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.Clinical Outcomes of ATOS-mediated SmartSight Lenticule Extraction
Chang Mok LEE ; Hyo Sung YOON ; Hye Ra KANG ; Mingue KIM ; Sheen Chull JOH ; Dong Ju YEOM
Journal of the Korean Ophthalmological Society 2023;64(8):666-671
Purpose:
To evaluate the clinical outcomes of a new refractive corneal lenticule extraction method (SmartSight) using a Schwind ATOS femtosecond laser (Schwind Eye-Tech-Solutions, Kleinostheim, Germany).
Methods:
The medical records of 338 eyes of 170 patients who underwent SmartSight treatment from April to September 2022 and were followed-up for at least 3 months were retrospectively analyzed. The patients were followed-up at 1 day, 1 week, and 1 and 3 months after operation. Refraction, visual acuity, and intraocular pressure were measured at each visit.
Results:
Preoperatively, the uncorrected distant visual acuity was 1.26 ± 0.33 logarithm of minimum angle or resolution (logMAR) and the spherical equivalent was -4.52 ± 1.77 diopters. The 3-month, postoperative, uncorrected distant visual acuity was 0.01 ± 0.03 logMAR and the spherical equivalent was -0.12 ± 0.22 diopters. The 3-month data were as follows: efficacy of refractive surgery, 0.99 ± 0.11; safety, 1.00 ± 0.05; predictabilities at ±0.5 and ± 1.0 diopters, 97% and 100%, respectively.
Conclusions
Myopic astigmatism correction using the SmartSight method was effective, safe, and predictable in terms of visual outcomes.
3.Impact of Cardiovascular Risk Factors and Cardiovascular Diseases on Outcomes in Patients Hospitalized with COVID-19 in Daegu Metropolitan City
Bo Eun PARK ; Jang Hoon LEE ; Hyuk Kyoon PARK ; Hong Nyun KIM ; Se Yong JANG ; Myung Hwan BAE ; Dong Heon YANG ; Hun Sik PARK ; Yongkeun CHO ; Bong Yul LEE ; Chang Wook NAM ; Jin Bae LEE ; Ung KIM ; Shung Chull CHAE ;
Journal of Korean Medical Science 2021;36(2):e15-
Background:
Data regarding the association between preexisting cardiovascular risk factors (CVRFs) and cardiovascular diseases (CVDs) and the outcomes of patients requiring hospitalization for coronavirus disease 2019 (COVID-19) are limited. Therefore, the aim of this study was to investigate the impact of preexisting CVRFs or CVDs on the outcomes of patients with COVID-19 hospitalized in a Korean healthcare system.
Methods:
Patients with COVID-19 admitted to 10 hospitals in Daegu Metropolitan City, Korea, were examined. All sequentially hospitalized patients between February 15, 2020, and April 24, 2020, were enrolled in this study. All patients were confirmed to have COVID-19 based on the positive results on the polymerase chain reaction testing of nasopharyngeal samples. Clinical outcomes during hospitalization, such as requiring intensive care and invasive mechanical ventilation (MV) and death, were evaluated. Moreover, data on baseline comorbidities such as a history of diabetes, hypertension, dyslipidemia, current smoking, heart failure, coronary artery disease, cerebrovascular accidents, and other chronic cardiac diseases were obtained.
Results:
Of all the patients enrolled, 954 (42.0%) had preexisting CVRFs or CVDs. Among the CVRFs, the most common were hypertension (28.8%) and diabetes mellitus (17.0%). The prevalence rates of preexisting CVRFs or CVDs increased with age (P < 0.001). The number of patients requiring intensive care (P < 0.001) and invasive MV (P < 0.001) increased with age.The in-hospital death rate increased with age (P < 0.001). Patients requiring intensive care (5.3% vs. 1.6%; P < 0.001) and invasive MV (4.3% vs. 1.7%; P < 0.001) were significantly greater in patients with preexisting CVRFs or CVDs. In-hospital mortality (12.9% vs. 3.1%; P < 0.001) was significantly higher in patients with preexisting CVRFs or CVDs. Among the CVRFs, diabetes mellitus and hypertension were associated with increased requirement of intensive care and invasive MV and in-hospital death. Among the known CVDs, coronary artery disease and congestive heart failure were associated with invasive MV and in-hospital death. In multivariate analysis, preexisting CVRFs or CVDs (odds ratio [OR], 1.79; 95% confidence interval [CI], 1.07–3.01; P = 0.027) were independent predictors of in-hospital death adjusting for confounding variables. Among individual preexisting CVRF or CVD components, diabetes mellitus (OR, 2.43; 95% CI, 1.51–3.90; P < 0.001) and congestive heart failure (OR, 2.43; 95% CI, 1.06–5.87; P = 0.049) were independent predictors of in-hospital death.
Conclusion
Based on the findings of this study, the patients with confirmed COVID-19 with preexisting CVRFs or CVDs had worse clinical outcomes. Caution is required in dealing with these patients at triage.after
4.Effect of omalizumab as add-on therapy to Quality of Life Questionnaire for Korean Asthmatics (KAQLQ) in Korean patients with severe persistent allergic asthma
Jae-Woo JUNG ; Hae-Sim PARK ; Choon-Sik PARK ; Sang-Heon CHO ; Inseon S. CHOI ; Hee-Bom MOON ; Soon Seog KWON ; Ho Joo YOON ; Jung Won PARK ; Jong-Myung LEE ; Dong-Chull CHOI ; Byoung Whui CHOI
The Korean Journal of Internal Medicine 2021;36(4):1001-1013
Background/Aims:
Omalizumab is the first biologic known to be effective in patients with severe allergic asthma.
Methods:
This study was conducted as a multicenter, single-group, open trial to evaluate the improvement in the quality of life with the additional administration of omalizumab for 24 weeks in Korean patients with severe persistent allergic asthma.
Results:
Of the 44 patients, 31.8% were men and the mean age was 49.8 ± 11.8 years. A score improvement of 0.5 points or more in the Quality of Life Questionnaire for Korean Asthmatics (KAQLQ) was noted in 50.0% (22/44) of the patinets. In the improved group, the baseline total immunoglobulin E (IgE) level and the amount of omalizumab used were higher, and the day and night asthma symptoms were more severe, compared to those in the non-improved group. According to the Global Evaluation of Treatment Effectiveness, favorable outcomes were found in 78.6% of patients. The Korean asthma control test (p < 0.005) and forced expiratory volume in 1 second % predicted (FEV1%; p < 0.01) improved significantly in patients who received omalizumab treatment, compared to that at week 0, and the total dose of rescue systemic corticosteroids significantly decreased (p < 0.05). The improved group on KAQLQ showed a significant improvement in FEV1% (p < 0.001).
Conclusions
Omalizumab can be considered a biological treatment for Korean patients with severe allergic asthma. It is recommended to consider omalizumab as add-on therapy in patients with high baseline total IgE levels and severe asthma symptoms.
5.Effect of omalizumab as add-on therapy to Quality of Life Questionnaire for Korean Asthmatics (KAQLQ) in Korean patients with severe persistent allergic asthma
Jae-Woo JUNG ; Hae-Sim PARK ; Choon-Sik PARK ; Sang-Heon CHO ; Inseon S. CHOI ; Hee-Bom MOON ; Soon Seog KWON ; Ho Joo YOON ; Jung Won PARK ; Jong-Myung LEE ; Dong-Chull CHOI ; Byoung Whui CHOI
The Korean Journal of Internal Medicine 2021;36(5):1260-
6.Incidence of adverse drug reaction among 6 iodinated contrast media
Eunsil KOH ; Yu Jin KIM ; Noeul KANG ; Seong-Rye JIN ; Jin-Young LEE ; Hong EO ; Dong-Chull CHOI ; Byung-Jae LEE
Allergy, Asthma & Respiratory Disease 2021;9(2):84-92
Purpose:
Contrast media is one of the most common cause of adverse drug reaction (ADR) in adult. However, there was little data reported about differences in ADR ratio and severity among iodinated contrast media (ICM).
Methods:
Medical records of 627,049 patients who performed computed tomography scan using low-osmolar nonionic iodinated contrast media from January 2015 to December 2018 were retrospectively reviewed. A total of 6 ICMs including iomeprol, iohexol, iopromide, iobitridol, ioversol, and iopamidol were used in this period. The incidence of ADR was compared to their total usage and dosage between each contrast media.
Results:
The incidence of ADR of iopromide (1.36%) and iomeprol (1.27%) was the highest when compared with the average incidence of 1% of 6 ICMs. Ioversol (0.67%), iohexol, and iobitridol (0.74%) had the lower incidence of ADR. The order of results adjusted by actual administered dosage, the use of premedication, and the prior exposure history of ICMs was similar. The fraction of moderate and severe ADR in overall ADR was slightly different, but not proportional to the incidence of ADR.
Conclusion
The incidence of ADR among 6 low-osmolar nonionic ICMs was significantly different when compared by the total number of usage and the total volume of dose. The incidence of ADR varied by nearly 2-fold depending on ICMs. Further study might need to explore the reason for the difference of incidence.
7.Effect of omalizumab as add-on therapy to Quality of Life Questionnaire for Korean Asthmatics (KAQLQ) in Korean patients with severe persistent allergic asthma
Jae-Woo JUNG ; Hae-Sim PARK ; Choon-Sik PARK ; Sang-Heon CHO ; Inseon S. CHOI ; Hee-Bom MOON ; Soon Seog KWON ; Ho Joo YOON ; Jung Won PARK ; Jong-Myung LEE ; Dong-Chull CHOI ; Byoung Whui CHOI
The Korean Journal of Internal Medicine 2021;36(4):1001-1013
Background/Aims:
Omalizumab is the first biologic known to be effective in patients with severe allergic asthma.
Methods:
This study was conducted as a multicenter, single-group, open trial to evaluate the improvement in the quality of life with the additional administration of omalizumab for 24 weeks in Korean patients with severe persistent allergic asthma.
Results:
Of the 44 patients, 31.8% were men and the mean age was 49.8 ± 11.8 years. A score improvement of 0.5 points or more in the Quality of Life Questionnaire for Korean Asthmatics (KAQLQ) was noted in 50.0% (22/44) of the patinets. In the improved group, the baseline total immunoglobulin E (IgE) level and the amount of omalizumab used were higher, and the day and night asthma symptoms were more severe, compared to those in the non-improved group. According to the Global Evaluation of Treatment Effectiveness, favorable outcomes were found in 78.6% of patients. The Korean asthma control test (p < 0.005) and forced expiratory volume in 1 second % predicted (FEV1%; p < 0.01) improved significantly in patients who received omalizumab treatment, compared to that at week 0, and the total dose of rescue systemic corticosteroids significantly decreased (p < 0.05). The improved group on KAQLQ showed a significant improvement in FEV1% (p < 0.001).
Conclusions
Omalizumab can be considered a biological treatment for Korean patients with severe allergic asthma. It is recommended to consider omalizumab as add-on therapy in patients with high baseline total IgE levels and severe asthma symptoms.
8.Effect of omalizumab as add-on therapy to Quality of Life Questionnaire for Korean Asthmatics (KAQLQ) in Korean patients with severe persistent allergic asthma
Jae-Woo JUNG ; Hae-Sim PARK ; Choon-Sik PARK ; Sang-Heon CHO ; Inseon S. CHOI ; Hee-Bom MOON ; Soon Seog KWON ; Ho Joo YOON ; Jung Won PARK ; Jong-Myung LEE ; Dong-Chull CHOI ; Byoung Whui CHOI
The Korean Journal of Internal Medicine 2021;36(5):1260-
9.Pre-hospital delay and emergency medical services in acute myocardial infarction
Seung Hun LEE ; Hyun Kuk KIM ; Myung Ho JEONG ; Joo Myung LEE ; Hyeon-Cheol GWON ; Shung Chull CHAE ; In-Whan SEONG ; Jong-Seon PARK ; Jei Keon CHAE ; Seung-Ho HUR ; Kwang Soo CHA ; Hyo-Soo KIM ; Ki-Bae SEUNG ; Seung-Woon RHA ; Tae Hoon AHN ; Chong-Jin KIM ; Jin-Yong HWANG ; Dong-Ju CHOI ; Junghan YOON ; Seung-Jae JOO ; Kyung-Kuk HWANG ; Doo-Il KIM ; Seok Kyu OH ;
The Korean Journal of Internal Medicine 2020;35(1):119-132
Background/Aims:
Minimising total ischemic time (TIT) is important for improving clinical outcomes in patients with ST-segment elevation myocardial infarction who have undergone percutaneous coronary intervention (PCI). TIT has not shown a significant improvement due to persistent pre-hospital delay. This study aimed to investigate the risk factors associated with pre-hospital delay.
Methods:
Individuals enrolled in the Korea Acute Myocardial Infarction Registry-National Institutes of Health between 2011 and 2015 were included in this study. The study population was analyzed according to the symptom-to-door time (STDT; within 60 or > 60 minutes), and according to the type of hospital visit (emergency medical services [EMS], non-PCI center, or PCI center).
Results:
A total of 4,874 patients were included in the analysis, of whom 28.4% arrived at the hospital within 60 minutes of symptom-onset. Old age (> 65 years), female gender, and renewed ischemia were independent predictors of delayed STDT. Utilising EMS was the only factor shown to reduce STDT within 60 minutes, even when cardiogenic shock was evident. The overall frequency of EMS utilisation was low (21.7%). Female gender was associated with not utilising EMS, whereas cardiogenic shock, previous myocardial infarction, familial history of ischemic heart disease, and off-hour visits were associated with utilising EMS.
Conclusions
Factors associated with delayed STDT and not utilising EMS could be targets for preventive intervention to improve STDT and TIT.
10.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.

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