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.Guideline for the Surgical Management of Locally Invasive Differentiated Thyroid Cancer From the Korean Society of Head and Neck Surgery
Jun-Ook PARK ; Joo Hyun KIM ; Young Hoon JOO ; Sang-Yeon KIM ; Geun-Jeon KIM ; Hyun Bum KIM ; Dong-Hyun LEE ; Hyun Jun HONG ; Young Min PARK ; Eun-Jae CHUNG ; Yong Bae JI ; Kyoung Ho OH ; Hyoung Shin LEE ; Dong Kun LEE ; Ki Nam PARK ; Myung Jin BAN ; Bo Hae KIM ; Do Hun KIM ; Jae-Keun CHO ; Dong Bin AHN ; Min-Su KIM ; Jun Girl SEOK ; Jeon Yeob JANG ; Hyo Geun CHOI ; Hee Jin KIM ; Sung Joon PARK ; Eun Kyung JUNG ; Yeon Soo KIM ; Yong Tae HONG ; Young Chan LEE ; Ho-Ryun WON ; Sung-Chan SHIN ; Seung-Kuk BAEK ; Soon Young KWON
Clinical and Experimental Otorhinolaryngology 2023;16(1):1-19
The aim of this study was to develop evidence-based recommendations for determining the surgical extent in patients with locally invasive differentiated thyroid cancer (DTC). Locally invasive DTC with gross extrathyroidal extension invading surrounding anatomical structures may lead to several functional deficits and poor oncological outcomes. At present, the optimal extent of surgery in locally invasive DTC remains a matter of debate, and there are no adequate guidelines. On October 8, 2021, four experts searched the PubMed, Embase, and Cochrane Library databases; the identified papers were reviewed by 39 experts in thyroid and head and neck surgery. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the quality of evidence, and to develop and report recommendations. The strength of a recommendation reflects the confidence of a guideline panel that the desirable effects of an intervention outweigh any undesirable effects, across all patients for whom the recommendation is applicable. After completing the draft guidelines, Delphi questionnaires were completed by members of the Korean Society of Head and Neck Surgery. Twenty-seven evidence-based recommendations were made for several factors, including the preoperative workup; surgical extent of thyroidectomy; surgery for cancer invading the strap muscles, recurrent laryngeal nerve, laryngeal framework, trachea, or esophagus; and surgery for patients with central and lateral cervical lymph node involvement. Evidence-based guidelines were devised to help clinicians make safer and more efficient clinical decisions for the optimal surgical treatment of patients with locally invasive DTC.
3.Null Association between BRAF V600E Mutation and Tumor Recurrence in Patients with Papillary Thyroid Microcarcinoma in South Korea
Ji Yoon KIM ; Kyoung Jin KIM ; Jae Hyun BAE ; Joo Hyung KIM ; Nam Hoon KIM ; Hee Young KIM ; Hoon Yub KIM ; Seung-Kuk BAEK ; Sin Gon KIM ; Kwang Yoon JUNG ; Kyeong Jin KIM
International Journal of Thyroidology 2021;14(2):135-142
Background and Objectives:
The clinical implications of the BRAF V600E mutation in papillary thyroid microcarcinoma (PTMC), defined as ≤1.0 cm of tumor size, remain controversial. We investigated the association between the BRAFV600E mutation and PTMC recurrence in a retrospective cohort of patients with thyroid cancer.
Materials and Methods:
This study included 2319 patients with PTMC (median age, 50 years [interquartile range (IQR), 41-57 years]) who underwent thyroid surgery from 2010 to 2019 at a single tertiary medical center. The median follow-up time was 75 months (IQR, 30-98 months). Tumor recurrence was confirmed by histological, cytological, radiographic, and biochemical criteria, combined with persistent and recurrent disease.
Results:
A total of 60.2% (1395/2319) patients with PTMC had the BRAF V600E mutation. The tumor recurrence rate was 2.1% (19/924) in BRAF mutation-negative patients and 2.9% (41/1395) in BRAF mutation-positive patients, with a hazard ratio (HR) of 1.05 (95% confidence interval [CI], 0.61-1.84) after adjusting for clinicopathological risk factors. Similar results were found in patients with high-risk PTMC (adjusted HR, 1.09; 95% CI, 0.56-2.11) who had lymph node metastasis (LNM), extrathyroidal extension (ETE), or distant metastasis (DM) at diagnosis and in patients with low-risk PTMC (adjusted HR, 1.00; 95% CI, 0.35-2.83) who had no LNM, ETE, or DM.
Conclusion
The finding that the BRAF V600E mutation was not associated with tumor recurrence in our cohort of Korean patients with PTMC, especially in patients with low-risk PTMC, suggests that its value in the prediction of disease progression is limited.
4.Survival Benefits From Surgery for Stage IVa Head and Neck Squamous Cell Carcinoma: A Multi-Institutional Analysis of 1,033 Cases
Jun-Ook PARK ; Young Min PARK ; Woo-Jin JEONG ; Yoo Seob SHIN ; Yong Tae HONG ; Ik Joon CHOI ; Ji Won KIM ; Seung Hoon WOO ; Yeon Soo KIM ; Jae Won CHANG ; Min-Sik KIM ; Kwang-Yoon JUNG ; Soon-Hyun AHN ; Chul-Ho KIM ; Ki Hwan HONG ; Phil-Sang CHUNG ; Young-Mo KIM ; Se-Heon KIM ; Seung-Kuk BAEK
Clinical and Experimental Otorhinolaryngology 2021;14(2):225-234
Objectives:
. Head and neck squamous cell carcinomas (HNSCs) are frequently diagnosed at the locoregional advanced stage (stage IVa), but controversy remains regarding whether stage IVa HSNCs should be treated with upfront surgery or definitive chemoradiation therapy (CRT). The purpose of this study was to compare overall survival (OS) and disease-free survival (DFS) in patients with stage IVa HNSC treated primarily by surgery with curative intent with/without (neo)adjuvant treatment (surgery group) versus those treated primarily with CRT (CRT group).
Methods:
. We reviewed data of 1,033 patients with stage IVa HNSC treated with curative intent at 17 cancer centers between 2010 and 2016.
Results:
. Among 1,033 patients, 765 (74.1%) received upfront surgery and 268 (25.9%) received CRT. The 5-year OS and DFS rates were 64.4% and 62.0% in the surgery group and 49.5% and 45.4% in the CRT group, respectively. In multivariate analyses, OS and DFS were better in the surgery group than in the CRT group (odds ratio [OR] for death, 0.762; 95% confidence interval [CI], 0.592–0.981; OR for recurrence, 0.628; 95% CI, 0.492–0.802). In subgroup analyses, the OS and DFS of patients with oropharyngeal cancer were better in the surgery group (OR for death, 0.548; 95% CI, 0.341–0.879; OR for recurrence, 0.598; 95% CI, 0.377–0.948). In the surgery group, patients with laryngeal cancer showed better OS (OR for death, 0.432; 95% CI, 0.211–0.882), while those with hypopharyngeal cancer DFS was improved (OR for recurrence, 0.506; 95% CI, 0.328–0.780).
Conclusion
. A survival benefit from surgery may be achieved even in patients with stage IVa HNSC, particularly those with oropharyngeal and laryngeal cancer. Surgery led to a reduction in the recurrence rate in patients with hypopharyngeal cancer.
5.Survival Benefits From Surgery for Stage IVa Head and Neck Squamous Cell Carcinoma: A Multi-Institutional Analysis of 1,033 Cases
Jun-Ook PARK ; Young Min PARK ; Woo-Jin JEONG ; Yoo Seob SHIN ; Yong Tae HONG ; Ik Joon CHOI ; Ji Won KIM ; Seung Hoon WOO ; Yeon Soo KIM ; Jae Won CHANG ; Min-Sik KIM ; Kwang-Yoon JUNG ; Soon-Hyun AHN ; Chul-Ho KIM ; Ki Hwan HONG ; Phil-Sang CHUNG ; Young-Mo KIM ; Se-Heon KIM ; Seung-Kuk BAEK
Clinical and Experimental Otorhinolaryngology 2021;14(2):225-234
Objectives:
. Head and neck squamous cell carcinomas (HNSCs) are frequently diagnosed at the locoregional advanced stage (stage IVa), but controversy remains regarding whether stage IVa HSNCs should be treated with upfront surgery or definitive chemoradiation therapy (CRT). The purpose of this study was to compare overall survival (OS) and disease-free survival (DFS) in patients with stage IVa HNSC treated primarily by surgery with curative intent with/without (neo)adjuvant treatment (surgery group) versus those treated primarily with CRT (CRT group).
Methods:
. We reviewed data of 1,033 patients with stage IVa HNSC treated with curative intent at 17 cancer centers between 2010 and 2016.
Results:
. Among 1,033 patients, 765 (74.1%) received upfront surgery and 268 (25.9%) received CRT. The 5-year OS and DFS rates were 64.4% and 62.0% in the surgery group and 49.5% and 45.4% in the CRT group, respectively. In multivariate analyses, OS and DFS were better in the surgery group than in the CRT group (odds ratio [OR] for death, 0.762; 95% confidence interval [CI], 0.592–0.981; OR for recurrence, 0.628; 95% CI, 0.492–0.802). In subgroup analyses, the OS and DFS of patients with oropharyngeal cancer were better in the surgery group (OR for death, 0.548; 95% CI, 0.341–0.879; OR for recurrence, 0.598; 95% CI, 0.377–0.948). In the surgery group, patients with laryngeal cancer showed better OS (OR for death, 0.432; 95% CI, 0.211–0.882), while those with hypopharyngeal cancer DFS was improved (OR for recurrence, 0.506; 95% CI, 0.328–0.780).
Conclusion
. A survival benefit from surgery may be achieved even in patients with stage IVa HNSC, particularly those with oropharyngeal and laryngeal cancer. Surgery led to a reduction in the recurrence rate in patients with hypopharyngeal cancer.
6.J-curve relationship between corrected QT interval and mortality in acute heart failure patients
Chan Soon PARK ; Hyun-Jai CHO ; Eue-Keun CHOI ; Sang Eun LEE ; Min-Seok KIM ; Jae-Joong KIM ; Jin-Oh CHOI ; Eun-Seok JEON ; Kyung-Kuk HWANG ; Shung Chull CHAE ; Sang Hong BAEK ; Seok-Min KANG ; Byungsu YOO ; Dong-Ju CHOI ; Youngkeun AHN ; Kye-Hoon KIM ; Myeong-Chan CHO ; Byung-Hee OH ; Hae-Young LEE
The Korean Journal of Internal Medicine 2020;35(6):1371-1384
Background/Aims:
This study investigated the prognostic power of corrected QT (QTc) interval in patients with acute heart failure (AHF) according to sex.
Methods:
We analyzed multicenter Korean Acute Heart Failure registry with patients with AHF admitted from 2011 to 2014. Among them, we analyzed 4,990 patients who were followed up to 5 years. Regarding QTc interval based on 12 lead electrocardiogram, patients were classified into quartiles according to sex.
Results:
During follow-up with median 43.7 months, 2,243 (44.9%) patients died. The relationship between corrected QT interval and all-cause mortality followed a J-curve relationship. In Kaplan-Meier analysis, both sex had lowest mortality in the second QTc quartile. There were significant prognostic differences between the second and the fourth quartiles in male (log-rank p = 0.002), but not in female (log-rank p = 0.338). After adjusting covariates, the third (hazard ratio [HR], 1.185; 95% confidence interval [CI], 1.001 to 1.404; p = 0.049) and the fourth (HR, 1.404; 95% CI, 1.091 to 1.535; p = 0.003) quartiles demonstrated increased risk of mortality compared to the second quartile in male. In female, however, there was no significant difference across quartiles. QTc interval was associated with 5-year all-cause mortality in J-shape with nadir of 440 to 450 ms in male and 470 to 480 ms in female.
Conclusions
QTc interval was an independent predictor of overall death in male, but its significance decreased in female. The relationship between QTc interval and all-cause mortality was J-shaped in both sex.
7.Predicting Extrathyroidal Extension in Patients With Papillary Thyroid Microcarcinoma According to a BRAF Mutation.
Doh Young LEE ; Soo Min HWANG ; Jee Hyun AN ; Kyu Ri SON ; Seung Kuk BAEK ; Sin Gon KIM ; Yang Seok CHAE ; Kwang Yoon JUNG
Clinical and Experimental Otorhinolaryngology 2017;10(2):174-180
OBJECTIVES: The aim of this study was to evaluate the association between preoperative parameters and extrathyroidal extension (ETE) of papillary thyroid microcarcinoma (PTMC) according to the BRAF mutation and to evaluate the preoperative predictability of ETE. METHODS: We analyzed the medical records of 332 patients with PTMC (140 in the BRAF– group and 192 in the BRAF+ group). The presence of ETE was subjected to a correlation analysis with age, sex, tumor size, clinical nodal status, and ultrasonography (US) findings. Among the US findings, the correlation between tumors and the thyroid capsule was categorized into four groups; US group A, intraparechymal; US group B, tumor abutting the capsule <50% of diameter; US group C, tumor abutting >50% of diameter; and US group D, tumor destroyed the capsule. The predictive value of ETE, including sensitivity, specificity, and positive and negative predictive values were evaluated. RESULTS: Tumor size and US group were significantly correlated with gross ETE in the BRAF– and BRAF+ groups. Tumor size of 0.5 cm and US groups B and C in the BRAF– group were cutoff values for gross ETE, with a negative predictive value of 100%, whereas tumor size of 0.7 cm and US groups A and B in the BRAF+ group had negative predictive values of 92.4% and 100%, respectively. CONCLUSION: Excluding of ETE by US was categorized according to tumor size and US findings. A different categorization to exclude ETE is needed according to the BRAF mutation.
Capsules
;
Humans
;
Medical Records
;
Sensitivity and Specificity
;
Thyroid Gland*
;
Ultrasonography
8.Guidelines for the Surgical Management of Laryngeal Cancer: Korean Society of Thyroid-Head and Neck Surgery.
Soon Hyun AHN ; Hyun Jun HONG ; Soon Young KWON ; Kee Hwan KWON ; Jong Lyel ROH ; Junsun RYU ; Jun Hee PARK ; Seung Kuk BAEK ; Guk Haeng LEE ; Sei Young LEE ; Jin Choon LEE ; Man Ki CHUNG ; Young Hoon JOO ; Yong Bae JI ; Jeong Hun HAH ; Minsu KWON ; Young Min PARK ; Chang Myeon SONG ; Sung Chan SHIN ; Chang Hwan RYU ; Doh Young LEE ; Young Chan LEE ; Jae Won CHANG ; Ha Min JEONG ; Jae Keun CHO ; Wonjae CHA ; Byung Joon CHUN ; Ik Joon CHOI ; Hyo Geun CHOI ; Kang Dae LEE
Clinical and Experimental Otorhinolaryngology 2017;10(1):1-43
Korean Society of Thyroid-Head and Neck Surgery appointed a Task Force to develop clinical practice guidelines for the surgical treatment of laryngeal cancer. This Task Force conducted a systematic search of the EMBASE, MEDLINE, Cochrane Library, and KoreaMed databases to identify relevant articles, using search terms selected according to the key questions. Evidence-based recommendations were then created on the basis of these articles. An external expert review and Delphi questionnaire were applied to reach consensus regarding the recommendations. The resulting guidelines focus on the surgical treatment of laryngeal cancer with the assumption that surgery is the selected treatment modality after a multidisciplinary discussion in any context. These guidelines do not, therefore, address non-surgical treatment such as radiation therapy or chemotherapy. The committee developed 62 evidence-based recommendations in 32 categories intended to assist clinicians during management of patients with laryngeal cancer and patients with laryngeal cancer, and counselors and health policy-makers.
Advisory Committees
;
Consensus
;
Counseling
;
Drug Therapy
;
Glottis
;
Humans
;
Laryngeal Neoplasms*
;
Neck*
9.Clinical Characteristics and Outcome of Acute Heart Failure in Korea: Results from the Korean Acute Heart Failure Registry (KorAHF).
Sang Eun LEE ; Hae Young LEE ; Hyun Jai CHO ; Won Seok CHOE ; Hokon KIM ; Jin Oh CHOI ; Eun Seok JEON ; Min Seok KIM ; Jae Joong KIM ; Kyung Kuk HWANG ; Shung Chull CHAE ; Sang Hong BAEK ; Seok Min KANG ; Dong Ju CHOI ; Byung Su YOO ; Kye Hun KIM ; Hyun Young PARK ; Myeong Chan CHO ; Byung Hee OH
Korean Circulation Journal 2017;47(3):341-353
BACKGROUND AND OBJECTIVES: The burden of heart failure has increased in Korea. This registry aims to evaluate demographics, clinical characteristics, management, and long-term outcomes in patients hospitalized for acute heart failure (AHF). SUBJECTS AND METHODS: We prospectively enrolled a total of 5625 consecutive subjects hospitalized for AHF in one of 10 tertiary university hospitals from March 2011 to February 2014. Descriptive statistics were used to determine the baseline characteristics of the study population and to compare them with those from other registries. RESULTS: The mean age was 68.5±14.5 years, 53.2% were male, and 52.2% had de novo heart failure. The mean systolic and diastolic blood pressures were 131.2±30.3 mmHg and 78.6±18.8 mmHg at admission, respectively. The left ventricular ejection fraction was ≤40% in 60.5% of patients. Ischemia was the most frequent etiology (37.6%) and aggravating factor (26.3%). Angiotensin converting enzyme inhibitors/angiotensin receptor blockers, beta-blockers, and aldosterone antagonists were prescribed in 68.8%, 52.2%, and 46.6% of the patients at discharge, respectively. Compared with the previous registry performed in Korea a decade ago, extracorporeal membrane oxygenation (ECMO) and heart transplantation have been performed more frequently (ECMO 0.8% vs. 2.8%, heart transplantation 0.3% vs. 1.2%), and in-hospital mortality decreased from 7.6% to 4.8%. However, the total cost of hospital care increased by 40%, and one-year follow-up mortality remained high. CONCLUSION: While the quality of acute clinical care and AHF-related outcomes have improved over the last decade, the long-term prognosis of heart failure is still poor in Korea. Therefore, additional research is needed to improve long-term outcomes and implement cost-effective care.
Demography
;
Extracorporeal Membrane Oxygenation
;
Follow-Up Studies
;
Guideline Adherence
;
Heart Failure*
;
Heart Transplantation
;
Heart*
;
Hospital Mortality
;
Hospitals, University
;
Humans
;
Ischemia
;
Korea*
;
Male
;
Mineralocorticoid Receptor Antagonists
;
Mortality
;
Peptidyl-Dipeptidase A
;
Prognosis
;
Prospective Studies
;
Quality of Health Care
;
Registries
;
Stroke Volume
;
Treatment Outcome
10.2016 Revised Korean Thyroid Association Management Guidelines for Patients with Thyroid Nodules and Thyroid Cancer.
Ka Hee YI ; Eun Kyung LEE ; Ho Cheol KANG ; Yunwoo KOH ; Sun Wook KIM ; In Joo KIM ; Dong Gyu NA ; Kee Hyun NAM ; So Yeon PARK ; Jin Woo PARK ; Sang Kyun BAE ; Seung Kuk BAEK ; Jung Hwan BAEK ; Byung Joo LEE ; Ki Wook CHUNG ; Yuh Seog JUNG ; Gi Jeong CHEON ; Won Bae KIM ; Jae Hoon CHUNG ; Young Soo RHO
International Journal of Thyroidology 2016;9(2):59-126
No abstract available.
Humans
;
Thyroid Gland*
;
Thyroid Neoplasms*
;
Thyroid Nodule*

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