Search Results for: Guida pratica all’uso farmaci ipoglicemizzanti inclusi nella Nota 100 AIFA

Clinical presentation The patient was a 36-year-old man, who had a 4-year history of ulcerative colitis (UC), for which he had received mesalazine, oral prednisolone and infliximab, neither of which had any long-lasting therapeutic benefit. This patient was admitted to our hospital with skin lesions, abdominal pain and diarrhoea. Two types of skin lesions were evident. First, one well-demarcated superficial ulcer, covered by yellow secretions and surrounded by a purple halo, was seen over the patient’s left knee region (figure 1A). Second, on the patient’s face (figure 1B) and trunk (figure 1C), there was a polymorphic rash consisting of open comedones, papules and some deeply set cysts, in association with numerous hyperpigmented scars. He was treated with minocycline 100 mg/day for 2 months, with no benefit. The lesions responded to treatment with prednisolone (40 mg/day), but recurred as soon as prednisolone was tapered below…

Background
Lesion size is an independent risk factor for recurrence following endoscopic mucosal resection of large (≥20 mm) non-pedunculated colorectal polyps. Post-resection margin thermal ablation (MTA) reduces the risk of recurrence. Its impact on the uncommon larger (≥40 mm) lesions is unknown.

Objective
We sought to analyse the impact of MTA on ≥40 mm lesions in a large, prospective cohort.

Design
A prospective cohort of patients with colorectal polyps ≥20 mm treated with piecemeal endoscopic mucosal resection in an expert tissue resection centre was divided into three phases: ‘pre-MTA’, July 2009–June 2012; ‘MTA-adoption’, July 2012–June 2017 and ‘standardised-MTA’, July 2017–July 2023. Recurrence was defined as adenomatous tissue endoscopically and/or histologically detected at the first surveillance colonoscopy. The primary outcome was the recurrence rate over the three time periods in three size groups: 20–39 mm, 40–59 mm and ≥60 mm.

Results
Over 14 years until July 2023, 1872 sporadic colorectal polyps ≥20 mm in 1872 patients underwent endoscopic mucosal resection (median lesion size 35 mm (IQR 25–45mm)). Of these, 1349 patients underwent surveillance colonoscopy at a median of 6 months (IQR 4–8 months). The overall rates of recurrence in the pre-MTA, MTA-adoption and standardised-MTA phases were 13.5% (n=42/310), 12.6% (n=72/560) and 2.1% (n=10/479), respectively, (p≤0.001). When MTA was applied in the standardised-MTA phase, the rate of recurrence was the same among 20–39 mm (1.5% (3/205)), 40–59 mm (1.6% (3/190)) and ≥60 mm polyps (1.4% (1/73)) (p=1.00).

Conclusion
MTA negates the effect of size on the incidence of recurrence after piecemeal endoscopic mucosal resection of colorectal polyps ≥40 mm.

Trial registration number
Australian Colonic Endoscopic Resection cohort (NCT01368289; NCT02000141).

Circulation, Ahead of Print. BACKGROUND:Despite reported racial disparities between Black and White adults in short-term outcomes after abdominal aortic aneurysmal intervention, there is a paucity of literature aimed at understanding long-term disparities. The present study aims to characterize racial disparities in long-term outcomes, perioperative outcomes, and health care use after endovascular aortic aneurysm repair.METHODS:We conducted a retrospective cohort study from 2011 to 2019 with outcome assessment through 2020. Using a 100% sample of national Medicare data, we identified beneficiaries ≥66 years of age who underwent intact infrarenal endovascular aortic aneurysm repair. The primary outcome was a composite of endovascular or open aortic reintervention, late aneurysm rupture, and all-cause mortality. Secondary outcomes included other reinterventions, perioperative outcomes, and annual rates of health care use.RESULTS:A cohort of 107 636 Black (3.9%) and White (96.1%) beneficiaries was identified. The cumulative incidence of the primary outcome was 72.9% (95% CI, 71.8%–73.9%) in White patients versus 80.0% (95% CI, 76.4–83.0) in Black patients (P

Stroke, Ahead of Print. BACKGROUND:While interindividual variations in concentration and function of coagulation cascade proteins are established risk factors for venous thromboembolism (VTE), their associations with arterial ischemic stroke are less well defined.METHODS:We identified and validated genetic proxies for lifelong, randomized perturbations of coagulation cascade proteins in genome-wide association studies of circulating protein levels (deCODE, n=35 559; UK Biobank, n=46 218) and of VTE risk (81 190 cases and 1 419 671 controls). Study participants were all of European ancestry. We performed 2-sample Mendelian randomization and colocalization analyses to test associations of these genetic proxies with risk of ischemic stroke (62 100 cases and 1 234 808 controls from the GIGASTROKE consortium) and ischemic stroke subtypes, and further contextualized associations with VTE and secondary efficacy and safety outcomes.RESULTS:We identified genetic proxies for 30 coagulation factors, with cross-trait associations recapitulating canonical coagulation biology. Mendelian randomization and colocalization analyses supported causal associations of genetically proxied levels of 5 proteins with risk of ischemic stroke, with all proteins associating with the cardioembolic stroke subtype: factor XI (odds ratio [OR] of cardioembolic stroke per 1-SD increase, 1.31 [95% CI, 1.19–1.44];P=3.30×10−8), high-molecular-weight kininogen (OR, 1.19 [95% CI, 1.09–1.30];P=7.79×10−5), prothrombin (OR, 1.83 [95% CI, 1.31–2.57];P=4.20×10−4), soluble PROCR (protein C receptor; OR, 0.88 [95% CI, 0.82–0.95];P=6.19×10−4), and γ′ fibrinogen (OR per doubling in VTE risk due to lower γ′ fibrinogen levels, 1.44 [95% CI, 1.25–1.66];P=3.96×10−7). γ′ Fibrinogen and prothrombin also associated with large artery atherosclerotic stroke, and no proteins were associated with small vessel stroke risk. By contrast, genetic proxies for several coagulation factors (including proteins C and S and factors V and VII) showed selective associations with VTE.CONCLUSIONS:These data highlight specific coagulation cascade components implicated in ischemic stroke pathogenesis, while identifying proteins with distinct roles in VTE. These findings may inform development of novel anticoagulants and optimize their use in targeted populations with stroke.

Carta valoriale per chi si prende cura degli altri

A rischio settore dei farmaci generici-equivalenti e biosimilari

Stroke, Ahead of Print. BACKGROUND:Recent randomized control trials have demonstrated the efficacy and safety of middle meningeal artery embolization (MMAE) as an adjunct to conventional management for patients with nonacute subdural hematoma (SDH); however, a large majority of trial participants received surgical evacuation as part of the standard of care. Thus, the efficacy and safety of standalone MMAE compared with conservative management (CM) for patients with nonsurgical SDH are unclear.METHODS:This was a retrospective cohort study of the 2019 to 2021 Nationwide Readmissions Database in the United States. Patients with nonsurgical nontraumatic SDH were identified, and MMAE patients were matched with similar CM patients using propensity score matching calculated from demographics, comorbidities, and initial hospitalization outcomes. Patients were followed up to 300 days. The primary end point was composite surgical rescue or death, and secondary end points included surgical rescue and all-cause mortality by 180 days.RESULTS:24 465 patients with nonsurgical nontraumatic SDH were identified; 2228 (9.1%) underwent MMAE. After propensity score matching, 6675 patients remained in the CM group and 2217 in the MMAE group. At 180 days, MMAE patients had a significantly lower risk of surgery or death compared with CM (8.2% versus 10.9%; relative risk, 0.75 [95% CI, 0.59–0.96];P=0.022) and lower risk of death (1.1% versus 3.0%; relative risk, 0.38 [95% CI, 0.17–0.86];P=0.020). Rates of surgical rescue among MMAE and CM patients at 180 days were similar (7.1% versus 8.4%; relative risk, 0.85 [95% CI, 0.63–1.14];P=0.27). Time-to-event analyses for the entire 300-day study follow-up period confirmed that while MMAE was associated with a lower cumulative risk of all-cause mortality (hazard ratio, 0.55 [95% CI, 0.35–0.87];P=0.010), it was not associated with a different risk of surgical rescue (hazard ratio, 1.00 [95% CI, 0.76–1.31];P=1.00).CONCLUSIONS:Standalone MMAE may be beneficial for patients with nonsurgical nontraumatic SDH by reducing the long-term risk of all-cause mortality.

Introduction
Effective glucose control in surgical patients at risk of hyperglycaemia and hypoglycaemia is crucial, as these conditions can lead to surgical site infections, prolonged hospital stays and death. Fingerstick glucose monitoring (FSGM), the standard measurement of glucose, can be painful for patients and time-consuming for nursing staff, especially with hourly monitoring around surgery. Continuous glucose monitoring systems (CGMS) offer a less invasive alternative with better glucose regulation in outpatients.
The GLUCOSENS study compares the effects of CGMS and FSGM on point-of-care measurements and time-in-range (3.9–10.0 mmol/l) glucose levels (primary outcome), patient satisfaction and experience and nursing staff workload and experience in surgical wards. Furthermore, it evaluates CGMS accuracy during perioperative periods and medical imaging.

Methods and analysis
This Danish two-centre study will be conducted at the general surgical wards of Odense and Zealand University Hospital and will involve 305 patients over 18 months. The study is divided into three periods: first, a standard care period with point-of-care FSGM (110 patients); second, an intervention period with point-of-care CGMS (110 patients); third, another standard care period with point-of-care FSGM combined with a blinded sensor for comparing continuous glucose data from this period with continuous glucose data from the intervention period (85 patients). Furthermore, the study will include 24 nursing staff.
Data will be collected through medical file reviews on glucose levels, patient satisfaction questionnaires, a patient field study, an observation study of the nursing staff’s workload and qualitative interviews of nursing staff.

Ethics and dissemination
The study is registered with the Records of Processing Activities in the Region of Southern Denmark for research and quality projects (ID number: 23/36734) and has been approved by the Regional Scientific Ethical Committee in Southern Denmark (ID number: S-20240041). The results will be published in international peer-reviewed journals.

Trail registration number
ClinicalTrials.gov Registry (NCT06473480)

Objective
To assess HIV testing and status disclosure rates and explore their associated predictors among young adolescents (10–17 years) who received health education through the Orphans and Vulnerable Children programme in Nimule, South Sudan.

Design
A pre–post evaluation study with data collected at baseline (December 2020) and at the endline (December 2022).

Setting
The study was conducted in Nimule, a densely populated periurban town characterised by high HIV prevalence and substantial cross-border movement between Uganda and South Sudan, making it a relevant setting for an HIV prevention project.

Intervention
The primary intervention was HIV risk education delivered through forty peer-led health clubs. Adolescents were screened for HIV risk factors and referred for HIV and other sexually transmitted infection testing at health facilities.

Participants
The study included young adolescents aged 10–17 years recruited from HIV-affected households within 17 neighbourhoods in Nimule periurban town. Informed consent was obtained from both caregivers and adolescents.

Primary and secondary outcome measures
The primary outcome was self-reported HIV testing and status disclosure. Binary logistic regression was used to assess the association between the study outcome variables and associated sociodemographic factors.

Results
A total of 557 (73.0%) of the 768 enrolled adolescents were surveyed at baseline and endline, including 301 (54.0%) females and 276 (46.0%) males. The median age was 14 years (IQR: 11–16) at baseline and 15 years (IQR: 12–17) at endline.
HIV testing increased from 315 (56.7%) at baseline to 557 (100%). The odds of undisclosed HIV status were 49% lower at endline adjusted OR (aOR) 0.51 (95% CI 0.92, 0.67; p

Cattani, serve una risposta politica ai dazi, siamo in una posizione di forza

Stroke, Ahead of Print. BACKGROUND:The VIPS (Vascular Effects of Infection in Pediatric Stroke) II prospective cohort study aimed to better understand published findings that common acute infections, particularly respiratory viruses, can trigger childhood arterial ischemic stroke (AIS). The COVID-19 pandemic developed midway through enrollment, creating an opportunity to assess its impact.METHODS:Twenty-two sites (North America, Australia) prospectively enrolled 205 children (aged 28 days to 18 years) with AIS from December 2016 to January 2022, including 100 cases during the COVID-19 pandemic epoch, defined here as January 2020 to January 2022. To assess background rates of subclinical infection, we enrolled 100 stroke-free well children, including 39 during the pandemic. We measured serum SARS-CoV-2 nucleocapsid total antibodies (present after infection, not vaccination; half-life of 3–6 months). We assessed clinical infection via parental interview.RESULTS:The monthly rate of eligible AIS cases declined from spring through fall 2020, recovering in early 2021 and peaking in the spring. The prepandemic and pandemic cases were similar except pandemic cases had fewer clinical infections in the prior month (17% versus 30%;P=0.02) and more focal cerebral arteriopathy (20% versus 11%;P=0.09). Among pandemic cases, 26 of 100 (26%) had positive antibodies, versus 4 of 39 (10%) of pandemic-era well children (P=0.04). The first SARS-CoV-2 positive case occurred in July 2020. Ten of the 26 (38%) positive cases had a recent infection by parental report, and 7 of those 10 had received a diagnosis of COVID-19. Only 1 had multisystem inflammatory syndrome in children. Median (interquartile range) nucleocapsid IgG total levels were 50.1 S/CO (specimen to calibrator absorbance ratio; 26.9–95.3) in the positive cases and 18.8 (12.0–101) in the positive well children (P=0.33).CONCLUSIONS:The COVID-19 pandemic may have had dual effects on childhood AIS: an indirect protective effect related to public health measures reducing infectious exposure in general, and a deleterious effect as COVID-19 emerged as another respiratory virus that can trigger childhood AIS.

Dalla scuola al welfare aziendale fino alla vita nei borghi

Background and objective
In a drive-the-doctor (DD) paradigm, an interventionalist travels from a comprehensive stroke centre (CSC) to primary stroke centres (PSCs) to perform endovascular thrombectomy (EVT) for acute ischaemic stroke due to large vessel occlusion (LVO). The DD paradigm may reduce time delays from onset to recanalisation. This study aimed to analyse the cost-effectiveness of the DD paradigm versus a drip-and-ship (DS) paradigm, where LVO patients are transferred from PSCs to a CSC for EVT in the northern Netherlands.

Design
Economic evaluation was performed using a simulation model combined with a decision tree and a Markov model.

Setting
Stroke centres in the northern Netherlands.

Participants
A hypothetical cohort of 100 000 LVO patients with an average age of 70 years.

Interventions
Two strategies were tested, including the DD paradigm with one upgraded PSC and the DD paradigm with two upgraded PSCs.

Main outcome measures
Total costs and quality-adjusted life years (QALYs) were measured over a 15-year time horizon from a Dutch healthcare provider perspective. An incremental cost-effectiveness ratio (ICER) of 50 000 was used as a willingness-to-pay threshold. One-way sensitivity, probabilistic sensitivity and scenario analyses (interventionalist transportation by car, ambulance and helicopter) were conducted to examine parameter uncertainty.

Results
The DD paradigm using car as a transport modality and two PSCs was the optimal strategy, resulting in the lowest ICER. This strategy provided an additional 0.13 QALYs at incremental costs of 2367, yielding an ICER of 18 306 compared with current practice. The DD paradigm with two PSCs reduced ICERs compared with the scenario with one PSC when varying transportation modalities (car, ambulance and helicopter). Probabilistic sensitivity analyses showed that the DD paradigm with two PSCs using car was preferred in 72% of 10 000 Monte Carlo simulations.

Conclusions
The DD paradigm appeared cost-effective for LVO patients and may be considered a promising evolution for a regional stroke network.

Objectives
To describe temporal trends in hospitalisation episodes for venous thromboembolic events (VTEs) in England, and compare hospitalisation rates for pulmonary emboli (PEs) and deep vein thrombosis (DVT).

Methods
Retrospective observational study.

Setting
Secondary care in England, UK, between April 1998 and March 2022.

Participants
Individuals with hospitalisations for VTE recorded in the NHS Digital Hospital Episode Statistics dataset.

Primary and secondary outcomes
The primary outcome was temporal trends in hospitalisation episodes for PE, DVT and VTE overall between 1 April 1998 and 31 March 2022. Secondary outcomes included the proportion of all-cause hospital admissions that were due to VTE; the proportion of all VTE hospitalisations that were recorded as primary admission diagnoses; the male/female split in hospitalisation episodes for VTE; and temporal changes in hospitalisation rates by age.

Results
Between 1998 and 2022, hospitalisations for VTE increased by 62.6%, from 109.5 to 178.1 per 100 000 population. This was driven by a 202% increase in hospitalisations for PE (from 40.4 to 122.2 per 100 000 population). In contrast, hospitalisations for DVT decreased by 19.1% over this period (from 69.1 to 55.9 per 100 000 population). Overall, VTE remained stable as a proportion of all-cause hospital admissions between 1998/1999 and 2019/2020 (0.45% and 0.43%, respectively), before increasing after the onset of the COVID-19 pandemic in England (0.59% in 2020/2021 and 0.51% in 2021/2022).

Conclusion
Hospitalisations for VTE increased markedly in England between 1998 and 2022, driven by large increases in hospitalisations for PE. In contrast, hospitalisations for DVT decreased overall, which may reflect the success of primary care DVT management pathways. Our findings suggest that preventative measures are needed to reduce the incidence of hospitalisations for PE.

Objectives
Early evaluation and treatment of patients with acute chest pain pose a massive challenge to the emergency care system worldwide. This study aims to determine the current burden and early management of acute chest pain presenting to the emergency departments (EDs) in China.

Design
The Evaluation and Management of Patients with Acute ChesT pain study is a prospective, multicentre and provincially representative registry of acute chest pain patients in Chinese EDs.

Setting
A stratified random sampling design generated the province representative sample of 21 public hospitals with independent EDs in Shandong, China. Each participating site consecutively enrolled patients for at least 12 months from August 2015 to September 2017.

Participants
A total of 8349 adult patients presenting with acute chest pain or suspected acute coronary syndrome (ACS) were included.

Primary outcome measures
The annual incidence of ED-assessed acute chest pain was estimated. The aetiology, process of care and 30-day major adverse cardiac events (MACE) of included patients were analysed.

Results
The estimated annual incidence of ED-assessed acute chest pain was 96.6 (95% CI 95.9 to 97.3) per 100 000 adults, significantly increasing with age. The mean age of included patients was 63.8 years, with 57.9% males. Prehospital delay was a median of 2.8 (IQR, 1.2–10.3) hours, with 17.9% transported by ambulance. About 75.6% of patients received their first ECG within 10 min. Cardiac troponin was tested in 54.2%, with high-sensitivity cardiac troponin in 24.5% and serial troponins in 5.1% during the ED stay. Most (74.0%) were admitted to the inpatient ward, with a median ED stay of 65.0 (IQR, 27.0–385.0) min. Within 30 days, 6.8% experienced MACE. Among included patients, 62.9% were diagnosed with ACS, with specific management varying by ST-segment elevation status.

Conclusions
China’s first regionally representative registry of acute chest pain revealed a lower incidence of ED-assessed cases but a higher proportion of high-risk patients compared with other countries. Gaps persist in aligning emergency management with guidelines. More programmes and policies are needed to enhance the quality of acute chest pain care in China.

Trial registration number
This study was registered at URL: https://www.clinicaltrials.gov (NCT02536677).