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.Comparison of Two Types of 1-L Polyethylene Glycol-ascorbic Acid as Colonoscopic Bowel Preparation: A Prospective Randomized Study
Suh Hyun CHOI ; Won Eui YOON ; Seung Hyuk KIM ; Hee Jun MYUNG ; Seo Hyun KIM ; Soon Oh SO ; Se Hun KIM ; Hyun Mi LEE ; Yeoun Jung OH ; Jeong Seop MOON ; Tae Yeong PARK ; You Sun KIM
The Korean Journal of Gastroenterology 2022;80(2):85-92
Background/Aims:
Recently, 1-L polyethylene glycol-ascorbic acid (PEG-Asc) has been used to reduce the volume of preparation agents in colonoscopy. This clinical trial aimed to compare the efficacy and safety of two types of 1-L PEG-Asc (CleanViewAL ® [Tae Joon Pharmaceutical Company, Seoul, Korea] and Plenvu ® [Norgine, Harefield, United Kingdom]) in average-aged adults.
Methods:
This study was a prospective, randomized, non-inferiority, open-label, phase 4 clinical trial. The primary endpoint was the efficacy evaluated using the Boston bowel preparation scale (BBPS), and the secondary endpoint was clinical safety.
Results:
In total, 173 patients were assigned to either the CleanViewAL ® (n=84) or Plenvu ® (n=89) group. Overall cleansing successes of 97.6% (82/84) and 98.8% (88/89) were achieved in the CleanViewAL ® group and in the Plenvu ® group, respectively, showing that CleanViewAL ® has similar bowel cleansing efficacy to Plenvu ® (95% CI, -0.052 to 0.027; p=0.207). The total BBPS score was 8.67±1.00 and 8.70±0.76 in the CleanViewAL ® group and Plenvu ® group, respectively (p=0.869). The most common adverse symptom was nausea, and no adverse symptoms requiring hospitalization were reported in either group. There were no cases of critical hypernatremia and liver dysfunction exceeding the common terminology criteria for adverse events grade I. An overall satisfaction score (scale of 1 to 10) showed no difference between the two groups (p=0.289). However, the CleanViewAL ® group showed a higher taste satisfaction score (scale of 1 to 5) than the Plenvu ® group (CleanViewAL ® : 2.90±0.91, Plenvu ® : 2.60±0.86, p=0.028).
Conclusions
Both types of 1-L PEG-Asc, CleanViewAL ® and Plenvu ® , are effective and safe bowel cleansing agents in average-aged adults. CleanViewAL ® was preferred in terms of taste satisfaction.
3.Dietary Diversity during Early Infancy Increases Microbial Diversity and Prevents Egg Allergy in High-Risk Infants
Bo Ra LEE ; Hye-In JUNG ; Su Kyung KIM ; Mijeong KWON ; Hyunmi KIM ; Minyoung JUNG ; Yechan KYUNG ; Byung Eui KIM ; Suk-Joo CHOI ; Soo-Young OH ; Sun-Young BAEK ; Seonwoo KIM ; Jaewoong BAE ; Kangmo AHN ; Jihyun KIM
Immune Network 2022;22(2):e17-
We aimed to investigate associations of dietary diversity (DD) with gut microbial diversity and the development of hen's egg allergy (HEA) in infants. We enrolled 68 infants in a highrisk group and 32 infants in a control group based on a family history of allergic diseases. All infants were followed from birth until 12 months of age. We collected infant feeding data, and DD was defined using 3 measures: the World Health Organization definition of minimum DD, food group diversity, and food allergen diversity. Gut microbiome profiles and expression of cytokines were evaluated by bacterial 16S rRNA sequencing and real-time reverse transcriptase-polymerase chain reaction. High DD scores at 3 and 4 months were associated with a lower risk of developing HEA in the high-risk group, but not in the control group. In the high-risk group, high DD scores at 3, 4, and 5 months of age were associated with an increase in Chao1 index at 6 months. We found that the gene expression of IL-4, IL-5, IL-6, and IL-8 were higher among infants who had lower DD scores compared to those who had higher DD scores in high-risk infants. Additionally, high-risk infants with a higher FAD score at 5 months of age showed a reduced gene expression of IL-13. Increasing DD within 6 months of life may increase gut microbial diversity, and thus reduce the development of HEA in infants with a family history of allergic diseases.
4.Breastfeeding Success Experience of Primiparas
Sun Ok LEE ; Sung Soon NA ; Hee Sook KIM ; Kyung Eui BAE ; Mi Sun YOUN ; Eun Ju OH
Journal of the Korean Society of Maternal and Child Health 2022;26(4):254-269
Purpose:
This study aims to describe and identify in-depth the breastfeeding experience of primiparas for more than one year using a phenomenological research method and to raise the understanding of the primiparas’ subjective experiences during the breastfeeding process to contribute to the improving and maintaining maternal and child health.
Methods:
This research was a phenomenological and qualitative study conducted on 5 primiparas who continued breastfeeding for more than 12 months. Data was collected through individual in-depth interviews from November 1, 2021 to March 20, 2022, and it was analyzed through the sixth stage of phenomenological research analysis presented by Colaizzi.
Results:
The study consisted of 10 theme clusters and 26 themes from meaningful statements about the breastfeeding success experiences of primiparas for more than one year. The 10 theme collections were "Planning breastfeeding during pregnancy," "Commitment to breastfeeding through information and education," "Challenges faced during breastfeeding," "Continuous hard work," "Continued conflict over breastfeeding amid confusion," "Connects with experts who lead the way," "Establishes one's own standards and direction," "Peace after hard work," "Solid and firm confidence," and "Deep-rooted beliefs brestfeeding serve as reminders."
Conclusion
It is expected that this study will help to understand the individual difficulties and problems experienced by primiparas during breastfeeding, the importance of breastfeeding education, the role of medical personnel in the early stage of childbirth, social and environmental support, and the importance of an active window for information exchange. By identifying these factors, this study can serve as basic data for nursing practice to promote successful breastfeeding.
5.Clinical outcomes of acute upper gastrointestinal bleeding according to the risk indicated by Glasgow-Blatchford risk score-computed tomography score in the emergency room
Hyun Ae LEE ; Hye-Kyung JUNG ; Tae Oh KIM ; Ju-Ran BYEON ; Eui-Sun JEONG ; Hyun-Ji CHO ; Chung Hyun TAE ; Chang Mo MOON ; Seong-Eun KIM ; Ki-Nam SHIM ; Sung-Ae JUNG
The Korean Journal of Internal Medicine 2022;37(6):1176-1185
Background/Aims:
Acute upper gastrointestinal (UGI) bleeding is a significant emergency situation with a mortality rate of 2% to 10%. Therefore, initial risk stratification is important for proper management. We aimed to evaluate the role of contrast-enhanced multidetector computed tomography (MDCT) for risk stratification in patients with acute UGI bleeding in the emergency room (ER).
Methods:
This retrospective study included patients with UGI bleeding in the ER. Glasgow-Blatchford risk score-computed tomography (GBS-CT) was assessed using a combination of GBS and the MDCT scan scoring system.
Results:
Of the 297 patients with UGI bleeding, 124 (41.8%) underwent abdominal MDCT. Among them, 90.3% were classified as high-risk by GBS, and five patients died (4.0%). Rebleeding occurred in nine patients (7.3%). The high-risk GBS-CT group had significantly higher in-hospital mortality (10.5% in high-risk vs. 1.4% in moderate risk vs. 0% in low-risk, p = 0.049), transfusion amount (p < 0.001), and endoscopic hemostasis (p < 0.001) compared to the moderate- and low-risk groups.
Conclusions
Adding MDCT scans to the existing validated prognosis model when predicting the risk of UGI bleeding in patients in the ER plays a significant role in determining in-hospital mortality, transfusions, and the need for endoscopic hemostasis.
6.Analysis of Medical Use and Treatment Costs of Hepatocellular Carcinoma Patients Using National Patient Sample Data
Byeong-Chan OH ; Jeong-Yeon CHO ; Sun-Hong KWON ; Eui-Kyung LEE ; Hye-Lin KIM
Korean Journal of Clinical Pharmacy 2021;31(2):153-159
Background:
With increasing economic evaluation studies on the treatment of or screening tools for liver diseases that cause hepatocellular carcinoma (HCC), interest in the analysis of the medical utilization and costs of HCC treatment is increasing. Therefore, we aimed to estimate the medical utilization and costs of HCC patients, and calculate the cost of main procedures for HCC treatment, including liver transplant (LT), hepatic resection (HR), radiofrequency ablation (RFA), and transarterial chemoembolization (TACE).
Methods:
We analyzed claim data from January to December 2018 from the Health Insurance and Review and Assessment Service–National Patient Sample (HIRA-NPS-2018) dataset, including data of patients diagnosed with HCC (Korean Standard Classification of Diseases code C22.0) who had at least one inpatient claim for HCC.
Results:
A total of 715 HCC patients were identified. In 2018, the yearly average medical cost per HCC patient was ₩18,460K (thousand), of which ₩14,870K was attributed to HCC. Among the total medical costs of HCC patients, the inpatient cost accounted for the largest portion of both the total medical and HCC-related costs. The major procedures of HCC treatment occurred most frequently in the order of TACE, RFA, HR, and LT. The average medical cost per treatment episode was the highest for LT (₩87,280K), followed by HR (₩10,026K), TACE (₩4,047K), and RFA (₩2,927K).
Conclusion
By identifying the medical costs of HCC patients and the costs of the main procedures of HCC treatment, our results provide basic information that could be utilized for cost estimation in liver disease-related economic evaluation studies.
7.A novel subdermal anchoring technique for the effective treatment of congenital melanocytic nevus using de-epithelialized dermal flaps
Jin Woo HAN ; Hook SUN ; Jin Woo KIM ; Ji Young YUN ; Eui Han CHUNG ; Min Jun OH
Archives of Plastic Surgery 2021;48(1):55-60
Background:
In patients with congenital melanocytic nevus (CMN), single-stage removal of large lesions can be difficult because the high tension created by excising and repairing a large lesion may result in scar widening. Herein, we introduce a method to effectively excise lesions while minimizing scarring and compare its outcomes to those of existing surgical methods.
Methods:
We compared patients who underwent surgery using the anchoring technique (n=42) or the conventional elliptical technique (n=36). One side of the lesion was removed via en bloc resection up to the superficial fascia. The other side of the lesion was removed via de-epithelialization. The de-epithelialized dermal flap was then fixed by suturing it to the superficial fascia on the opposite side. The length of the lesion’s long axis and amount of scar widening were measured immediately after surgery and at 2, 6, and 12 months postoperatively. At 12 months, patients were assessed using the Patient and Observer Scar Assessment Scale.
Results:
The lesion locations included the face, arms, legs, back, and abdomen. The anchoring method resulted in shorter and smaller scars than the conventional method. There were no cases of postoperative hematoma or wound dehiscence. Significant differences in postoperative scar widening were found in the arm and leg areas (P<0.05).
Conclusions
The anchoring method introduced in this study can provide much better outcomes than the conventional method. The anchoring method is particularly useful for the removal of CMN around the joints or extremities, where the surgical site is subjected to high tension.
8.Analysis of Medical Use and Treatment Costs of Hepatocellular Carcinoma Patients Using National Patient Sample Data
Byeong-Chan OH ; Jeong-Yeon CHO ; Sun-Hong KWON ; Eui-Kyung LEE ; Hye-Lin KIM
Korean Journal of Clinical Pharmacy 2021;31(2):153-159
Background:
With increasing economic evaluation studies on the treatment of or screening tools for liver diseases that cause hepatocellular carcinoma (HCC), interest in the analysis of the medical utilization and costs of HCC treatment is increasing. Therefore, we aimed to estimate the medical utilization and costs of HCC patients, and calculate the cost of main procedures for HCC treatment, including liver transplant (LT), hepatic resection (HR), radiofrequency ablation (RFA), and transarterial chemoembolization (TACE).
Methods:
We analyzed claim data from January to December 2018 from the Health Insurance and Review and Assessment Service–National Patient Sample (HIRA-NPS-2018) dataset, including data of patients diagnosed with HCC (Korean Standard Classification of Diseases code C22.0) who had at least one inpatient claim for HCC.
Results:
A total of 715 HCC patients were identified. In 2018, the yearly average medical cost per HCC patient was ₩18,460K (thousand), of which ₩14,870K was attributed to HCC. Among the total medical costs of HCC patients, the inpatient cost accounted for the largest portion of both the total medical and HCC-related costs. The major procedures of HCC treatment occurred most frequently in the order of TACE, RFA, HR, and LT. The average medical cost per treatment episode was the highest for LT (₩87,280K), followed by HR (₩10,026K), TACE (₩4,047K), and RFA (₩2,927K).
Conclusion
By identifying the medical costs of HCC patients and the costs of the main procedures of HCC treatment, our results provide basic information that could be utilized for cost estimation in liver disease-related economic evaluation studies.
9.Phase II Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiotherapy with Gemcitabine in Patients with Resected Pancreatic Cancer
Kyung-Hun LEE ; Eui Kyu CHIE ; Seock-Ah IM ; Jee Hyun KIM ; Jihyun KWON ; Sae-Won HAN ; Do-Youn OH ; Jin-Young JANG ; Jae-Sung KIM ; Tae-You KIM ; Yung-Jue BANG ; Sun Whe KIM ; Sung W. HA
Cancer Research and Treatment 2021;53(4):1096-1103
Purpose:
Despite curative resection, the 5-year survival for patients with resectable pancreatic cancer is less than 20%. Recurrence occurs both locally and at distant sites and effective multimodality adjuvant treatment is needed.
Materials and Methods:
Patients with curatively resected stage IB-IIB pancreatic adenocarcinoma were eligible. Treatment consisted of chemotherapy with gemcitabine 1,000 mg/m2 on days 1 and 8 and cisplatin 60 mg/m2 on day 1 every 3 weeks for two cycles, followed by chemoradiotherapy (50.4 Gy/28 fx) with weekly gemcitabine (300 mg/m2/wk), and then gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks for four cycles. The primary endpoint was 1-year disease-free survival rate. The secondary endpoints were disease-free survival, overall survival, and safety.
Results:
Seventy-four patients were enrolled. One-year disease-free survival rate was 57.9%. Median disease-free and overall survival were 15.0 months (95% confidence interval [CI], 11.6 to 18.4) and 33.0 months (95% CI, 21.8 to 44.2), respectively. At the median follow-up of 32 months, 57 patients (77.0%) had recurrence including 11 patients whose recurrence was during the adjuvant treatment. Most of the recurrences were systemic (52 patients). Stage at the time of diagnosis (70.0% in IIA, 51.2% in IIB, p=0.006) were significantly related with 1-year disease-free survival rate. Toxicities were generally tolerable, with 53 events of grade 3 or 4 hematologic toxicity and four patients with febrile neutropenia.
Conclusion
Adjuvant gemcitabine and cisplatin chemotherapy followed by chemoradiotherapy with gemcitabine and maintenance gemcitabine showed efficacy and good tolerability in curatively resected pancreatic cancer.
10.Baseline Serum Interleukin-6 Levels Predict the Response of Patients with Advanced Non-small Cell Lung Cancer to PD-1/PD-L1 Inhibitors
Da Hyun KANG ; Cheol-Kyu PARK ; Chaeuk CHUNG ; In-Jae OH ; Young-Chul KIM ; Dongil PARK ; Jinhyun KIM ; Gye Cheol KWON ; Insun KWON ; Pureum SUN ; Eui-Cheol SHIN ; Jeong Eun LEE
Immune Network 2020;20(3):e27-
Although various studies on predictive markers in the use of PD-1/PD-L1 inhibitors are in progress, only PD-L1 expression levels in tumor tissues are currently used. In the present study, we investigated whether baseline serum levels of IL-6 can predict the treatment response of patients with advanced non-small cell lung cancer (NSCLC) treated with PD-1/PD-L1 inhibitors. In our cohort of 125 NSCLC patients, the objective response rate (ORR) and disease control rate (DCR) were significantly higher in those with low IL-6 (<13.1 pg/ml) than those with high IL-6 (ORR 33.9% vs. 11.1%, p=0.003; DCR 80.6% vs. 34.9%, p<0.001). The median progression-free survival was 6.3 months (95% confidence interval [CI], 3.9–8.7) in the low IL-6 group, significantly longer than in the high IL-6 group (1.9 months, 95% CI, 1.6–2.2, p<0.001). The median overall survival in the low IL-6 group was significantly longer than in the high IL-6 group (not reached vs. 7.4 months, 95% CI, 4.8–10.0). Thus, baseline serum IL-6 levels could be a potential biomarker for predicting the efficacy and survival benefit of PD-1/PD-L1 inhibitors in NSCLC.

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