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Efficacy and safety of epaminurad, a potent hURAT1 inhibitor, in patients with gout: a randomized, placebo-controlled, dose-finding study
No full textBACKGROUND: Gout is the most common inflammatory arthritis. Current urate-lowering therapies have limitations, such as adverse drug reactions or limited efficacy. Epaminurad is a novel selective human urate transporter 1 (hURAT1) inhibitor that has been shown to reduce serum urate (sUA) levels in healthy volunteers and patients with gout. The aims of the current study were to evaluate the urate-lowering efficacy and safety of epaminurad compared with placebo in patients with gout, and to determine the optimal dose. METHODS: This multicenter, randomized, double-blind, placebo-controlled, dose-finding phase 2b clinical trial, which incorporated a standard-treatment reference arm, enrolled patients aged 19-70 years with gout and sUA level >/= 0.42 mmol/L. Participants received gout prophylaxis and followed therapeutic lifestyle changes, and were randomized to receive epaminurad 3 mg, 6 mg or 9 mg, or febuxostat 80 mg, or matching placebo, once daily for 12 weeks. The primary efficacy endpoint was the proportion of patients with sUA level < 0.36 mmol/L at week 4 after initiation of study treatment. Statistical comparisons were performed between the epaminurad and placebo groups. RESULTS: Overall, 169 patients received study medication (99.40% male, mean +/- SD age 48.26 +/- 13.15 years, sUA level 0.53 +/- 0.09 mmol/L). Mean adherence to treatment was > 90% in all groups. The proportion of patients with sUA < 0.36 mmol/L at week 4 was significantly higher in each epaminurad group (9 mg, 88.89%; 6 mg, 71.79%; 3 mg, 54.05%) compared with placebo (0.00%) (all p < 0.0001). The response rate in the febuxostat group was 84.21%. The proportion of patients who achieved sUA < 0.30 mmol/L, and mean percent and absolute change in sUA, were also significantly greater in all epaminurad groups versus placebo at week 4. Outcomes were consistent at weeks 8 and 12. The adverse event rate did not differ between epaminurad groups and placebo, and most events were mild. There were no significant differences in mean serum creatinine levels or liver function parameters between the epaminurad groups and placebo. CONCLUSIONS: Epaminurad was effective at reducing sUA levels in patients with gout. The study also confirmed the safety and tolerability profile during 12 weeks of treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT04804111 (registered on 15 November 2020)
Osfit™, a Novel Stent Designed for the Treatment of Coronary Ostial Lesions: Initial Clinical Experience and Intravascular Ultrasound Evaluation
No full textBACKGROUND AND OBJECTIVES: Stent implantation for coronary ostial lesions is challenging. This study evaluated the feasibility, safety, and immediate procedural results of the Osfit, innovatively designed sirolimus drug-eluting stent delivery system for the treatment of coronary ostial lesions. METHODS: The Osfit has a 5 mm long extended balloon proximal to the stent (bare balloon without mounted stent). When inflated at 1.5 atm, only bare balloon inflated and acts like a stopper. We evaluated the technical feasibility in 49 patients with a coronary ostial lesion (defined as stenosis within 3 mm from the origin of the vessel) who had received the Osfit. Intravascular ultrasound (IVUS) analysis was done in 11 patients who consented to IVUS examination, and the depth from the proximal edge of the stent to the ostial plane (DSO) was measured. RESULTS: In all 49 lesions, stents were successfully implanted in one single angiographic view without obvious stent protrusion or definite angiographic missing of the ostium. The proportions of aorto-ostial, and bifurcation lesions were 28.6% and 71.4%, respectively. The DSO was 0.2+/-0.69 mm, and the proximal stent edges were located within 1 mm of the ostial edge in all patients. No adverse events like death, myocardial infarction, target lesion revascularization, target vessel revascularization or stent thrombosis were reported during the in-hospital period or within 30 days. CONCLUSIONS: The implantation of the Osfit for coronary ostial lesions appears to be an accurate and safe procedure that may reduce multiple angiographic projections and advanced skills
Large-Scale Analysis of Age and Sex Effects on Corrected QT and JT Intervals: Insights From Hospital-Based Controls and Moxifloxacin-Treated Cases
No full textThe corrected QT (QTc) interval is a critical marker for assessing proarrhythmic potential in drug development, while the corrected JT (JTc) interval provides specific insight into ventricular repolarization. This study quantitatively analyzed the relationships of QTc and JTc intervals with age and sex utilizing a large real-world dataset of hospital-based controls and moxifloxacin-treated patients. This retrospective study analyzed 1,039,550 electrocardiograms and associated clinical data extracted from a previously constructed electrocardiogram database, categorizing cases as hospital-based controls (n = 119,882) or moxifloxacin-treated (n = 1586) based on predefined criteria. We observed a general trend of QTc and JTc interval prolongation with age in both groups, with moxifloxacin-treated cases showing longer QTc and JTc intervals than hospital-based controls. Multiple linear regression analysis indicated that in hospital-based controls, QTc and JTc intervals increased with age, with males exhibiting shorter intervals than females. Meanwhile, in moxifloxacin-treated cases, QTc and JTc intervals showed similar age-dependent increases, although no significant sex differences were observed in the QTc interval. Therefore, this study quantified the effects of age and sex on QTc and JTc intervals in hospital-based controls and highlighted similar age-related trends in moxifloxacin-treated cases, underscoring the relevance of age and sex as key factors in interpreting QTc and JTc intervals across diverse clinical contexts
Author Correction: Performance of the comprehensive nutrition screening index in predicting mortality after cardiac surgery
No full textDevelopment of a Scoring System to Predict Suboptimal Peak Inspiratory Flow in Patients With Chronic Obstructive Pulmonary Disease
No full textBACKGROUND: Peak inspiratory flow rate (PIFR) is a critical indicator for the successful use of dry powder inhalers (DPIs). However, resource constraints often limit the practicality of measuring PIFR prior to DPI prescription. METHODS: A cross-sectional observational study was conducted across seven hospitals in Korea, including patients with chronic obstructive pulmonary disease (COPD). To develop a scoring system to predict suboptimal PIFR without direct measurement, variables were selected through a literature review and logistic regression model, considering practicality in clinical settings. RESULTS: The study involved 436 patients and was divided into training and test datasets with a 7:3 ratio. Age (>/= 80 years), weight (/= 2), and post-bronchodilator forced vital capacity
The Religious Dimensions of Epidemic Disease: Cholera, the Ghost Rite, and Missionary Medicine in Nineteenth-Century Korea
No full textOne of the most catastrophic pandemics in human history was the repeated spread of cholera in the nineteenth century. In spite of its historical significance, few scholars have studied cholera's influence in East Asia. This paper illustrates how cholera was considered, conceptualized, and treated by Korean people prior to contact with North American medical missionaries in 1885. In particular, the article compares the government-ordered public health measures during the Joseon dynasty, focusing on the "ghost rite" performed during outbreaks of epidemic disease with the work of medical missionaries in the late nineteenth century. This study finds that even after the introduction of Western biomedicine, the Korean people persisted with a religious-based etiology of cholera and other infectious diseases until the twentieth century
Updating the classification and routine diagnosis of NSAID hypersensitivity reactions: A WAO Statement
No full textHypersensitivity reactions to non-steroidal anti-inflammatory drugs (NSAIDs) have been classified as immediate (or acute) and delayed. Immediate reactions can be further classified into 4 clinical types: NSAID-exacerbated respiratory disease (N-ERD), NSAID-exacerbated cutaneous disease (NECD), NSAID-induced urticaria/angioedema (NIUA), and single NSAID-induced urticaria/angioedema/anaphylaxis (SNIUAA). Specifically, the NIUA type references reactions to >/=2 NSAIDs belonging to different chemical groups, involving urticaria and/or angioedema in patients with no underlying chronic spontaneous urticaria. However, there are patients meeting cross-reactive criteria for NIUA phenotype who report reactions that involve 2 organ systems (eg, cutaneous and respiratory; cutaneous and gastrointestinal) and have been termed "blended". In pediatrics, this type of reaction is recognized and has been termed NSAID-induced urticaria/angioedema/anaphylaxis (NIUAA), an acronym we suggest be extended now to adults. There are small subgroups of N-ERD patients who also report skin symptoms and, alternatively, NECD patients who report respiratory symptoms. These 2 subgroups could be diagnosed as having mixed N-ERD and mixed NECD, respectively. In fact, they are patients suffering from N-ERD or NECD who have had reactions consistent with anaphylaxis. In the current classifications of NSAID hypersensitivity, the reactions in which NSAIDs act as aggravating factors or cofactors in subjects with sensitization to foods are not included. Recently, this type of reactions has been defined as NSAID-exacerbated food allergy (NEFA) and NSAID-induced food allergy (NIFA), respectively. This Statement of the World Allergy Organization (WAO) aims to update both the classification of hypersensitivity reactions to NSAIDs and their diagnosis, addressing the novel issues
EffiCacy and safety of ANagliptin when added to iNsulin and metformin therapy in patients with uncontrolled type 2 diAbetes; randomized, placebo-controlled, double-blind, multicentre trial (CANNA study)
No full textHow Shift Nurses' Presenteeism is Related to Insomnia and Care Left Undone: A Cross-Sectional Study Using Generalised Structural Equation Modelling
No full textAIM: To examine the association between nurses' insomnia, presenteeism and care left undone and explore the mediating effect of presenteeism on the relationship between insomnia and care left undone among nurses in acute care hospitals, applying a dynamic model of presenteeism and absenteeism. DESIGN: A cross-sectional design. METHODS: A secondary data analysis was conducted using online survey data collected in January 2023. Participants were 1154 registered nurses who provided direct nursing care to patients in tertiary or general hospitals (hospitals with 300 or more beds) in South Korea. Poisson regression analysis was used to examine the association between nurses' insomnia, presenteeism and care left undone. Generalised structural equation modelling was performed to examine the mediating effect of presenteeism on the relationship between insomnia and care left undone. RESULTS: The prevalence of insomnia was 15.3%. More than half of the participants (63.7%) reported experiencing presenteeism in the past 4 weeks. All reported at least one nursing care left undone during their last shift. Insomnia and presenteeism were positively associated with care left undone, and presenteeism mediated the relationship between insomnia and care left undone among nurses in acute care hospitals. CONCLUSION: Nurses experienced insomnia and presenteeism, related to higher rates of care left undone. Nurses' insomnia had a direct effect on care left undone and an indirect effect through presenteeism. IMPLICATIONS FOR THE PROFESSION: Nurse managers and administrators need to make greater efforts to reduce insomnia and presenteeism among nurses, thereby reducing care left undone and improving patient safety in acute care settings. IMPACT: Nurse managers and administrators should consider proactive interventions to address nurses' insomnia and foster a workplace with healthy systems and culture to reduce sleep disturbance and presenteeism, which can effectively decrease care left undone. REPORTING METHOD: STROBE guidelines. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution
통합간호역량과 학부 프로그램 학습성과 비교를 통한 국가시험 핵심 범주 도출
No full textPURPOSE: This study aimed to identify core domains for pre-registered nurses by comparing licensing competencies with program outcomes (POs) in undergraduate nursing education. This was accomplished in preparation for the transition of the Korean Nurse Licensing Examination (KNLE) from a tradition seven-subject format to a newly integrated, competency-based single-subject format that reflects current trends in nursing assessment. METHODS: A literature review and survey were conducted. From 828 studies retrieved via PubMed, CINAHL, and Google Scholar using keywords such as "newly graduated registered nurses" and "competency OR competence," 18 were selected according to pre-established inclusion and exclusion criteria. Documents from national and international nursing organizations were included to extract relevant licensing competencies. We also reviewed POs from all undergraduate nursing schools in South Korea to align educational outcomes with the identified core domains. RESULTS: The core domains identified were clinical performance and decision-making, professional attitudes and ethics, communication and interpersonal skills, leadership and teamwork, quality improvement and safety, health promotion and prevention, and information technology and digital health. These domains showed strong alignment with POs under the fourth-cycle accreditation standards. CONCLUSION: It concludes the seven core domains will be appropriate for evaluating pre-registered nurses in the integrated KNLE. Based on the seven identified core domains, expert consensus should be sought in the next phase to support the development of integrated, competency-based test items grounded in these domains