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Effectiveness of low-intensity atorvastatin 5 mg and ezetimibe 10 mg combination therapy compared with moderate-intensity atorvastatin 10 mg monotherapy: A randomized, double-blinded, multi-center, phase III study.
Lee, SA, Hong, SJ, Sung, JH, Kim, KS, Kim, SH, Cho, JM, Chun, SW, Lee, SR, Kim, CS, Kim, TN, et al
Medicine. 2023;(47):e36122
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Abstract
BACKGROUND We compared the efficacy and safety of low-intensity atorvastatin and ezetimibe combination therapy with moderate-intensity atorvastatin monotherapy in patients requiring cholesterol-lowering therapy. METHODS At 19 centers in Korea, 290 patients were randomized to 4 groups: atorvastatin 5 mg and ezetimibe 10 mg (A5E), ezetimibe 10 mg (E), atorvastatin 5 mg (A5), and atorvastatin 10 mg (A10). Clinical and laboratory examinations were performed at baseline, and at 4-week and 8-week follow-ups. The primary endpoint was percentage change from baseline in low-density lipoprotein (LDL) cholesterol levels at the 8-week follow-up. Secondary endpoints included percentage changes from baseline in additional lipid parameters. RESULTS Baseline characteristics were similar among the study groups. At the 8-week follow-up, percentage changes in LDL cholesterol levels were significantly greater in the A5E group (49.2%) than in the E (18.7%), A5 (27.9%), and A10 (36.4%) groups. Similar findings were observed regarding the percentage changes in total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B levels. Triglyceride levels were also significantly decreased in the A5E group than in the E group, whereas high-density lipoprotein levels substantially increased in the A5E group than in the E group. In patients with low- and intermediate-cardiovascular risk, 93.3% achieved the target LDL cholesterol levels in the A5E group, 40.0% in the E group, 66.7% in the A5 group, and 92.9% in the A10 group. In addition, 31.4% of patients in the A5E group, 8.1% in E, 9.7% in A5, and 7.3% in the A10 group reached the target levels of both LDL cholesterol < 70 mg/dL and reduction of LDL ≥ 50% from baseline. CONCLUSIONS The addition of ezetimibe to low-intensity atorvastatin had a greater effect on lowering LDL cholesterol than moderate-intensity atorvastatin alone, offering an effective treatment option for cholesterol management, especially in patients with low and intermediate risks.
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A spurious elevation of serum creatinine level in a patient with Crohn's disease without histologic kidney damage: a case report and review of the literature.
Lee, SA, McMahon, GM
Jornal brasileiro de nefrologia. 2023;(4):497-501
Abstract
Patients with inflammatory bowel disease (IBD) are prone to develop kidney injury. Renal involvement in IBD patients is usually diagnosed by the measurement of serum creatinine and the estimation of the glomerular filtration rate. We describe a patient with IBD who presented with large fluctuations in his serum creatinine level (~3.0-fold) without significant histologic abnormalities and with a normal cystatin C level. This appears to be related to a high-protein diet and intermittent fasting. Even though the impact of a high-protein diet on mild elevations of the serum creatinine level has been described, large fluctuations in serum creatinine from diet alone, as seen in this case, have never been reported, raising the question about the potential contribution of inflamed bowel on gut absorption or metabolism of creatinine. This case highlights the importance of a detailed history, including the dietary habits, when encountering a patient with increased serum creatinine level, and careful interpretation of serum creatinine in a patient with a creatinine high-protein diet or underlying IBD.
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Association of aortic valvular complex calcification burden with procedural and long-term clinical outcomes after transcatheter aortic valve replacement.
Ko, E, Kang, DY, Ahn, JM, Kim, TO, Kim, JH, Lee, J, Lee, SA, Kim, DH, Kim, HJ, Kim, JB, et al
European heart journal. Cardiovascular Imaging. 2022;(11):1502-1510
Abstract
AIMS: This study aimed to assess the impact of valvular/subvalvular calcium burden on procedural and long-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). METHODS AND RESULTS In this prospective observational cohort study, we included patients with AS undergoing TAVR between March 2010 and December 2019. Calcium burden at baseline was quantified using multidetector computed tomography and the patients were classified into tertile groups according to the amount of calcium. Procedural outcomes [paravalvular leakage (PVL) or permanent pacemaker insertion (PPI)] and 12-month clinical outcomes (composite of death, stroke, or rehospitalization, and all-cause mortality) were assessed. A total of 676 patients (age, 79.8 ± 5.4 years) were analysed. The 30-day rates of moderate or severe PVL (P-for-trend = 0.03) and PPI (P-for-trend = 0.002) proportionally increased with the tertile levels of calcium volume. The 12-month rate of primary composite outcomes was 34.2% in low-tertile, 23.9% in middle-tertile, and 25.8% in high-tertile groups (log-rank P = 0.02). After multivariable adjustment, the risk for primary composite outcomes at 12 months was not significantly different between the tertile groups of calcium volume [reference = low-tertile; middle-tertile, hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.54-1.22; P = 0.31; high-tertile, HR 0.93; 95% CI 0.56-1.57; P = 0.80]. A similar pattern was observed for all-cause mortality. CONCLUSION The rates of PVL and PPI proportionally increased according to the levels of valvular/subvalvular calcium volume, while the adjusted risks for composite outcomes and mortality at 12 months were not significantly different.
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Correlational analysis of bone health status and vitamin D-related biomarkers in women working in agriculture.
Cho, MC, Park, KS, Shin, JK, Lee, SA, Cho, IA, Jo, HC, Kim, SC, Choi, WJ
Medicine. 2021;(34):e27071
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Abstract
The purpose of this study was to investigate the status of bone health in women working in agriculture and analyze the associations between bone health and various vitamin D-related biomarkers.This observational study enrolled women working in agriculture (n = 210) and control occupations (n = 180). The concentration of serum total 25-hydroxy vitamin D [25(OH)D] was measured using the Elecsys Vitamin D Total Kit, and serum vitamin D-binding protein (VDBP) was measured by enzyme-linked immunosorbent assay. Along with albumin, 25(OH)D and VDBP were used to calculate the concentrations of bioavailable and free 25(OH)D. Bone mineral density (BMD) and T-score were measured at lumbar 1 to 4 and the femur neck using dual-energy X-ray absorptiometry. To identify factors affecting BMD, log-linear model and linear regression analysis were performed for statistical analysis.Agricultural women workers showed higher serum concentrations of bioavailable 25(OH)D (12.8 ± 3.7 vs 8.7 ± 5.1 ng/mL) and lower VDBP concentrations (201.8 ± 45.0 vs 216.0 ± 68.2 μg/mL) than control women. The association between these 2 vitamin D related-biomarkers and femur neck BMD were confirmed through univariable and multivariable linear model analysis. Although lumbar BMD did not differ between groups, the agricultural group displayed a lower femur BMD and a 4.3-fold increase in the risk of osteoporosis compared with the control group.Women working in agriculture showed lower femur BMD than the control group. Of the vitamin D-related biomarkers tested, bioavailable 25(OH)D and VDBP were associated with BMD. As bioavailable 25(OH)D levels are affected mainly by VDBP levels, VDBP may play a role in the lower femur neck BMD values observed in the agricultural group. Thus, the measurement of VDBP concentration might be considered a simple and non-invasive method for measuring bone health status.
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Improving the care of inflammatory bowel disease (IBD) patients: perspectives and strategies for IBD center management.
Park, J, Park, S, Lee, SA, Park, SJ, Cheon, JH
The Korean journal of internal medicine. 2021;(5):1040-1048
Abstract
The incidence and prevalence rates of inf lammatory bowel disease (IBD) have been increasing in East Asian countries over the past few decades. Accordingly, the general understanding and awareness of IBD among healthcare professionals has increased considerably in this region. This increase is ultimately associated with the evolving focus of IBD clinicians devoted to comprehensive patient care, especially in establishing IBD clinics/centers capable of providing multidisciplinary counseling. Comprehensive IBD care at IBD clinics/centers usually includes surgical and medication decision-making, transition from pediatric to adult clinics, care of extraintestinal manifestations, care of infectious diseases in patients undergoing immunomodulatory or biologic therapies, and nutritional, psychosocial, socioeconomic, and pharmacological care. Team members comprise specialists from various departments related to IBD and can be divided into core and ad hoc members. Usually, the scope of work in IBD clinics/centers involves patient care, patient outreach, and system management. Considering the environmental changes in IBD treatment, it is necessary to perform comprehensive IBD patient care in the form of a program based on competencies, rather than simply following the organization of previous IBD centers. The present review summarizes recent trends in IBD patient care and offers perspectives regarding IBD center management.
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The Fragility of Temporal Memory in Alzheimer's Disease.
Park, JH, Lee, SA
Journal of Alzheimer's disease : JAD. 2021;(4):1631-1646
Abstract
BACKGROUND Although episodic memory impairment is one of the hallmarks of Alzheimer's disease (AD), the relative decline in the components of episodic memory (What, Where, and When) and the effects of cognitive training on each of them are still unknown. OBJECTIVE We aimed to independently assess the impairment in each component of episodic memory in early to moderate AD and address whether it can be enhanced through active, spatiotemporal episodic training. METHODS A non-verbal scene-based episodic memory task was developed to assess the ability to remember What, Where, and When information. Experiment 1 tested whether this task can differentiate AD subjects (N = 16) from healthy controls (N = 16). In Experiment 2, 13 AD subjects underwent 16 training sessions, followed by a re-administration of the scene-based memory task. Experiment 3 tested 42 healthy older adults and 51 younger adults on the same task to investigate the effects of normal aging. RESULTS Of the three components, When memory had the highest predictive power in distinguishing AD from normal aging. Following training of AD subjects, only Where memory improved. Only What memory revealed a significant decline in healthy subjects from 65-85 years of age. CONCLUSION These findings shed new light on the importance of the temporal component of episodic memory as a behavioral marker of AD. The selective improvement of spatial but not temporal memory through training further demonstrates the fragility of temporal memory even in early AD. Neuroscientific research is needed to distinguish whether the Where component was enhanced by improvements in hippocampal spatial representation or by other compensatory mechanisms.
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Whole-genome sequencing from the New Zealand Saccharomyces cerevisiae population reveals the genomic impacts of novel microbial range expansion.
Higgins, P, Grace, CA, Lee, SA, Goddard, MR
G3 (Bethesda, Md.). 2021;(1)
Abstract
Saccharomyces cerevisiae is extensively utilized for commercial fermentation, and is also an important biological model; however, its ecology has only recently begun to be understood. Through the use of whole-genome sequencing, the species has been characterized into a number of distinct subpopulations, defined by geographical ranges and industrial uses. Here, the whole-genome sequences of 104 New Zealand (NZ) S. cerevisiae strains, including 52 novel genomes, are analyzed alongside 450 published sequences derived from various global locations. The impact of S. cerevisiae novel range expansion into NZ was investigated and these analyses reveal the positioning of NZ strains as a subgroup to the predominantly European/wine clade. A number of genomic differences with the European group correlate with range expansion into NZ, including 18 highly enriched single-nucleotide polymorphism (SNPs) and novel Ty1/2 insertions. While it is not possible to categorically determine if any genetic differences are due to stochastic process or the operations of natural selection, we suggest that the observation of NZ-specific copy number increases of four sugar transporter genes in the HXT family may reasonably represent an adaptation in the NZ S. cerevisiae subpopulation, and this correlates with the observations of copy number changes during adaptation in small-scale experimental evolution studies.
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Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Jun, JE, Jeong, IK, Yu, JM, Kim, SR, Lee, IK, Han, KA, Choi, SH, Kim, SK, Park, HK, Mok, JO, et al
Diabetes & metabolism journal. 2020;(1):78-90
Abstract
BACKGROUND Cardiovascular risk remains increased despite optimal low density lipoprotein cholesterol (LDL-C) level induced by intensive statin therapy. Therefore, recent guidelines recommend non-high density lipoprotein cholesterol (non-HDL-C) as a secondary target for preventing cardiovascular events. The aim of this study was to assess the efficacy and tolerability of omega-3 fatty acids (OM3-FAs) in combination with atorvastatin compared to atorvastatin alone in patients with mixed dyslipidemia. METHODS This randomized, double-blind, placebo-controlled, parallel-group, and phase III multicenter study included adults with fasting triglyceride (TG) levels ≥200 and <500 mg/dL and LDL-C levels <110 mg/dL. Eligible subjects were randomized to ATOMEGA (OM3-FAs 4,000 mg plus atorvastatin calcium 20 mg) or atorvastatin 20 mg plus placebo groups. The primary efficacy endpoints were the percent changes in TG and non-HDL-C levels from baseline at the end of treatment. RESULTS After 8 weeks of treatment, the percent changes from baseline in TG (-29.8% vs. 3.6%, P<0.001) and non-HDL-C (-10.1% vs. 4.9%, P<0.001) levels were significantly greater in the ATOMEGA group (n=97) than in the atorvastatin group (n=103). Moreover, the proportion of total subjects reaching TG target of <200 mg/dL in the ATOMEGA group was significantly higher than that in the atorvastatin group (62.9% vs. 22.3%, P<0.001). The incidence of adverse events did not differ between the two groups. CONCLUSION The addition of OM3-FAs to atorvastatin improved TG and non-HDL-C levels to a significant extent compared to atorvastatin alone in subjects with residual hypertriglyceridemia.
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Antiretroviral Therapy Concentrations Differ in Gut vs. Lymph Node Tissues and Are Associated With HIV Viral Transcription by a Novel RT-ddPCR Assay.
Lee, SA, Telwatte, S, Hatano, H, Kashuba, ADM, Cottrell, ML, Hoh, R, Liegler, TJ, Stephenson, S, Somsouk, M, Hunt, PW, et al
Journal of acquired immune deficiency syndromes (1999). 2020;(5):530-537
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BACKGROUND Most HIV-infected cells during antiretroviral therapy (ART) persist in lymphoid tissues. Studies disagree on whether suboptimal tissue ART concentrations contribute to ongoing HIV replication during viral suppression. METHODS We performed a cross-sectional study in virally-suppressed HIV+ participants measuring lymphoid tissue ART [darunavir (DRV), atazanavir (ATV), and raltegravir (RAL)] concentrations by LC-MS/MS assay. Tissue and plasma ART concentrations were used to estimate TPRs and drug-specific tissue:inhibitory concentration ratios (TICs). HIV DNA and sequentially produced HIV RNA transcripts were quantified from rectal biopsies using droplet digital PCR (ddPCR) assays. RESULTS Tissue samples were collected in duplicate from 19 participants: 38 rectal, 8 ileal (4 RAL, 2 DRV, 2 ATV), and 6 lymph node (4 RAL, 2 DRV) samples. Overall, median TICs were higher for RAL than DRV or ATV (both P = 0.006). Median TICs were lower in lymph nodes vs. ileum (0.49 vs. 143, P = 0.028) or rectum (33, P = 0.019), and all ART levels were below target concentrations. Higher rectal TICs were associated with lower HIV RNA transcripts (read-through, long LTR, and Nef, P all < 0.026) and a lower long LTR RNA/long LTR DNA ratio (P = 0.021). CONCLUSIONS We observed higher tissue ART concentrations in ileum and rectum compared with lymph nodes. We observed higher HIV transcription in participants with lower rectal ART concentrations. These findings add to the limited data supporting the idea that viral transcription may be influenced by ART concentrations in lymphoid tissues. Further exploration of tissue pharmacokinetics is needed in future HIV eradication strategies.
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Effects of probiotic bacterium Weissella cibaria CMU on periodontal health and microbiota: a randomised, double-blind, placebo-controlled trial.
Kang, MS, Lee, DS, Lee, SA, Kim, MS, Nam, SH
BMC oral health. 2020;(1):243
Abstract
BACKGROUND Weissella cibaria CMU (oraCMU) has been commercially available in the market for several years as oral care probiotics. The present study aimed to evaluate the effects of oraCMU-containing tablets on periodontal health and oral microbiota. METHODS A randomised, double-blind, placebo-controlled trial was conducted in 92 adults without periodontitis (20-39 years of age). All subjects received dental scaling and root planing, and were randomly assigned to either probiotic or placebo groups. The tablets were administered once daily for 8 weeks. Periodontal clinical parameters included bleeding on probing (BOP), probing depth (PD), gingival index (GI), and plaque index (PI). In addition, microbiota in the gingival sulcus were analysed. RESULTS BOP improved more in the probiotic group over 8 weeks. There were statistically significant differences in BOP of the maxilla buccal and lingual sites between the groups during the intervention (P < 0.05). No significant inter-group differences in PD, GI, and PI were observed during the intervention. Oral bacteria were observed to be fewer in the probiotic group. There was a significant change in levels of Fusobacterium nucleatum at four and 8 weeks between the two groups. Besides, there were significant differences at 8 weeks in levels of Staphylococcus aureus. CONCLUSIONS We reported an improvement in BOP and microbial environment and demonstrated the antimicrobial activity of oraCMU against F. nucleatum. Thus, its supplementation may contribute to overall oral health. TRIAL REGISTRATION Ethical issues approved by the Kangwon National University Institutional Review Board with a number of KWNUIRB-2018-05-003-005 and CRIS code Number of KCT0005078 were retrospectively registered on 06/02/2020. This study was conducted in the period of July to November 2018.