Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee

Background To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). Methods The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI. Results A total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI. Conclusions We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies

La diagnosi elettrocardiografica di infarto miocardico acuto nell'era dell'angioplastica primaria e delle reti hub and spoke

A più di 100 anni dalla sua invenzione, l’ECG standard sta vivendo un vero e proprio “rinascimento”. Per quanto riguarda la cardiopatia ischemica acuta, il fenomeno è dovuto, soprattutto, alla disponibilità di grandi database in cui le caratteristiche elettrocardiografiche di migliaia di pazienti sono raccolte in maniera ordinata e predefinita e sono affiancate, e quindi correlabili, alle caratteristiche cliniche e coronarografiche e ai dati di outcome. La presente rassegna analizza criticamente il ruolo diagnostico dell’ECG standard nelle sindromi coronariche acute con (STEMI) e senza (NSTEMI) sopraslivellamento del tratto ST, con particolare attenzione ai possibili trabocchetti interpretativi e a quelle caratteristiche del tracciato in grado di contribuire a orientare le decisioni terapeutiche. Di fronte al paziente con presentazione clinica suggestiva per infarto miocardico acuto, l’ECG può aiutare a dare una risposta a molte domande. In caso di sospetto STEMI: siamo sicuri di poter escludere che sia in atto un infarto? (il problema dei falsi negativi); siamo sicuri che sia un vero infarto e non un falso positivo? Qual è la coronaria ostruita e a quale livello? Si è verificata riperfusione miocardica? In caso di sospetto NSTEMI: siamo sicuri che sia un vero infarto miocardico acuto (piuttosto che un’embolia polmonare o una dissezione aortica)? Siamo sicuri che sia in atto un NSTEMI piuttosto che uno STEMI dorsale “mascherato”? Quale substrato coronarico e quale grado di estensione dell’ischemia sono ipotizzabili in questo paziente? In particolare è presente un substrato a rischio molto alto, tale da suggerire un approccio invasivo in emergenza

Intravenous Iron Replacement Therapy Improves Cardiovascular Outcomes in Hemodialysis Patients

BACKGROUND/AIM: More than half of deaths among hemodialysis patients are due to cardiovascular disease. This study examined whether intravenous administration of ferric carboxymaltose (FCM) has an impact on cardiovascular events in iron-deficient hemodialysis patients. PATIENTS AND METHODS: We performed a retrospective study concerning patients undergoing hemodialysis in our center from September 2016 to December 2019. We identified those who began FCM therapy (FCM group) during this period and those who did not (control group). We analyzed clinical, echocardiographic and laboratory parameters at the beginning (t0) and after one year (t1), to detect differences between the two groups. RESULTS: We identified 53 patients for the FCM group and 19 for the control group. Median follow-up was 1 year±3 months for both groups. In the FCM group, we observed a reduction in the doses of erythropoiesis-stimulating agents (ESA) (p<0.001) and a significative difference in cardiovascular events (p<0.01), but no differences in echocardiographic parameters. CONCLUSION: Patients who received FCM reached satisfactory values of transferrin saturation and ferritin, presented fewer coronary artery events and cardiovascular events, and could reduce doses of ESA

Understanding Factors Associated With Psychomotor Subtypes of Delirium in Older Inpatients With Dementia

Objectives: Few studies have analyzed factors associated with delirium subtypes. In this study, we investigate factors associated with subtypes of delirium only in patients with dementia to provide insights on the possible prevention and treatments. Design: This is a cross-sectional study nested in the “Delirium Day” study, a nationwide Italian point-prevalence study. Setting and Participants: Older patients admitted to 205 acute and 92 rehabilitation hospital wards. Measures: Delirium was evaluated with the 4-AT and the motor subtypes with the Delirium Motor Subtype Scale. Dementia was defined by the presence of a documented diagnosis in the medical records and/or prescription of acetylcholinesterase inhibitors or memantine prior to admission. Results: Of the 1057 patients with dementia, 35% had delirium, with 25.6% hyperactive, 33.1% hypoactive, 34.5% mixed, and 6.7% nonmotor subtype. There were higher odds of having venous catheters in the hypoactive (OR 1.82, 95% CI 1.18-2.81) and mixed type of delirium (OR 2.23, CI 1.43-3.46), whereas higher odds of urinary catheters in the hypoactive (OR 2.91, CI 1.92-4.39), hyperactive (OR 1.99, CI 1.23-3.21), and mixed types of delirium (OR 2.05, CI 1.36-3.07). We found higher odds of antipsychotics both in the hyperactive (OR 2.87, CI 1.81-4.54) and mixed subtype (OR 1.84, CI 1.24-2.75), whereas higher odds of antibiotics was present only in the mixed subtype (OR 1.91, CI 1.26-2.87). Conclusions and Implications: In patients with dementia, the mixed delirium subtype is the most prevalent followed by the hypoactive, hyperactive, and nonmotor subtype. Motor subtypes of delirium may be triggered by clinical factors, including the use of venous and urinary catheters, and the use of antipsychotics. Future studies are necessary to provide further insights on the possible pathophysiology of delirium in patients with dementia and to address the optimization of the management of potential risk factors