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To evaluate and compare the incidence of cardiovascular (CV) events in a large contemporary cohort of patients diagnosed with prostate cancer (PCa) and in treatment with GnRH agonists or GnRH antagonists. An Italian observational retrospective cohort study based on administrative databases of three local health units and two Regions was performed. PCa patients treated with GnRH agonists or antagonist were included between January 01, 2013 and December 31, 2016. Index date (ID) was the date of first GnRH agonist/antagonist prescription during inclusion period. Follow-up was from ID to December 31, 2017. Patients were excluded if they were under abiraterone treatment or combination therapy with antiandrogens during follow-up. The incidence rate of CV events (acute myocardial infarction, ischemic heart diseases, cerebrovascular diseases, cardiac dysrhythmias, heart failure, atherosclerosis, aneurism, other CV-related conditions) was calculated among patients not switching to androgen deprivation therapy (ADT) in the overall cohort and in a sub-cohort of patients without previous CV events. In total, 9785 (mean age 76.8 ± 8.5) patients were included: 9158 (93.6%) were treated with a GnRH agonist and 627 (6.4%) with a GnRH antagonist. Of them, 9627 did not switch to ADT and were considered in the analyses. The incidence of CV events was significantly higher in patients treated with GnRH agonists rather than antagonists (8.8 vs 6.2, p=0.002). Mean time to CV event was beyond 1 year of treatment in both groups. In the multivariable regression analysis, the risk of experiencing CV events was significantly lower in patients treated with GnRH antagonist rather than those treated with GnRH agonists [HR (95% CI): 0.76 (0.60-0.95), p=0.018]. These findings were confirmed in the sub-cohort of patients without previous CV events. This Italian observational study shows that most patients received a GnRH agonist rather than a GnRH antagonist prescription. GnRH antagonist seems to have a better CV risk profile than GnRH agonist, both in patients with and without a history of CV events.

INTRODUCTION This study assessed real‐world use of diagnostic tests, such as neuroimaging (e.g., magnetic resonance imaging [MRI], or positron emission tomography [PET]), and computed tomography (CT), cerebrospinal fluid (CSF) biomarker, and blood tests for mild cognitive impairment (MCI), Alzheimer's disease (AD), and other dementias in a large US elderly population. METHODS Medicare fee‐for‐service data (2015–2020) were used to identify patients aged ≥ 67 newly diagnosed with MCI, AD, or other dementias. Descriptive analyses were conducted to understand the test use within 1 year before disease diagnosis and trends. RESULTS Among 653,420 patients (9.1% MCI, 30.3% AD, 60.6% other dementias), 71.9% had blood tests, 53.9% neuroimaging (46.4% CT, 17.7% MRI, and 0.7% PET), and 2.2% CSF test. Test use slightly increased from 2015 to 2020. DISCUSSION Findings from this study suggest low use of diagnostic tests, especially PET and CSF. Highlights Blood tests, magnetic resonance imaging, and computed tomography were predominant for diagnosing mild cognitive impairment, Alzheimer's disease, or other dementias prior to the arrival of disease‐modifying therapies. Cerebrospinal fluid biomarker and positron emission tomography tests were infrequently used despite their diagnostic value. The study indicates a modest increase in diagnostic test usage over 6 years between 2015 and 2020. Patients often received combined or repeated diagnostic tests.

To describe the characteristics, management and outcomes of hospitalised patients with Clostridioides difficile infection (CDI) treated with and without fidaxomicin. This prospective, multicentre, observational study (DAFNE) enrolled hospitalised patients with CDI, including 294 patients treated with fidaxomicin (outcomes recorded over a 3-month period) and 150 patients treated with other CDI therapies during three 1-month periods. The primary endpoint was baseline and CDI characteristics of fidaxomicin-treated patients. At baseline, the fidaxomicin-treated population included immunocompromised patients (39.1%) and patients with severe (59.2%) and recurrent (36.4%) CDI. Fidaxomicin was associated with a high rate of clinical cure (92.2%) and low CDI recurrence (16.3% within 3 months). Clinical cure rates were ≥90% in patients aged ≥65 years, those receiving concomitant antibiotics and those with prior or severe CDI. There were 121/296 (40.9%) patients with adverse events (AEs), 5.4% with fidaxomicin-related AEs and 1.0% with serious fidaxomicin-related AEs. No fidaxomicin-related deaths were reported. Fidaxomicin is an effective and well-tolerated CDI treatment in a real-world setting in France, which included patients at high risk of adverse outcomes. Trial registration: Description of the use of fidaxomicin in hospitalised patients with documented Clostridium difficile infection and the management of these patients (DAFNE), NCT02214771, www.ClinicalTrials.gov.

Background and Aim The efficacy of sofosbuvir (SOF)‐based regimens in the treatment of chronic hepatitis C (HCV) patients with and without human immunodeficiency virus (HIV) co‐infected patients in real‐world setting is limited. Methods This was a retrospective cohort study, conducted between 1 January 2017 and 31 December 2021 at Bamrasnaradura Infectious Disease Institute, Thailand. All HCV patients received 12 weeks of SOF‐based regimens and had follow‐up for at least 12 weeks after therapy discontinuation. The primary outcome was sustained virological response (SVR) at 12 weeks after the end of treatment. Treatment outcomes were compared between HCV patients with and without HIV co‐infection. Results A total of 163 patients were included in the study, 130 (79.8%) were HCV/HIV co‐infected, and 33 (20.2%) were HCV mono‐infected. Of all, 106 (64%) patients received SOF and ledipasvir. Genotype 1 (GT1) was predominant at 66.4%, followed by GT3 at 22.2%, and GT6 at 11.4%. Overall SVR was 96.9%. SVR in HCV mono‐infected was 96.9% and SVR in HIV‐HCV co‐infected patients was 96.9%. The factor associated with SVR was HCV genotype (P = 0.001). Patients with HCV GT6 had lower SVR rates compared with GT1 and GT3 patients (83.3%, 100%, and 97.1% [P = 0.000] respectively). There was no association between SVR and other factors such as gender, age, BMI, underlying cirrhosis, baseline HCV viral load, or prior treatment history (all P > 0.05). All patients completed 12‐week SOF‐based treatment. Conclusion In real‐world setting, HCV treatment with SOF‐based regimens between patients with and without HIV co‐infection showed high rates of SVR. SOF‐based regimens were highly efficacious and tolerated. In real‐world setting, hepatitis C virus treatment with sofosbuvir (SOF)‐based regimens between patient with and without human immunodeficiency virus co‐infection showed similar high rates of sustained virological response. SOF‐based regimens were highly efficacious and tolerated.

Aim This study aimed to evaluate a team‐based systematic prevention and management program for delirium (a multicomponent intervention addressing potentially modifiable risk factors based on the DELirium Team Approach [DELTA]) in older patients undergoing orthopedic surgery within a real‐world clinical setting. The DELTA program was initiated at our hospital in January 2019. Methods A retrospective before–after study was conducted during a preintervention period (January 1, 2017 to December 31, 2018) and a postintervention period (January 1, 2020 to December 31, 2021) at orthopedic wards of an advanced acute care hospital in Japan. A total of 787 inpatients were evaluated before the preintervention period, and 833 inpatients were evaluated after the postintervention period. Results After the DELTA program's implementation, a significant decrease in benzodiazepine receptor agonist prescriptions (odds ratio [OR], 0.39; 95% confidence interval [CI], 0.29–0.53) and an increase in prescriptions of either melatonin receptor agonists or dual orexin receptor antagonists (OR, 3.83; 95% CI, 2.49–5.88) were observed. However, no significant difference was observed in the incidence of falls, self‐extubation, or required level of medical and nursing care, including risky behavior and inability to follow medical or care instructions following the intervention, despite a reduction in the length of hospital stay and institutionalization. Conclusion Implementing the DELTA program for older patients undergoing orthopedic surgery contributed to optimizing the prescription of hypnotics; however, the impact on other patient outcomes, such as falls, self‐extubation, and required level of medical and nursing care was limited. This study aimed to evaluate a team‐based systematic prevention and management program for delirium, a multicomponent intervention addressing potentially modifiable risk factors based on the DELirium Team Approach (DELTA), in older patients undergoing orthopedic surgery within a real‐world practice setting. The results of this study suggest that implementing the DELTA in older patients undergoing orthopedic surgery contributed to optimizing the prescription of hypnotics; however, the impact on other patient outcomes, such as falls, self‐extubation, and required level of medical and nursing care, was limited.

The aim of the study was to assess all-cause mortality and cardiovascular (CV) events in patients after a period of 12 months of treatment with dual antiplatelet therapy (DAPT) after hospitalization for acute myocardial infarction (AMI) in a real-world setting. Health care costs for the management of patients post-AMI was also assessed. A retrospective analysis using data from the administrative databases of six local health units (LHUs) was performed. All beneficiaries of these LHUs hospitalized with AMI between January 01, 2010, and December 31, 2011, and exposed to a treatment period with DAPT up to 12 months after AMI discharge were included. All-cause mortality, CV hospitalizations, and health care costs occurring during the 36-month follow-up period from end of treatment with DAPT were considered. For the cost analysis, only patients still alive at the end of the follow-up period were included. A total of 2,721 patients were included (mean ± SD age 63.6±17.3 years, 67.8% males). About 17% and 18% of all patients had CV events and died during the follow-up period, respectively. The annual mean cost per patient was €3,523.27. During the follow-up period, 63 patients had a second AMI event; for whom, the mean health care cost per patient was €19,570.70. In a real-world setting in Italy, considering a 36-month follow-up period, all-cause mortality, CV events, and related health care cost of patients hospitalized with an AMI undergoing a 12-month treatment period with DAPT remained relevant. This study suggests that increased efforts aimed at the prevention of recurrent AMI are warranted, as well as an accurate risk stratification in order to improve long-term outcome.

Background and aims This retrospective review of patients with recurrent glioblastoma treated at the Preston Robert Tisch Brain Tumor Center investigated treatment patterns, survival, and safety with bevacizumab in a real‐world setting. Methods Adult patients with glioblastoma who initiated bevacizumab at disease progression between January 1, 2009, and May 14, 2012, were included. A Kaplan‐Meier estimator was used to describe overall survival (OS), progression‐free survival (PFS), and time to greater than or equal to 20% reduction in Karnofsky Performance Status (KPS). The effect of baseline demographic and clinical factors on survival was examined using a Cox proportional hazards model. Adverse event (AE) data were collected. Results Seventy‐four patients, with a median age of 59 years, were included in this cohort. Between bevacizumab initiation and first failure, defined as the first disease progression after bevacizumab initiation, biweekly bevacizumab and bevacizumab/irinotecan were the most frequently prescribed regimens. Median duration of bevacizumab treatment until failure was 6.4 months (range, 0.5‐58.7). Median OS and PFS from bevacizumab initiation were 11.1 months (95% confidence interval [CI], 7.3‐13.4) and 6.4 months (95% CI, 3.9‐8.5), respectively. Median time to greater than or equal to 20% reduction in KPS was 29.3 months (95% CI, 13.8‐∞). Lack of corticosteroid usage at the start of bevacizumab therapy was associated with both longer OS and PFS, with a median OS of 13.2 months (95% CI, 8.6‐16.6) in patients who did not initially require corticosteroids versus 7.2 months (95% CI, 4.8‐12.5) in those who did (P = 0.0382, log‐rank), while median PFS values were 8.6 months (95% CI, 4.6‐9.7) and 3.7 months (95% CI, 2.7‐6.6), respectively (P = 0.0243, log‐rank). Treatment failure occurred in 70 patients; 47 of whom received salvage therapy, and most frequently bevacizumab/carboplatin (7/47; 14.9%). Thirteen patients (18%) experienced a grade 3 AE of special interest for bevacizumab. Conclusions Treatment patterns and outcomes for patients with recurrent glioblastoma receiving bevacizumab in a real‐world setting were comparable with those reported in prospective clinical trials.

BackgroundMyasthenia gravis (MG) leads to exertion-dependent muscle weakness, but also psychological and social well-being are limited. We aim to describe the burden of disease in MG including sociodemographic, economical, psychosocial as well as clinical aspects, to compare health-related quality of life (HRQoL) of patients with MG to the general population (genP) and to explore risk factors for a lower HRQoL.MethodsThis case–control study was conducted with MG patients of the German Myasthenia Association. A questionnaire-based survey included sociodemographic and clinical data as well as standardized questionnaires, e.g. the Short Form Health (SF-36). HRQoL was compared to genP in a matched-pairs analysis. Participants of the German Health Interview and Examination Survey for Adults (DEGS1) served as control group.ResultsIn our study, 1660 MG patients participated and were compared to 2556 controls from the genP. Patients with MG showed lower levels of physical functioning (SF-36 mean 56.0, SD 30.3) compared to the genP (mean 81.8, SD 22.1, adjusted difference: 25, 95% CI 22–29) and lower mental health sub-score (SF-36 mean 67.3, SD 19.8, vs. 74.1, SD 16.7, adjusted difference: 5, 95% CI 2–8). Female gender, higher age, low income, partnership status, lower activities of daily life, symptoms of depression, anxiety and fatigue and self-perceived low social support were associated with a lower HRQoL in MG patients.DiscussionHRQoL is lower in patients with MG compared to genP. The burden of MG on patients includes economic and social aspects as well as their emotional well-being. New therapies must achieve improvements for patients in these areas.Trial registration informationClinicaltrials.gov, NCT03979521, submitted: June 7, 2019, first patient enrolled: May 1, 2019, https://clinicaltrials.gov/ct2/show/NCT03979521

Aims/Introduction This study aimed to evaluate and compare the effectiveness of oral semaglutide after adding to or switching from incretin‐related drugs by assessing the changes in HbA1c and body weight (BW) in participants with type 2 diabetes in clinical settings. Materials and Methods A total of 368 participants were divided into groups according to antidiabetic medications before oral semaglutide treatment; incretin‐related drug‐naïve (naïve), switching from dipeptidyl peptide‐4 inhibitors (DPP‐4i) or glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA) groups. Adjusted mean changes in HbA1c and BW at 6 months after oral semaglutide administration were compared among the three groups. Similar analyses were performed in the GLP‐1 RAs group between GLP‐1RAs before switching. Results Mean change of HbA1c in DPP‐4i and GLP‐1 RA groups was −0.67% (95% confidence interval [CI]: −0.79 to −0.54) and −0.13% (95% CI: −0.40 to 0.15), respectively, which were significantly smaller than incretin‐related drug‐naïve group; −0.85% (95% CI: −1.08 to −0.62). Mean change in BW between the naïve and DPP‐4i groups had no differences; however, these changes were lower in the GLP‐1 RA group than in the naïve group. Mean change in HbA1c between pretreatment with GLP‐1 RAs had no differences; however, the mean change in BW in the dulaglutide group was significantly higher than that in the injectable semaglutide group. Conclusion Oral semaglutide reduced HbA1c levels and BW after adding or switching from other incretin‐related drugs in Japanese participants with type 2 diabetes. Oral semaglutide reduced HbA1c levels and BW after adding or switching from other incretin‐related drugs in Japanese participants with type 2 diabetes. Oral semaglutide had effects on HbA1c and BW similar to that of injectable GLP‐1 RAs.

To compare the validity and robustness of five methods for handling missing characteristics when using cardiovascular disease risk prediction models for individual patients in a real-world clinical setting. The performance of the missing data methods was assessed using data from the Swedish National Diabetes Registry (n = 419,533) with external validation using the Scottish Care Information ˗ diabetes database (n = 226,953). Five methods for handling missing data were compared. Two methods using submodels for each combination of available data, two imputation methods: conditional imputation and median imputation, and one alternative modeling method, called the naïve approach, based on hazard ratios and populations statistics of known risk factors only. The validity was compared using calibration plots and c-statistics. C-statistics were similar across methods in both development and validation data sets, that is, 0.82 (95% CI 0.82–0.83) in the Swedish National Diabetes Registry and 0.74 (95% CI 0.74–0.75) in Scottish Care Information-diabetes database. Differences were only observed after random introduction of missing data in the most important predictor variable (i.e., age). Validity and robustness of median imputation was not dissimilar to more complex methods for handling missing values, provided that the most important predictor variables, such as age, are not missing.