1.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
2.Single System Cutaneous Langerhans Cell Histiocytosis Mimicking Prurigo Nodularis
Juhyun CHUNG ; Kyujin YEOM ; Dongho KIM ; Myung Hwa KIM ; Byung Cheol PARK ; Mi Soo CHOI
Korean Journal of Dermatology 2024;62(2):110-113
Langerhans cell histiocytosis (LCH) is a rare inflammatory neoplasia of the dendritic cells that can affect the whole body and commonly affect the pediatric age. Adult onset LCH is relatively rare, and the cutaneous form without any other organ involvement is much more uncommon. A 62-year-old woman visited the clinic presenting pruritic erythematous papule and nodules on the whole body, from which she suffered for several years. Skin biopsy showed hyperkeratosis, mild acanthosis, intra-epidermal tumor cell infiltration, and band-like tumor cell infiltration. Cells infiltrating the epidermis and dermis showed characteristics consistent with Langerhans cells. Immunohistochemical analysis revealed tumor cells highlighted with CD1a and S-100, but not with CD68, and therefore, diagnosed as LCH. The patient showed no evidence of any other organ manifestation, which led the final diagnosis of single-system LCH. This case highlights a rare adult-onset cutaneous form of single-system LCH with skin manifestations very similar to prurigo nodularis.
3.Cutaneous Adverse Reactions after COVID-19 Vaccination
Dea Kwan YUN ; Doyeon KIM ; Juhyun CHUNG ; Kyujin YEOM ; Dongho KIM ; Young LEE ; Mi Soo CHOI ; Byung Cheol PARK ; Myung Hwa KIM
Korean Journal of Dermatology 2024;62(2):69-76
Background:
In the current situation, where severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is rapidly spreading, vaccines for coronavirus are thought to be the most effective approach to containing the situation.However, limited comparative data are available on cutaneous adverse reactions to coronavirus vaccination in Korea.
Objective:
We retrospectively reviewed the clinical and histopathological characteristics of adverse cutaneous reactions following coronavirus vaccination.
Methods:
We retrospectively reviewed the clinical and histopathological characteristics of 95 patients who were vaccinated with Pfizer, Moderna, AstraZeneca, and Janssen vaccines and visited the Dermatology Departments of Dankook University Hospital and Chungnam National University Hospital.
Results:
The mean age was 49.3±17.5 years. Patients who received the AstraZeneca vaccine had an average age of 61.7±10.8 years, significantly higher than those in the Pfizer (44.1±18.7 years) and Moderna (42.5±15.0 years) groups (p<0.001). Of the 95 patients, 36 (37.9%) were diagnosed with urticaria, 24 (25.3%) with morbilliform eruption, 18 (18.9%) with petechiae and purpura, and eight (8.4%) with erythema multiforme. Additionally, there were diagnoses of erythema nodosum, alopecia areata, eczema, generalized pustular psoriasis, acute generalized exanthematous pustulosis, pityriasis rosea, and bullous pemphigoid. In the AstraZeneca-vaccinated group, the proportion of morbilliform eruptions was significantly higher than that in the Pfizer- and Moderna-vaccinated groups (p=0.008). The Pfizer- and Moderna-vaccinated groups had higher rates of urticaria than did the AstraZeneca-vaccinated group. However, this difference was not statistically significant (p=0.083).
Conclusion
This study described the clinical characteristics of cutaneous adverse reactions after coronavirus vaccination.
4.The First Case of Cutaneous Acanthamoebiasis Caused by Acanthamoeba triangularis in Korea
Mi Soo CHOI ; Na Hye MYONG ; Min SEO ; Sukbin JANG ; Dae Kwan YUN ; Kyujin YEOM ; Dong-Il CHUNG ; Byung Cheol PARK ; Yeonchul HONG ; Myung Hwa KIM
Annals of Dermatology 2023;35(Suppl2):S275-S280
A 62-year-old man with multiple myeloma visited our clinic with multiple painful erythematous to purpuric nodules on his whole body. He received a skin biopsy which showed septal and lobular inflammation with vasculitis, and multiple amoebic organisms were found.Polymerase chain reaction and culture were performed and an Acanthamoeba triangularis infection was diagnosed. This is the first report on cutaneous acanthamoebiasis caused by A. triangularis, suggesting that A. triangularis should be regarded as a clinical pathogen that can cause ocular as well as disseminated infection.
5.Diagnosis of Residual Tumors after Unplanned Excision of Soft-Tissue Sarcomas: Conventional MRI Features and Added Value of Diffusion-Weighted Imaging
Kiok JIN ; Min Hee LEE ; Min A YOON ; Hwa Jung KIM ; Wanlim KIM ; Choong Geun CHEE ; Hye Won CHUNG ; Sang Hoon LEE ; Myung Jin SHIN
Investigative Magnetic Resonance Imaging 2022;26(1):20-31
Purpose:
To assess conventional MRI features associated with residual soft-tissue sarcomas following unplanned excision (UPE), and to compare the diagnostic performance of conventional MRI only with that of MRI including diffusion-weighted imaging (DWI) for residual tumors after UPE.
Materials and Methods:
We included 103 consecutive patients who had received UPE of a soft-tissue sarcoma with wide excision of the tumor bed between December 2013 and December 2019 and who also underwent conventional MRI and DWI in this retrospective study. The presence of focal enhancement, soft-tissue edema, fascial enhancement, fluid collections, and hematoma on MRI including DWI was reviewed by two musculoskeletal radiologists. We used classification and regression tree (CART) analysis to identify the most significant MRI features. We compared the diagnostic performances of conventional MRI and added DWI using the McNemar test.
Results:
Residual tumors were present in 69 (66.9%) of 103 patients, whereas no tumors were found in 34 (33.1%) patients. CART showed focal enhancement to be the most significant predictor of residual tumors and correctly predicted residual tumors in 81.6% (84/103) and 78.6% (81/103) of patients for Reader 1 and Reader 2, respectively. Compared with conventional MRI only, the addition of DWI for Reader 1 improved specificity (32.8% vs. 56%, 33.3% vs. 63.0%, P < 0.05), decreased sensitivity (96.8% vs. 84.1%, 98.7% vs. 76.7%, P < 0.05), without a difference in diagnostic accuracy (76.7% vs. 74.8%, 72.9% vs. 71.4%) in total and in subgroups. For Reader 2, diagnostic performance was not significantly different between the sets of MRI (P > 0.05).
Conclusion
After UPE of a soft-tissue sarcoma, the presence or absence of a focal enhancement was the most significant MRI finding predicting residual tumors. MRI provided good diagnostic accuracy for detecting residual tumors, and the addition of DWI to conventional MRI may increase specificity.
6.The Incidence and risk factors of delirium in elderly surgical patients
Eun Ju LEE ; Mi JANG ; Myung Hwa KIM ; Hye Jun YUN ; Eun Mi KIM ; Young In CHUNG ; Bo Kyung KIM ; Eun Su IM ; Kyoung Soon HONG
Journal of Korean Clinical Nursing Research 2022;28(2):137-145
Purpose:
This retrospective chart review study was conducted to examine the frequency of delirium and to identify the risk factors of delirium in elderly surgical patients.
Methods:
The subjects of this study were 394 patients aged 65 years or older who underwent surgery. The diagnosis of delirium was based on the nursing assessment records with scores from the day of surgery to the 4th day after surgery. The collected data were analyzed by binary logistic regression analysis.
Results:
The incidence of delirium was 4.3%, and delirium occurred most frequently on the first day of surgery and lasted for 2.16 days on average. Of delirium patients, 76.5% underwent gastrointestinal surgery, and the most common delirium pattern was disorientation. In terms of the characteristics of the subjects, the occurrence of delirium was statistically different by age (x 2=10.79, p=.005), systemic-specific disease (x 2 =9.63, p=.047), use of delirium-inducing drug(benzodiazepine) before surgery (x 2 =15.90, p<.001), walking ability before surgery (x 2 =7.65, p=.006), history of delirium (x 2 =35.92, p<.001), and emergency surgery (x 2 =16.40, p<.001). As risk factors of delirium, gastrointestinal surgery was found to increase the risk of delirium by 12.57 times (95% CI=2.45~64.46, p=.002), and the use of benzodiazepines before surgery was shown to increase delirium by 10.07 times (95% CI=2.21~45.87, p=.003).
Conclusion
It is necessary for nurses to actively evaluate delirium using screening tools for early detection and prevention of delirium in elderly surgical patients with delirium risk factors.
7.Flat Pattern Peaks of Tacrolimus Absorption and Associated Pharmacogenomic Variants in Kidney Transplantation Recipients
Suh Min KIM ; Younggyun LIM ; Sangil MIN ; Byung-Joo MIN ; Myung-Eui SEO ; Kye Hwa LEE ; Ju Han KIM ; Jongwon HA
Journal of Korean Medical Science 2022;37(5):e33-
Background:
Tacrolimus is the most commonly used immunosuppressive drug in solid organ transplantation. After administering a conventional twice-daily dose of tacrolimus, peak levels were achieved within the first 1.5 to 2 hours. A group of patients showed different early absorption phase of tacrolimus after kidney transplantation.
Methods:
Trough(C0 ) and 1.5-hour blood levels (C1.5 ) of tacrolimus were measured in 95 kidney transplantation recipients. Patients with a C1.5 /C0 < 1.5 and > 1.5 were defined as those having flat pattern peaks and as controls, respectively. Transplantation outcomes were compared between the groups. Whole exome sequencing was performed to investigate the genetic susceptibility to flat pattern peaks.
Results:
Twenty-eight patients showed flat pattern peaks. The mean C1.5 /C0 values were 1.13 ± 0.22 and 3.78 ± 1.25 in the flat pattern peak and control groups, respectively. In multivariate analysis, flat pattern peak was an independent risk factor for biopsy-proven acute rejection (BPAR) and/or borderline change (P = 0.014). Patients having flat pattern peaks showed significantly lower post-transplant 36-month estimated glomerular filtration rate (P = 0.001). Two single nucleotide variants in ABCB1 genes, rs1922242 and rs2235035, were associated with flat pattern peaks (P = 0.019 and P = 0.027, respectively).
Conclusion
Both of C1.5 and C0should be measured to distinguish the patients showing unique initial absorption. A C1.5 /C0 ratio lower than 1.5 was associated with an increased risk of BPAR and/or borderline change. Single nucleotide variants s in ABCB1 gene might influence the flat pattern peaks of tacrolimus absorption.
8.Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study
Jin Hwa PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung-Gyu CHOI ; Hyunsoo CHUNG ; Suck-Chei CHOI ; Nayoung KIM ; Hyojin PARK ; In-Kyung SUNG ; Chong Il SOHN ; Sam Ryong JEE ; Jae Young JANG ; Poong-Lyul RHEE ; Moo In PARK ; Joong Goo KWON ; Kyung Sik PARK ; Kwang Jae LEE ; Joon Seong LEE
Journal of Neurogastroenterology and Motility 2021;27(1):87-96
Background/Aims:
Prokinetics such as mosapride citrate CR (conventional-release; Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day mosapride citrate SR (DWJ1252), a sustained-release formulation of mosapride citrate, compared with mosapride citrate CR 3 times a day, in patients with FD.
Methods:
In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for mosapride citrate SR and 59 for mosapride citrate CR) were randomly allocated to mosapride citrate SR once daily or mosapride citrate CR thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed.
Results:
The study included 51 and 49 subjects in the mosapride citrate SR and mosapride citrate CR groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD: − 10.04 ± 4.45 and − 10.86 ± 5.53 in the mosapride citrate SR and mosapride citrate CR groups, respectively; P < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, − 1.17, 2.81; P = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events.
Conclusion
In patients with FD, mosapride citrate SR once daily is as effective as mosapride citrate CR thrice daily, with a similar safety profile.
9.Lenalidomide for anemia correction in lower-risk del(5q) myelodysplastic syndrome patients of Asian ethnicity
Junshik HONG ; Yoo Jin LEE ; Sung Hwa BAE ; Jun Ho YI ; Sungwoo PARK ; Myung Hee CHANG ; Young Hoon PARK ; Shin Young HYUN ; Joo-Seop CHUNG ; Ji Eun JANG ; Joo Young JUNG ; So-Yeon JEON ; Seo-Young SONG ; Hawk KIM ; Dae Sik KIM ; Sung-Hyun KIM ; Min Kyoung KIM ; Sang Hoon HAN ; Seonyang PARK ; Yoo-Jin KIM ; Je-Hwan LEE ;
Blood Research 2021;56(2):102-108
Background:
To estimate real-world outcomes in East Asian populations, we conducted a nationwide retrospective analysis of the efficacy and safety of lenalidomide for del(5q) myelodysplastic syndrome (MDS) patients with transfusion-dependent anemia in Korea.
Methods:
Patients aged ≥19 years who had received lenalidomide for the treatment of lower-risk, red blood cell (RBC) transfusion-dependent del(5q) MDS were selected. A filled case report form (CRF) with information from electronic medical records was requested from members of the acute myeloid leukemia (AML)/MDS Working Party of the Korean Society of Hematology. All the CRFs were gathered and analyzed.
Results:
A total of 31 patients were included in this study. Of 28 evaluable patients, 19 (67.9%) achieved RBC transfusion independence (RBC-TI). Female sex and the development of thrombocytopenia during treatment were associated with achieving RBC-TI. The most common non-hematologic toxicities were pruritus, fatigue, and rashes. All non-hematologic toxicities of grades ≥3 were limited to rash (12.9%) and pruritus (6.5%). Dose reduction was required in 15 of the 19 responders (78.9%). The most common final stable dosing schedule for the responders was 5 mg once every other day (31.6%).
Conclusion
Lenalidomide efficacy and tolerability were similar in the Asian del(5q) MDS patients and western patients. Dose reduction during treatment was common, but it was not associated with inferior outcomes.
10.Exome Chip Analysis of 14,026 Koreans Reveals Known and Newly Discovered Genetic Loci Associated with Type 2 Diabetes Mellitus
Seong Beom CHO ; Jin Hwa JANG ; Myung Guen CHUNG ; Sang Cheol KIM
Diabetes & Metabolism Journal 2021;45(2):231-240
Most loci associated with type 2 diabetes mellitus (T2DM) discovered to date are within noncoding regions of unknown functional significance. By contrast, exonic regions have advantages for biological interpretation. We analyzed the association of exome array data from 14,026 Koreans to identify susceptible exonic loci for T2DM. We used genotype information of 50,543 variants using the Illumina exome array platform. In total, 7 loci were significant with a Bonferroni adjusted We found exonic loci having a susceptibility for T2DM. We found that such genetic information is advantageous for predicting T2DM in a subgroup of obese individuals.

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