Osservatorio comorbidità nei grandi anziani con Fibrillazione Atriale

La Fibrillazione Atriale (FA) è una patologia correlata all’età - colpisce il 16% degli ultra ottantacinquenni - che aumenta di circa cinque volte il rischio di ictus cerebrale. La terapia anticoagulante ha un ruolo centrale nel trattamento della FA, e la sua applicazione nel paziente anziano è ostacolata dalla presenza di comorbidità, di politerapia e dalla necessità di gestione delle possibili interazioni farmacologiche. Ulteriori elementi di difficoltà derivano dalla interazione tra diversi specialisti, dall’inerzia prescrittiva, dalla complessità del sistema di accesso alle cure e, non ultimo, anche dalle difficoltà di gestione del paziente anziano in terapia anticoagulante da parte dei caregiver familiari. Obiettivo dell’Osservatorio è stato identificare le problematiche dei pazienti con FA riguardo la gestione della terapia anticoagulante in presenza di diverse patologie e terapie concomitanti, attraverso il contributo del Board multistakeholder, dell’analisi della comunicazione on line sulla FA, nonché a due survey su medici e pazienti. È stato delineato un quadro della condizione dei pazienti anziani con FA e delle difficoltà nella gestione quotidiana della malattia, a partire dal quale sono state formulate alcune proposte di intervento rivolte ai decisori, ai clinici e in generale a tutti coloro che sono chiamati alla gestione concreta della malattia insieme a pazienti e caregive

Monitoring registries at Italian medicines agency: Fostering access, guaranteeing sustainability

Objectives: The AIFA (Agenzia Italiana del Farmaco - Italian Medicines Agency) Monitoring Registries track the eligibility of patients and the complete flow of treatments, guaranteeing appropriateness in use of pharmaceutical products, according to approved indications. Methods: This study describes the Italian pharmaceutical context and the aims and functioning of AIFA Monitoring Registries, focusing on the applications to the Managed Entry Agreements (MEAs) and HTA approaches. Results: The AIFA Monitoring Registries System has been operational in Italy since 2005. In 2012, the system became part of the NHS Information Technology system, aiming at enhancing appropriate use of pharmaceuticals and efficiency of the administrative activity. Currently, seventy-six medicines are monitored through the system, corresponding to fifty-eight therapeutic indications; individual treatments recorded are more than 515,000, for a population of approximately 505,000 patients. For each monitored product, patients eligible for treatment are registered in the specific therapeutic indication dynamic monitoring database to collect epidemiologic and clinical data, including data on the safety profile, and ex-post information missing at first evaluation stage. Conclusions: AIFA Monitoring Registries allow the evaluation of the pharmaceuticals' performance in clinical practice and may promote innovation and quicker access to medicines at affordable prices, for the benefit of patients

Ibogaine reduces organ colonization in murine systemic and gastrointestinal Candida albicans infections

In the present study the effect of the indole alkaloid ibogaine on the in vitro lipolytic activity and adherence to epithelial cells of Candida albicans was investigated. The substance was administered intraperitoneally at a dose of 5 mg kg(-1) day(-1) in mice with disseminated and gastrointestinal C. albicans infections. Ibogaine significantly decreased the rate of mortality and the number of C. albicans c.f.u. recovered from the kidney, liver and spleen. Ibogaine interfered with the early stages of both disseminated and gastrointestinal C. albicans infections but did not reduce the number of C. albicans c.f.u. in the organs at the late phase of infections. The development of a specific immune response was not influenced by ibogaine, since the delayed-type hypersensitivity reaction to C. albicans and the production of interferon (IFN)-gamma were similar in control and ibogaine-treated mice. The combined use of amphotericin B plus ibogaine in the treatment of mice with gastrointestinal infection reduced organ colonization more strongly than each substance alone

Pricing and reimbursement experiences and insights in the EU and US: Lessons learned to approach adaptive payer pathways.

Earlier patient access to beneficial therapeutics that address unmet need is one of the main requirements of innovation in global healthcare systems– already burdened by unsustainable budgets. ‘Adaptive pathways’ (1), encompass earlier cross-stakeholder engagement, regulatory tools, and iterative evidence generation through the life cycle of the medicinal product. A key enabler of earlier patient access is through more flexible and adaptive payer approaches to pricing and reimbursement that reflect the emerging evidence generated

Insights Into the Concept of Rheumatoid Arthritis Flare

Identification of a pathological change in the course of systemic chronic immune-inflammatory diseases is key to delivering effective treatment strategies. In this context, one of the most compelling issues is the concept of flare. The multifaceted expression of disease activity in rheumatoid arthritis (RA) makes it challenging to provide an omni-comprehensive definition of flare, encompassing the pathology's different objective and subjective domains. Our incomplete understanding of the pathophysiological mechanisms underlying this process contributes to the partial comprehension of its potential clinical expression. This review focuses on the proposed pathophysiological processes underlying disease recrudescence in RA and the variable definitions adopted to capture flare in clinical practice through its objective, subjective, and temporal domains. Overall, what emerges is a complex landscape far from being unraveled

Disease-related malnutrition in outpatients with systemic sclerosis.

Disease-related malnutrition is known to negatively affect clinical outcomes. The aim of the present study was to evaluate the prevalence of malnutrition in a cohort of outpatients affected by Systemic Sclerosis (SSc) and its association with clinical variables.One hundred sixty SSc patients were consecutively evaluated. The following clinical variables were assessed: disease duration, activity and severity, treatments, functional status, gastrointestinal involvement. Nutritional assessment included: body mass index (BMI), weight loss (WL) history, nutritional intakes and serum prealbumin. Malnutrition was defined as BMI <20 kg/m² and/or previous 6-month WL ≥ 10\%.Prevalence of malnutrition was 15\% (10-21\%). Logistic regression showed that malnutrition was independently associated with disease activity (OR 3.72; p < 0.001) and low serum prealbumin (OR 8.58; p < 0.001). The association with gastrointestinal involvement was not statistically significant, although a trend was detected (OR 1.88).Malnutrition is common in SSc outpatients. It appears associated with disease activity and not influenced by nutritional intakes; gastrointestinal involvement might contribute to its development over time. Serum prealbumin could be an early marker of malnutrition in SSc, whose role should be confirmed by further longitudinal investigations. Prospective studies are also required to clarify the clinical significance of the association between malnutrition and disease activity in SSc