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 Pretreatment of Ezetimibe/Simvastatin on Arterial Healing and Endothelialization after Drug-Eluting Stent Implantation in a Porcine Coronary Restenosis Model.
Doo Sun SIM ; Myung Ho JEONG ; Dae Sung PARK ; Jung Ha KIM ; Kyung Seob LIM ; Hyun Kuk KIM ; Sung Soo KIM ; Jae Yeong CHO ; Hae Chang JEONG ; Keun Ho PARK ; Young Joon HONG ; Ju Han KIM ; Youngkeun AHN ; Jeong Gwan CHO ; Jong Chun PARK
Korean Circulation Journal 2015;45(2):110-116
BACKGROUND AND OBJECTIVES: We sought to evaluate the effect of the early use of ezetimibe/simvastatin (Vytorin(R)) on arterial healing and endothelialization after the implantation of a drug-eluting stent (DES) in a porcine model of coronary restenosis. MATERIALS AND METHODS: A total of 20 pigs (40 coronary arteries) were randomly allocated to a pretreatment or no treatment group. The pretreatment group (n=20) received oral ezetimibe/simvastatin (10/20 mg) daily for 7 days before stenting and the no pretreatment group (n=20) did not. All pigs were treated with ezetimibe/simvastatin (10/20 mg) daily after stenting for 4 weeks. Stenting was performed using a bare-metal stent (BMS, n=10) and three types of DES: biolimus A9-eluting stent (BES, n=10), zotarolimus-eluting stent (ZES, n=10), and everolimus-eluting stents (EES, n=10). Four weeks later, pigs underwent a follow-up coronary angiography and were sacrificed for histopathologic analysis. RESULTS: There were no significant differences between the pretreatment and no pretreatment groups in the internal elastic lamina area, lumen area, neointima area, stenotic area, injury score, fibrin score, and inflammation score. In both groups, the fibrin score was higher in pigs with DES than in BMS, particularly in ZES and EES. The inflammatory score was not different between DES and BMS. CONCLUSION: In a porcine model of coronary restenosis, pretreatment with ezetimibe/simvastatin before DES implantation failed to improve arterial healing and endothelialization compared to treatment after stenting.
Coronary Angiography
;
Coronary Restenosis*
;
Drug-Eluting Stents*
;
Fibrin
;
Follow-Up Studies
;
Hydroxymethylglutaryl-CoA Reductase Inhibitors
;
Inflammation
;
Neointima
;
Stents
;
Swine
;
Ezetimibe
8.Predictors of Progression and Prognosis of Paroxysmal Atrial Fibrillation.
Ji Eun KIM ; Ki Hong LEE ; Seunghun LEE ; Hyukjin PARK ; Hyun Kuk KIM ; Sung Soo KIM ; Hae Chang JEONG ; Jae Yeong CHO ; Keun Ho PARK ; Doo Sun SIM ; Hyun Joo YOON ; Nam Sik YOON ; Hyung Wook PARK ; Kye Hun KIM ; Young Joon HONG ; Ju Han KIM ; Youngkeun AHN ; Myung Ho JEONG ; Jeong Gwan CHO ; Jong Chun PARK
Korean Journal of Medicine 2015;88(6):672-679
BACKGROUND/AIMS: Significant numbers of patients with paroxysmal atrial fibrillation (AF) proceed to persistent AF and have poor clinical outcomes despite the use of antiarrhythmic agents or direct-current cardioversion. We compared the CHADS2, CHA2DS2-VASc, and HATCH scoring systems to predict AF progression and prognosis and identify the most useful scoring system in Korea. METHODS: A total of 559 consecutive patients with paroxysmal symptomatic AF were analyzed. The progression of AF and clinical outcomes were determined after at least 1 year of follow-up. Clinical outcomes were defined as the composite of death, hospitalization due to heart failure, and new-onset stroke. Each score was calculated, and its predictive accuracy for AF progression and prognosis was compared. RESULTS: A total of 147 patients with paroxysmal AF (26.3%) proceeded to persistent AF. The HATCH score (area under the curve [AUC], 0.601; p < 0.001) was the most powerful scoring system for the prediction of AF progression, although the CHADS2 (AUC, 0.565) and CHA2DS2-VASc (AUC, 0.558) were also useful. The CHA2DS2-VASc (AUC, 0.734; p < 0.001) was the most powerful scoring system for the prediction of clinical outcomes with a more significant linear correlation (0: 3.3% vs. 1: 6.3% vs. 2: 15.4% vs. 3: 20.7% vs. 4: 18.0% vs. 5: 53.6% vs. > or = 6: 55.6%, linear p < 0.001) than the CHADS2 (AUC, 0.720) and HATCH scoring systems (AUC, 0.723). CONCLUSIONS: Although the CHADS2, CHA2DS2-VASc, and HATCH scoring systems were useful predictors of progression from paroxysmal to persistent AF, the CHA2DS2-VASc score was the most useful and accurate for the prediction of clinical outcomes.
Atrial Fibrillation*
;
Electric Countershock
;
Follow-Up Studies
;
Heart Failure
;
Hospitalization
;
Humans
;
Korea
;
Prognosis*
;
Stroke
9.Cardioprotective Effect of Fimasartan, a New Angiotensin Receptor Blocker, in a Porcine Model of Acute Myocardial Infarction.
Doo Sun SIM ; Myung Ho JEONG ; Ho Chun SONG ; Jahae KIM ; Ari CHONG ; Hee Seung BOM ; In Seok JEONG ; Sang Gi OH ; Jong Min KIM ; Dae Sung PARK ; Jung Ha KIM ; Kyung Seob LIM ; Min Suk KIM ; Shi Hyun RYU ; Hyun Kuk KIM ; Sung Soo KIM ; Su Young JANG ; Jae Yeong CHO ; Hae Chang JEONG ; Ki Hong LEE ; Keun Ho PARK ; Nam Sik YOON ; Hyun Ju YOON ; Kye Hun KIM ; Young Joon HONG ; Hyung Wook PARK ; Ju Han KIM ; Youngkeun AHN ; Jeong Gwan CHO ; Jong Chun PARK ; Jung Chaee KANG
Journal of Korean Medical Science 2015;30(1):34-43
Cardioprotective effect of fimasartan, a new angiotensin receptor blocker (ARB), was evaluated in a porcine model of acute myocardial infarction (MI). Fifty swine were randomized to group 1 (sham, n=10), group 2 (no angiotensin-converting enzyme inhibitor [ACEI] or ARB, n=10), group 3 (perindopril 2 mg daily, n=10), group 4 (valsartan 40 mg daily, n=10), or group 5 (fimasartan 30 mg daily, n=10). Acute MI was induced by occlusion of the left anterior descending artery for 50 min. Echocardiography, single photon emission computed tomography (SPECT), and F-18 fluorodeoxyglucose cardiac positron emission tomography (PET) were performed at baseline, 1 week, and 4 weeks. Iodine-123 meta-iodobenzylguanidine (MIBG) scan was done at 6 weeks for visualization of cardiac sympathetic activity. Left ventricular function and volumes at 4 weeks were similar between the 5 groups. No difference was observed in groups 2 to 5 in SPECT perfusion defect, matched and mismatched segments between SPECT and PET at 1 week and 4 weeks. MIBG scan showed similar uptake between the 5 groups. Pathologic analysis showed similar infarct size in groups 2 to 5. Infarct size reduction was not observed with use of fimasartan as well as other ACEI and ARB in a porcine model of acute MI.
3-Iodobenzylguanidine
;
Angiotensin II Type 1 Receptor Blockers/therapeutic use
;
Angiotensin Receptor Antagonists/*therapeutic use
;
Angiotensin-Converting Enzyme Inhibitors/therapeutic use
;
Animals
;
Anterior Wall Myocardial Infarction/*drug therapy/physiopathology
;
Biphenyl Compounds/*therapeutic use
;
Cardiotonic Agents/*therapeutic use
;
Disease Models, Animal
;
Echocardiography
;
Fluorodeoxyglucose F18
;
Perindopril/therapeutic use
;
Positron-Emission Tomography
;
Pyrimidines/*therapeutic use
;
Random Allocation
;
Swine
;
Tetrazoles/*therapeutic use
;
Tomography, Emission-Computed, Single-Photon
;
Valsartan/therapeutic use
;
Ventricular Function, Left/*physiology
10.A New Risk Score to Predict 1-Year Mortality in Acute Non-ST Elevation Myocardial Infarction.
Jin Hee PARK ; In Hyae PARK ; Myung Ho JEONG ; Sook Ja LEE ; Soo Yong JANG ; Jae Young CHO ; Hae Chang JEONG ; Ki Hong LEE ; Keun Ho PARK ; Doo Sun SIM ; Kye Hun KIM ; Young Joon HONG ; Hyung Wook PARK ; Ju Han KIM ; Young Keun AHN ; Jeong Gwan CHO ; Jong Chun PARK
Korean Journal of Medicine 2015;88(2):168-176
BACKGROUND/AIMS: Accurate risk stratification is important in the management of patients with acute myocardial infarction (AMI). This study aimed to develop a new assessment tool for the prediction of 1-year mortality in patients with AMI, including biochemical markers. The author developed a new assessment tool (new risk score) that takes biochemical markers into account for 1-year mortality in patients with non-ST elevation myocardial infarction (NSTEMI) and identifies the risk factors related to 1-year mortality. METHODS: A total of 1,427 patients (65 +/- 11.8 years of age, 985 males) who were admitted to the Chonnam National University Hospital with NSTEMI from November 2005 to March 2012 were retrospectively analyzed for score derivation. Multivariable Cox-regression analysis was used to select correlates of 1-year mortality that were subsequently weighted and integrated into an integer scoring system. RESULTS: Seven variables selected from the initial multivariate model were weighted proportionally to their respective hazard ratio for 1-year mortality; age > or = 65 years (2 points), N-terminal pro-brain natriuretic peptide (NT pro-BNP) > 991 pg/mL (1 point), baseline left ventricular ejection fraction < 40% (1 point), high sensitivity C-reactive protein (hs-CRP) > 3 mg/dL (1 point), glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 (1 point), heart rate > 82 beats/min (2 points), and final thrombolysis In myocardial infarction flow < 3 (2 points). CONCLUSIONS: In NSTEMI patients, our new score that incorporates seven risk factors accurately predicts the 1-year mortality. Additionally, the biochemical markers hs-CRP, NT pro-BNP, and GFR are reliable predictors of 1-year mortality.
Biomarkers
;
C-Reactive Protein
;
Glomerular Filtration Rate
;
Heart Rate
;
Humans
;
Jeollanam-do
;
Mortality*
;
Myocardial Infarction*
;
Prognosis
;
Retrospective Studies
;
Risk Factors
;
Stroke Volume

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