1.Real-World Eligibility and Cost-Effectiveness Analysis of Empagliflozin for Heart Failure in Korea
Eui-Soon KIM ; Sun-Kyeong PARK ; Jong-Chan YOUN ; Hye Sun LEE ; Hae-Young LEE ; Hyun-Jai CHO ; Jin-Oh CHOI ; Eun-Seok JEON ; Sang Eun LEE ; Min-Seok KIM ; Jae-Joong KIM ; Kyung-Kuk HWANG ; Myeong-Chan CHO ; Shung Chull CHAE ; Seok-Min KANG ; Jin Joo PARK ; Dong-Ju CHOI ; Byung-Su YOO ; Jae Yeong CHO ; Kye Hun KIM ; Byung-Hee OH ; Barry GREENBERG ; Sang Hong BAEK
Journal of Korean Medical Science 2024;39(1):e8-
Background:
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved empagliflozin for reducing cardiovascular mortality and heart failure (HF) hospitalization in patients with both HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). However, limited data are available on the generalizability of empagliflozin to clinical practice. Therefore, we evaluated real-world eligibility and potential cost-effectiveness based on a nationwide prospective HF registry.
Methods:
A total of 3,108 HFrEF and 2,070 HFpEF patients from the Korean Acute Heart Failure (KorAHF) registry were analyzed. Eligibility was estimated by inclusion and exclusion criteria of EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced) and EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) trials and by FDA & EMA label criteria. The cost-utility analysis was done using a Markov model to project the lifetime medical cost and quality-adjusted life year (QALY).
Results:
Among the KorAHF patients, 91.4% met FDA & EMA label criteria, while 44.7% met the clinical trial criteria. The incremental cost-effectiveness ratio of empagliflozin was calculated at US$6,764 per QALY in the overall population, which is far below a threshold of US$18,182 per QALY. The cost-effectiveness benefit was more evident in patients with HFrEF (US$5,012 per QALY) than HFpEF (US$8,971 per QALY).
Conclusion
There is a large discrepancy in real-world eligibility for empagliflozin between FDA & EMA labels and clinical trial criteria. Empagliflozin is cost-effective in HF patients regardless of ejection fraction in South Korea health care setting. The efficacy and safety of empagliflozin in real-world HF patients should be further investigated for a broader range of clinical applications.
2.Korean Practice Guidelines for Gastric Cancer 2022: An Evidence-based, Multidisciplinary Approach
Tae-Han KIM ; In-Ho KIM ; Seung Joo KANG ; Miyoung CHOI ; Baek-Hui KIM ; Bang Wool EOM ; Bum Jun KIM ; Byung-Hoon MIN ; Chang In CHOI ; Cheol Min SHIN ; Chung Hyun TAE ; Chung sik GONG ; Dong Jin KIM ; Arthur Eung-Hyuck CHO ; Eun Jeong GONG ; Geum Jong SONG ; Hyeon-Su IM ; Hye Seong AHN ; Hyun LIM ; Hyung-Don KIM ; Jae-Joon KIM ; Jeong Il YU ; Jeong Won LEE ; Ji Yeon PARK ; Jwa Hoon KIM ; Kyoung Doo SONG ; Minkyu JUNG ; Mi Ran JUNG ; Sang-Yong SON ; Shin-Hoo PARK ; Soo Jin KIM ; Sung Hak LEE ; Tae-Yong KIM ; Woo Kyun BAE ; Woong Sub KOOM ; Yeseob JEE ; Yoo Min KIM ; Yoonjin KWAK ; Young Suk PARK ; Hye Sook HAN ; Su Youn NAM ; Seong-Ho KONG ;
Journal of Gastric Cancer 2023;23(1):3-106
Gastric cancer is one of the most common cancers in Korea and the world. Since 2004, this is the 4th gastric cancer guideline published in Korea which is the revised version of previous evidence-based approach in 2018. Current guideline is a collaborative work of the interdisciplinary working group including experts in the field of gastric surgery, gastroenterology, endoscopy, medical oncology, abdominal radiology, pathology, nuclear medicine, radiation oncology and guideline development methodology. Total of 33 key questions were updated or proposed after a collaborative review by the working group and 40 statements were developed according to the systematic review using the MEDLINE, Embase, Cochrane Library and KoreaMed database. The level of evidence and the grading of recommendations were categorized according to the Grading of Recommendations, Assessment, Development and Evaluation proposition. Evidence level, benefit, harm, and clinical applicability was considered as the significant factors for recommendation. The working group reviewed recommendations and discussed for consensus. In the earlier part, general consideration discusses screening, diagnosis and staging of endoscopy, pathology, radiology, and nuclear medicine. Flowchart is depicted with statements which is supported by meta-analysis and references. Since clinical trial and systematic review was not suitable for postoperative oncologic and nutritional follow-up, working group agreed to conduct a nationwide survey investigating the clinical practice of all tertiary or general hospitals in Korea. The purpose of this survey was to provide baseline information on follow up. Herein we present a multidisciplinary-evidence based gastric cancer guideline.
3.Effects of Particulate Matter Exposure on the Eustachian Tube and Middle Ear Mucosa of Rats
Hyun Min LEE ; Youn-Suk SON ; Hyang-Sook KIM ; Joo-Young KIM ; Seok-Hyun KIM ; Jung Hee LEE ; Sung-Won CHOI ; Se-Joon OH ; Soo-Keun KONG ; Moo Jin BAEK ; Il-Woo LEE
Clinical and Experimental Otorhinolaryngology 2023;16(3):225-235
Objectives:
. Particulate matter (PM) is a risk factor for various diseases. Recent studies have established an association between otitis media (OM) and PM exposure. To confirm this relationship, we developed a novel exposure model designed to control the concentration of PM, and we observed the effects of PM exposure on the Eustachian tube (ET) and middle ear mucosa of rats.
Methods:
. Forty healthy, 10-week-old, male Sprague-Dawley rats were divided into 3-day, 7-day, 14-day exposure, and control groups (each, n=10). The rats were exposed to incense smoke as the PM source for 3 hours per day. After exposure, bilateral ETs and mastoid bullae were harvested, and histopathological findings were compared using microscopy and transmission electron microscopy (TEM). The expression levels of interleukin (IL)-1β, IL-6, tumor necrosis factor-α, and vascular endothelial growth factor (VEGF) in the middle ear mucosa of each group were compared using real-time reverse transcription polymerase chain reaction (RT-PCR).
Results:
. In the ET mucosa of the exposure group, the goblet cell count significantly increased after PM exposure (P=0.032). In the middle ear mucosa, subepithelial space thickening, increased angio-capillary tissue, and inflammatory cell infiltration were observed. Moreover, the thickness of the middle ear mucosa in the exposure groups increased compared to the control group (P<0.01). The TEM findings showed PM particles on the surface of the ET and middle ear mucosa, and RT-PCR revealed that messenger RNA (mRNA) expression of IL-1β significantly increased in the 3-day and 7-day exposure groups compared to the control group (P=0.035). VEGF expression significantly increased in the 7-day exposure group compared to the control and 3-day exposure groups (P<0.01).
Conclusion
. The ET and middle ear mucosa of rats showed histopathologic changes after acute exposure to PM that directly reached the ET and middle ear mucosa. Therefore, acute exposure to PM may play a role in the development of OM.
4.Erratum: Korean Practice Guidelines for Gastric Cancer 2022: An Evidencebased, Multidisciplinary Approach
Tae-Han KIM ; In-Ho KIM ; Seung Joo KANG ; Miyoung CHOI ; Baek-Hui KIM ; Bang Wool EOM ; Bum Jun KIM ; Byung-Hoon MIN ; Chang In CHOI ; Cheol Min SHIN ; Chung Hyun TAE ; Chung sik GONG ; Dong Jin KIM ; Arthur Eung-Hyuck CHO ; Eun Jeong GONG ; Geum Jong SONG ; Hyeon-Su IM ; Hye Seong AHN ; Hyun LIM ; Hyung-Don KIM ; Jae-Joon KIM ; Jeong Il YU ; Jeong Won LEE ; Ji Yeon PARK ; Jwa Hoon KIM ; Kyoung Doo SONG ; Minkyu JUNG ; Mi Ran JUNG ; Sang-Yong SON ; Shin-Hoo PARK ; Soo Jin KIM ; Sung Hak LEE ; Tae-Yong KIM ; Woo Kyun BAE ; Woong Sub KOOM ; Yeseob JEE ; Yoo Min KIM ; Yoonjin KWAK ; Young Suk PARK ; Hye Sook HAN ; Su Youn NAM ; Seong-Ho KONG
Journal of Gastric Cancer 2023;23(2):365-373
5.Endoscopic Submucosal Dissection for Superficial Barrett’s Neoplasia in Korea: a Single-Center Experience
Dong Chan JOO ; Gwang Ha KIM ; Bong Eun LEE ; Moon Won LEE ; Dong Hoon BAEK ; Geun Am SONG ; Sojeong LEE ; Do Youn PARK
Journal of Gastric Cancer 2021;21(4):426-438
Purpose:
While the incidence of Barrett’s neoplasia has been increasing in Western countries, the disease remains rare in Asian countries. Therefore, very few studies have investigated the endoscopic treatment for Barrett’s neoplasia in Korea. Endoscopic submucosal dissection (ESD) enables en bloc and complete resection of gastrointestinal neoplastic lesions. This study aimed to evaluate the therapeutic outcomes of ESD for Barrett’s neoplasia in a single center in Korea and to examine the predictive factors for incomplete resection.
Materials and Methods:
We conducted a retrospective observational study of 18 patients who underwent ESD for superficial Barrett’s neoplasia (dysplasia and early cancer) between January 2010 and December 2019 at Pusan National University Hospital. The therapeutic outcomes of ESD and procedure-related complications were analyzed.
Results:
En bloc resection, complete resection, and curative resection were performed in 94%, 72%, and 61% of patients, respectively. Histopathology (submucosal or deeper invasion of the tumor) was a significant predictive factor for incomplete resection (P=0.047). Procedure-related bleeding and stenosis were not observed, whereas perforation occurred in one case. During the median follow-up period of 12 months (range, 6–74 months), local recurrence occurred in 2 patients with incomplete resection, one patient underwent repeat ESD, and the other patient received concurrent chemoradiotherapy. The 3-year overall and disease-specific survival rates were 73% and 93%, respectively.
Conclusions
ESD seems to be an effective and safe treatment for superficial Barrett’s neoplasia in Korea. Nevertheless, the suitability of ESD for Barrett’s cancer cases should be determined considering the high risk of deep submucosal invasion.
6.Association between family structure and food group intake in children.
Youn Joo BAEK ; Hee Young PAIK ; Jae Eun SHIM
Nutrition Research and Practice 2014;8(4):463-468
BACKGROUNDS/OBJECTOVES: Family has an impact on dietary intake of children as a proximal food environment and family structures are changing and becoming more diverse. This study was performed to identify the association between family structure and food group intake of children aged 3-18 years in Korea. SUBJECTS/METHODS: A total of 3,217 children with complete data on variables for household information, dietary intake and sampling weights were obtained from 2010-2011 Korea National Health and Nutrition Examination Survey. Children's family structure was classified into 3 groups (Living with both parents, Living with one parent and Living without parents). To evaluate children's food group intake, scores of individual food groups ('Grains', 'Meat, Fish, Eggs and Beans', 'Vegetables', 'Fruits' and 'Milk and Dairy products') was calculated from percent adherence to the recommended servings of the Korean Food Guidance System (KFGS). 'Food group mean score' was obtained by calculating the average of five food group scores. RESULTS: After adjusting for age, sex, number of family members, and household income, children living with both parents had higher scores in 'Fruits' (P < 0.01), 'Milk and Dairy products' (P < 0.05), and mean score of individual food group score (P < 0.001) compared to children living with one parent. Individual food group scores and mean scores of individual food group scores were associated with different socio-demographic factors in study children. Family structure was associated with 'Fruits,' 'Milk and Dairy products' score and mean scores of food group scores. CONCLUSIONS: These results suggested that different approach might be required to solve nutrition problem in children depending on their family structure and other socio-demographic factors.
Child*
;
Eggs
;
Family Characteristics
;
Humans
;
Korea
;
Nutrition Surveys
;
Ovum
;
Parents
;
Weights and Measures
7.Efficacy and safety of entecavir plus carnitine complex (GODEX(R)) compared to entecavir monotherapy in patient with ALT elevated chronic hepatitis B: randomized, multicenter open-label trials. The GOAL study.
Dae Won JUN ; Byung Ik KIM ; Yong Kyun CHO ; Hong Ju KIM ; Young Oh KWON ; Soo Young PARK ; Sang Young HAN ; Yang Hyun BAEK ; Yong Jin JUNG ; Hwi Young KIM ; Won KIM ; Jeong HEO ; Hyun Young WOO ; Seong Gyu HWANG ; Kyu Sung RIM ; Jong Young CHOI ; Si Hyun BAE ; Young Sang LEE ; Young Suck LIM ; Jae Youn CHEONG ; Sung Won CHO ; Byung Seok LEE ; Seok Hyun KIM ; Joo Hyun SOHN ; Tae Yeob KIM ; Yong Han PAIK ; Ja Kyung KIM ; Kwan Sik LEE
Clinical and Molecular Hepatology 2013;19(2):165-172
BACKGROUND/AIMS: Carnitine and vitamin complex (Godex(R)) is widely used in patients with chronic liver disease who show elevated liver enzyme in South Korea. The purpose of this study is to identify the efficacy and safety of carnitine from entecavir combination therapy in Alanine aminotransferase (ALT) elevated Chronic Hepatitis B (CHB) patients. METHODS: 130 treatment-naive patients with CHB were enrolled from 13 sites. The patients were randomly selected to the entecavir and the complex of entecavir and carnitine. The primary endpoint of the study is ALT normalization level after 12 months. RESULTS: Among the 130 patients, 119 patients completed the study treatment. The ALT normalization at 3 months was 58.9% for the monotherapy and 95.2% for the combination therapy (P<0.0001). ALT normalization rate at 12 months was 85.7% for the monotherapy and 100% for the combination group (P=0.0019). The rate of less than HBV DNA 300 copies/mL at 12 months was not statistically significant (P=0.5318) 75.9% for the monotherapy, 70.7% for the combination and it was. Quantification of HBsAg level was not different from the monotherapy to combination at 12 months. Changes of ELISPOT value to evaluate the INF-gamma secretion by HBsAg showed the increasing trend of combination therapy compare to mono-treatment. CONCLUSIONS: ALT normalization rate was higher in carnitine complex combination group than entecavir group in CHB. Combination group was faster than entecavir mono-treatment group on ALT normalization rate. HBV DNA normalization rate and the serum HBV-DNA level were not changed by carnitine complex treatment.
Adult
;
Alanine Transaminase/blood
;
Antiviral Agents/*therapeutic use
;
Carnitine/*therapeutic use
;
DNA, Viral/analysis
;
Drug Therapy, Combination
;
Enzyme-Linked Immunospot Assay
;
Female
;
Guanine/*analogs & derivatives/therapeutic use
;
Hepatitis B Surface Antigens/blood
;
Hepatitis B e Antigens/blood
;
Hepatitis B virus/genetics
;
Hepatitis B, Chronic/*drug therapy
;
Humans
;
Interferon-gamma/metabolism
;
Male
;
Middle Aged
;
Mitochondria/physiology
;
Treatment Outcome
;
Vitamin B Complex/*therapeutic use
8.Early Cardiac Function Monitoring for Detection of Subclinical Doxorubicin Cardiotoxicity in Young Adult Patients with Breast Cancer.
Woo Baek CHUNG ; Jeong Eun YI ; Jung Yeon JIN ; Yun Seok CHOI ; Chan Seok PARK ; Woo Chan PARK ; Byung Joo SONG ; Ho Joong YOUN
Journal of Breast Cancer 2013;16(2):178-183
PURPOSE: As doxorubicin cardiotoxicity is considered irreversible, early detection of cardiotoxicity and prevention of overt heart failure is essential. Although there are monitoring guidelines for cardiotoxicity, optimal timing for early detection of subclinical doxorubicin cardiotoxicity is still obscure. The purpose of this study is to determine optimal timing of cardiac monitoring and risk factors for early detection of doxorubicin cardiotoxicity in young adult patients with breast cancer. METHODS: Medical records of 1,013 breast cancer patients diagnosed from January 2009 to December 2010 is being reviewed and analyzed. Properly monitored patients are defined as patients who underwent transthoracic echocardiography before and after the chemotherapy. The definition of subclinical cardiotoxicity (SC) either decreases left ventricular ejection fraction (LVEF) more than 10% or the LVEF declines under 55% from baseline without heart failure symptoms. RESULTS: Twenty-nine out of 174 (16.7%) properly monitored young adult female patients (mean age, 52+/-10 years old) developed SC. The mean interval of cardiac evaluation of SC group was 5.5+/-3.0 months. Among the risk factors, the history of coronary artery disease, cumulative dose of doxorubicin > or =300 mg/m2 and use of trastuzumab after doxorubicin therapy were associated with development of SC. At cumulative dose of doxorubicin 244.5 mg/m2, SC can be predicted (sensitivity, 71.4%; specificity, 70.9%; area under the curve, 0.741; 95% confidence interval, 0.608-0.874; p=0.001). CONCLUSION: In young adult patients with breast cancer, SC was common at cumulative dose of doxorubicin <300 mg/m2 and early performance of cardiac monitoring before reaching the conventional critical dose of doxorubicin might be a proper strategy for early detection of SC.
Antibodies, Monoclonal, Humanized
;
Breast
;
Breast Neoplasms
;
Coronary Artery Disease
;
Doxorubicin
;
Echocardiography
;
Female
;
Heart Failure
;
Humans
;
Medical Records
;
Risk Factors
;
Sensitivity and Specificity
;
Stroke Volume
;
Young Adult
;
Trastuzumab
9.Depression Among HIV-infected Patients in Korea: Assessment of Clinical Significance and Risk Factors.
Joon Young SONG ; Jin Soo LEE ; Yu Bin SEO ; In Seon KIM ; Ji Youn NOH ; Ji Hyeon BAEK ; Hee Jin CHEONG ; Woo Joo KIM
Infection and Chemotherapy 2013;45(2):211-216
BACKGROUND: With prolonged life expectancies, mental illness has emerged as a disabling disorder among people with HIV. MATERIALS AND METHODS: This study was conducted to assess the prevalence of depression and its risk factors among Korean patients with HIV infections. Eighty-two HIV-infected patients completed structured questionnaires including the Beck Depression Inventory and the State-Trait Anxiety Inventory. Subjects with depression were compared to those without depression in terms of demographics, comorbidities, CD4 T-cell count, RNA copy numbers, highly active antiretroviral therapy (HAART) regimens, and adherence. RESULTS: The estimated depression rate was 21% (17 of 82 subjects). Comorbidities (47% vs. 20%, P = 0.01) and unemployment (65% vs. 31%, P = 0.02) were risk factors for depression. Depressive patients were more likely to be anxious (71% vs. 29%, P < 0.01), to frequently miss clinical appointments each year (P = 0.04), and to have higher cumulative time lost to follow-up per month (P <0.01) compared to non-depressive patients. Only three depressive patients were referred to neuropsychologists. CONCLUSIONS: More than 20% of the Korean HIV patients in this study suffered from depression associated with poor adherence. Considering the low level of recognition of depression by clinicians, risk factor-based active assessment is recommended to manage depression properly in HIV-infected patients.
Acquired Immunodeficiency Syndrome
;
Antiretroviral Therapy, Highly Active
;
Anxiety
;
Appointments and Schedules
;
Coat Protein Complex I
;
Comorbidity
;
Demography
;
Depression
;
HIV
;
HIV Infections
;
Humans
;
Life Expectancy
;
Lost to Follow-Up
;
Prevalence
;
Risk Factors
;
RNA
;
T-Lymphocytes
;
Unemployment
;
Surveys and Questionnaires
10.Pediatric Sweet Syndrome.
Jeong Hwan YOUN ; Joon Seok CHOI ; Hong Kyu KANG ; Young Min SON ; Jin Ok BAEK ; Joo Young ROH ; Jong Rok LEE
Korean Journal of Dermatology 2011;49(9):850-852
Sweet syndrome or acute febrile neutrophilic dermatosis is characterized by abrupt onset of fever, leucocytosis, and tender erythematous nodules or plaques that respond to systemic corticosteroids. It occurs most commonly in middle aged women and is rare in children. We report a 2-year-old boy with Sweet syndrome who had fever, leukocytosis, neutrophilia and presented with erythematous maculopapules with tiny pustules over the whole body. Additionally he had an antecedent infection. Our evaluation and long term follow-up of this child failed to reveal evidence of an underlying malignancy or a chronic systemic illness.
Adrenal Cortex Hormones
;
Child
;
Female
;
Fever
;
Follow-Up Studies
;
Humans
;
Leukocytosis
;
Middle Aged
;
Preschool Child
;
Sweet Syndrome

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