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.Efficacy of single-dose evolocumab injection in early-phase acute myocardial infarction: a retrospective single-center study
Yongcheol KIM ; Ji Woong ROH ; Oh-Hyun LEE ; Seok-Jae HEO ; Eui IM ; Deok-Kyu CHO ; Byeong-Keuk KIM
The Korean Journal of Internal Medicine 2024;39(5):793-800
Background/Aims:
Achieving rapid reduction of low-density lipoprotein cholesterol (LDL-C) levels below 55 mg/dL in patients with acute myocardial infarction (AMI) can be challenging with statins alone. This single-center, retrospective study aimed to assess the impact of single-dose injection of evolocumab 140 mg on LDL-C levels during the peri-percutaneous coronary intervention (PCI) period in patients with AMI.
Methods:
A total of 95 patients with AMI who underwent PCI were divided into the evolocumab (n = 50) and non-evolocumab (n = 45) groups.
Results:
The percentage change of LDL-C level at 1–3 weeks from baseline was 78.4 ± 13.4% reduction in the evolocumab group versus 45.6 ± 22.6% in the non-evolocumab group, with a mean difference of -33.5% between the groups (95% CI: -42.6 to -24.5%; p < 0.001). The achievement rate of LDL-C levels below 55 mg/dL at 1–3 weeks was significantly higher in the evolocumab group than in the non-evolocumab group (97.7% vs. 60.0%, p < 0.001).
Conclusions
Patients with AMI who received single-dose injection of evolocumab 140 mg during the peri-PCI period had a significantly greater LDL-C reduction and higher proportion of patients achieved the target LDL-C level in the early phase AMI than those who did not receive evolocumab.
3.Efficacy of a Synbiotic Containing Lactobacillus paracasei DKGF1and Opuntia humifusa in Elderly Patients with Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial
Joo Hyun OH ; Yeon Sil JANG ; Danbee KANG ; Hong Seog KIM ; Eui-Joong KIM ; So-Young PARK ; Cheol-Hyun KIM ; Yang Won MIN ; Dong Kyung CHANG
Gut and Liver 2023;17(1):100-107
Background/Aims:
There is increasing evidence that supplementation with pre- and probiotics appears to have positive effects on irritable bowel syndrome (IBS). The aim of this study was to determine the effects of a new synbiotic formulation on gastrointestinal symptoms in elderly patients with IBS.
Methods:
Sixty-seven IBS patients aged ≥60 years were randomly assigned to either a placebogroup (n=34) or a synbiotic group (n=33). During a 4-week intervention, subjects used a placebo or a synbiotic containing Lactobacillus paracasei DKGF1 and extracts of Opuntia humifusa once a day. Patients were evaluated with the subject global assessment, visual analog scale, and Bristol stool chart. The primary outcome was the overall responder rate and the secondary outcome was the responder rates for abdominal symptom reduction at week 4.
Results:
Overall, responder rates were significantly higher in the synbiotic group (51.5%) than in the placebo group (23.5%) (p=0.017). Abdominal pain (58.8% vs 81.8%) and psychological wellbeing (26.4% vs 60.6%) were noticeably improved in the synbiotic group (p=0.038 and p=0.004, respectively). However, there were no significant differences in gas and bloating symptoms (p=0.88 and p=0.88, respectively). In patients with constipation-dominant and diarrhea-dominant IBS (n=16), the synbiotic significantly improved abdominal pain and defecation symptoms (responder rates for the placebo vs the synbiotic: 22.2% vs 85.7%, p=0.04). There were no adverse events in either group.
Conclusions
The results indicate that this new synbiotic supplement can potentially relieve abdominal symptoms in elderly IBS patients.
4.Cedrol, a Sesquiterpene Isolated from Juniperus chinensis, Inhibits Human Colorectal Tumor Growth associated through Downregulation of Minichromosome Maintenance Proteins
Soojung JIN ; Jung-ha PARK ; Hee Jung YUN ; You Na OH ; Seunghye OH ; Yung Hyun CHOI ; Byung Woo KIM ; Hyun Ju KWON
Journal of Cancer Prevention 2023;28(2):75-75
5.Cedrol, a Sesquiterpene Isolated from Juniperus chinensis, Inhibits Human Colorectal Tumor Growth associated through Downregulation of Minichromosome Maintenance Proteins
Soojung JIN ; Jung-ha PARK ; Hee Jung YUN ; You Na OH ; Seunghye OH ; Yung Hyun CHOI ; Byung Woo KIM ; Hyun Ju KWON
Journal of Cancer Prevention 2022;27(4):221-228
Cedrol, a sesquiterpene alcohol, isolated from Juniperus chinensis has been reported to inhibit minichromosome maintenance (MCM) proteins as cancer biomarkers in human lung cancer in vitro. In the present study, we investigated the anti-cancer activity of cedrol in vitro and in vivo using human colorectal cancer HT29 cells and a human colorectal tumor xenograft model. Cedrol inhibited MCM protein expression and cell growth in HT29 cells, which are associated with G1 arrest and the induction of apoptosis. We demonstrated that cedrol effectively reduced HT29 tumor growth without apparent weight loss in a human tumor xenograft model.Compared with vehicle- and adriamycin-treated tumor tissues, cedrol induced changes in the tumor tissue structure, resulting in a reduced cell density within the tumor parenchyma and reduced vascularization. Moreover, the expression of MCM7, an important subunit of MCM helicase, was significantly suppressed by cedrol in tumor tissue. Collectively, these results suggest that cedrol may act as a potential anti-cancer agent for colorectal cancer by inhibiting MCM protein expression and tumor growth.
6.Association between the Korean Triage and Acuity Scale level and severity of children with dyspnea in the emergency department
Kwansoo HAN ; Eui-Soon KIM ; Young Min OH ; Yeon Young KYONG ; Kiwook KIM ; Hyun Ho JEONG ; Jung Taek PARK ; Joo Suk OH ; Se Min CHOI ; Kyoung Ho CHOI
Pediatric Emergency Medicine Journal 2022;9(2):69-75
Purpose:
Triage tools play a vital role in classifying the severity of children in emergency departments (EDs). We investigated the association between the Korean Triage and Acuity Scale (KTAS) and severity of dyspnea in the ED.
Methods:
We conducted a retrospective study of children aged 3-14 years with dyspnea who visited the ED from January 2015 through December 2021. They were divided into severe (KTAS level 1-3) and non-severe (KTAS level 4-5) groups. Between the groups, we compared the clinical characteristics, including age, sex, associated symptoms, vital signs, route of visit, treatment at ED, and outcomes.
Results:
Among a total of 468 children with dyspnea, 267 and 201 were assigned to the severe and non-severe groups, respectively. The severe group had higher frequencies of fever (21.7% vs. 13.9%; P = 0.031), cough (53.2% vs. 43.3%; P = 0.034), systemic steroids (42.3% vs. 25.9%; P < 0.001), intravenous fluids (47.6% vs. 25.4%; P < 0.001), oxygen therapy (16.5% vs. 6.5%; P = 0.001), inotropics (4.1% vs. 1.0%; P = 0.042), and hospitalization (24.7% vs. 11.9%; P = 0.002). The severe group also showed a higher mean heart rate, respiratory rate, and temperature, and lower mean oxygen saturation (all Ps < 0.001). Among these findings, fever, heart rate, respiratory rate, temperature, intravenous fluids, oxygen therapy, inotropics, and hospitalization remained significantly different between the groups after defining the severe group as a KTAS level 1-2.
Conclusion
This study shows the association between KTAS and severity of dyspnea in the ED. Therefore, KTAS may reflect not only the initial clinical conditions but also emergency measures and outcomes in children with dyspnea who visit EDs.
7.Effects of a Spouse’s Aromatherapy Hand Massage on Fatigue, Stress, and a Couple’s Relationship in Pregnant Women
Hyang Mi JUNG ; Eun Jung OH ; Hyun Chul SUNG ; Myungja KIM
Journal of the Korean Society of Maternal and Child Health 2022;26(1):35-43
Purpose:
The purpose of this study was to investigate the effect of a spouse’s aromatherapy hand massage on fatigue, stress, and a couple’s relationship in pregnant women.
Methods:
A nonequivalent control group pretest-posttest design was used. Pregnant women were selected as participants on prenatal education program of 2 health centers. For the experimental group, 28 pregnant women were selected from 1 health centers. Thirty-two pregnant women were assigned to a control group from another. Bergamot, lavender, and sandalwood oil were mixed at a ratio of 1:1:1 and diluted to 1% in a jojoba carrier oil. This oil was used for aromatherapy and had already been identified as not being hazardous to pregnant women. Participants received an aroma hand massage from their spouses 5 times a week for 4 weeks, a total of 20 times. Pre and post written survey were collected from both groups. The data were analyzed by χ2 test, independent t-test, paired t-test and analysis of covariance using IBM SPSS Statistics ver. 25.0 program.Result: There was a statistically significant difference in stress (F=17.39, p<0.001) and the couple’s relationship (F=18.87, p<0.001) between the experimental group and the control group. Fatigue was not significantly different between the 2 groups (F=2.61, p=0.112), but there was a difference pre and post the experimental group (t=-5.30, p<0.001).
Conclusion
These findings indicate that a spouse’s aroma hand massage is effective as a nursing intervention for pregnant women to relieve fatigue and stress, and improve the couple’s relationship.
8.Successful Primary Percutaneous Coronary Intervention without Stenting: Insight from Optimal Coherence Tomography
Ji Woong ROH ; Yongcheol KIM ; Oh-Hyun LEE ; Eui IM ; Deok-Kyu CHO ; Donghoon CHOI
Yonsei Medical Journal 2022;63(4):399-404
For patients with acute myocardial infarction, current management guidelines recommend implantation of a drug-eluting stent, dual antiplatelet therapy (including potent P2Y 12 inhibitors) for at least 1 year, and maintenance of life-long antiplatelet therapy.However, a pilot study showed favorable results with antithrombotic therapy without stent implantation when plaque erosion, not definite plaque rupture, was confirmed using optical coherence tomography (OCT), despite the patients having acute myocardial infarction. Here, we present a case where successful primary percutaneous coronary intervention was performed without stenting with the aid of OCT in a patient with ST-elevation myocardial infarction who developed thrombotic total occlusion of the right coronary artery.
9.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.
10.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.

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