Background and Objectives: Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min). Methods: XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints. Results: XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year. Conclusions XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.

Background and Objectives: Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min). Methods: XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints. Results: XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year. Conclusions XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.

Background: The significance of risk modification in patients with acute coronary syndrome (ACS) is well recognized; however, the optimal timing for adminstering PCSK9 inhibitors remains unclear. Additionally, the lipid-lowering efficacy of evolocumab and alirocumab has not been fully established. This study evaluated the lipid-lowering effects of these two PCSK9 inhibitors. Methods: Patients diagnosed with ACS, including unstable angina, ST-segment elevation myocardial infarction, and non-ST-segment elevation myocardial infarction, who were treated with a PCSK9 inhibitor (evolocumab or alirocumab) during hospitalization for ACS between 2021 and 2023 were retrospectively analyzed. Baseline low-density lipoprotein cholesterol (LDL-C) levels were assessed, and changes in LDL-C levels during the acute and subacute phases after PCSK9 inhibitor administration were compared between the evolocumab and alirocumab groups. Results: Among 80 patients diagnosed with ACS, 36 received evolocumab, while 44 were treated with alirocumab. The mean baseline LDL-C level was 123 mg/dL in the evolocumab group and 128 mg/dL in the alirocumab group (p=0.456). In the subacute phase, the mean follow-up LDL-C levels were 47.05 mg/dL in the evolocumab group and 49.5 mg/dL in the alirocumab group (p=0.585). The mean percentage reduction in LDL-C levels during the subacute phase was 60.41% in the evolocumab group and 58.51% in the alirocumab group (p=0.431). These differences were not statistically significant. Conclusions No significant differences were observed between evolocumab and alirocumab. LDL-C levels exhibited a similar trend, characterized by a rapid decline in the acute phase, followed by a slight rebound in the subacute phase.

Objective: Previous studies have reported an association between cancer-related symptoms and perceived social support (PSS). The objective of this study was to analyze whether Chemotherapy-Induced Peripheral Neuropathy (CIPN), a prevalent side effect of chemotherapy, varies according to PSS level using a validated tool for CIPN at prospective follow-up. Methods: A total of 39 breast cancer patients were evaluated for PSS using the Multidimensional Scale of Perceived Social Support (MSPSS) prior to chemotherapy and were subsequently grouped into one of two categories for each subscale: low-to-moderate PSS and high PSS. CIPN was prospectively evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) at five time points. A linear mixed-effects model with square root transformation was employed to investigate whether the CIPN20 scales varied by PSS level and time point. Results: Statistical analysis of the MSPSS total scale and subscales revealed a significant effect of the friends subscale group and time point on the CIPN20 sensory scale. The sensory scale score of CIPN20 was found to be lower in participants with high PSS from friends in comparison to those with low-to-moderate PSS at 1 month post-chemotherapy (p=0.010). Conclusion This is the first study to prospectively follow the long-term effect of pre-treatment PSS from friends on CIPN. Further studies based on larger samples are required to analyze the effects of PSS on the pathophysiology of CIPN.

Background: Small cell lung cancer (SCLC) is called ‘smoker’s disease’ because it is strongly associated with smoking and most cases occur in smokers. However, it can also occur in never smokers. We investigated the clinical features of never smokers with SCLC and compared their treatment outcomes with those of smokers with SCLC. Methods: We retrospectively reviewed the clinical data of patients who had proven SCLC and had received chemotherapy at a single cancer center between July 2002 and April 2021. Results: Of 1,643 patients, 1,416 (86.2%) were enrolled in this study. A total of 162 (11.4%) and 1,254 (88.6%) patients were never smokers and smokers, respectively. There were more female never smokers than smokers (n=130; 80.2% vs. 79, 6.3%, p=0.000), and the incidence of ischemic heart disease was lower among never smokers than among smokers (4/1,416, [2.5%] vs. 83/1,416 [6.6%], p=0.036). Never smokers showed less symptoms at diagnosis than smokers (80.9% vs. 87.2%, p=0.037); however, they showed more toxicity after first-line treatment (61.7% vs. 47.8%, p=0.001). The objective response rate (ORR) was significantly higher in never smokers (74.1% vs. 59.6%, p=0.000). In the multivariate analysis, never smoking and second-line treatment were associated with a better ORR. However, progression-free survival and overall survival were not significantly different between never smokers and smokers. Conclusion In conclusion, never smokers accounted for 11.4% of patients with SCLC. They had distinguishing clinical characteristics and showed better chemotherapeutic responses than smokers.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Background and Objectives: This study aimed to investigate the potential impact of earphone use on the occurrence of otitis externa (OE) by conducting a survey. Subjects and Methods: This study included 517 participants. The questionnaire comprised 22 items divided into three categories; general information, earphone use, and OE. The questionnaire was designed using Google Forms and distributed through a notice posted on a hospital bulletin board. This notice included a QR code that enabled any interested individual to participate, and the responses were collected automatically. Results: The proportion of respondents who had experienced OE at least once was 21%. Among them, 33.7% experienced OE within the preceding month. For “adhering to the recommendation usage time,” individuals who responded “likely” had a 0.440 (odds ratio=0.440, 95% confidence interval=0.195-0.993) times higher likelihood; they were at lower risk of experiencing OE compared to those who responded “very unlikely.” Conclusions Our findings suggest that proper earphone use can reduce the risk of OE. Despite the lack of a significant relationship between earphone type, physical activity, and cleaning practices, continued adherence to these factors is recommended to prevent OE.

Background and Objectives: This study aimed to investigate the effects of hearing aids (HAs) on reducing symptoms of dizziness in patients with hearing loss (HL) and dizziness. Subjects and Methods: A pre- and post-intervention study was conducted between February 2022 and July 2022 at the outpatient clinic of a tertiary hospital in Seoul, South Korea. Ten participants (four males and six females) with HL and dizziness were recruited. Participants were screened using pure-tone audiometry and visual analog scale scores at baseline. Selected participants underwent the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) and Korean Dizziness Handicap Inventory (K-DHI) in the unaided state. Thereafter, participants were provided HAs and instructed to use them for at least 6 hours every day. At the 1-month follow-up, all participants were assessed in the aided state using the same tests as at baseline. All tests were performed bilaterally. Results: In the mCTSIB, a significant difference was observed in the foam surface-eyes closed score before (median=2.35) and after (median=2.2) HA use (p=0.049). No significant differences were observed in the K-DHI scores before and after HA use. Conclusions HA use may improve the static and subjective perception of balance in patients with HL and dizziness. Future research should explore the benefits of HAs under various balance conditions such as dynamic balance and gait.

Background: This study aimed to compare the intraoperative stability and early clinical outcomes of 40-mm diameter dual mobility (DM)-total hip arthroplasty (THA) with 36-mm ceramic head (large head) THA in active elderly patients with hip fractures. Methods: A prospective randomized controlled trial was conducted from May 2022 to December 2022. Inclusion criteria were as follows: age ≥ 60 years, displaced femoral neck fracture, Koval grade 1 or 2, planned 54-mm acetabular component, and over 1-year follow-up. Intraoperative stability tests were performed on all patients (internal rotation at 45°, 60°, and 90° of hip fracture). Functional outcomes (Harris Hip Score and University of California, Los Angeles [UCLA] Score) were evaluated at 6 weeks and 3 months postoperatively. Gait analysis using artificial intelligence (AI) techniques was conducted at 3 months postoperatively. Results: The study included 36 DM-THA patients (mean age, 69.6 ± 2.2 years; 44% women) and 37 large head THA patients (mean age, 69.6 ± 1.2 years; 64% women). No statistically significant differences were observed in functional outcomes and hip range of motion between the 2 groups. However, there was a significant difference in the gait speed and stance-swing phase of the large head THA group and the DM-THA group: the DM-THA group demonstrated superior gait speed (2.85 ± 0.83 kph vs. 2.04 ± 1.04 kph, p = 0.003) and higher stance phase ratios (operated side: 63.57% ± 3.82% vs. 48.19% ± 5.50%, p < 0.001; opposite side: 62.77% ± 2.27% vs. 49.93% ± 6.94%, p < 0.001). In the stability test at 90° of hip flexion, the DM-THA group had a measurement of 48.40° ± 5.17°, while the large head THA group had a measurement of 30.94° ± 2.98° (p = 0.012). Despite the lack of statistical significance, the intraoperative stability test showed the dislocation angle was notably different between the groups in the hip flexion position of 60° (51.60° ± 6.09° in the DM-THA group and 40.00° ± 2.80° in the large head THA group, p = 0.072). Conclusions Superior results were observed in the intraoperative stability test and early recovery of gait after DM-THA compared to large head THA. We believe that DM-THA can be a useful surgical option for THA in elderly patients with hip fractures.