1.Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension
Jun Sung MOON ; Il Rae PARK ; Hae Jin KIM ; Choon Hee CHUNG ; Kyu Chang WON ; Kyung Ah HAN ; Cheol-Young PARK ; Jong Chul WON ; Dong Jun KIM ; Gwan Pyo KOH ; Eun Sook KIM ; Jae Myung YU ; Eun-Gyoung HONG ; Chang Beom LEE ; Kun-Ho YOON
Diabetes & Metabolism Journal 2023;47(6):808-817
Background:
This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.
Methods:
In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).
Results:
Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.
Conclusion
Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.
2.Effect of Renal Denervation on Suppression of PVC and QT Prolongation in a Porcine Model of Acute Myocardial Infarction
Sung Soo KIM ; Hyun Kuk KIM ; Hyung Wook PARK ; Myung Ho JEONG ; Kyung Seob LIM ; Hae Jin KEE ; Yu Hee RYU ; Han Byul KIM ; Joo Young NA ; Young Jae KI ; Keun Ho PARK ; Dong Hyun CHOI ; Ki Hong LEE ; Nam Sik YOON ; Jeong Gwan CHO
Korean Circulation Journal 2020;50(1):38-49
BACKGROUND AND OBJECTIVES: Antiarrhythmic effect of renal denervation (RDN) after acute myocardial infarction (AMI) remains unclear. The goal of this study was to evaluate the effect of RDN on ventricular arrhythmia (VA) after AMI in a porcine model.METHODS: Twenty pigs were randomly divided into 2 groups based on RDN (RDN, n=10; Sham, n=10). After implanting a loop recorder, AMI was induced by occlusion of the middle left anterior descending coronary artery. Catheter-based RDN was performed for each renal artery immediately after creating AMI. Sham procedure used the same method, but a radiofrequency current was not delivered. Electrocardiography was monitored for 1 hour to observe VA. One week later, the animals were euthanized and the loop recorder data were analyzed.RESULTS: Ventricular fibrillation event rate and the interval from AMI creation to first VA in acute phase were not different between the 2 groups. However, the incidence of premature ventricular complex (PVC) was lower in the RDN than in the Sham. Additionally, RDN inhibited prolongation of the corrected QT (QTc) interval after AMI. The frequency of non-sustained or sustained ventricular tachycardia, arrhythmic death was lower in the RDN group in the early period.CONCLUSIONS: RDN reduced the incidence of PVC, inhibited prolongation of the QTc interval, and reduced VA in the early period following an AMI. These results suggest that RDN might be a therapeutic option in patients with electrical instability after AMI.
Animals
;
Arrhythmias, Cardiac
;
Autonomic Denervation
;
Coronary Vessels
;
Denervation
;
Electrocardiography
;
Humans
;
Incidence
;
Methods
;
Myocardial Infarction
;
Renal Artery
;
Swine
;
Tachycardia, Ventricular
;
Ventricular Fibrillation
;
Ventricular Premature Complexes
3.Effect of Renal Denervation on Suppression of PVC and QT Prolongation in a Porcine Model of Acute Myocardial Infarction
Sung Soo KIM ; Hyun Kuk KIM ; Hyung Wook PARK ; Myung Ho JEONG ; Kyung Seob LIM ; Hae Jin KEE ; Yu Hee RYU ; Han Byul KIM ; Joo Young NA ; Young Jae KI ; Keun Ho PARK ; Dong Hyun CHOI ; Ki Hong LEE ; Nam Sik YOON ; Jeong Gwan CHO
Korean Circulation Journal 2020;50(1):38-49
BACKGROUND AND OBJECTIVES:
Antiarrhythmic effect of renal denervation (RDN) after acute myocardial infarction (AMI) remains unclear. The goal of this study was to evaluate the effect of RDN on ventricular arrhythmia (VA) after AMI in a porcine model.
METHODS:
Twenty pigs were randomly divided into 2 groups based on RDN (RDN, n=10; Sham, n=10). After implanting a loop recorder, AMI was induced by occlusion of the middle left anterior descending coronary artery. Catheter-based RDN was performed for each renal artery immediately after creating AMI. Sham procedure used the same method, but a radiofrequency current was not delivered. Electrocardiography was monitored for 1 hour to observe VA. One week later, the animals were euthanized and the loop recorder data were analyzed.
RESULTS:
Ventricular fibrillation event rate and the interval from AMI creation to first VA in acute phase were not different between the 2 groups. However, the incidence of premature ventricular complex (PVC) was lower in the RDN than in the Sham. Additionally, RDN inhibited prolongation of the corrected QT (QTc) interval after AMI. The frequency of non-sustained or sustained ventricular tachycardia, arrhythmic death was lower in the RDN group in the early period.
CONCLUSIONS
RDN reduced the incidence of PVC, inhibited prolongation of the QTc interval, and reduced VA in the early period following an AMI. These results suggest that RDN might be a therapeutic option in patients with electrical instability after AMI.
4.Analysis of risk factors affecting a suicidal attempter exposing suicidal intensions for the development of the active intervention strategy for suicide prevention
Ji Min KIM ; Hae Ju LEE ; Ga Won JU ; Sang Chul KIM ; Hyuk Jin JEON ; Gwan Jin PARK ; Yong Nam IN ; Hoon KIM ; Seok Woo LEE
Journal of the Korean Society of Emergency Medicine 2019;30(2):155-165
OBJECTIVE: This study examined the clinical characteristics of suicide attempters who exposed their suicidal intension to suggest an active intervention strategy for suicide prevention based on the regional emergency medical service system. METHODS: A prospective database of suicide attempters who visited the emergency department of Chungbuk National University Hospital between October 2013 and December 2017 was used. All of the adult patients who provided consent for the initial assessment for suicidal attempters were eligible, excluding cases with unknown exposure of suicidal intension. The primary and secondary endpoints were the risk factors affecting exposure to the suicidal intension and characteristics of the exposure group. The adjusted odds ratios (AORs) of exposure to suicidal attempts after adjusting for potential confounders was calculated. RESULTS: Of a total 1,035 suicidal attempters enrolled, 332 (32.1%) were included in the exposure group. The exposure group was more likely to have an educational level above high school and no religion, and have suicidal characteristics at night time (18:00–08:00), under the influence of alcohol, suicidal plan before 1 week, and suicidal method involving asphyxia (P<0.05). The exposure group was more likely to have no guardian (AORs, 1.46; 95% confidence interval [CI], 1.00–2.12), use methods involving asphyxia (AORs, 2.07; 95% CI, 1.46–2.91), and attempt suicide at night (18:00 to 08:00) (AORs, 1.38; 95% CI, 1.05–1.83) compared to the no exposure group. CONCLUSION: Models need to be established, where regional mental health welfare center, local government, fire headquarter, and tele-communication companies can participate in the implementation of an active intervention strategy.
Adult
;
Asphyxia
;
Chungcheongbuk-do
;
Emergency Medical Services
;
Emergency Service, Hospital
;
Fires
;
Humans
;
Local Government
;
Mental Health
;
Methods
;
Odds Ratio
;
Prospective Studies
;
Risk Factors
;
Suicidal Ideation
;
Suicide
;
Suicide, Attempted
5.Optimal Timing of Percutaneous Coronary Intervention for Nonculprit Vessel in Patients with ST-Segment Elevation Myocardial Infarction and Multivessel Disease.
Inna KIM ; Min Chul KIM ; Hae Chang JEONG ; Keun Ho PARK ; Doo Sun SIM ; Young Joon HONG ; Ju Han KIM ; Myung Ho JEONG ; Jeong Gwan CHO ; Jong Chun PARK ; Ki Bae SEUNG ; Kiyuk CHANG ; Youngkeun AHN
Korean Circulation Journal 2017;47(1):36-43
BACKGROUND AND OBJECTIVES: In patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD), the optimal timing of staged percutaneous coronary intervention (PCI) remains unclear. SUBJECTS AND METHODS: This study was a retrospective analysis of 753 STEMI patients with MVD who were treated by multivessel PCI in the Convergent Registry of Catholic and Chonnam University for Acute myocardial infarction (MI). Patients were divided into 3 groups according to the time from initial to staged PCI: group 1 (n=316, multivessel PCI performed during the index procedure), group 2 (n=360, staged PCI within 1 week), and group 3 (n=77, staged PCI after 1 week). The endpoint was major adverse cardiac events (MACEs), including all-cause mortality, non-fatal MI, and repeat PCI during 3.4 years follow-up. RESULTS: The incidence of composite MACEs was higher in group 3 than in group 1 (odds ratio [OR]: 1.83, 95% confidence interval [CI]: 1.06 to 3.18, p=0.031). However, the risk of MACEs in groups 1 and 2 was comparable (OR: 1.01, 95% CI: 0.70 to 1.46, p=0.950). In multivariate logistic regression, independent predictors of 3-year MACEs were high Killip class (OR: 2.72, 95% CI: 1.38 to 5.37, p=0.004), left ventricular ejection fraction <45% (OR: 1.57, 95% CI: 1.06 to 2.32, p=0.024), and group 3 (OR: 1.83, 95% CI: 1.06 to 3.18, p=0.009). CONCLUSION: Deferred staged PCI after one week index PCI was associated with the highest MACE, as compared to both simultaneous multivessel PCI and early staged PCI <1 week.
Follow-Up Studies
;
Humans
;
Incidence
;
Jeollanam-do
;
Logistic Models
;
Mortality
;
Myocardial Infarction*
;
Percutaneous Coronary Intervention*
;
Retrospective Studies
;
Stroke Volume
6.Long-Term Clinical Outcomes of Transient and Persistent No Reflow Phenomena following Percutaneous Coronary Intervention in Patients with Acute Myocardial Infarction.
Min Chul KIM ; Jae Yeong CHO ; Hae Chang JEONG ; Ki Hong LEE ; Keun Ho PARK ; Doo Sun SIM ; Nam Sik YOON ; Hyun Joo YOUN ; Kye Hun KIM ; Young Joon HONG ; Hyung Wook PARK ; Ju Han KIM ; Myung Ho JEONG ; Jeong Gwan CHO ; Jong Chun PARK ; Ki Bae SEUNG ; Kiyuk CHANG ; Youngkeun AHN
Korean Circulation Journal 2016;46(4):490-498
BACKGROUND AND OBJECTIVES: There is limited information on the transient or persistent no reflow phenomenon in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI). SUBJECTS AND METHODS: The study analyzed 4329 patients with AMI from a Korean multicenter registry who underwent PCI using coronary stents (2668 ST-elevation and 1661 non-ST-elevation myocardial infarction [MI] patients): 4071 patients without any no reflow, 213 with transient no reflow (no reflow with final thrombolysis in myocardial infarction [TIMI] flow grade 3), and 45 with persistent no reflow (no reflow with final TIMI flow grade≤2). The primary endpoint was all-cause mortality during 3-year follow-up. We also analyzed the incidence of cardiac mortality, non-fatal MI, re-hospitalization due to heart failure, target vessel revascularization, and stent thrombosis. RESULTS: The persistent no reflow group was associated with higher all-cause mortality (hazard ratio [HR] 1.98, 95% confidence interval [CI] 1.08-3.65, p=0.028) and cardiac mortality (HR 3.28, 95% CI 1.54-6.95, p=0.002) compared with the normal reflow group. Transient no reflow increased all-cause mortality only when compared with normal reflow group (HR 1.58, 95% CI 1.11-2.24, p=0.010). When comparing transient and persistent no reflow, persistent no reflow was associated with increased all-cause mortality (46.7 vs. 24.4%, log rank p=0.033). CONCLUSION: The persistent no reflow phenomenon was associated with a poor in-hospital outcome and increased long-term mortality mainly driven by increased cardiac mortality compared to the transient no reflow phenomenon or normal reflow.
Follow-Up Studies
;
Heart Failure
;
Humans
;
Incidence
;
Mortality
;
Myocardial Infarction*
;
No-Reflow Phenomenon
;
Percutaneous Coronary Intervention*
;
Stents
;
Thrombosis
7.Effect of revascularization strategy in patients with acute myocardial infarction and renal insufficiency with multivessel disease.
Hyukjin PARK ; Young Joon HONG ; Si Hyun RHEW ; Sung Soo KIM ; Young Wook JEONG ; Hae Chang JEONG ; Jae Yeong CHO ; Soo Young JANG ; Ki Hong LEE ; Keun Ho PARK ; Doo Sun SIM ; Nam Sik YOON ; Hyun Ju YOON ; Kye Hun KIM ; Hyung Wook PARK ; Ju Han KIM ; Youngkeun AHN ; Myung Ho JEONG ; Jeong Gwan CHO ; Jong Chun PARK
The Korean Journal of Internal Medicine 2015;30(2):177-190
BACKGROUND/AIMS: The aim of this study was to compare the risk of complications and outcome between infarct-related artery (IRA)-only revascularization and multivessel (MV) revascularization in patients with acute myocardial infarction (MI) with renal insufficiency and MV disease. METHODS: A total of 1,031 acute MI patients with renal insufficiency and MV disease who were registered in the Korea Working Group on Myocardial Infarction were enrolled. They were divided into two groups (IRA-only revascularization group, n = 404; MV revascularization group, n = 627), and investigated the cumulative incidence of major adverse cardiac events (MACE) and the incidence of complications after percutaneous coronary intervention (PCI). RESULTS: Complications after PCI occurred in 19.9% of all patients (206/1,031). Complications after PCI occurred more frequently in the MV revascularization group compared with the IRA-only revascularization group (20.1% [126/627] vs. 15.3% [62/404], respectively; p = 0.029]. The overall in-hospital mortality rate was 6.3%, and there was no significant difference between the groups (5.2% in the IRA-only revascularization group vs. 7.0% in the MV revascularization group; p = 0.241). The total incidence of MACE was 11.1%, and there was no significant difference between the groups (11.6% in the IRA-only revascularization group vs. 10.7% in the MV revascularization group; p = 0.636). CONCLUSIONS: The incidence of complications after PCI was significantly lower in the IRA-only revascularization group compared with the MV revascularization group. However, there were no significant difference in the 12-month outcomes between groups in patients with acute MI and renal insufficiency with MV disease.
Aged
;
Aged, 80 and over
;
Coronary Artery Disease/complications/diagnosis/mortality/*therapy
;
Female
;
Glomerular Filtration Rate
;
Hospital Mortality
;
Humans
;
Kaplan-Meier Estimate
;
Kidney/physiopathology
;
Male
;
Middle Aged
;
Myocardial Infarction/complications/diagnosis/mortality/*therapy
;
Percutaneous Coronary Intervention/adverse effects/*methods/mortality
;
Prospective Studies
;
Recurrence
;
Registries
;
Renal Insufficiency/diagnosis/*etiology/mortality/physiopathology
;
Republic of Korea
;
Risk Factors
;
Time Factors
;
Treatment Outcome
8.Clinical Outcome Comparison of Everolimus- and Biolimus-eluting Stents in Patients with Acute Myocardial Infarction.
In Cheol PARK ; Myung Ho JEONG ; In Soo KIM ; Jung Ae RHEE ; Jin Su CHOI ; In Hyae PARK ; Leem Soon CHAI ; Yun Ah JEONG ; Dae Yong HYUN ; Hae Chang JEONG ; Ki Hong LEE ; Keun Ho PARK ; Doo Sun SIM ; Kye Hun KIM ; Young Joon HONG ; Hyung Uk PARK ; Ju Han KIM ; Young Keun AHN ; Jeong Gwan CHO ; Jong Chun PARK
Korean Journal of Medicine 2015;89(4):418-427
BACKGROUND/AIMS: We compared the efficacy and safety of the second-generation everolimus-eluting stent (EES) and the third generation biolimus-eluting stent (BES) in patients with acute myocardial infarction (AMI). METHODS: We analyzed 629 consecutive patients (mean age 65.1 +/- 11.2 years, 426 males) with AMI undergoing percutaneous coronary intervention from February 2008 to April 2012. They were divided into two groups according to stent type (EES group, n = 426; BES group, n = 203). The primary end-point was 2-year major adverse cardiac events (MACEs), defined as the composite of all-cause death, myocardial infarction, target vessel revascularization, non-target vessel revascularization and target lesion revascularization. The secondary end-point was 2-year target lesion failure (TLF). RESULTS: There were no significant differences in baseline characteristics, except that the patients with EES had a significantly higher prevalence of diabetes mellitus (34.7 vs. 22.7%, p = 0.002) and were older (67.1 +/- 11.3 vs. 64 +/- 12.9 years, p = 0.039) compared with the patients with BES. After propensity score matching, 2-year clinical outcomes showed no differences in composite MACEs or TLF between the two groups. Multivariate Cox regression analysis showed that stent type was not a predictor of 2-year mortality or MACEs. However, older age (hazard ratio [HR] 1.037, 95% confidence interval [CI] 1.014-1.060, p = 0.001), diabetes mellitus (HR 2.247, 95% CI 1.426-3.539, p = 0.001) and a left ventricular ejection fraction < or = 45% (HR 3.007, 95% CI 1.978-4.573, p = 0.001) were independent predictors for 2-year MACEs in patients undergoing EES or BES. CONCLUSIONS: Patients with BES had similar clinical 2-year outcomes compared with EES patients with AMI.
Diabetes Mellitus
;
Humans
;
Mortality
;
Myocardial Infarction*
;
Percutaneous Coronary Intervention
;
Prevalence
;
Prognosis
;
Propensity Score
;
Stents*
;
Stroke Volume
9.Comparison of Clinical Outcomes after Implantation of First- and Second-Generation Overlapping Drug-Eluting Stents to Treat Diffuse Long Coronary Lesions.
Kyung Soo OH ; Myung Ho JEONG ; Jung Ae RHEE ; Jin Su CHOI ; Doo Hwan LEE ; Jeong Hun KIM ; Soo Hwan PARK ; In Soo KIM ; Dae Yong HYUN ; Yun Ah JEONG ; Hae Chang JEONG ; Keun Ho PARK ; Doo Sun SIM ; Hyun Ju YOON ; Kye Hun KIM ; Hyung Uk PARK ; Young Joon HONG ; Youngkeun AHN ; Jeong Gwan CHO ; Jong Chun PARK
Korean Journal of Medicine 2015;89(2):192-200
BACKGROUND/AIMS: Despite improved revascularization techniques, the clinical outcomes of patients with diffuse coronary artery lesions after percutaneous coronary intervention are unsatisfactory. However, few studies have compared the efficacy of first- and second-generation drug-eluting stents (DES) in patients with diffuse long coronary artery lesions. METHODS: Between January 2006 and July 2012, 364 patients who were treated with DES for long coronary artery stenosis (> 30 mm) were enrolled in this study and assigned to either Group I (first-generation DES, 62.3 +/- 10.4 years, 136 males, n = 183) or Group II (second-generation DES, 64.3 +/- 10.7 years, 134 males, n = 181). The incidence of major adverse cardiac events (MACE) was compared between the two groups over 2 years of follow-up, and predictive factors associated with MACE were evaluated through a multivariate analysis. RESULTS: Although several coronary angiographic characteristics were different between the two groups, most demographic and baseline clinical variables were the same. The cumulative incidence of MACE was significantly higher in Group I than in Group II (25.7 vs. 6.6%; p < 0.001), mainly due to reduced target lesion revascularization (21.9 vs. 2.2%; p < 0.001). According to the results of the multivariate analysis, the use of a paclitaxel-eluting stent (PES) (hazard ratio [HR], 5.168; 95% confidence interval [CI], 2.515-10.617; p < 0.001), decreased left ventricular function (< or = 45%; HR, 3.586; 95% CI, 1.839-6.990; p < 0.001), and diabetes mellitus (HR, 2.984; 95% CI, 1.605-5.548; p < 0.001) were independent contributors to MACE. CONCLUSIONS: For patients with diffuse long coronary artery stenosis, the use of second-generation DES improved the clinical outcome compared with first-generation DES. In addition, the use of a PES, left ventricular dysfunction, and diabetes were predictors of MACE after overlapping stenting.
Coronary Stenosis
;
Coronary Vessels
;
Diabetes Mellitus
;
Drug-Eluting Stents*
;
Follow-Up Studies
;
Humans
;
Incidence
;
Male
;
Multivariate Analysis
;
Percutaneous Coronary Intervention
;
Stents
;
Ventricular Dysfunction, Left
;
Ventricular Function, Left
10.Cardiac Involvement of Churg-Strauss Syndrome as a Reversible Cause of Dilated Cardiomyopathy.
Hae Chang JEONG ; Kye Hun KIM ; Jae Yeong CHO ; Ji Eun SONG ; Hyun Ju YOON ; Hyun Ju SEON ; Youngkeun AHN ; Myung Ho JEONG ; Jeong Gwan CHO ; Jong Chun PARK
Journal of Cardiovascular Ultrasound 2015;23(1):40-43
A 31-year-old male who had been treated for Churg-Strauss syndrome (CSS) presented with sudden onset of dysarthria. Brain magnetic resonance imaging (MRI) showed acute multifocal bilateral cerebral infarctions suggesting embolic causes. Cardiac MRI showed dilated cardiomyopathy with severe biventricular dysfunction with intracardiac thrombi, and multiple high signal intensity spots in myocardium of the left ventricle with multifocal delayed enhancement suggesting multifocal myocarditis due to small vessel vasculitis associated with CSS. After anticoagulation therapy, treatments for heart failure, and immunosuppressive therapy including parenteral steroids and cyclophosphamide to control CSS, the symptoms and signs of heart failure and cardiac function of the patient were improved. Considering the pathophysiologic mechanism of cardiac involvement in CSS, immunosuppressive therapy to control the disease activity of CSS should be taken into account, besides usual management for heart failure.
Adult
;
Brain
;
Cardiomyopathy, Dilated*
;
Cerebral Infarction
;
Churg-Strauss Syndrome*
;
Cyclophosphamide
;
Dysarthria
;
Heart Failure
;
Heart Ventricles
;
Humans
;
Magnetic Resonance Imaging
;
Male
;
Myocarditis
;
Myocardium
;
Prognosis
;
Steroids
;
Vasculitis

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