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.Giant Coronary Artery Aneurysm with Thrombosis Complicated in a Patient with Idiopathic Hypereosinophilic Syndrome
Noeul KANG ; Ki Hong CHOI ; Sung Mok KIM ; Duk-Kyung KIM ; Kiick SUNG ; Dong-Chull CHOI
Yonsei Medical Journal 2023;64(2):148-151
Idiopathic hypereosinophilic syndrome (iHES) is a rare systemic disease that is characterized by persistent peripheral eosinophilia (absolute eosinophil count ≥1500/uL) for more than 6 months, with end-organ damage and absence of a primary cause for eosinophilia. Coronary artery aneurysm (CAA) is a rare but life-threatening complication. Here, we report a case of CAA with thrombosis in a patient with iHES in whom the disease activity was well-controlled (eosinophil count <500/uL) for several years. Despite modest control of the disease activity, giant CAA can be associated with iHES; and therefore, close surveillance and monitoring for the development of complications is warranted.
3.The current status and outcomes of in-hospital P2Y12 receptor inhibitor switching in Korean patients with acute myocardial infarction
Keun-Ho PARK ; Myung Ho JEONG ; Hyun Kuk KIM ; Young-Jae KI ; Sung Soo KIM ; Youngkeun AHN ; Hyun Yi KOOK ; Hyo-Soo KIM ; Hyeon Cheol GWON ; Ki Bae SEUNG ; Seung Woon RHA ; Shung Chull CHAE ; Chong Jin KIM ; Kwang Soo CHA ; Jong Seon PARK ; Jung Han YOON ; Jei Keon CHAE ; Seung Jae JOO ; Dong-Joo CHOI ; Seung Ho HUR ; In Whan SEONG ; Myeong Chan CHO ; Doo Il KIM ; Seok Kyu OH ; Tae Hoon AHN ; Jin Yong HWANG ;
The Korean Journal of Internal Medicine 2022;37(2):350-365
Background/Aims:
While switching strategies of P2Y12 receptor inhibitors (RIs) have sometimes been used in acute myocardial infarction (AMI) patients, the current status of in-hospital P2Y12RI switching remains unknown.
Methods:
Overall, 8,476 AMI patients who underwent successful revascularization from Korea Acute Myocardial Infarction Registry-National Institute of Health (KAMIR-NIH) were divided according to in-hospital P2Y12RI strategies, and net adverse cardiovascular events (NACEs), defined as a composite of cardiac death, non-fatal myocardial infarction (MI), stroke, or thrombolysis in myocardial infarction (TIMI) major bleeding during hospitalization were compared.
Results:
Patients with in-hospital P2Y12RI switching accounted for 16.5%, of which 867 patients were switched from clopidogrel to potent P2Y12RI (C-P) and 532 patients from potent P2Y12RI to clopidogrel (P-C). There were no differences in NACEs among the unchanged clopidogrel, the unchanged potent P2Y12RIs, and the P2Y12RI switching groups. However, compared to the unchanged clopidogrel group, the C-P group had a higher incidence of non-fatal MI, and the P-C group had a higher incidence of TIMI major bleeding. In clinical events of in-hospital P2Y12RI switching, 90.9% of non-fatal MI occurred during pre-switching clopidogrel administration, 60.7% of TIMI major bleeding was related to pre-switching P2Y12RIs, and 71.4% of TIMI major bleeding was related to potent P2Y12RIs. Only 21.6% of the P2Y12RI switching group switched to P2Y12RIs after a loading dose (LD); however, there were no differences in clinical events between patients with and without LD.
Conclusions
In-hospital P2Y12RI switching occurred occasionally, but had relatively similar clinical outcomes compared to unchanged P2Y12RIs in Korean AMI patients. Non-fatal MI and bleeding appeared to be mainly related to pre-switching P2Y12RIs.
4.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.
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(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.
6.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-
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.Beta-blocker Therapy at Discharge in Patients with Acute Heart Failure and Atrial Fibrillation
Min-Soo AHN ; Byung-Su YOO ; Jung-Woo SON ; Min Heui YU ; Dae Ryong KANG ; Hae-Young LEE ; Eun-Seok JEON ; Jae-Joong KIM ; Shung Chull CHAE ; Sang Hong BAEK ; Seok-Min KANG ; Dong-Ju CHOI ; Kye Hun KIM ; Myeong-Chan CHO ; Seong Yoon KIM
Journal of Korean Medical Science 2020;35(33):e278-
Background:
β-blockers (BBs) are considered primary therapy in stable heart failure (HF) with reduced ejection fraction (HFrEF) without atrial fibrillation (AF); evidence-based benefits of BB on outcome have been documented. However, BBs have not been shown to improve mortality or reduce hospital admissions in HF patients with AF. This study assessed the relationship between BBs at discharge and relevant clinical outcomes in acute heart failure (AHF) patients with AF.
Methods:
From the Korean Acute Heart Failure Registry, 936 HFrEF and 639 HF patients with preserved ejection fraction (HFpEF) and AF were selected. Propensity score (PS) matching accounted for BB selection bias when assessing associations.
Results:
BB-untreated patients in the overall cohort of HFrEF and HFpEF had greater deteriorated clinical and laboratory characteristics. In the 670 PS-matched cohort of HFrEF patients, incidences of all clinical events at 60 days and 1 year were not different according to use of BBs. In the 470 PS-matched cohort of HFpEF, rehospitalization and composite outcome at 6 months and 1 year more frequently occurred in non-users of BBs. After adjusting for covariates in the multivariable Cox model of matched cohorts, BB was not associated with clinical outcomes at 60 days and 1 year in HFrEF with AF patients. In HFpEF patients with AF, BB use was associated with reduced 6-month (hazard ratio [HR], 0.38; 95% confidence interval [CI], 0.20–0.74) and 1-year rehospitalization (HR, 0.53; 95% CI, 0.34–0.82).
Conclusion
In the HFrEF with AF PS-matched cohort, the use of BBs at discharge was not associated with clinical outcome. However, in HFpEF with AF, the use of BB was associated with reduced rehospitalization during the 6-month and 1-year follow up.
10.Implantable Cardioverter-defibrillator Utilization and Its Outcomes in Korea:Data from Korean Acute Heart Failure Registry
Youngjin CHO ; Sang-Yeong CHO ; Il-Young OH ; Ji Hyun LEE ; Jin Joo PARK ; Hae-Young LEE ; Kye Hun KIM ; Byung-Su YOO ; Seok-Min KANG ; Sang Hong BAEK ; Eun-Seok JEON ; Jae-Joong KIM ; Myeong-Chan CHO ; Shung Chull CHAE ; Byung-Hee OH ; Dong-Ju CHOI
Journal of Korean Medical Science 2020;35(46):e397-
Background:
There are sparse data on the utilization rate of implantable cardioverterdefibrillator (ICD) and its beneficial effects in Korean patients with heart failure with reduced left ventricular ejection fraction (LVEF).
Methods:
Among 5,625 acute heart failure (AHF) patients from 10 tertiary university hospitals across Korea, 485 patients with reassessed LVEF ≤ 35% at least 3 months after the index admission were enrolled in this study. The ICD implantation during the follow-up was evaluated. Mortality was compared between patients with ICDs and age-, sex-, and follow-up duration matched control patients.
Results:
Among 485 patients potentially indicated for an ICD for primary prevention, only 56 patients (11.5%) underwent ICD implantation during the follow-up. Patients with ICD showed a significantly lower all-cause mortality compared with their matched control population: adjusted hazard ratio (HR) (95% confidence interval [CI]) = 0.39 (0.16–0.92), P = 0.032. The mortality rate was still lower in the ICD group after excluding patients with cardiac resynchronization therapy (adjusted HR [95% CI] = 0.09 [0.01–0.63], P = 0.015).According to the subgroup analysis for ischemic heart failure, there was a significantly lower all-cause mortality in the ICD group than in the no-ICD group (HR [95% CI] = 0.20 [0.06– 0.72], P = 0.013), with a borderline statistical significance (interaction P = 0.069).
Conclusion
Follow-up data of this large, multicenter registry suggests a significant underutilization of ICD in Korean heart failure patients with reduced LVEF. Survival analysis implies that previously proven survival benefit of ICD in clinical trials could be extrapolated to Korean patients.

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