Pharmacol Res. 2025 Mar 22:107689. doi: 10.1016/j.phrs.2025.107689. Online ahead of print.
NO ABSTRACT
PMID:40122723 | DOI:10.1016/j.phrs.2025.107689
Tag: pubmed
Clin Ther. 2025 Mar 22:S0149-2918(25)00074-8. doi: 10.1016/j.clinthera.2025.03.001. Online ahead of print.
ABSTRACT
PURPOSE: This study aimed to evaluate the efficacy and safety of triple combination of ezetimibe (Eze)/atorvastatin (Ato) 10/40 mg + amlodipine (Aml) 10 mg therapy for lowering the low-density lipoprotein cholesterol (LDL-C) and blood pressure compared with either Eze/Ato 10/40 mg or Aml 10 mg therapies in patients with comorbid primary hypercholesterolemia and essential hypertension.
METHODS: This was a randomized, multicenter, double-blind, active-controlled, Phase III clinical trial. Participants underwent a wash-out period (2 weeks for nonfibrate medications, 6 weeks for fibrates) followed by 4 weeks of therapeutic lifestyle changes. Subsequently, 109 participants were randomly assigned to 3 groups: (1) Eze/Ato 10/40 mg + Aml 10 mg, (2) Eze/Ato 10/40 mg, and (3) Aml 10 mg. The coprimary end points were percentage change in LDL-C and change in mean sitting systolic blood pressure (SBP) compared with baseline at week 8.
FINDINGS: A total of 109 participants were enrolled in the study, and there were no statistically significant differences in the baseline characteristics of participants across the 3 groups. After 8 weeks of treatment, the least-square (LS) mean (SE) of percent change from baseline in LDL-C was -57.95% (3.52%) for the Eze/Ato 10/40 mg + Aml 10 mg group and 8.93% (3.54%) for the Aml 10 mg group. The LS mean difference (SE) between these 2 groups was statistically significant at -66.88 (4.95) (95% CI, -76.77% to -56.99%) (P < 0.0001). Furthermore, at week 8, the LS mean (SE) change in mean sitting SBP between the Eze/Ato 10/40 mg + Aml 10 mg group and the Eze/Ato 10/40 mg group was -19.24 (2.42) mm Hg and -4.43 (2.56) mm Hg, respectively. The LS mean difference (SE) between the 2 groups was statistically significant -14.81 (3.53) (95% CI, -21.87 to -7.74) mm Hg (P < 0.0001). No serious adverse drug reactions occurred in any of the study groups.
IMPLICATIONS: Triple combination therapy with Eze/Ato + Aml has effectively reduced the LDL-C and SBP independently, compared with either Eze/Ato or Aml therapies over 8 weeks of treatment period. In terms of safety, there were no significant differences among the 3 treatment groups. This research lays the groundwork for the development of a triple fixed-dose combination in the future, which could improve patient convenience and adherence by reducing pill burden. Clinical Research Information Service (CRIS), Republic of Korea: KCT0006283.
PMID:40122716 | DOI:10.1016/j.clinthera.2025.03.001
Musculoskeletal Care. 2025 Mar;23(1):e70089. doi: 10.1002/msc.70089.
ABSTRACT
OBJECTIVE: This study aimed to determine the number and proportion of exercise interventions within preexisting clinical trials for people with knee osteoarthritis (KOA) that satisfied the World Health Organisation’s (WHO) guidelines for physical activity.
METHODS: A descriptive analysis of studies included in an umbrella review was undertaken. Data from each exercise intervention relating to the type, dose and intensity of exercise was extracted, and the number and proportion of interventions that satisfied the WHO guidelines (aerobic, muscle strengthening, balance [for studies where the average age was more than 65 years old], a combination or all) was recorded at the study and intervention level.
RESULTS: Data were extracted from 199 studies containing 266 exercise interventions. Overall, only one study (0.5%) satisfied all components of the WHO guidelines. Of the 122 interventions that had an average participant age over 65, none fulfiled all aspects of the WHO guidelines, which included balance. There were 16 (6.0%) and 12 (4.5%) other interventions that satisfied the aerobic or muscle strengthening components of the guidelines, respectively.
CONCLUSION: This descriptive analysis highlighted the lack of exercise interventions in clinical trials for people with KOA that satisfied the WHO guidelines. Thus, they may not be dosed appropriately to achieve broader health outcomes associated with following the physical activity guidelines.
PMID:40122701 | DOI:10.1002/msc.70089
Respirology. 2025 Mar 23. doi: 10.1111/resp.70031. Online ahead of print.
NO ABSTRACT
PMID:40122681 | DOI:10.1111/resp.70031
Int J Psychol. 2025 Apr;60(2):e70040. doi: 10.1002/ijop.70040.
ABSTRACT
Intensive longitudinal designs (ILD) are increasingly used in applied psychology to investigate research questions and deliver interventions at both within- and between-individual levels. However, while relatively complex analyses such as cross-level interaction models are trending in the field, little guidance has been provided on ILD data manipulation, including all procedures to be applied to the raw data points for getting the final dataset to be analysed. Here, we provide an introductory step-by-step tutorial and open-source R code on required and recommended data pre-processing (e.g., data reading, merging and cleaning), psychometric (e.g., level-specific reliability), and other ILD data manipulation procedures (e.g., data centering, lagging and leading). We built our tutorial on an illustrative example aimed at testing the job demand-control model at the within-individual level based on data from 211 back-office workers who received up to 18 surveys over three workdays, supporting both the strain and (partially) the buffer hypotheses. Being the common starting point of many types of analyses, data manipulation is crucial to determine the quality and validity of the resulting study outcomes. Hence, this tutorial and the attached code aim to contribute to removing methodological barriers among applied psychology researchers and practitioners in the handling of ILD data.
PMID:40122677 | DOI:10.1002/ijop.70040
Occup Environ Med. 2025 Mar 23:oemed-2024-109702. doi: 10.1136/oemed-2024-109702. Online ahead of print.
ABSTRACT
INTRODUCTION: Quantitative job-exposure matrices (JEMs) have been developed to assign exposure using International Standard Classification of Occupations (ISCO)-68 coded job information. For extended compatibility with the less detailed ISCO-88 coding, a quantitative JEM using the same underlying model was developed. We compared exposure-response relationships between cumulative respirable crystalline silica (RCS) and lung cancer risk using a quantitative JEM based on ISCO-88 (88-JEM) and ISCO-68 (68-JEM).
METHODS: Based on a common set of approximately 15 000 RCS measurements, job-specific, region-specific and time-specific exposure levels were estimated for the 88-JEM and the 68-JEM and linked to participants’ job histories. Exposure-response relationships in an international lung cancer case-control study were analysed by logistic regression and generalised additive models.
RESULTS: The 88-JEM and the 68-JEM yielded similar RCS-lung cancer associations, with elevated lung cancer risks across each cumulative exposure quartile. The 88-JEM exhibited a minor not statistically significant upward bend in the exposure-response curve at higher exposures.
CONCLUSION: To accurately detect associations between disease risk and occupational exposure, quantitative JEMs can be applied in community-based studies that provide job histories in either ISCO-88 or ISCO-68.
PMID:40122614 | DOI:10.1136/oemed-2024-109702
Heart. 2025 Mar 23:heartjnl-2024-323947. doi: 10.1136/heartjnl-2024-323947. Online ahead of print.
ABSTRACT
Cardiac telemetry has evolved into a vital tool for continuous cardiac monitoring and early detection of cardiac abnormalities. In recent years, artificial intelligence (AI) has become increasingly integrated into cardiac telemetry, making a shift from traditional statistical machine learning models to more advanced deep neural networks. These modern AI models have demonstrated superior accuracy and the ability to detect complex patterns in telemetry data, enhancing real-time monitoring, predictive analytics and personalised cardiac care. In our review, we examine the current state of AI in cardiac telemetry, focusing on deep learning techniques, their clinical applications, the challenges and limitations faced by these models, and potential future directions in this promising field.
PMID:40122590 | DOI:10.1136/heartjnl-2024-323947
Hemodial Int. 2025 Mar 23. doi: 10.1111/hdi.13231. Online ahead of print.
ABSTRACT
BACKGROUND: Pulmonary hypertension affects patients with hemodialysis-dependent end-stage kidney failure; however, the estimated prevalence varies greatly due to the underutilization of right heart catheterization and the evolving diagnostic criteria of pulmonary hypertension. Pulmonary hypertension in end-stage kidney failure is often attributed to arteriovenous (AV) access; therefore, we hypothesized that patients with AV fistula/graft would have a greater prevalence of pulmonary hypertension on right heart catheterization compared to those with central venous (CV) catheter accesses.
METHODS: In this retrospective single-center cohort study, we identified and randomly sampled patients from July 2012 to August 2022 receiving hemodialysis for ≥ 3 months and who underwent right heart catheterization, using Current Procedural Terminology codes. Pulmonary hypertension was defined as mean pulmonary arterial pressure (mPAP) > 20 mmHg. Our primary outcome was the prevalence of pulmonary hypertension among patients with AV fistula/graft versus CV hemodialysis access, tested with descriptive statistics. We evaluated survival as a secondary outcome using a Cox proportional hazards model.
RESULTS: A total of 3834 patient charts were extracted. Overall, 444 charts were randomly sampled, resulting in 137 subjects meeting the inclusion criteria. The mean age was 63.8 ± 10.5 years, and 62% were male. The most common etiology of end-stage kidney failure was diabetic kidney disease (57.7%). Eighty percent of end-stage kidney failure patients had pulmonary hypertension; however, the type of hemodialysis access was not associated with pulmonary hypertension (85% CV catheter vs. 79.5% AV access, p = 0.59). Patients with pulmonary hypertension had lower hemoglobin (9.6 ± 0.8 vs. 11.2 ± 1.3 g/dL, p < 0.0001) and serum albumin (2.3 ± 0.9 vs. 3.4 ± 0.6 g/dL, p < 0.0001) than those without pulmonary hypertension. Those with pulmonary hypertension had an increased risk of mortality (hazard ratio: 2.2, 95% confidence interval: 1.04-4.61; p = 0.04).
CONCLUSION: Our findings show a high burden of pulmonary hypertension among this heterogeneous cohort of end-stage kidney failure patients, with no association between pulmonary hypertension and the type of hemodialysis access. This study highlights the need for prospective investigations incorporating current strategies for pulmonary hypertension diagnosis and treatment among the dialysis-dependent population.
PMID:40122584 | DOI:10.1111/hdi.13231
Lupus Sci Med. 2025 Mar 23;12(1):e001406. doi: 10.1136/lupus-2024-001406.
ABSTRACT
OBJECTIVE: SLE is a multisystem autoimmune disease where periods of disease activity, often difficult to predict, can cause irreversible disease damage. This study aimed to develop a patient-centric predictive model using real-world data that can identify patients with SLE at a higher risk of hospitalisation compared with the general SLE population.
METHODS: This observational, retrospective analysis used data from the Georgians Organized Against Lupus (GOAL) cohort from 2011 to 2013. The GOAL cohort is a population-based SLE cohort that collects yearly self-report surveys covering participants’ sociodemographic characteristics, clinical characteristics and perceived SLE symptoms (using the Systemic Lupus Activity Questionnaire (SLAQ)). GOAL data were linked to the Georgia Hospital Discharge Database to collect participants’ all-cause hospitalisation events in the 6 months following survey completion. A two-step approach was used to predict all-cause hospitalisations-logistic regressions selected a list of GOAL predictors that were subsequently included in the classification and regression tree (CART) models to generate patient subsets based on estimated hospitalisation rates.
RESULTS: There were 846 participants who completed 1486 surveys. Participants who were hospitalised within 6 months after survey completion were more likely to be younger, living in poverty and have more reported SLE symptoms than participants without a hospitalisation. CART modelling identified participants who reported any weight loss without trying, severe fatigue and Raynaud’s symptoms as most likely to have an all-cause hospitalisation: one in three (34%) patients in this subset were hospitalised in the 6 months following survey completion, 2.6-fold the hospitalisation rates of the overall GOAL cohort (13%) and 6.8-fold the rate in the subset with the lowest hospitalisation rate (5%).
CONCLUSIONS: This study suggests that patient-reported SLE symptoms and disease activity, specifically certain components of the SLAQ, may be of value in SLE risk management when considering hospitalisation reduction as a treatment goal.
PMID:40122582 | DOI:10.1136/lupus-2024-001406
BMJ Open Qual. 2025 Mar 23;14(1):e003198. doi: 10.1136/bmjoq-2024-003198.
ABSTRACT
BACKGROUND: Diagnostic errors (DEs) are a significant global patient safety issue, often associated with increased morbidity and mortality due to overlooked, delayed, or incorrect diagnoses. Our aim was to study the occurrence of DEs and adverse events (AEs), patient-related harm to identify vulnerable steps in the diagnostic process.
METHODS: A retrospective analysis of data from two public, national databases-National Health Care Compensation Claims Database (2009-2018) and Danish Patient Safety Database with AEs (2015-2020). Vulnerable steps in the diagnostic process were identified using a scoring tool developed by The Controlled Risk Insurance Company.
RESULTS: In the analysis of patient compensation claims, 14.5% of all settled cases (n=90 000) were classified as due to a DE, with a 59% compensation rate for DEs, twice the rate compared with other compensated cases (25%). DEs constituted 29% of all compensated cases. Death due to DEs was 8.3% (n=680 cases), 1.8 times higher compared with other cases and DEs resulted in higher degrees of disability.In the overall reported AEs, 0.3% of AEs were fatal and 1.7% AEs caused severe patient harm, per year. In a representative sample of AEs with a severe or fatal consequence (n=269), 33% were due to DEs.The initial clinical assessment was a cause or contributor to the DE in 80% of the compensation cases and in 83% of the severe or fatal AEs. The follow-up and coordination phase were a cause in 33% of compensation cases and 46% of severe or fatal AEs.
CONCLUSIONS: Errors and AEs in the diagnostic process are prevalent and a significant patient safety issue in Danish healthcare. This study identifies vulnerable steps in the diagnostic process, with patterns correlated to different degrees of severity, and highlights steps for future improvements efforts needed to mitigate the risk of DEs.
PMID:40122576 | DOI:10.1136/bmjoq-2024-003198