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Moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with metabolic syndrome and atherosclerotic cardiovascular disease: A post-hoc analysis of the RACING trial.
Lee, YJ, Lee, SH, You, SC, Lee, YH, Lee, SJ, Hong, SJ, Ahn, CM, Kim, BK, Ko, YG, Choi, D, et al
Diabetes, obesity & metabolism. 2024;(3):829-839
Abstract
AIM: This study evaluated the safety and efficacy of a moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with metabolic syndrome (MetS) and atherosclerotic cardiovascular disease. MATERIALS AND METHODS In this post-hoc subgroup analysis of the RACING trial, patients were analysed based on the presence of MetS. MetS was defined as meeting at least three of the five following criteria: (a) elevated waist circumference; (b) elevated triglycerides; (c) reduced high-density lipoprotein cholesterol; (d) elevated blood pressure; and (e) elevated fasting glucose. The primary outcome was a 3-year composite of cardiovascular death, major cardiovascular events, or non-fatal stroke. RESULTS Of the 3780 patients enrolled in the RACING trial, 1703 (45.1%) had MetS at baseline. The primary outcome rate was 10.1% and 10.3% in patients with MetS receiving ezetimibe combination therapy versus high-intensity statin monotherapy (hazard ratio = 0.97; 95% confidence interval = 0.72-1.32; p = .868). Lower rates of intolerance-related drug discontinuation or dose reduction (3.9% vs. 8.0%; p < .001) and lower low-density lipoprotein cholesterol levels (57 vs. 65 mg/dl; p < .001) were observed with ezetimibe combination therapy versus high-intensity statin monotherapy. Furthermore, the rate of new-onset diabetes was 18.5% and 19.1% in each group (p = .822). There were no significant interactions between MetS and therapy regarding study outcomes in the total population. CONCLUSIONS In patients with MetS and atherosclerotic cardiovascular disease, a moderate-intensity statin with ezetimibe combination therapy had comparable cardiovascular benefits with those of high-intensity statin monotherapy. Meanwhile, ezetimibe combination therapy was associated with lower drug intolerance and low-density lipoprotein cholesterol levels, but there was no apparent between-group difference in new-onset diabetes.
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Optimal antithrombotic strategy in patients with atrial fibrillation beyond 1 year after drug-eluting stent implantation: Design and rationale of the randomized ADAPT AF-DES trial.
Lee, SH, Lee, SJ, Heo, JH, Ahn, SG, Doh, JH, Shin, S, Shim, J, Her, AY, Kim, BG, Lim, SW, et al
American heart journal. 2024;:48-54
Abstract
BACKGROUND Both anticoagulation and antiplatelet therapies are recommended after percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF). Although contemporary guidelines recommend discontinuation of antiplatelet therapy 1 year after drug-eluting stent (DES) implantation due to excessive bleeding risk, supporting randomized trials are still lacking. METHODS The ADAPT AF-DES trial is a multicenter, prospective, open-label, randomized, non-inferiority trial, enrolling 960 patients with AF with a CHA2DS2-VASc score > 1, who underwent PCI with DES implantation at least 12 months before enrollment. Eligible patients are randomly assigned to receive either non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy or NOAC plus clopidogrel combination therapy. The primary outcome is net adverse clinical event (NACE) at 1 year after randomization, defined as a composite of all-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, and major or clinically relevant non-major bleeding, as defined by the International Society on Thrombosis and Hemostasis criteria. We hypothesize that NOAC monotherapy would be non-inferior to NOAC plus clopidogrel combination therapy for NACE in patients with AF beyond 12 months after DES implantation. CONCLUSIONS The ADAPT AF-DES trial will evaluate the efficacy and safety of NOAC monotherapy versus NOAC plus clopidogrel combination therapy in patients with AF beyond 12 months after PCI with DES implantation. The ADAPT AF-DES trial will provide robust evidence for an optimal antithrombotic strategy in patients with AF after DES implantation. CLINICAL TRIAL REGISTRATION https://www. CLINICALTRIALS gov. Unique identifier: NCT04250116.
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Bronchitis, COPD, and pneumonia after viral endemic of patients with leprosy on Sorok Island in South Korea.
Lee, JH, Kanwar, B, Khattak, A, Altschuler, E, Sergi, C, Lee, SJ, Choi, SH, Park, J, Coleman, M, Bourbeau, J
Naunyn-Schmiedeberg's archives of pharmacology. 2023;(7):1501-1511
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Viral respiratory diseases (VRDs) cause lung inflammation and inflammatory cytokine production. We study whether dapsone is responsible for its observed preventive treatment effects of the sustained viral RNA interferon response. Around 2008 and 2012, Korea's Dementia Management Act stipulated drastic changes in the administration of dementia medication by medical staff. Participants were randomized and we compared leprosy patients with VRDs after prescribing dapsone as a standard treatment from 2005 to 2019. Significance was evaluated based on the dapsone-prescribed (+) subgroup and the dapsone-unprescribed (-) subgroup of the VRD diagnosed (+) and VRD undiagnosed (-) subgroup. We analyzed VRD ( +)/(- with dapsone (+)/(-) group and used a T-test, and designed the equation of acetylation with dapsone and acetylcholine (AA) equation. The 6394 VRD participants who received the dapsone intervention compared to the 3255 VRD participants in the control group demonstrated at T2 VRD (+) dapsone (-) (mean (M) = 224.80, SD = 97.50): T3 VRD (-) dapsone (+) (M = 110.87, SD = 103.80), proving that VRD is low when dapsone is taken and high when it is not taken. The t value is 3.10, and the p value is 0.004395 (significant at p < 0.05). After an increase in VRDs peaked in 2009, bronchitis, COPD, and pneumonia surged in 2013. The AA equation was strongly negatively correlated with the prevalence of bronchitis and chronic obstructive pulmonary disease (COPD): with bronchitis, r(15) = -0.823189, p = 0.005519, and with COPD, r(15) = -0.8161, p = 0.000207 (significant at p < 0.05). Dapsone treated both bronchitis and COPD. This study provides theoretical clinical data to limit acetylcholine excess during the VRD pandemic for bronchitis, COPD, and pneumonia.
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Effects of music therapy as an alternative treatment on depression in children and adolescents with ADHD by activating serotonin and improving stress coping ability.
Park, JI, Lee, IH, Lee, SJ, Kwon, RW, Choo, EA, Nam, HW, Lee, JB
BMC complementary medicine and therapies. 2023;23(1):73
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Attention-deficit hyperactivity disorder (ADHD) is characterised by the presence of attention deficit, hyperactivity, and impulsivity as major symptoms, along with characteristics overlapping with other psychiatric disorders such as anxiety, depression, defiant disorder, and learning disability. The aim of this study was to confirm the possibility of continuous application and utilisation of music therapy as an alternative to medicine for preventing and treating depression in children and adolescents with ADHD. This study was a randomised controlled trial which enrolled a total of 60 subjects. They were divided into an ADHD control group (n =30) and an ADHD music therapy group (n= 30) each on a 1:1 basis. Results showed that the application of music therapy as an alternative treatment for depression in ADHD children and adolescents showed positive neurophysiological and psychological effects. Authors conclude that music therapy may contribute to the establishment and spread of clinical foundations through active use in the medical field.
Abstract
OBJECTIVE The objective of this study was to determine the effect of music therapy as an alternative treatment on depression in children and adolescents with attention-deficit hyperactivity disorder (ADHD) by activating serotonin (5-HT) and improving stress coping ability. METHODS This study is designed based on randomization method. A total of 36 subjects participated in the experiment, consisting of an ADHD control group (n = 18) and ADHD music therapy group (n = 18). The ADHD control group received standard care, while the ADHD music therapy group received music therapy and standard care. The ADHD music therapy group received both active music therapy (improvisation) and receptive music therapy (music listening) for 50 minutes, twice a week, for 3 months: a total of 24 times. From a neurophysiological perspective, changes in depression and stress were tracked by measuring 5-HT secretion, cortisol expression, blood pressure (BP), heart rate (HR), and CDI and DHQ psychological scales. RESULTS The ADHD music therapy group's 5-HT secretion increased (p < 0.001), whereas cortisol expression (p < 0.001), BP (p < 0.001) and HR (p < 0.001) decreased. The CDI and DHQ psychological scales also showed positive changes (p < 0.01 and p < 0.001, respectively). However, the ADHD Con G's (who did not receive music therapy) 5-HT secretion did not increase, whereas cortisol expression, BP, and HR did not decrease. In addition, the CDI and DHQ psychological scales did not display positive changes. CONCLUSIONS In conclusion, the application of music therapy as an alternative treatment for ADHD children and adolescents showed positive neurophysiological and psychological effects. Therefore, this study would like to propose a new alternative to medicine for preventing and treating depression through various uses of music therapy.
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Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease: A Randomized Clinical Trial.
Hong, SJ, Lee, YJ, Lee, SJ, Hong, BK, Kang, WC, Lee, JY, Lee, JB, Yang, TH, Yoon, J, Ahn, CM, et al
JAMA. 2023;(13):1078-1087
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IMPORTANCE In patients with coronary artery disease, some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in low-density lipoprotein cholesterol (LDL-C). An alternative approach is to begin with moderate-intensity statins and titrate to a specific LDL-C goal. These alternatives have not been compared head-to-head in a clinical trial involving patients with known coronary artery disease. OBJECTIVE To assess whether a treat-to-target strategy is noninferior to a strategy of high-intensity statins for long-term clinical outcomes in patients with coronary artery disease. DESIGN, SETTING, AND PARTICIPANTS A randomized, multicenter, noninferiority trial in patients with a coronary disease diagnosis treated at 12 centers in South Korea (enrollment: September 9, 2016, through November 27, 2019; final follow-up: October 26, 2022). INTERVENTIONS Patients were randomly assigned to receive either the LDL-C target strategy, with an LDL-C level between 50 and 70 mg/dL as the target, or high-intensity statin treatment, which consisted of rosuvastatin, 20 mg, or atorvastatin, 40 mg. MAIN OUTCOMES AND MEASURES Primary end point was a 3-year composite of death, myocardial infarction, stroke, or coronary revascularization with a noninferiority margin of 3.0 percentage points. RESULTS Among 4400 patients, 4341 patients (98.7%) completed the trial (mean [SD] age, 65.1 [9.9] years; 1228 females [27.9%]). In the treat-to-target group (n = 2200), which had 6449 person-years of follow-up, moderate-intensity and high-intensity dosing were used in 43% and 54%, respectively. The mean (SD) LDL-C level for 3 years was 69.1 (17.8) mg/dL in the treat-to-target group and 68.4 (20.1) mg/dL in the high-intensity statin group (n = 2200) (P = .21, compared with the treat-to-target group). The primary end point occurred in 177 patients (8.1%) in the treat-to-target group and 190 patients (8.7%) in the high-intensity statin group (absolute difference, -0.6 percentage points [upper boundary of the 1-sided 97.5% CI, 1.1 percentage points]; P < .001 for noninferiority). CONCLUSIONS AND RELEVANCE Among patients with coronary artery disease, a treat-to-target LDL-C strategy of 50 to 70 mg/dL as the goal was noninferior to a high-intensity statin therapy for the 3-year composite of death, myocardial infarction, stroke, or coronary revascularization. These findings provide additional evidence supporting the suitability of a treat-to-target strategy that may allow a tailored approach with consideration for individual variability in drug response to statin therapy. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02579499.
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Moderate-intensity statin plus ezetimibe vs high-intensity statin according to baseline LDL-C in the treatment of atherosclerotic cardiovascular disease: A post-hoc analysis of the RACING randomized trial.
Lee, B, Hong, SJ, Rha, SW, Heo, JH, Hur, SH, Choi, HH, Kim, KJ, Kim, JH, Kim, HK, Kim, U, et al
Atherosclerosis. 2023;:117373
Abstract
BACKGROUND AND AIMS Whether the effect of a combination strategy rather than increasing doses of one drug to lower low-density lipoprotein cholesterol (LDL-C) levels is consistent across baseline LDL-C levels remains uncertain. METHODS In the RACING trial, which showed a non-inferiority of moderate-intensity statin with ezetimibe (rosuvastatin 10 mg with ezetimibe 10 mg) to high-intensity statin (rosuvastatin 20 mg) for the primary outcome (3-year composite of cardiovascular death, major cardiovascular event, or stroke), the heterogeneity in treatment effect according to baseline LDL-C levels was assessed for the primary and secondary outcomes (clinical efficacy and safety). RESULTS Of 3780 participants, 2817 participants (74.5%) had LDL-C <100 mg/dL, and 963 participants (25.5%) had LDL-C ≥100 mg/dL. The treatment effect of combination therapy versus high-intensity statin monotherapy was similar among the lower LDL-C subset (8.8% vs. 10.2%; hazard ratio [HR] 0.85, 95% confidence interval [CI] 0.67 to 1.08, p = 0.19) and the higher LDL-C subset (10.8% vs. 9.6 %; HR 1.14, 95% CI 0.76 to 1.7, p = 0.53) without a significant interaction (interaction p = 0.22). Of the secondary outcomes, the 1-, 2-, and 3-year achievement of LDL-C <70 mg/dL was greater in the combination therapy group regardless of baseline LDL-C levels. CONCLUSIONS Among ASCVD patients, there was no heterogeneity in the effect of moderate-intensity statin plus ezetimibe combination therapy in the higher and lower baseline LDL-C levels for the 3-year composite of cardiovascular outcomes.
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24-h urine collection in patients with urolithiasis: perspective on renal function.
Kim, HW, Lee, SJ, Lee, DS
Urolithiasis. 2023;(1):5
Abstract
A prospective observational study involving consecutive patients diagnosed with symptomatic urolithiasis was conducted to evaluate the serial change of urinary protein and 24-h urine chemistry with time after surgical procedures for urolithiasis. A consecutive 24-h urine samples, including calcium, uric acid and citrate were collected before surgical treatments, 4 ~ 8 weeks after surgery and 6 months after surgery. The urinary protein to creatinine ratio was also repeated at each timepoint. Forty-seven patients completed the study. The quantity of 24-h urine chemistry, including calcium, uric acid and citrate, changed over time and tended to increase (p = 0.013, 0.076 and 0.004, respectively), but the changes were not prominent during short-term follow-up. In contrast, the urinary protein to creatinine ratio decreased (p < 0.001) after surgical treatment for symptomatic renal stones, and the change was reflected in short-term follow-up. However, the serial changes in the urinary protein to creatinine ratio were significantly related to the serial changes in the 24-h urinary chemistry (p < 0.001). Surgical decompression for symptomatic urolithiasis could decrease the urinary protein to creatinine ratio, indicating improvement from renal damage, which may be reflected in the increase in 24-h urinary chemistry, including calcium, uric acid and citrate. These results strengthen the previous guidelines for the timing of 24-h urine collection and provide new insight into the optimal timing from the perspective of renal function.
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Combination Lipid-Lowering Therapy in Patients Undergoing Percutaneous Coronary Intervention.
Lee, SJ, Joo, JH, Park, S, Kim, C, Choi, DW, Hong, SJ, Ahn, CM, Kim, JS, Kim, BK, Ko, YG, et al
Journal of the American College of Cardiology. 2023;(5):401-410
Abstract
BACKGROUND The RACING (randomized comparison of efficacy and safety of lipid-lowering with statin monotherapy versus statin/ezetimibe combination for high-risk cardiovascular diseases) trial examined the effects of combination therapy with moderate-intensity statin and ezetimibe in patients with atherosclerotic cardiovascular disease compared with high-intensity statin monotherapy. OBJECTIVES This observational study was conducted to evaluate the impact of 2 treatment strategies used in the RACING trial in clinical practice. METHODS After stabilized inverse probability of treatment weighting, a total of 72,050 patients who were prescribed rosuvastatin after drug-eluting stent implantation were identified from a nationwide cohort database: 10,794 patients with rosuvastatin 10 mg plus ezetimibe 10 mg (combination lipid-lowering therapy) and 61,256 patients with rosuvastatin 20 mg monotherapy. The primary endpoint was the 3-year composite event of cardiovascular death, myocardial infarction, coronary artery revascularization, hospitalization for heart failure treatment, or nonfatal stroke in accordance with the RACING trial. RESULTS Combination lipid-lowering therapy was associated with a lower occurrence of the primary endpoint (11.6% vs 15.2% for those with high-intensity statin monotherapy; HR: 0.75; 95% CI: 0.70-0.79; P < 0.001). Compared with high-intensity statin monotherapy, combination lipid-lowering therapy was associated with fewer discontinuations of statin (6.5% vs 7.6%; HR: 0.85; 95% CI: 0.78-0.94: P < 0.001) and a lower occurrence of new-onset diabetes requiring medication (7.7% vs 9.6%; HR: 0.80; 95% CI: 0.72-0.88; P < 0.001). CONCLUSIONS In clinical practice, combination lipid-lowering therapy with ezetimibe and moderate-intensity statin was associated with favorable clinical outcomes and drug compliance in patients treated with drug-eluting stent implantation. (CONNECT DES Registry; NCT04715594).
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Moderate-Intensity Statin With Ezetimibe Combination Therapy vs High-Intensity Statin Monotherapy in Patients at Very High Risk of Atherosclerotic Cardiovascular Disease: A Post Hoc Analysis From the RACING Randomized Clinical Trial.
Lee, SJ, Cha, JJ, Choi, WG, Lee, WS, Jeong, JO, Choi, S, Cho, YH, Park, W, Yoon, CH, Lee, YJ, et al
JAMA cardiology. 2023;(9):853-858
Abstract
IMPORTANCE High-intensity statin is strongly recommended in patients at very high risk (VHR) of atherosclerotic cardiovascular disease (ASCVD). However, concerns about statin-associated adverse effects result in underuse of this strategy in practice. OBJECTIVE To evaluate the outcomes of a moderate-intensity statin with ezetimibe combination in VHR and non-VHR patients with ASCVD. DESIGN, SETTING, AND PARTICIPANTS This was a post hoc analysis of the Randomized Comparison of Efficacy and Safety of Lipid Lowering With Statin Monotherapy vs Statin/Ezetimibe Combination for High-Risk Cardiovascular Disease (RACING) open-label, multicenter, randomized clinical trial. The study was conducted from February 2017 to December 2018 at 26 centers in Korea. Study participants included patients with documented ASCVD. Data were analyzed from April to June 2022. INTERVENTIONS Patients were randomly assigned to moderate-intensity statin with ezetimibe (rosuvastatin, 10 mg, with ezetimibe, 10 mg) or high-intensity statin monotherapy (rosuvastatin, 20 mg). Patients at VHR for ASCVD were defined according to the 2018 American Heart Association/American College of Cardiology guidelines. MAIN OUTCOMES AND MEASURES The primary end point was the 3-year outcome of cardiovascular death, coronary or peripheral revascularization, hospitalization of cardiovascular events, or nonfatal stroke. RESULTS A total of 3780 patients (mean [SD] age, 64 [10] years; 2826 male [75%]) in the RACING trial, 1511 (40.0%) were categorized as VHR, which was associated with a greater occurrence of the primary end point (hazard ratio [HR], 1.42; 95% CI, 1.15-1.75). There was no significant difference in the primary end point between those who received combination therapy and high-intensity statin monotherapy among patients with VHR disease (11.2% vs 11.7%; HR, 0.96; 95% CI, 0.71-1.30) and non-VHR disease (7.7% vs 8.7%; HR, 0.88; 95% CI, 0.66-1.18). The median low-density lipoprotein cholesterol (LDL-C) level was significantly lower in the combination therapy group than in the high-intensity statin group (VHR, 1 year: 57 [47-71] mg/dL vs 65 [53-78] mg/dL; non-VHR, 1 year: 58 mg/dL vs 68 mg/dL; P < .001). Furthermore, in both the VHR and non-VHR groups, combination therapy was associated with a significantly greater mean change in LDL-C level (VHR, 1 year: -19.1 mg/dL vs -10.1 mg/dL; 2 years: -22.3 mg/dL vs -13.0 mg/dL; 3 years: -18.8 mg/dL vs -9.7 mg/dL; non-VHR, 1 year: -23.7 mg/dL vs -12.5 mg/dL; 2 years: -25.2 mg/dL vs -15.1 mg/dL; 3 years: -23.5 mg/dL vs -12.6 mg/dL; all P < .001) and proportion of patients with LDL-C level less than 70 mg/dL (VHR, 1 year: 73% vs 58%; non-VHR, 1 year: 72% vs 53%; P < .001). Discontinuation or dose reduction of the lipid-lowering drug due to intolerance occurred less frequently in the combination therapy group (VHR, 4.6% vs 7.7%; P = .02; non-VHR, 5.0% vs 8.7%; P = .001). CONCLUSIONS AND RELEVANCE Results suggest that the outcomes of ezetimibe combination observed in the RACING trial were consistent among patients at VHR of ASCVD. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03044665.
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Evaluation of Fluidity and Strength of High-Early-Strength Cement-Based Repair Materials by Adding SB Latex and Wollastonite Mineral Fibers.
Choo, YJ, Koo, JH, Lee, SJ, Park, CG
Materials (Basel, Switzerland). 2023;(15)
Abstract
Concrete structures often fail to perform their original functions due to problems such as deterioration and damage over time. Therefore, various repair materials have been studied to maintain deteriorated concrete structures. This study experimentally investigated the mechanical properties of high-early-strength cement-based repair materials for spraying. For spraying, the cement-based materials should have adoptable fluidity and strength: 200 ± 100 mm for flow; 20 MPa at 24 h and 40 MPa at 28 days for compressive strength, and 8 MPa at 28 days for flexural strength. Wollastonite mineral fibers (3-5 wt.%) and styrene-butadiene (SB) latex (5-7 wt.%) were studied to enhance this requirement. Fluidity was evaluated by flow test and measuring the heat of hydration; mechanical properties were evaluated in terms of compressive and flexural strength. The cement-to-silica sand ratio (C:S ratio) was also applied differently to adjust the pot life of polymer cement-based material (1:1 and 1:1.5) as a binder. Because wollastonite mineral fibers and SB latex affect workability, the water-to-binder ratio was regulated to reach the target flow according to the amount of wollastonite mineral fibers and SB latex. Regardless of the C:S ratio, all studied mixtures met the target 28 day compressive strength at 24 h, decreasing in strength with increasing amounts of wollastonite mineral fibers and latex. Flexural strength also fulfilled the target value, and it increased with increasing amounts of wollastonite mineral fibers and latex, unlike compressive strength. The optimal mix proportion of high-early-strength cement-based repair materials constituted 3 wt.% wollastonite mineral fibers and 5 wt.% SB latex as the binder in a C:S ratio of 1:1.5.