Comparative Effectiveness of Biosimilar, Reference Product and Other Erythropoiesis-Stimulating Agents (ESAs) Still Covered by Patent in Chronic Kidney Disease and Cancer Patients: An Italian Population-Based Study

Background Since 2007 biosimilars of erythropoiesis-stimulating agents (ESAs) are available on the Italian market. Very limited post-marketing data exist on the comparative effectiveness of biosimilar and originator ESAs. Aim This population-based study was aimed to compare the effects of biosimilars, reference product and other ESAs still covered by patent on hemoglobinemia in chronic kidney disease (CKD) and cancer patients in a Local Health Unit (LHU) from Northern Italy. Methods A retrospective cohort study was conducted during the years 2009-2014 using data from Treviso LHU administrative database. Incident ESA users (no ESA dispensing within 6 months prior to treatment start, i.e. index date (ID)) with at least one hemoglobin measurement within one month prior to ID (baseline Hb value) and another measurement between 2nd and 3rd month after ID (follow-up Hb value) were identified. The strength of the consumption (as total number of defined daily dose (DDD) dispensed during the follow-up divided by days of follow-up) and the difference between follow-up and baseline Hb values [delta Hb (ΔHb)] were evaluated. Based on Hb changes, ESA users were classified as non-responders (ΔHb≤0 g/dl), responders (0Delta;Hb≤2 g/dl), and highly responders (ΔHb>2 g/ dl). A multivariate ordinal logistic regression model to identify predictors for responsiveness to treatment was performed. All analyses were stratified by indication for use and type of dispensed ESA at ID. Results Overall, 1,003 incident ESA users (reference product: 252, 25.1%; other ESAs covered by patent: 303, 30.2%; biosimilars: 448, 44.7%) with CKD or cancer were eligible for the study. No statistically significant difference in the amount of dose dispensed during the follow-up among biosimilars, reference product and other ESAs covered by patent was found in both CKD and cancer. After three months from treatment start, all ESAs increased Hb values on average by 2g/dl. No differences in ΔHb as well as in frequency of non-responders, responders and highly responders among different types of ESAs were observed in both indications of use. Overall, around 15-20% of ESA users were non-responders. Strength of treatment, but no type of dispensed ESAs was found to be predictor of responsiveness to treatment. Conclusions No difference on the effects on hemoglobinemia among users of either biosimilars or reference product or ESAs covered by patent was observed in a general population from Northern Italy, despite a comparable dispensed dose of the different ESAs during the first three months of treatment

Burden of disease, healthcare pathways and costs of cardiovascular high-risk patients with type 2 diabetes: a real world analysis:

Objective: To estimate the burden of disease and to describe healthcare pathways and costs of type-2diabetes (DMT2) patients at high cardiovascular risk (HRCV). Methods: A real-world analysis was performed by using a subset of the AR-CO database, containing administrative health data of >4.3 million of inhabitants. A cohort of adult patients with DMT2 and HRCV was selected in 2013, and followed for 1 year. Through this period, information on antidiabetic and cardiovascular therapies, other co-treatments, hospitalisations, and outpatient services, was collected and analysed. The costs associated with each variable were assessed to estimate the integrated health care expenditure. Results: Overall, 7,167 patients with DMT2 and HRCV were identified, corresponding to 3.1% of all diabetic patients and 0.2% of adult population. During the 1-year follow-up, 90.1% of the cohort received at least a prescription of an antidiabetic drug, 98.0% of a cardiovascular medication and 95.9% used at least an outpatient service. 44.5% had an admission during the follow-up period, especially for cardiovascular events. The integrated cost analysis showed that the overall average cost for each subject was € 13,567. Hospitalisations generated 86.8% of this expenditure, followed by drugs (7.7%) and by outpatient services (5.5%). Conclusions: Although patients with DMT2 and HRCV represent a small percentage of the overall population with diabetes, they generate very high costs for National Healthcare System. These costs are mainly due to the hospitalisations, especially for cardiovascular events. New therapeutic strategies involving these patients should allow reduction of hospital admission, resulting in savings for National Healthcare System

Local and transboundary transmission of methicillin-resistant Staphylococcus aureus sequence type 398 through pig trading

Livestock-associated methicillin-resistant Staphylococcus aureus sequence type (ST) 398 (LA-MRSA ST398) is a genetic lineage for which pigs are regarded as the main reservoir. An increasing prevalence of LA-MRSA ST398 has been reported in areas with high livestock density throughout Europe. In this study, we have investigated the drivers contributing to the introduction and spread of LA-MRSA ST398 along the pig farming system in Southern Italy. Whole-genome sequencing (WGS) of LA-MRSA ST398 isolates collected in 2018 from pigs (n=53) and employees (n=14) from 10 farms in the Calabria region were comparatively analysed with previously published WGS data from Italian ST398 isolates (n=45), an international ST398 reference collection (n=89) and isolates from Danish pigs farms (n=283), which are the main suppliers of pigs imported to Italy. Single-nucleotide polymorphisms (SNP) were used to infer isolates relatedness and, together with data from animal trading, factors contributing to LA-MRSA ST398 dissemination were identified. The analyses support the existence of two concurrent pathways for the spread of LA-MRSA ST398 in Southern Italy: i) multiple introductions of LA-MRSA ST398 through the import of colonized pigs from other European countries including Denmark and France and; ii) the spread of distinct clones dependent on local trading of pigs between farms. Phylogenetically related Italian and Danish LA-MRSA ST398 isolates shared extensive similarities including carriage of antimicrobial resistance genes. Our findings highlight the potential risk of transboundary transmission of antimicrobial-resistant bacterial clones with a high zoonotic potential when importing pigs from countries with high LA-MRSA prevalence

Introduzione al volume "La pesca in Campania e Sicilia. Aspetti storici"

la pesca nel Mediterraneo: aspetti e problem

DISC HERNIATION POSTERIOR TO THE DURAL SAC

Generally speaking, when herniation occurs the free fragment of the extruded disc tends to migrate towards the anterior lumbar canal in a median, paramedian and/or intraforaminal location above or below the level of the disc spac