una empresa de formación tecnológica y técnica durante el 2024, vinculándose al Objetivo de Desarrollo Sostenible (ODS) N.º 8: “Trabajo decente y crecimiento económico”, especialmente a las metas 8.1 y 8.3, que promueven el crecimiento económico sostenido y la formalización empresarial. El estudio fue de tipo básico, con enfoque cuantitativo y diseño no experimental, descriptivo y de corte transversal. La muestra estuvo conformada por 15 trabajadores de las áreas de gerencia, contabilidad y administración. Se aplicó directamente un cuestionario estructurado a los participantes para recolectar los datos necesarios. Los resultados mostraron que el 100% de los encuestados calificaron la planificación financiera como regular, debido a deficiencias en el seguimiento presupuestario y la falta de coordinación entre áreas. En cuanto a la rentabilidad, el 87.0% la calificó como regular, mientras que el 13.0% la consideró óptima. Se concluyó que la empresa presentó limitaciones en su gestión financiera, ya que los ingresos apenas cubrieron los gastos operativos y existió poca diversificación de fuentes de ingreso, lo que afectó negativamente su rentabilidad y sostenibilidad.

Albania is considered endemic for cystic echinococcosis (CE). Recent data on prevalence and incidence of CE in Europe suggests that the Balkan region is the epicentre of this neglected parasitic disease in Europe. In Albania, a retrospective study has estimated a mean incidence of 1.49 cases/100,000 people. We aimed to assess the prevalence of CE in eight municipalities across the country. We enrolled participants aged >5 years in an ultrasound (US)-based screening for CE in 23 villages in eight municipalities from three prefectures. Participants were enrolled in the study after signing an informed consent and underwent a complete abdominal US. CE cysts were classified according to the WHO-IWGE ultrasound classification. A total of 3,710 participants were included in the study, of whom 2,685 (72.4%) were female. The median age of participants was 55 years (interquartile range, 42-64). Six confirmed CE cases were identified by US with cysts in the liver (1 CE2, 2 CE3a, 1 CE4 and 2 CE5). The crude prevalence of CE detected by US was 0.16% (95% CI 0.06-0.35), with a standardized prevalence of 0.11% (95% CI 0.02-0.21) according to the reference rural population 2023 in Albania. We calculated that the number of individuals who might currently be infected with CE in the rural area of this country was 908 (95% CI 138-1,678). This was the first population-based US field survey on CE conducted in Albania. Our screening yielded a lower prevalence than expected. However, the presence of active cysts points to ongoing transmission. Our study had several limitations including the use of a convenience sample that limited the attendance of males and children. In the future, surveillance activities for CE should be strengthened in Albania to better characterize the epidemiology of the disease.

Objective Cenobamate has recently been introduced as new anti-seizure medication (ASM) for patients with focal onset seizures (FOS) who are insufficiently controlled despite the use of three previous ASMs. To date, few evaluations have addressed the budgetary impact for the healthcare payer of add-on ASMs in patients with drug-resistant epilepsy (DRE). This study aims to assess the budgetary implications for the Belgian health insurer, the National Institute for Health and Disability Insurance (NIHDI), if cenobamate were reimbursed for the adjuvant treatment of FOS in adults with DRE. Methods A prevalence-based budget impact model (BIM) was developed from the perspective of the Belgian NIHDI, considering all direct healthcare costs over a 3-year time horizon. A standardized expert elicitation process with experienced epileptologists was conducted to collect data on Belgian clinical practice. Source data uncertainty impact was investigated through a one-way sensitivity analysis (OWSA). Results Over a 3-year period, considering the cumulative drug costs of cenobamate, replacement of other third-generation ASMs, and savings generated at medical cost level, the introduction of cenobamate as adjunctive treatment for the target population was estimated to reduce the NIHDI budget by −€8,105,616. The robustness of these savings was confirmed through an OWSA. Conclusion The savings at medical cost level fully offset the impact of cenobamate on the drug budget, leading to an overall healthcare budget saving of −€8,105,616 for NIHDI. This favourable outcome is largely due to cenobamate’s high efficacy reflected in its high response rate and significant effect on reducing seizure frequency.

IntroductionThe prescription of non-steroidal anti-inflammatory drugs (NSAIDs) covered by the Italian National Health Service is limited to certain pathologies defined in the 2018 update of Note 66 of the Italian Medicines Agency (AIFA), meant to ensure appropriate use of NSAIDs. This analysis was conducted in real clinical practice to describe NSAID utilization from 2019 to 2022 with respect to Note 66 update.MethodsFor this real-world analysis, data were extracted from the administrative databases of healthcare institutions covering ~ 9.1 million citizens. From 2019 to 2022, all subjects with ≥ 1 NSAID prescription were identified. Demographic and clinical characteristics, the proportion of NSAID-treated patients over time, the most prescribed molecules, and drug consumption defined as daily dose (DDD) per 1000 inhabitants/day were recorded.ResultsThe percentage NSAID-treated patients showed a slight increase over time (1.9–3.0%). The most prescribed active ingredients were diclofenac, ketoprofen, nimesulide, etoricoxib, and ibuprofen. NSAID consumption increased from 15.5 to 16.8 DDD/1000 inhabitants/day over 2020–2022, especially in older patients (65–74 years group: 36.2–39.3 DDD/1000 inhabitants/day). From 2019 to 2022, 2,811,910 patients with NSAID prescription(s) in Note 66 were identified, whose average age was 59.7 years. Among them, 0.1–1.0% received NSAIDs for rheumatic diseases and 11.9% in the oncological setting. While diclofenac, etoricoxib, and ketoprofen were commonly prescribed at medium–low dosage as recommended, ibuprofen was used at high dosage (600 mg) in 80% of cases.ConclusionThe analysis showed that patients prescribed with NSAIDs were relatively young (~ 60 years), in contrast with the pathologies covered by Note 66, which typically affect elderly people. Moreover, rheumatic and oncological diseases were poorly represented, thus it is possible that NSAIDs might have been prescribed for indications outside the note. These findings suggest that the use of NSAIDs for pain management in Italy should be optimized, properly weighting their risks and benefits.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-025-03153-3.

This systematic literature review (SLR) assessed the humanistic and economic burden of focal epilepsy and primary generalized tonic–clonic seizures (PGTCS) in adults to evaluate these domains in both populations and identify evidence gaps to inform future research. A search was conducted on December 7, 2022, using MEDLINE and Embase to identify studies published from 2012 onwards reporting humanistic burden (patient‐reported or caregiver‐reported outcomes or utilities, qualitative evaluations), economic burden (productivity loss, caregiver and societal costs of epilepsy), and sleep‐related outcomes. Of the 2830 citations identified, 136 were included. Most studies were in the focal epilepsy population; very few studies reported outcomes in the PGTCS population. The presence of epilepsy‐specific instruments varied based on the domain evaluated. Epilepsy exerted considerable humanistic and economic burden. Indicators of poor disease control (e.g., high seizure frequency, resistance to anti‐seizure medications, polypharmacy) increased epilepsy burden. Seizure frequency and type, disease severity, and polypharmacy also affected work productivity. Adults with epilepsy, particularly focal epilepsy, reported higher indirect costs, more sick days accrued, and early entry into retirement. Caregivers similarly reported high productivity loss and absenteeism related to caregiving duties. The results of this SLR highlight the high humanistic and economic burden of focal epilepsy and PGTCS, although limited data were available for the PGTCS population. The results include patient‐reported outcome data specific to focal epilepsy and PGTCS, expanding the limited humanistic burden evidence identified in previous reviews, and show the effect of poor disease control on individuals' lives and as a driver of indirect costs.Plain Language SummaryOur systematic literature review identified studies that evaluated the impact of focal epilepsy and primary generalized tonic–clonic seizures on patients and their caregivers. We found that focal epilepsy negatively impacted patients' mental health and sleep and was associated with higher indirect costs and lower work productivity in people with more severe disease. The impact of primary generalized tonic–clonic seizures on patients was rarely reported, and future research is needed.

Background and ObjectivesThe aim of this analysis was to evaluate the long-term safety and effectiveness of lurasidone in the treatment of schizophrenia in adolescents and young adults (13–25).MethodsThe 2 pooled studies used similar designs and outcome measures. Patients (13–25) with schizophrenia completed an initial double-blind 6-week trial of lurasidone (40 and 80 mg/day) in the adolescent trial and (80 and 160 mg/day) in the young adult trial. In open-label long-term trials, adolescent patients were treated with 20–80 mg/day lurasidone, and adults were treated with 40–160 mg/day lurasidone. Efficacy was evaluated based on the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Scale (CGI-S).ResultsThe safety population consisted of 306 patients (mean age, 16.2 years; 208 patients (68.0%) who completed 12 months of treatment; 8.2% who discontinued treatment by 12 months due to an adverse event). The mean (SD) changes in the PANSS total score from the extension baseline to months 6 and 12 were − 11.8 (13.9) and – 15.3 (15.0), respectively (OC), and the mean (SD) changes in the CGI-S score were − 0.8 (1.0) and − 1.0 (1.1), respectively (OC). The most frequent adverse events were headache (17.6%), anxiety (11.4%), schizophrenia (9.8%), and nausea (9.8%). No clinically meaningful changes were observed in weight, metabolic parameters, or prolactin.ConclusionsIn adolescents and young adults with schizophrenia, treatment with lurasidone was generally well tolerated and effective. Long-term treatment was associated with a continued reduction in symptoms of schizophrenia. Long-term treatment was associated with minimal effects on weight, metabolic parameters, and prolactin.Clinicaltrials.gov identifiers D1050234, D1050302.