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.Efficacy and Safety of Lurasidone vs. Quetiapine XR in Acutely Psychotic Patients With Schizophrenia in Korea: A Randomized, Double-Blind, Active-Controlled Trial
Se Hyun KIM ; Do-Un JUNG ; Do Hoon KIM ; Jung Sik LEE ; Kyoung-Uk LEE ; Seunghee WON ; Bong Ju LEE ; Sung-Gon KIM ; Sungwon ROH ; Jong-Ik PARK ; Minah KIM ; Sung Won JUNG ; Hong Seok OH ; Han-yong JUNG ; Sang Hoon KIM ; Hyun Seung CHEE ; Jong-Woo PAIK ; Kyu Young LEE ; Soo In KIM ; Seung-Hwan LEE ; Eun-Jin CHEON ; Hye-Geum KIM ; Heon-Jeong LEE ; In Won CHUNG ; Joonho CHOI ; Min-Hyuk KIM ; Seong-Jin CHO ; HyunChul YOUN ; Jhin-Goo CHANG ; Hoo Rim SONG ; Euitae KIM ; Won-Hyoung KIM ; Chul Eung KIM ; Doo-Heum PARK ; Byung-Ook LEE ; Jungsun LEE ; Seung-Yup LEE ; Nuree KANG ; Hee Yeon JUNG
Psychiatry Investigation 2024;21(7):762-771
Objective:
This study was performed to evaluate the efficacy and safety of lurasidone (160 mg/day) compared to quetiapine XR (QXR; 600 mg/day) in the treatment of acutely psychotic patients with schizophrenia.
Methods:
Patients were randomly assigned to 6 weeks of double-blind treatment with lurasidone 160 mg/day (n=105) or QXR 600 mg/day (n=105). Primary efficacy measure was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions severity (CGI-S) score. Adverse events, body measurements, and laboratory parameters were assessed.
Results:
Lurasidone demonstrated non-inferiority to QXR on the PANSS total score. Adjusted mean±standard error change at week 6 on the PANSS total score was -26.42±2.02 and -27.33±2.01 in the lurasidone and QXR group, respectively. The mean difference score was -0.91 (95% confidence interval -6.35–4.53). The lurasidone group showed a greater reduction in PANSS total and negative subscale on week 1 and a greater reduction in end-point CGI-S score compared to the QXR group. Body weight, body mass index, and waist circumference in the lurasidone group were reduced, with significantly lower mean change compared to QXR. Endpoint changes in glucose, cholesterol, triglycerides, and low-density lipoprotein levels were also significantly lower. The most common adverse drug reactions with lurasidone were akathisia and nausea.
Conclusion
Lurasidone 160 mg/day was found to be non-inferior to QXR 600 mg/day in the treatment of schizophrenia with comparable efficacy and tolerability. Adverse effects of lurasidone were generally tolerable, and beneficial effects on metabolic parameters can be expected.
3.The Economic Burden of Psoriasis in Korea
Byeol HAN ; Ki-Heon JEONG ; Tae-Gyun KIM ; Kwang Joong KIM ; Dong Hyun KIM ; Byung-Soo KIM ; Kyung Duck PARK ; Chul Jong PARK ; Hai-Jin PARK ; Chul Hwan BANG ; Bong Seok SHIN ; Sang Woong YOUN ; Jai Il YOUN ; Ju Hee LEE ; Kyung Eun JUNG ; Yong Beom CHOE ; Seong-jin JO
Korean Journal of Dermatology 2021;59(5):321-331
Background:
Psoriasis is a chronic disease that can have accompanying comorbidities including arthritis, metabolic syndrome, and cardiovascular diseases. Patients with psoriasis tend to frequently visit medical institutions, and their economic burden for medical services is high.
Objective:
To investigate the economic burden of psoriasis in Korea.
Methods:
The Korean Society for Psoriasis conducted a multi-center field survey of the patients and analyzed the national insurance claim data. Also, we discussed the medical environment of psoriasis in Korea based on the results.
Results:
The economic burden of psoriasis patients is substantial and varied by the type of medical institute. Patients also paid the indirect and intangible medical costs. Biological agents, which is used in patients with severe psoriasis, led to an increase in the cost.
Conclusion
This is the first study to estimate the economic burden of psoriasis in Korea comprehensively. To improve the medical environment of psoriasis and alleviate the burden of patients, discussion on the more efficient health policy and medical insurance criteria for psoriasis would be needed.
4.The Economic Burden of Psoriasis in Korea
Byeol HAN ; Ki-Heon JEONG ; Tae-Gyun KIM ; Kwang Joong KIM ; Dong Hyun KIM ; Byung-Soo KIM ; Kyung Duck PARK ; Chul Jong PARK ; Hai-Jin PARK ; Chul Hwan BANG ; Bong Seok SHIN ; Sang Woong YOUN ; Jai Il YOUN ; Ju Hee LEE ; Kyung Eun JUNG ; Yong Beom CHOE ; Seong-jin JO
Korean Journal of Dermatology 2021;59(5):321-331
Background:
Psoriasis is a chronic disease that can have accompanying comorbidities including arthritis, metabolic syndrome, and cardiovascular diseases. Patients with psoriasis tend to frequently visit medical institutions, and their economic burden for medical services is high.
Objective:
To investigate the economic burden of psoriasis in Korea.
Methods:
The Korean Society for Psoriasis conducted a multi-center field survey of the patients and analyzed the national insurance claim data. Also, we discussed the medical environment of psoriasis in Korea based on the results.
Results:
The economic burden of psoriasis patients is substantial and varied by the type of medical institute. Patients also paid the indirect and intangible medical costs. Biological agents, which is used in patients with severe psoriasis, led to an increase in the cost.
Conclusion
This is the first study to estimate the economic burden of psoriasis in Korea comprehensively. To improve the medical environment of psoriasis and alleviate the burden of patients, discussion on the more efficient health policy and medical insurance criteria for psoriasis would be needed.
5.Clinical outcomes and prognostic factors of mortality in liver cirrhosis patients on continuous renal replacement therapy in two tertiary hospitals in Korea
You Hyun JEON ; Il Young KIM ; Gum Sook JANG ; Sang Heon SONG ; Eun Young SEONG ; Dong Won LEE ; Soo Bong LEE ; Hyo Jin KIM
Kidney Research and Clinical Practice 2021;40(4):687-697
Background:
Data on liver cirrhosis (LC) patients undergoing continuous renal replacement therapy (CRRT) are lacking despite the dismal prognosis. We therefore evaluated clinical characteristics and predictive factors related to mortality in LC patients undergoing CRRT.
Methods:
We performed a retrospective observational study at two tertiary hospitals in Korea. A total of 229 LC patients who underwent CRRT were analyzed. Patients were classified into survivor and non-survivor groups. We used multivariable Cox regression analyses to identify factors predictive of in-hospital mortality.
Results:
During a median follow-up of 5 days (interquartile range, 1–19 days), in-hospital mortality rate was 66.4%. In multivariable analysis, the Acute Physiology and Chronic Health Evaluation II (APACHE II) score (hazard ratio [HR], 1.03; 95% confidence interval [CI], 1.01–1.06; p = 0.02), Model for End-Stage Liver Disease (MELD) score (HR, 1.08; 95% CI, 1.04–1.11; p <0.001), and delivered CRRT dose (HR, 0.95; 95% CI, 0.92¬–0.98; p = 0.002) were significant risk factors for in-hospital mortality. Patients with a CRRT delivered dose < 25 mL/kg/hr had a higher mortality rate than those with a delivered dose > 35 mL/kg/hr (HR, 3.13; 95% CI, 1.62–6.05; p = 0.001). Subgroup analysis revealed that a CRRT delivered dose < 25 mL/kg/hr was a significant risk factor for in-hospital mortality among LC patients with a MELD score ≥ 30.
Conclusion
High APACHE II score, high MELD score, and low delivered CRRT dose were significant risk factors for in-hospital mortality. CRRT delivered dose impacted mortality significantly, especially in patients with a MELD score ≥ 30.
6.Consensus statement on coronary intervention during the coronavirus disease 19 pandemic: from the Korean Society of Interventional Cardiology
Kwan Yong LEE ; Bong-Ki LEE ; Won-Jang KIM ; Se Hun KANG ; Taek Kyu PARK ; Song-Yi KIM ; Jung-Won SUH ; Chang-Hwan YOON ; Dong Heon YANG ; Sung Kee RYU ; Sang-Hyun KIM ; Sung Yun LEE ; In-Ho CHAE ;
The Korean Journal of Internal Medicine 2020;35(4):749-757
Coronavirus disease 2019 (COVID-19) is a highly contagious disease caused by the novel virus severe acute respiratory syndrome coronavirus 2. The first case developed in December, 2019 in Wuhan, China; several months later, COVID-19 has become pandemic, and there is no end in sight. This disaster is also causing serious health problems in the area of cardiovascular intervention. In response, the Korean Society of Interventional Cardiology formed a COVID-19 task force to develop practice guidelines. This special article introduces clinical practice guidelines to prevent secondary transmission of COVID-19 within facilities; the guidelines were developed to protect patients and healthcare workers from this highly contagious virus. We hope these guidelines help healthcare workers and cardiovascular disease patients around the world cope with the COVID-19 pandemic.
7.Consensus Statement on Coronary Intervention during the Coronavirus Disease 2019 (COVID-19) Pandemic: from the Korean Society of Interventional Cardiology (KSIC)
Kwan Yong LEE ; Bong-Ki LEE ; Won-Jang KIM ; Se Hun KANG ; Taek Kyu PARK ; Song-Yi KIM ; Jung-Won SUH ; Chang-Hwan YOON ; Dong Heon YANG ; Sung Kee RYU ; Sang-Hyun KIM ; Sung Yun LEE ; In-Ho CHAE ;
Korean Circulation Journal 2020;50(11):974-983
Coronavirus disease 2019 (COVID-19) is a highly contagious disease caused by the novel virus severe acute respiratory syndrome coronavirus-2. The first case developed in December, 2019 in Wuhan, China; several months later, COVID-19 has become pandemic, and there is no end in sight. This disaster is also causing serious health problems in the area of cardiovascular intervention. In response, the Korean Society of Interventional Cardiology formed a COVID-19 task force to develop practice guidelines. This special article introduces clinical practice guidelines to prevent secondary transmission of COVID-19 within facilities;the guidelines were developed to protect patients and healthcare workers from this highly contagious virus. We hope these guidelines help healthcare workers and cardiovascular disease patients around the world cope with the COVID-19 pandemic.
8.Percutaneous peritoneal dialysis catheter implantation with no break-in period: a viable option for patients requiring unplanned urgent-start peritoneal dialysis
Joo Hui KIM ; Min Jeong KIM ; Byung-Min YE ; June Hyun KIM ; Min Jeong KIM ; Seorin KIM ; Il Young KIM ; Hyo Jin KIM ; Miyeun HAN ; Harin RHEE ; Sang Heon SONG ; Eun Young SEONG ; Soo Bong LEE ; Dong Won LEE
Kidney Research and Clinical Practice 2020;39(3):365-372
Background:
Urgent-start peritoneal dialysis (PD) is applied to patients who need PD within two weeks but are able to wait for more than 48 hours before starting PD. To evaluate the usefulness of percutaneous PD catheter insertion in urgent-start PD, we reviewed the clinical outcomes of percutaneous catheter insertion with immediate start PD and surgical insertion with longer break-in time in Pusan National University Hospital.
Methods:
This study included 177 patients who underwent urgent-start PD. Based on the PD catheter insertion techniques, the patients with urgent-start PD were divided into percutaneous (n = 103) and surgical (n = 74) groups. For the percutaneous group, a modified Seldinger percutaneous catheter insertion with immediate initiation of continuous ambulatory PD was performed by nephrologists.
Results:
The percutaneous group showed higher serum urea nitrogen, creatinine, and lower serum albumin compared with the surgical group (P < 0.05). Ninety-day infectious and mechanical complications showed no significant differences between the two groups. Ninety-day peritonitis in the percutaneous group was 9.7% compared to 5.4% in the surgical group (P = not significant [NS]). Major leakage was 3.9% in the percutaneous group compared to 1.4% in the surgical group (P = NS). Overall infectious and mechanical complication-free survival was not significantly different between the two groups. The percutaneous group and surgical group showed no statistical difference with respect to catheter survival over the entire observation period (P = NS).
Conclusion
This study suggests that urgent-start PD can be applied safely with percutaneous catheter insertion by nephrologists with no break-in period.
9.Switching Antipsychotics to Blonanserin in Patients with Schizophrenia: An Open-label, Prospective, Multicenter Study
Young Sup WOO ; Bo Hyun YOON ; Bong Hee JEON ; Jeong Seok SEO ; Beomwoo NAM ; Sang Yeol LEE ; Young Myo JAE ; Sae Heon JANG ; Hun Jeong EUN ; Seung Hee WON ; Kwanghun LEE ; Jonghun LEE ; Won Myong BAHK
Clinical Psychopharmacology and Neuroscience 2019;17(3):423-431
OBJECTIVE: This study was performed to investigate the efficacy and tolerability of blonanserin in schizophrenic patients who were previously treated with other antipsychotics but, due to insufficient response, were switched to blonanserin. METHODS: A total of 52 patients with schizophrenia who were unresponsive to treatment with antipsychotic monotherapy or combination therapy were recruited into this 12-week, open-label, prospective, multicenter study. Patients were switched to blonanserin from their existing antipsychotics over a maximum 2-week tapering-off period. Efficacy was primarily evaluated using the 18-item Brief Psychiatric Rating Scale (BPRS). Assessments were performed at baseline, and at weeks 1, 2, 4, 8, and 12. RESULTS: Switching to blonanserin resulted in a significant decrease in the mean total score on the BPRS from baseline (56.8 ± 9.4) to week 12 (42.1 ± 13.8, p < 0.001). The most common adverse events were extrapyramidal symptoms (n = 12, 23.1%), insomnia (n = 10, 19.2%), and emotional arousal (n = 6, 11.5%). Overweight or obese patients (body mass index ≥ 23 kg/m2, n = 33) who switched to blonanserin exhibited significant weight loss from 75.2 ± 9.3 kg at baseline to 73.5 ± 9.2 kg at week 12 (p = 0.006). The total cholesterol (baseline, 236.1 ± 47.6 mg/dl; endpoint [week 12], 209.9 ± 28.0 mg/dl; p = 0.005) and prolactin levels (baseline, 80.0 ± 85.2 ng/ml; endpoint [week 12], 63.2 ± 88.9 ng/ml; p = 0.003) were also significantly improved in patients with hypercholesterolemia or hyperprolactinemia. CONCLUSION: The results of the present study suggest that switching to blonanserin may be an effective strategy for schizophrenic patients unresponsive to other antipsychotic treatments.
Antipsychotic Agents
;
Arousal
;
Body Weight
;
Brief Psychiatric Rating Scale
;
Cholesterol
;
Humans
;
Hypercholesterolemia
;
Hyperprolactinemia
;
Overweight
;
Prolactin
;
Prospective Studies
;
Schizophrenia
;
Sleep Initiation and Maintenance Disorders
;
Treatment Outcome
;
Weight Loss
10.Metabolomic Analysis Identifies Alterations of Amino Acid Metabolome Signatures in the Postmortem Brain of Alzheimer's Disease
Yoon Hwan KIM ; Hyun Soo SHIM ; Kyoung Heon KIM ; Junghee LEE ; Bong Chul CHUNG ; Neil W KOWALL ; Hoon RYU ; Jeongae LEE
Experimental Neurobiology 2019;28(3):376-389
Despite significant advances in neuroscience research over the past several decades, the exact cause of AD has not yet fully understood. The metabolic hypothesis as well as the amyloid and tau hypotheses have been proposed to be associated with AD pathogenesis. In order to identify metabolome signatures from the postmortem brains of sporadic AD patients and control subjects, we performed ultra performance liquid chromatography coupled with linear ion trap-Orbitrap mass spectrometer (UPLC-LTQ–Orbitrap-MS). Not only our study identified new metabolome signatures but also verified previously known metabolome profiles in the brain. Statistical modeling of the analytical data and validation of the structural assignments discovered metabolic biomarkers associated with the AD pathogenesis. Interestingly, hypotaurin, myo-inositol and oxo-proline levels were markedly elevated in AD while lutamate and N-acetyl-aspartate were decreased in the postmortem brain tissue of AD patients. In addition, neurosteroid level such as cortisol was significantly increased in AD. Together, our data indicate that impaired amino acid metabolism is associated with AD pathogenesis and the altered amino acid signatures can be useful diagnostic biomarkers of AD. Thus, modulation of amino acid metabolism may be a possible therapeutic approach to treat AD.
Alzheimer Disease
;
Amyloid
;
Biomarkers
;
Brain
;
Chromatography, Liquid
;
Humans
;
Hydrocortisone
;
Metabolism
;
Metabolome
;
Metabolomics
;
Models, Statistical
;
Neurosciences

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