5.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.
6.Asia-Pacific consensus on long-term and sequential therapy for osteoporosis
Ta-Wei TAI ; Hsuan-Yu CHEN ; Chien-An SHIH ; Chun-Feng HUANG ; Eugene MCCLOSKEY ; Joon-Kiong LEE ; Swan Sim YEAP ; Ching-Lung CHEUNG ; Natthinee CHARATCHAROENWITTHAYA ; Unnop JAISAMRARN ; Vilai KUPTNIRATSAIKUL ; Rong-Sen YANG ; Sung-Yen LIN ; Akira TAGUCHI ; Satoshi MORI ; Julie LI-YU ; Seng Bin ANG ; Ding-Cheng CHAN ; Wai Sin CHAN ; Hou NG ; Jung-Fu CHEN ; Shih-Te TU ; Hai-Hua CHUANG ; Yin-Fan CHANG ; Fang-Ping CHEN ; Keh-Sung TSAI ; Peter R. EBELING ; Fernando MARIN ; Francisco Javier Nistal RODRÍGUEZ ; Huipeng SHI ; Kyu Ri HWANG ; Kwang-Kyoun KIM ; Yoon-Sok CHUNG ; Ian R. REID ; Manju CHANDRAN ; Serge FERRARI ; E Michael LEWIECKI ; Fen Lee HEW ; Lan T. HO-PHAM ; Tuan Van NGUYEN ; Van Hy NGUYEN ; Sarath LEKAMWASAM ; Dipendra PANDEY ; Sanjay BHADADA ; Chung-Hwan CHEN ; Jawl-Shan HWANG ; Chih-Hsing WU
Osteoporosis and Sarcopenia 2024;10(1):3-10
Objectives:
This study aimed to present the Asia-Pacific consensus on long-term and sequential therapy for osteoporosis, offering evidence-based recommendations for the effective management of this chronic condition.The primary focus is on achieving optimal fracture prevention through a comprehensive, individualized approach.
Methods:
A panel of experts convened to develop consensus statements by synthesizing the current literature and leveraging clinical expertise. The review encompassed long-term anti-osteoporosis medication goals, first-line treatments for individuals at very high fracture risk, and the strategic integration of anabolic and anti resorptive agents in sequential therapy approaches.
Results:
The panelists reached a consensus on 12 statements. Key recommendations included advocating for anabolic agents as the first-line treatment for individuals at very high fracture risk and transitioning to anti resorptive agents following the completion of anabolic therapy. Anabolic therapy remains an option for in dividuals experiencing new fractures or persistent high fracture risk despite antiresorptive treatment. In cases of inadequate response, the consensus recommended considering a switch to more potent medications. The consensus also addressed the management of medication-related complications, proposing alternatives instead of discontinuation of treatment.
Conclusions
This consensus provides a comprehensive, cost-effective strategy for fracture prevention with an emphasis on shared decision-making and the incorporation of country-specific case management systems, such as fracture liaison services. It serves as a valuable guide for healthcare professionals in the Asia-Pacific region, contributing to the ongoing evolution of osteoporosis management.
7.Clinical Experience of Allogeneic Hematopoietic Stem Cell Transplantation in Elderly Patients Aged 60 Years and Older in South Korea
Young Sok JI ; Jae-Sook AHN ; Jina YUN ; Geum Ha JANG ; Sung Hee LIM ; Se Hyung KIM ; Chan Kyu KIM ; Jong Ho WON ; Seong Kyu PARK
Yonsei Medical Journal 2023;64(2):123-132
Purpose:
The purpose of this study is to share our outcomes and experiences on allogeneic hematopoietic stem cell transplantation (HSCT) in elderly patients aged 60 years and older with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) in South Korea, and to compare them with other studies.
Materials and Methods:
We analyzed the clinical outcomes of 116 patients with AML or MDS aged 60 years and older who underwent allogeneic HSCT. We also analyzed which pretreatment factors affect the overall survival (OS) after allogeneic HSCT.
Results:
Neutrophil and platelet engraftment were achieved at median day +11 [interquartile range (IQR) 10–15] and +14 (IQR 11–19), respectively. A complete donor chimerism was confirmed in 65 (56.0%) patients at 3 weeks and in 63 (54.3%) patients at 3 months after HSCT. The estimated incidence of grade II–IV acute graft-versus-host disease (GVHD) at day 100 was 13.7%. The estimated incidence of chronic GVHD at 2 years was 38.8%. Within a median follow-up of 14 months after HSCT, OS was 64% at 1 year and 55% at 2 years, and non-relapse mortality (NRM) was 20% at 1 year and 28% at 2 years. Multivariate analysis revealed that male sex and Hematopoietic Cell Transplantation-Specific Comorbidity Index ≥3 were associated with poor OS.
Conclusion
This study showed that allogeneic HSCT in elderly adults aged 60 and older can be performed with successful engraftment and acceptable NRM and OS are expected given the generally known survival of patients with higher risk MDS and poor risk AML.
8.Effects of Omicron Infection and Changes in Serum Antibody Response to Wild-Type, Delta, and Omicron After a Booster Dose With BNT163b2 Vaccine in Korean Healthcare Workers
Sung Hee LIM ; Han Jo KIM ; Se Hyung KIM ; Seong Hyeok CHOI ; Bora KIM ; Ji Youn KIM ; Young Sok JI ; Tark KIM ; Eun Ju CHOO ; Jung Chan JUNG ; Ji Eun MOON ; Chan Kyu KIM ; Seong Kyu PARK ; Jina YUN
Journal of Korean Medical Science 2023;38(13):e103-
Background:
Although the primary vaccine coverage rate for coronavirus disease 2019 (COVID-19) in South Korea has exceeded 80%, the coronavirus continues to spread, with reports of a rapid decline in vaccine effectiveness. South Korea is administering booster shots despite concerns about the effectiveness of the existing vaccine.
Methods:
Neutralizing antibody inhibition scores were evaluated in two cohorts after the booster dose. For the first cohort, neutralizing activity against the wild-type, delta, and omicron variants after the booster dose was evaluated. For the second cohort, we assessed the difference in neutralizing activity between the omicron infected and uninfected groups after booster vaccination. We also compared the effectiveness and adverse events (AEs) between homologous and heterologous booster doses for BNT162b2 or ChAdOx1 vaccines.
Results:
A total of 105 healthcare workers (HCWs) that were additionally vaccinated with BNT162b2 at Soonchunhyang University Bucheon Hospital were enrolled in this study.Significantly higher surrogate virus neutralization test (sVNT) inhibition (%) was observed for the wild-type and delta variants compared to sVNT (%) for the omicron after the booster dose (97%, 98% vs. 75%; P < 0.001). No significant difference in the neutralizing antibody inhibition score was found between variants in the BNT/BNT/BNT group (n = 48) and the ChA/ChA/BNT group (n = 57). Total AEs were not significantly different between the ChA/ ChA/BNT group (85.96%) and the BNT/BNT group (95.83%; P = 0.11). In the second cohort with 58 HCWs, markedly higher sVNT inhibition to omicron was observed in the omicroninfected group (95.13%) compared to the uninfected group (mean of 48.44%; P < 0.001) after four months of the booster dose. In 41 HCWs (39.0%) infected with the omicron variant, no difference in immunogenicity, AEs, or effectiveness between homogeneous and heterogeneous boosters was observed.
Conclusion
Booster vaccination with BNT162b2 was significantly less effective for the neutralizing antibody responses to omicron variant compared to the wild-type or delta variant in healthy population. Humoral immunogenicity was sustained significantly high after 4 months of booster vaccine in the infected population after booster vaccination.Further studies are needed to understand the characteristics of immunogenicity in these populations.
9.Is Treosulfan-Based Conditioning Attractive as a Reduced-Intensity Conditioning Regimen in Korea?
Se Hyung KIM ; Young Sok JI ; Jina YUN ; Seong Hyeok CHOI ; Sung Hee LIM ; Chan Kyu KIM ; Seong Kyu PARK
Journal of Korean Medical Science 2023;38(36):e281-
Background:
Allogeneic hematopoietic stem cell transplantation (HSCT) was not actively performed in elderly acute myeloid leukemia (AML) or myelodysplastic syndrome patients who are at a high-risk based on hematopoietic cell transplantation-specific comorbidity index (HCT-CI). The advent of reduced-intensity conditioning (RIC) regimens has made HSCT applicable in this population. However, the selection of appropriate conditioning is a major concern for the attending physician. The benefits of combination of treosulfan and fludarabine (Treo/Flu) have been confirmed through many clinical studies. Korean data on treosulfan-based conditioning regimen are scarce.
Methods:
A retrospective study was conducted to compare the clinical outcomes of allogeneic HSCT using RIC between 13 patients receiving Treo/Flu and 39 receiving busulfan/ fludarabine (Bu/Flu).
Results:
In terms of conditioning-related complications, the frequency of ≥ grade 2 nausea or vomiting was significantly lower and the duration of symptoms was shorter in the Treo/ Flu group than in the Bu/Flu group. The incidence of ≥ grade 2 mucositis tended to be lower in the Treo/Flu group. In the analysis of transplant outcomes, all events of acute graft versus host disease (GVHD) and ≥ grade 2 acute GVHD occurred more frequently in the Treo/ Flu group. The frequency of Epstein-Barr virus reactivation was significantly higher in the Treo/Flu group (53.8% vs. 23.1%, P = 0.037). Non-relapse mortality (NRM) at 12 months was higher in the Treo/Flu group (30.8% vs. 7.7%, P = 0.035). Significant prognostic factors included disease type, especially secondary AML, disease status and high-risk based on HCT-CI, ≥ grade 2 acute GVHD, and cases requiring ≥ 2 immunosuppressive drugs for treating acute GVHD. In the comparison of survival outcomes according to conditioning regimen, the Bu/Flu group seemed to show better results than the Treo/Flu group (60% vs.46.2%, P = 0.092 for overall survival; 56.4% vs. 38.5%, P = 0.193 for relapse-free survival). In additional analysis for only HCT-CI high-risk groups, there was no difference in transplant outcomes except that the Treo/Flu group tended to have a higher NRM within one year after transplantation. Survival outcomes of both groups were similar.
Conclusion
This study suggests that Treo/Flu conditioning may be an alternative to Bu/Flu regimen in elderly patients with high-risk who are not suitable for standard conditioning.
10.A Survey on the Quality of Life of Prostate Cancer Patients in Korean Prostate Cancer Patients Association
Yun-Sok HA ; Kwang Taek KIM ; Wook NAM ; Hongzoo PARK ; Sangjun YOO ; Chan Ho LEE ; Ho Seok CHUNG ; Woo Suk CHOI ; Jiyoun KIM ; Jaeeun SHIN ; Jeong Hyun KIM ; Cheol KWAK
Korean Journal of Urological Oncology 2022;20(4):265-272
Purpose:
We aimed to collect opinions on the diagnostic experiences and quality of life profiles for men with prostate cancer in Korea as part of the “Blue Ribbon Campaign” of the Korean Urological Oncology Society.
Materials and Methods:
Korean Urological Oncology Society conducted an online survey of 212 prostate cancer patients belonging to the Prostate Cancer Patient Association. A survey on diagnostic experience and quality of life based on Expanded Prostate Cancer Index Composite 26 Short Form were conducted.
Results:
About half of all respondents (50.5%) answered, “I experienced symptoms of urine leakage more than once a week,” during the last four weeks, 85% of the respondents said their sexual function level was “weak,” and 64.2% said, “very weak.” When asked about the level of erectile dysfunction, 58 percent of the respondents answered, “I never had an erection when I wanted one.” Of the respondents, 47.1% of men said that clinical stage at initial presentation was prostate cancer stage 3–4 and 99.1% of the respondents hoped that the prostate-specific antigen (PSA) test would be included in the national cancer screening.
Conclusions
Through this survey of patients, we were able to confirm the difficulties of the low quality of life currently experienced by prostate cancer patients and what they want to do with prostate cancer treatment. All patients are eager to include a PSA test in the national cancer screening so that prostate cancer can be detected early and patients can receive proper treatment at an appropriate time.

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