This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.
FIDELITY post hoc analysis; median follow-up of 3 years.
FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.
Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).
Randomised 1:1; finerenone or placebo.
Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.
Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged interaction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups interaction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were
Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.
Dipeptidase-1 (DPEP-1) is a recently discovered leucocyte adhesion receptor for neutrophils and monocytes in the lungs and kidneys and serves as a potential therapeutic target to attenuate inflammation in moderate-to-severe COVID-19. We aimed to evaluate the safety and efficacy of the DPEP-1 inhibitor, LSALT peptide, to prevent specific organ dysfunction in patients hospitalised with COVID-19.
Phase 2a randomised, placebo-controlled, double-blinded, trial.
Hospitals in Canada, Turkey and the USA.
A total of 61 subjects with moderate-to-severe COVID-19.
Randomisation to LSALT peptide 5 mg intravenously daily or placebo for up to 14 days.
The primary endpoint was the proportion of subjects alive and free of respiratory failure and/or the need for renal replacement therapy (RRT). Numerous secondary and exploratory endpoints were assessed including ventilation-free days, and changes in kidney function or serum biomarkers.
At 28 days, 27 (90.3%) and 28 (93.3%) of subjects in the placebo and LSALT groups were free of respiratory failure and the need for RRT (p=0.86). On days 14 and 28, the number of patients still requiring more intensive respiratory support (O2 ≥6 L/minute, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation) was 6 (19.4%) and 3 (9.7%) in the placebo group versus 2 (6.7%) and 2 (6.7%) in the LSALT group, respectively (p=0.14; p=0.67). Unadjusted analysis of ventilation-free days demonstrated 22.8 days for the LSALT group compared with 20.9 in the placebo group (p=0.4). LSALT-treated subjects had a significant reduction in the fold expression from baseline to end of treatment of serum CXCL10 compared with placebo (p=0.02). Treatment-emergent adverse events were similar between groups.
In a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19.
To better understand healthcare and social/community service providers’ learning needs associated with supporting transgender and gender diverse (trans) persons who have experienced intimate partner violence (IPV).
An online survey was distributed through the trans-LINK Network in Ontario, Canada.
163 of 225 healthcare and social/community service providers completed the survey (72.4% response rate) between November 2022 and February 2023.
Expertise, training, workplace practices and learning needs related to supporting trans survivors of IPV.
Quantitative survey results were analysed descriptively and open-ended responses were organised thematically. In March 2022, survey results were shared with 33 stakeholders who helped define goals and objectives for an e-learning curriculum using Jamboard, data from which were collated and organised into themes.
Most (66.3%) survey respondents described having provided professional support to trans survivors of IPV, but only one-third (38.0%) reported having received relevant training, and many of the trainings cited were in fact focused on other forms of violence or trans health generally. The majority reported a mid (44.9%) or low-mid (28.5%) level of expertise and almost unanimously agreed that they would benefit from (further) training (99.4%). The most commonly recommended goal/objective for a curriculum emerging from the stakeholder consultation was to facilitate collaboration, knowledge sharing and (safe) referrals among organisations.
The results of this study highlight the critical need for an IPV curriculum specific to trans survivors and responsive to the needs of providers. As no one profession can address this complex issue in isolation, it is important that the curriculum aims to facilitate collaboration across sectors. In the absence of appropriate training and referrals, practitioners may perpetuate harm when caring for trans survivors of IPV.
Many people living with dementia experience sleep disturbance and there are no known effective treatments. Non-pharmacological treatment options should be the first-line sleep management. For family carers, relatives’ sleep disturbance leads to interruption of their sleep, low mood and breakdown of care. Our team developed and delivered DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives), a multimodal non-pharmacological intervention, showing it to be feasible and acceptable. The aim of this randomised controlled trial is to establish whether DREAMS START is clinically cost-effective in reducing sleep disturbances in people living with dementia living at home compared with usual care.
We will recruit 370 participant dyads (people living with dementia and family carers) from memory services, community mental health teams and the Join Dementia Research Website in England. Those meeting inclusion criteria will be randomised (1:1) either to DREAMS START or to usual treatment. DREAMS START is a six-session (1 hour/session), manualised intervention delivered every 1–2 weeks by supervised, non-clinically trained graduates. Outcomes will be collected at baseline, 4 months and 8 months with the primary outcome being the Sleep Disorders Inventory score at 8 months. Secondary outcomes for the person with dementia (all proxy) include quality of life, daytime sleepiness, neuropsychiatric symptoms and cost-effectiveness. Secondary outcomes for the family carer include quality of life, sleep disturbance, mood, burden and service use and caring/work activity. Analyses will be intention-to-treat and we will conduct a process evaluation.
London—Camden & Kings Cross Ethics Committee (20/LO/0894) approved the study. We will disseminate our findings in high-impact peer-reviewed journals and at national and international conferences. This research has the potential to improve sleep and quality of life for people living with dementia and their carers, in a feasible and scalable intervention.
Poor sleep quality adversely affects the overall well-being and outcomes of patients with chronic kidney disease (CKD). However, it has not been well studied in Africans with CKD. We determined the prevalence of poor sleep quality and associated factors among patients with CKD.
This was a cross-sectional study that involved patients with CKD .
The study was carried out in the outpatient clinic of nine hospitals in Nigeria.
Sleep quality, depressive and anxiety symptoms and quality of life (QoL) were assessed among 307 patients with CKD using Pittsburgh Sleep Quality Index Questionnaire, Hospital Anxiety Depression Scale Questionnaire and 12-item Short Form Health Survey Quality of Life Questionnaire, respectively. The prevalence of poor sleep quality and associated factors were determined. A p
The mean age of the study participants was 51.40±15.17 years. The male:female ratio was 1.5:1 One hundred and twenty-one (39.4%) of the patients were on maintenance haemodialysis (MHD). The prevalence of poor sleep quality, anxiety symptoms and depressive symptoms among the patients was 50.2%, 37.8% and 17.6%, respectively. The prevalence of poor sleep quality in the CKD stages 3, 4, 5 and 5D was 38.1%, 42.6%, 52.2% and 58.7%, respectively. The prevalence of poor sleep quality was significantly higher in MHD patients compared with predialysis CKD (59.5% vs 43.6%; p=0.008). Factors associated with poor sleep quality were CKD stage (p=0.035), anaemia (p=0.003), pruritus (p=0.045), anxiety symptoms (p≤0.001), depressive symptoms (p≤0.001) and reduced QoL (p≤0.001). On multivariate analysis, factors associated with poor sleep were anxiety (AOR 2.19; 95% CI 1.27 to 3.79; p=0.005), anaemia (AOR 5.49; 95% CI 1.43 to 21.00;p=0.013) and reduced physical component of QoL (AOR 4.11; 95% CI 1.61 to 10.47; p=0.003).
Poor sleep quality is common among patients with CKD especially in the advanced stage. The significant factors associated with poor sleep quality were QoL, anaemia and anxiety symptoms. These factors should be adequately managed to improve the overall outcomes of patients with CKD.
Our aim was to investigate the association between early environmental factors and the development of coeliac disease (CeD) in adolescents, recruited from a cohort nested in the Danish National Birth Cohort (DNBC).
The study was designed as a prospective cohort study, nested in DNBC
The Glutenfunen cohort comprises 1266 participants, nested in DNBC. All participants were screened for CeD, and in total, 28 cases of biopsy proven CeD were identified. Data about breastfeeding, timing of introduction to solid food in infancy, use of antibiotics, infections and symptoms were parentally reported prospectively at 6 months and 18 months, respectively. We estimated ORs and 95% CIs of CeD in adolescents using logistic regression analysis.
Viral croup reported at 18 months of age was associated with CeD in adolescents with an OR of 3.2 (95% CI: 1.2 to 8.7). Furthermore, otitis media also reported at 18 months of age was linked with CeD with an OR of 3.2 (95% CI: 1.5 to 7.3). We were not able to find any statistical associations between CeD and breastfeeding, frequency of infections, parentally reported use of antibiotic and timing of solid foods.
In this study, we present an overview of the relationship between early environmental factors and occurrence of CeD in adolescents. Our findings, despite limitations due to a limited number of cases of CeD, suggest a role of viral infections in the pathogenesis of CeD
Opioid use disorder (OUD) is a major public health concern in the USA, resulting in high rates of overdose and other negative outcomes. Methadone, an OUD treatment, has been shown to be effective in reducing the risk of overdose and improving overall health and quality of life. This study analysed the distribution of methadone for the treatment of OUD across the USA over the past decade and through the COVID-19 pandemic.
Retrospective observational study using secondary data analysis of the Drug Enforcement Administration and Medicaid Databases.
USA.
Patients who were dispensed methadone at US opioid treatment programmes (OTPs).
The primary outcomes were the overall pattern in methadone distribution and the number of OTPs in the USA per year. The secondary outcome was Medicaid prescriptions for methadone.
Methadone distribution for OUD has expanded significantly over the past decade, with an average state increase of +96.96% from 2010 to 2020. There was a significant increase in overall distribution of methadone to OTP from 2010 to 2020 (+61.00%, p
There have been dynamic changes in methadone distribution for OUD. Furthermore, pronounced variation in methadone distribution among states was observed, with some states having no OTPs or Medicaid coverage. New policies are urgently needed to increase access to methadone treatment, address the opioid epidemic in the USA and reduce overdose deaths.
Chemsex is defined as drug use to enhance sexual pleasure. Global literature illustrated the pervasiveness of chemsex among men who have sex with men (MSM) and transgender women (hijra) for prolonging anal intercourse, reducing pain and intensifying pleasure, oftentimes without condoms. Global literature highlighted the association between chemsex and unsafe sexual behaviours. These circumstances warrant targeted chemsex research to explore the chemsex situation. The study aims to explore the overall dynamics of chemsex among MSM, male sex workers (MSW) and hijra in Dhaka, Bangladesh and formulate culturally relevant, context-specific, gender-sensitive and evidence-based recommendations for chemsex interventions.
This will be a sequential, exploratory, mixed-methods study. Data will be collected at four drop-in centres in Dhaka in three phases. To explore issues related to chemsex, the formative phase (phase 1) will generate evidence on the overall dynamics of chemsex through a literature review and qualitative interviews. Qualitative data will be manually analysed using thematic analysis. In phase 2, a cross-sectional survey will be conducted among 458 MSM, male sex workers and hijra to measure the prevalence, reasons and sexual risk behaviour associated with chemsex. In phase 3, qualitative interviews will be conducted with the participants involved in chemsex, service providers and relevant stakeholders to add qualitative depth to survey responses. In this phase, service provision will also be investigated for people engaging in chemsex. Moreover, based on the findings of phases 1 and 2, and qualitative interviews of phase 3, a preliminary chemsex intervention model will be developed through a series of intervention design workshops.
Ethical approval has been attained from the Ethical Review Committee of icddr,b. Informed consent will be obtained from the participants, and confidentiality will be maintained during data collection and storage. Findings will be disseminated via several platforms including dissemination seminars, scientific articles and study report.
This study aimed to determine the magnitude of occupational exposure to sharp injuries and identify its associated factors among nurses.
Institution-based cross-sectional study design was conducted from 1 to 30 November 2022.
The collected data were entered into EpiData V.4.2; then, exported to Stata V.14 for analysis. Variables with a p value of
The study was conducted in South Gondar zone public hospitals.
Nurses working in South Gondar zone public hospitals.
Of the total respondents, 213 (56.65%) were between the ages of 25 and 34 with the mean±SD of age 30.22±6.63 years. Similarly, 202 (53.72%) of the respondents were women. This study finding showed that the magnitude of occupational exposure to sharp injuries among nurses was 52.39% (95% CI: 47.92% to 56.37%). Moreover, this study finding showed that year of service >10 years (adjusted OR (AOR)=2.35, 95% CI: 1.21 to 4.57), lack of infection prevention training (AOR=1.85, 95% CI: 1.09 to 3.45), job-related stress (AOR=2.24, 95% CI: 1.27 to 3.89) and presence of contaminated sharps at the workplace (AOR=2.76, 95% CI: 1.67 to 4.72) were significantly associated with occupational exposure to sharp injuries among nurses.
Generally, this study finding reported that the magnitude of occupational exposure to sharp injuries among nurses was high. This study finding also showed that years of service >10 years, lack of infection prevention training, job-related stress and the presence of contaminated sharps at the workplace were independent predictors of occupational exposure to sharp injuries among nurses. Hence, all the concerned bodies should strengthen regular provision of infection prevention training to nurses at all levels. Nurses should practice proper use of safety box more than ever in order to avoid the presence of contaminated needles and other sharp materials at the workplace.