1.Clinical development and trial operations in COVID-19 era
Translational and Clinical Pharmacology 2021;29(4):181-185
no abstract available.
2.Safety and efficacy of fimasartan with essential hypertension patients in real world clinical practice: data from a post marketing surveillance in Korea
Su Eun HAN ; Seung Hee JEONG ; Hye Jeong KANG ; Myung Sook HONG ; Eunah PAEK ; Hijung CHO ; Seong Choon CHOE
Translational and Clinical Pharmacology 2018;26(3):118-127
The safety and efficacy of fimasartan have been evaluated through post-marketing surveillance in real world clinical practice. The multi-center, prospective, open-label and non-interventional study. A total of 3,945 patients (3,729 patients for safety assessment and 3,473 patients for efficacy assessment) were screened in patients with essential hypertension in 89 study centers from 9 September 2010 through 8 September 2016. Among the total patients, 2,893 patients (77.6%) were administered fimasartan for 24 weeks or longer and were classified as ‘patients with long-term follow-up’, and the additional safety and efficacy analysis were performed. The improvement was defined as systolic blood pressure (SBP) controlled to ≤ 140 mmHg or decreased SBP differences ≥ 20 mmHg after treatment or diastolic blood pressure (DBP) controlled to ≤ 90 mmHg or decreased DBP differences ≥ 10 mmHg after treatment. Adverse drug reactions (ADRs) were reported in 3.8% patients; dizziness, and hypotension were the most frequently reported ADRs in total patients. The results of patients with long-term follow-up were comparable with total patients. The overall improvement rate in all efficacy assessment at the last visit was 87.1% (3,025/3,473 patients). The overall improvement rate of the patients with long-term follow-up was 88.9%. Fimasartan was well tolerated, with no new safety concerns identified and an effective treatment in the real world clinical practice for Korean patients with hypertension.
Blood Pressure
;
Dizziness
;
Drug-Related Side Effects and Adverse Reactions
;
Follow-Up Studies
;
Humans
;
Hypertension
;
Hypotension
;
Korea
;
Marketing
;
Prospective Studies
3.Use of Oral Antibiotics in Elderly Gastrointestinal Patients.
Seong Choon CHOE ; Dong Ho LEE
Journal of the Korean Geriatrics Society 2012;16(3):108-113
Oral antibiotics are usually prescribed for geriatric patients for the treatment of infectious diarrhea and management of hepatic encephalopathy. But oral antibiotics have systemic adverse events, so many doctors face the issue of choosing the right antibiotics. Rifaximin, an intestinal topical antibiotic that exhibits a wide antimicrobial activity against both aerobic and anaerobic bacteria, has various indications, such as acute bacterial diarrhea caused by Gram positive and negative bacteria, traveler's diarrhea, small intestine bacterial overgrowth, prevention of infection after gastrointestinal surgery, and the management of hepatic encephalopathy with hyperammoniemia. But there are few clinical trial data on the geriatric population. Hence we reviewed the clinical study data that included geriatric patients in their clinical trials. Based on our literature searches, only one clinical trial on acute bacterial diarrhea was performed only for geriatric patients. Other clinical trials for various indications usually recruited elderly patients, but the number of elderly patients was limited. However, generally speaking, rifaximin showed good efficacy and safety profile in acute bacterial diarrhea caused by Gram positive and negative bacteria, traveler's diarrhea, small intestine bacterial overgrowth, prevention of infection after gastrointestinal surgery, and the management of hepatic encephalopathy with hyperammoniemia; and there were no differences in efficacy and safety, compared to the nongeriatric population. We concluded that rifaximin is a good therapeutic option for various gastrointestinal indications, and shows good efficacy and an excellent safety profile, compared to other oral agents. For more evidence on the geriatric population, we propose clinical trials on elderly patients for each indication.
Aged
;
Anti-Bacterial Agents
;
Bacteria
;
Bacteria, Anaerobic
;
Diarrhea
;
Hepatic Encephalopathy
;
Humans
;
Intestine, Small
;
Rifamycins
4.Myocardial injury occurs earlier than myocardial inflammation in acute experimental viral myocarditis.
Byung Kwan LIM ; Jae Ok SHIN ; Seong Choon CHOE ; Si Wan CHOI ; Jin Ok JEONG ; In Whan SEONG ; Duk Kyung KIM ; Eun Seok JEON
Experimental & Molecular Medicine 2005;37(1):51-57
Endomyocardial biopsy often fails to show myocardial inflammation for patients with clinically suspected myocarditis. The serum isoforms of troponin T (cTnT) level is a very sensitive marker of myocardial injury and it is elevated even in the absence of myocardial inflammation. We investigated the correlations for myocardial injury, virus titers and inflammation in acute viral infection. Using the murine coxsackievirus group B3 (CVB3) myocarditis model, the histopathologic findings and virus titers in mouse hearts were compared with the serum cTnT levels measured by ELISA at various time points. Viable virus titers in the hearts peaked at 3 days after infection (8.22+/-0.13 log10 PFU/100 mg of heart); they decreased at day 7 and no viable virus was detected from day 14. Myocardial inflammation was minimal at day 3, peaked at day 7 and markedly decreased at day 14. The individual serum TnT levels were significantly increased at day 3 (7.37+/-1.46 ng/ml), persisted to day 7 (0.73+/-0.08 ng/ml), and normalized at day 14. Serum cTnT levels were correlatable with virus titers in the heart (r=0.744, P <0.01), but the serum cTnT levels were not correlated with the degrees of inflammation. Using the less myocarditic strain of CVB3, similar relationships were observed between the changes for the serum cTnT levels and the heart virus titers. During the course of viral infection, myocardial injury precedes the pathologic evidence of inflammation, and the elevated cTnT levels provide evidence of myocardial injury even in the absence of any histologic findings of myocarditis.
Acute Disease
;
Animals
;
Coxsackievirus Infections/*pathology
;
Enterovirus B, Human/isolation & purification/pathogenicity/*physiology
;
Female
;
Heart/*virology
;
Hela Cells
;
Humans
;
Inflammation/*immunology
;
Mice
;
Mice, Inbred BALB C
;
Myocardial Infarction/immunology/*pathology
;
Myocarditis/immunology/pathology/*virology
;
*Myocardium/immunology/pathology
;
Research Support, Non-U.S. Gov't
;
Troponin T/blood
;
Virus Replication
5.Treatment of Hypercholesterolemia in Elderly Patients; From the Viewpoint of Statins.
Seong Choon CHOE ; Sora LEE ; Chul Joon KIM
Journal of the Korean Geriatrics Society 2002;6(4):253-260
No abstract available.
Aged*
;
Humans
;
Hydroxymethylglutaryl-CoA Reductase Inhibitors*
;
Hypercholesterolemia*
6.Incidence of eNOS gene mutationin Korean patients with coronary artery spasm.
Jung Hee KIM ; Byung Kwan LIM ; Bo Young KIM ; Jeong Woo LEE ; Jung A KANG ; Dae Seung LIM ; Min Soo LEE ; Yoon Cheol KIM ; Bo Young SUNG ; Seong Choon CHOE ; In Whan SEONG ; Eun Seok JEON
Korean Circulation Journal 2001;31(5):512-512
BACKGROUND: Coronary artery spasm is an important mechanism in producing myocardial ischemia. But the exact mechanism of the spasm is not well known. We investigated the mutation of endothelial nitric oxide synthase (eNOS) that produce nitric oxide and relationship between eNOS mutation and coronary artery spasm. MATERIALS AND METHODS: Blood were drawn from the patients with angiographically proven coronary artery spasm and normal controls. DNA were extracted and polymerase chain reaction and restriction analysis with Nae I were performed to find T-786--
7.Incidence of eNOS gene mutationin Korean patients with coronary artery spasm.
Jung Hee KIM ; Byung Kwan LIM ; Bo Young KIM ; Jeong Woo LEE ; Jung A KANG ; Dae Seung LIM ; Min Soo LEE ; Yoon Cheol KIM ; Bo Young SUNG ; Seong Choon CHOE ; In Whan SEONG ; Eun Seok JEON
Korean Circulation Journal 2001;31(5):512-512
BACKGROUND: Coronary artery spasm is an important mechanism in producing myocardial ischemia. But the exact mechanism of the spasm is not well known. We investigated the mutation of endothelial nitric oxide synthase (eNOS) that produce nitric oxide and relationship between eNOS mutation and coronary artery spasm. MATERIALS AND METHODS: Blood were drawn from the patients with angiographically proven coronary artery spasm and normal controls. DNA were extracted and polymerase chain reaction and restriction analysis with Nae I were performed to find T-786--
8.A Case of Dilated Cardiomyopathy Associated with Autosomal Dominant Polycystic Kidney Disease.
Seong Choon CHOE ; Eun Seok JEON ; Seung Duk HWANG
Journal of the Korean Society of Echocardiography 2001;9(2):152-156
Autosomal dominant polycystic kidney disease is a systemic disorder with cystic manifestations in the kidneys, liver, pancreas, seminal vesicles, and meninges; its noncystic manifestations affect mostly the vascular, cardiac, and connective tissues. Cardiovascular abnormalities, including mitral and aortic valvular prolapse and regurgitation and annuloaortic ectasia, have been considered important extrarenal manifestations of autosomal dominant polycystic kidney disease. But there were no reports with dilated cardiomyopathy in patients with polycystic kidney disease yet. We have experienced a case of dilated cardiomyopathy that is associated by autosomal dominant polycystic kidney disease in 40 year old male patient. Abdominal ultrasonography revealed variable sizes of multiple cysts in both kidneys and echocardiography showed the marked dilatation of left ventricle and severely depressed left ventricular systolic function (ejection fraction=19%). He was treated with diuretics intravenously and orally. Then dyspnea and abdominal distension was improved. This is the first case of dilated cardiomyopathy with autosomal dominant polycystic disease in Korea.
Adult
;
Cardiomyopathy, Dilated*
;
Cardiovascular Abnormalities
;
Connective Tissue
;
Dilatation
;
Dilatation, Pathologic
;
Diuretics
;
Dyspnea
;
Echocardiography
;
Heart Ventricles
;
Humans
;
Kidney
;
Korea
;
Liver
;
Male
;
Meninges
;
Pancreas
;
Polycystic Kidney Diseases
;
Polycystic Kidney, Autosomal Dominant*
;
Prolapse
;
Seminal Vesicles
;
Ultrasonography
9.Screening of the Presence of Hepatitis B and C Virus Infections in Terminally Failing Human Hearts.
Seong Choon CHOE ; Hyo Soo KIM ; Byung Hee OH
Korean Circulation Journal 2001;31(1):83-93
In order to evaluate the prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections in terminally failing hearts, we screened the explanted hearts of transplantation recipients for the presence of HBV DNA and HCV RNA. DNA and RNA extractions were taken from explanted failing hearts (N=7) and normal hearts (N=). Polymerase chain reaction (PCR) and in situ PCR of HBV or reverse transcription-polymerase chain reaction (RT-PCR) and in situ RT-PCR of HCV were performed. The positivity of HBV in failing hearts was 63% (17/27) and it was 50% (3/6) in normal hearts in PCR. There was no significant difference in the positivity of HBV DNA between failing and normal hearts. The positivity of HCV in failing hearts was 18.5% (5/27) and it was 16.7% (1/6) in normal hearts in nested RT-PCR. There was no significant difference in the positivity of HCV RNA between failing and normal hearts. HCV was very rarely observed in explanted terminally failing hearts and HBV was frequently found in both explanted failing hearts and normal hearts. We concluded that these viruses have little direct causal relationship with the development of heart failure.
DNA
;
Heart Failure
;
Heart*
;
Hepacivirus
;
Hepatitis B virus
;
Hepatitis B*
;
Hepatitis*
;
Humans*
;
Mass Screening*
;
Polymerase Chain Reaction
;
Prevalence
;
RNA
10.A Case of Histologically Confirmed Coxsackiviral Myocarditis Supported by a Left Ventricular Assist Device.
Bo Young SUNG ; Byung Kwan LIM ; Yoon Cheol KIM ; Min Su LEE ; Jung Hee KIM ; Hyun Woong YANG ; Seong Choon CHOE ; In Whan SEONG ; Shin Kwang KANG ; Eui Doo WHANG ; Young LEE ; Eun Seok JEON
Korean Circulation Journal 2000;30(10):1275-1280
Enteroviruses are the most common agents of myocarditis and have been implicates in the pathogenesis of dilated cardiopmyopathy. There are still discrepancies in the association of enterovirus and myocardial disease, partially due to lack of data on detection of virus antigen or viral culture in the tissue. For the treatment of fulminant myocarditis, aggressive hemodynamic support is warranted because of its excellent long-term prognosis. This 16 year-old girl was admitted because of anterior chest pain for a day. She had flu-like symptoms such as fever, sore throat and cough at 2 weeks ago. Electrocardiogram showed sinus tachycardia and ST segment elevations in lead II, III, aVF and V1-V4. Troponin T was positive and creatinine phosphokinase was elevated (1323 IU/L) at emergency room. On emergency echocardiogram, inferior wall motion was decreased and the ejection fraction (EF) was 70%. Coronary angiogram showed no thrombus and no significant stenosis in coronary artery, and spasm was not induced with ergonovine. Conventional treatment for congestive heart failure with digoxin (0.25 mg daily) and furosemide (20 mg t.i.d) was started under the impression of myocarditis. On the first hospital day, pulmonary edema and signs of shock were developed. The whole left ventricular(LV) wall motion were markedly decreased and EF was less than 20% on echocardiogram. Despite of intra-aortic balloon pump (IABP) for 4 hours, shock and pulmonary edema was progressed. Mechanical circulatory support was started with left ventricular assist device (LVAD, Bio-pump, Medtronic Bio-Medicus, USA). At the time of operation, central venous pressure was 24cmH20, systolic blood pressure was 75mmHg, left atrium(LA) and LV was dilated and the whole wall of LV showed almost akinesia , and LA appendage was biopsied. After 126 hours of LVAD, LV wall motion was restored and EF was 79% on echocardiogram. LVAD was removed 10 days after operation and she was discharged on 23 days of hospitalization without any heart failure symptoms. Immunohistochemistry of LA showed enteroviral VP1 capsid protein (primary antibody; NoVo Castra Laboratory, UK) over the entire LA wall. Her serum neutralized coxsackievirus B3 (CVB3, H3 variant of Woodruff strain) in neutralization test using horse anti-CVB3 (Nancy strain) antibody (ATCC, V030-501-560) as a positive control. The titer of neutralization Ab in her serum of 21 days increased more than 4 times than that of 2 days.
Adolescent
;
Blood Pressure
;
Capsid Proteins
;
Cardiomyopathies
;
Central Venous Pressure
;
Chest Pain
;
Constriction, Pathologic
;
Coronary Vessels
;
Cough
;
Creatinine
;
Digoxin
;
Electrocardiography
;
Emergencies
;
Emergency Service, Hospital
;
Enterovirus
;
Ergonovine
;
Female
;
Fever
;
Furosemide
;
Heart Failure
;
Heart-Assist Devices*
;
Hemodynamics
;
Horses
;
Hospitalization
;
Humans
;
Immunohistochemistry
;
Myocarditis*
;
Neutralization Tests
;
Pharyngitis
;
Prognosis
;
Pulmonary Edema
;
Shock
;
Spasm
;
Tachycardia, Sinus
;
Thrombosis
;
Troponin T

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