1.Efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for hepatitis C in Korea: a Phase 3b study
Jeong HEO ; Yoon Jun KIM ; Sung Wook LEE ; Youn-Jae LEE ; Ki Tae YOON ; Kwan Soo BYUN ; Yong Jin JUNG ; Won Young TAK ; Sook-Hyang JEONG ; Kyung Min KWON ; Vithika SURI ; Peiwen WU ; Byoung Kuk JANG ; Byung Seok LEE ; Ju-Yeon CHO ; Jeong Won JANG ; Soo Hyun YANG ; Seung Woon PAIK ; Hyung Joon KIM ; Jung Hyun KWON ; Neung Hwa PARK ; Ju Hyun KIM ; In Hee KIM ; Sang Hoon AHN ; Young-Suk LIM
The Korean Journal of Internal Medicine 2023;38(4):504-513
Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir–velpatasvir–voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir–velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir–velpatasvir–voxilaprevir achieved SVR 12. Overall, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir–velpatasvir or sofosbuvir–velpatasvir–voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.
2.Clinical safety and effectiveness of the Genoss drug-eluting stent in real-world clinical practice
Young Jin YOUN ; Jun-Won LEE ; Sung Gyun AHN ; Seung-Hwan LEE ; Junghan YOON ; Jae Hyoung PARK ; Sang-Yong YOO ; Woong Chol KANG ; Nam Ho LEE ; Ki Hwan KWON ; Joon Hyung DOH ; Sang-Wook LIM ; Yang Soo JANG ; Dong Woon JEON ; Jung Ho HEO ; Woong Gil CHOI ; Sungsoo CHO ; Bong-Ki LEE ; Hyonju JEONG ; Bum-Kee HONG ; Hyun-Hee CHOI
The Korean Journal of Internal Medicine 2023;38(5):683-691
Background/Aims:
The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt- chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention.
Methods:
The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months.
Results:
A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%.
Conclusions
In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.
3.Prasugrel-based De-Escalation of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With STEMI
You-Jeong KI ; Bong Ki LEE ; Kyung Woo PARK ; Jang-Whan BAE ; Doyeon HWANG ; Jeehoon KANG ; Jung-Kyu HAN ; Han-Mo YANG ; Hyun-Jae KANG ; Bon-Kwon KOO ; Dong-Bin KIM ; In-Ho CHAE ; Keon-Woong MOON ; Hyun Woong PARK ; Ki-Bum WON ; Dong Woon JEON ; Kyoo-Rok HAN ; Si Wan CHOI ; Jae Kean RYU ; Myung Ho JEONG ; Kwang Soo CHA ; Hyo-Soo KIM ; On behalf of the HOST-RP-ACS investigators
Korean Circulation Journal 2022;52(4):304-319
Background and Objectives:
De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events (NACEs) after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. Whether the benefits of de-escalation are sustained in highly thrombotic conditions such as ST-elevation myocardial infarction (STEMI) is unknown. We aimed to assess the efficacy and safety of de-escalation therapy in patients with STEMI or non-STsegment elevation ACS (NSTE-ACS).
Methods:
This is a pre-specified subgroup analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomized to prasugrel de-escalation (5 mg daily) or conventional dose (10 mg daily) at 1-month post-percutaneous coronary intervention. The primary endpoint was a NACE, defined as a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, clinically driven revascularization, stroke, and bleeding events of grade ≥2 Bleeding Academic Research Consortium (BARC) criteria at 1 year.
Results:
Among 2,338 patients included in the randomization, 326 patients were diagnosed with STEMI. In patients with NSTE-ACS, the risk of the primary endpoint was significantly reduced with de-escalation (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.48– 0.89; p=0.006 for de-escalation vs. conventional), mainly driven by a reduced bleeding. However, in those with STEMI, there was no difference in the occurrence of the primary outcome (HR, 1.04; 95% CI, 0.48–2.26; p=0.915; p for interaction=0.271).
Conclusions
Prasugrel dose de-escalation reduced the rate of NACE and bleeding, without increasing the rate of ischemic events in NSTE-ACS patients but not in STEMI patients.
4.Erratum: Correction of Text in the Article “Prasugrel-based De-Escalation of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With STEMI”
You-Jeong KI ; Bong Ki LEE ; Kyung Woo PARK ; Jang-Whan BAE ; Doyeon HWANG ; Jeehoon KANG ; Jung-Kyu HAN ; Han-Mo YANG ; Hyun-Jae KANG ; Bon-Kwon KOO ; Dong-Bin KIM ; In-Ho CHAE ; Keon-Woong MOON ; Hyun Woong PARK ; Ki-Bum WON ; Dong Woon JEON ; Kyoo-Rok HAN ; Si Wan CHOI ; Jae Kean RYU ; Myung Ho JEONG ; Kwang Soo CHA ; Hyo-Soo KIM ;
Korean Circulation Journal 2022;52(6):483-484
5.Impact of Skeletal Muscle Loss and Visceral Obesity Measured Using Serial CT on the Prognosis of Operable Breast Cancers in Asian Patients
Mi-ri KWON ; Eun Sook KO ; Min Su PARK ; Woo Kyoung JEONG ; Na Young HWANG ; Jae-Hun KIM ; Jeong Eon LEE ; Seok Won KIM ; Jong Han YU ; Boo-Kyung HAN ; Eun Young KO ; Ji Soo CHOI ; Ko Woon PARK
Korean Journal of Radiology 2022;23(2):159-171
Objective:
This study aimed to investigate the impact of baseline values and temporal changes in body composition parameters, including skeletal muscle index (SMI) and visceral adipose tissue area (VAT), measured using serial computed tomography (CT) imaging on the prognosis of operable breast cancers in Asian patients.
Materials and Methods:
This study retrospectively included 627 Asian female (mean age ± standard deviation [SD], 53.6 ± 8.3 years) who underwent surgery for stage I–III breast cancer between January 2011 and September 2012. Body composition parameters, including SMI and VAT, were semi-automatically calculated on baseline abdominal CT at the time of diagnosis and follow-up CT for post-treatment surveillance. Serial changes in SMI and VAT were calculated as the delta values. Multivariable Cox regression analysis was used to evaluate the association of baseline and delta SMI and VAT values with disease-free survival.
Results:
Among 627 patients, 56 patients (9.2%) had breast cancer recurrence after a median of 40.5 months. The mean value ± SD of the baseline SMI and baseline VAT were 43.7 ± 5.8 cm2 /m2 and 72.0 ± 46.0 cm2 , respectively. The mean value of the delta SMI was -0.9 cm2 /m2 and the delta VAT was 0.5 cm2 . The baseline SMI and VAT were not significantly associated with disease-free survival (adjusted hazard ratio [HR], 0.983; 95% confidence interval [CI], 0.937–1.031; p = 0.475 and adjusted HR, 1.001; 95% CI, 0.995–1.006; p = 0.751, respectively). The delta SMI and VAT were also not significantly associated with disease-free survival (adjusted HR, 0.894; 95% CI, 0.766–1.043; p = 0.155 and adjusted HR, 1.001; 95% CI, 0.989–1.014; p = 0.848, respectively).
Conclusion
Our study revealed that baseline and early temporal changes in SMI and VAT were not independent prognostic factors regarding disease-free survival in Asian patients undergoing surgery for breast cancer.
6.The Clinical Impact of β-Blocker Therapy on Patients With Chronic Coronary Artery Disease After Percutaneous Coronary Intervention
Jiesuck PARK ; Jung-Kyu HAN ; Jeehoon KANG ; In-Ho CHAE ; Sung Yun LEE ; Young Jin CHOI ; Jay Young RHEW ; Seung-Woon RHA ; Eun-Seok SHIN ; Seong-Ill WOO ; Han Cheol LEE ; Kook-Jin CHUN ; DooIl KIM ; Jin-Ok JEONG ; Jang-Whan BAE ; Han-Mo YANG ; Kyung Woo PARK ; Hyun-Jae KANG ; Bon-Kwon KOO ; Hyo-Soo KIM
Korean Circulation Journal 2022;52(7):544-555
Background and Objectives:
The outcome benefits of β-blockers in chronic coronary artery disease (CAD) have not been fully assessed. We evaluated the prognostic impact of β-blockers on patients with chronic CAD after percutaneous coronary intervention (PCI).
Methods:
A total of 3,075 patients with chronic CAD were included from the Grand DrugEluting Stent registry. We analyzed β-blocker prescriptions, including doses and types, in each patient at 3-month intervals from discharge. After propensity score matching, 1,170 pairs of patients (β-blockers vs. no β-blockers) were derived. Primary outcome was defined as a composite endpoint of all-cause death and myocardial infarction (MI). We further analyzed the outcome benefits of different doses (low-, medium-, and high-dose) and types (conventional or vasodilating) of β-blockers.
Results:
During a median (interquartile range) follow-up of 3.1 (3.0–3.1) years, 134 (5.7%) patients experienced primary outcome. Overall, β-blockers demonstrated no significant benefit in primary outcome (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.63–1.24), all-cause death (HR, 0.87; 95% CI, 0.60–1.25), and MI (HR, 1.25; 95% CI, 0.49–3.15). In subgroup analysis, β-blockers were associated with a lower risk of all-cause death in patients with previous MI and/ or revascularization (HR, 0.38; 95% CI, 0.14–0.99) (p for interaction=0.045). No significant associations were found for the clinical outcomes with different doses and types of β-blockers.
Conclusions
Overall, β-blocker therapy was not associated with better clinical outcomes in patients with chronic CAD undergoing PCI. Limited mortality benefit of β-blockers may exist for patients with previous MI and/or revascularization.
7.Clinical Application of the Standard Q COVID-19 Ag Test for the Detection of SARS-CoV-2 Infection
Sang-Min OH ; Hyeonju JEONG ; Euijin CHANG ; Pyoeng Gyun CHOE ; Chang Kyung KANG ; Wan Beom PARK ; Taek Soo KIM ; Woon Yong KWON ; Myoung-Don OH ; Nam Joong KIM
Journal of Korean Medical Science 2021;36(14):e101-
We evaluated the Standard Q COVID-19 Ag test for the diagnosis of coronavirus disease 2019 (COVID-19) compared to the reverse transcription-polymerase chain reaction (RT-PCR) test.We applied both tests to patients who were about to be hospitalized, had visited an emergency room, or had been admitted due to COVID-19 confirmed by RT-PCR. Two nasopharyngeal swabs were obtained; one was tested by RT-PCR and the other by the Standard Q COVID-19 Ag test. A total of 118 pairs of tests from 98 patients were performed between January 5 and 11, 2021. The overall sensitivity and specificity for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for the Standard Q COVID-19 Ag test compared to RT-PCR were 17.5% (95% confidence interval [CI], 8.8–32.0%) and 100% (95% CI, 95.3–100.0%). Analysis of the results using RT-PCR cycle thresholds of ≤ 30 or ≤ 25 increased the sensitivity to 26.9% (95% CI, 13.7–46.1%), and 41.1% (95% CI, 21.6–64.0%), respectively.
8.Clinical Application of the Standard Q COVID-19 Ag Test for the Detection of SARS-CoV-2 Infection
Sang-Min OH ; Hyeonju JEONG ; Euijin CHANG ; Pyoeng Gyun CHOE ; Chang Kyung KANG ; Wan Beom PARK ; Taek Soo KIM ; Woon Yong KWON ; Myoung-Don OH ; Nam Joong KIM
Journal of Korean Medical Science 2021;36(14):e101-
We evaluated the Standard Q COVID-19 Ag test for the diagnosis of coronavirus disease 2019 (COVID-19) compared to the reverse transcription-polymerase chain reaction (RT-PCR) test.We applied both tests to patients who were about to be hospitalized, had visited an emergency room, or had been admitted due to COVID-19 confirmed by RT-PCR. Two nasopharyngeal swabs were obtained; one was tested by RT-PCR and the other by the Standard Q COVID-19 Ag test. A total of 118 pairs of tests from 98 patients were performed between January 5 and 11, 2021. The overall sensitivity and specificity for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for the Standard Q COVID-19 Ag test compared to RT-PCR were 17.5% (95% confidence interval [CI], 8.8–32.0%) and 100% (95% CI, 95.3–100.0%). Analysis of the results using RT-PCR cycle thresholds of ≤ 30 or ≤ 25 increased the sensitivity to 26.9% (95% CI, 13.7–46.1%), and 41.1% (95% CI, 21.6–64.0%), respectively.
9.Multidisciplinary and Multisociety Practice Guideline on Reprocessing Flexible Gastrointestinal Endoscopes and Endoscopic Accessories
Dae Young CHEUNG ; Byung Ik JANG ; Sang Wook KIM ; Jie-Hyun KIM ; Hyung Keun KIM ; Jeong Eun SHIN ; Won Jae YOON ; Yong Kang LEE ; Kwang Hyun CHUNG ; Soo-Jeong CHO ; Hyun Phil SHIN ; Sun Young CHO ; Woon Geon SHIN ; Kee Don CHOI ; Byung-Wook KIM ; Joong Goo KWON ; Hee Chan YANG ; Tae-Geun GWEON ; Hyun Gun KIM ; Dong-Won AHN ; Kwang Bum CHO ; Sun Hee KIM ; Kyong Hwa HWANG ; Hee Hyuk IM
Clinical Endoscopy 2020;53(3):276-285
The area of endoscopic application has been continuously expanded since its introduction in the last century and the frequency of its use also increased stiffly in the last decades. Because gastrointestinal endoscopy is naturally exposed to diseased internal organs and contact with pathogenic materials, endoscopy mediated infection or disease transmission becomes a major concern in this field. Gastrointestinal endoscopy is not for single use and the proper reprocessing process is a critical factor for safe and reliable endoscopy procedures. What needed in these circumstances is a practical guideline for reprocessing the endoscope and its accessories which is feasible in the real clinical field to guarantee acceptable prevention of pathogen transmission. This guideline contains principles and instructions of the reprocessing procedure according to the step by step. And it newly includes general information and updated knowledge about endoscopy-mediated infection and disinfection. Multiple societies and working groups participated to revise; Korean Association for the Study of the Liver, the Korean Society of Infectious Diseases, Korean College of Helicobacter and Upper Gastrointestinal Research, the Korean Society of Gastroenterology, Korean Society of Gastrointestinal Cancer, Korean Association for the Study of Intestinal Diseases, Korean Pancreatobiliary Association, the Korean Society of Gastrointestinal Endoscopy Nurses and Associates and Korean Society of Gastrointestinal Endoscopy. Through this cooperation, we enhanced communication and established a better concordance. We still need more researches in this field and fill up the unproven area. And our guidelines will be renewed accordingly.
10.Medical Treatment with Somatostatin Analogues in Acromegaly: Position Statement
Sang Ouk CHIN ; Cheol Ryong KU ; Byung Joon KIM ; Sung Woon KIM ; Kyeong Hye PARK ; Kee Ho SONG ; Seungjoon OH ; Hyun Koo YOON ; Eun Jig LEE ; Jung Min LEE ; Jung Soo LIM ; Jung Hee KIM ; Kwang Joon KIM ; Heung Yong JIN ; Dae Jung KIM ; Kyung Ae LEE ; Seong Su MOON ; Dong Jun LIM ; Dong Yeob SHIN ; Se Hwa KIM ; Min Jeong KWON ; Ha Young KIM ; Jin Hwa KIM ; Dong Sun KIM ; Chong Hwa KIM
Endocrinology and Metabolism 2019;34(1):53-62
The Korean Endocrine Society (KES) published clinical practice guidelines for the treatment of acromegaly in 2011. Since then, the number of acromegaly cases, publications on studies addressing medical treatment of acromegaly, and demands for improvements in insurance coverage have been dramatically increasing. In 2017, the KES Committee of Health Insurance decided to publish a position statement regarding the use of somatostatin analogues in acromegaly. Accordingly, consensus opinions for the position statement were collected after intensive review of the relevant literature and discussions among experts affiliated with the KES, and the Korean Neuroendocrine Study Group. This position statement includes the characteristics, indications, dose, interval (including extended dose interval in case of lanreotide autogel), switching and preoperative use of somatostatin analogues in medical treatment of acromegaly. The recommended approach is based on the expert opinions in case of insufficient clinical evidence, and where discrepancies among the expert opinions were found, the experts voted to determine the recommended approach.
Acromegaly
;
Consensus
;
Expert Testimony
;
Insurance Coverage
;
Insurance, Health
;
Octreotide
;
Somatostatin

Result Analysis
Print
Save
E-mail