1.Low-Density Lipoprotein Cholesterol Level, the Lower the Better? Analysis of Korean Patients in the Treat Stroke to Target Trial
Hanim KWON ; Jae-Chan RYU ; Jae-Kwan CHA ; Sang Min SUNG ; Tae-Jin SONG ; Kyung Bok LEE ; Eung-Gyu KIM ; Yong-Won KIM ; Ji Hoe HEO ; Man Seok PARK ; Kyusik KANG ; Byung-Chul LEE ; Keun-Sik HONG ; Oh Young BANG ; Jei KIM ; Jong S. KIM
Journal of Stroke 2025;27(2):228-236
Background:
and Purpose The Treat Stroke to Target (TST) was a randomized clinical trial involving French and Korean patients demonstrating that a lower low-density lipoprotein cholesterol (LDL-C, <70 mg/dL) target group (LT) experienced fewer cerebro-cardiovascular events than a higher target (90–110 mg/dL) group (HT). However, whether these results can be applied to Asian patients with different ischemic stroke subtypes remains unclear.
Methods:
Patients from 14 South Korean centers were analyzed separately. Patients with ischemic stroke or transient ischemic attack with evidence of atherosclerosis were randomized into LT and HT groups. The primary endpoint was a composite of ischemic stroke, myocardial infarction, coronary or cerebral revascularization, and cardiovascular death.
Results:
Among 712 enrolled patients, the mean LDL-C level was 71.0 mg/dL in 357 LT patients and 86.1 mg/dL in 355 HT patients. The primary endpoint occurred in 24 (6.7%) of LT and in 31 (8.7%) of HT group patients (adjusted hazard ratio [HR]=0.78; 95% confidence interval [CI]=0.45–1.33, P=0.353). Cardiovascular events alone occurred significantly less frequently in the LT than in the HT group (HR 0.26, 95% CI 0.09–0.80, P=0.019), whereas there were no significant differences in ischemic stroke events (HR 1.12, 95% CI 0.60–2.10, P=0.712). The benefit of LT was less apparent in patients with small vessel disease and intracranial atherosclerosis than in those with extracranial atherosclerosis.
Conclusion
In contrast to the French TST, the outcomes in Korean patients were neutral. Although LT was more effective in preventing cardiovascular diseases, it was not so in stroke prevention, probably attributed to the differences in stroke subtypes. Further studies are needed to elucidate the efficacy of statins and appropriate LDL-C targets in Asian patients with stroke.
2.Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
Nam Hoon KIM ; Soo LIM ; In-Kyung JEONG ; Eun-Jung RHEE ; Jun Sung MOON ; Ohk-Hyun RYU ; Hyuk-Sang KWON ; Jong Chul WON ; Sang Soo KIM ; Sang Yong KIM ; Bon Jeong KU ; Heung Yong JIN ; Sin Gon KIM ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2025;49(2):225-234
Background:
The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated.
Methods:
This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243).
Conclusion
This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.
3.Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
Nam Hoon KIM ; Soo LIM ; In-Kyung JEONG ; Eun-Jung RHEE ; Jun Sung MOON ; Ohk-Hyun RYU ; Hyuk-Sang KWON ; Jong Chul WON ; Sang Soo KIM ; Sang Yong KIM ; Bon Jeong KU ; Heung Yong JIN ; Sin Gon KIM ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2025;49(2):225-234
Background:
The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated.
Methods:
This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243).
Conclusion
This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.
4.Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
Nam Hoon KIM ; Soo LIM ; In-Kyung JEONG ; Eun-Jung RHEE ; Jun Sung MOON ; Ohk-Hyun RYU ; Hyuk-Sang KWON ; Jong Chul WON ; Sang Soo KIM ; Sang Yong KIM ; Bon Jeong KU ; Heung Yong JIN ; Sin Gon KIM ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2025;49(2):225-234
Background:
The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated.
Methods:
This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243).
Conclusion
This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.
5.Low-Density Lipoprotein Cholesterol Level, the Lower the Better? Analysis of Korean Patients in the Treat Stroke to Target Trial
Hanim KWON ; Jae-Chan RYU ; Jae-Kwan CHA ; Sang Min SUNG ; Tae-Jin SONG ; Kyung Bok LEE ; Eung-Gyu KIM ; Yong-Won KIM ; Ji Hoe HEO ; Man Seok PARK ; Kyusik KANG ; Byung-Chul LEE ; Keun-Sik HONG ; Oh Young BANG ; Jei KIM ; Jong S. KIM
Journal of Stroke 2025;27(2):228-236
Background:
and Purpose The Treat Stroke to Target (TST) was a randomized clinical trial involving French and Korean patients demonstrating that a lower low-density lipoprotein cholesterol (LDL-C, <70 mg/dL) target group (LT) experienced fewer cerebro-cardiovascular events than a higher target (90–110 mg/dL) group (HT). However, whether these results can be applied to Asian patients with different ischemic stroke subtypes remains unclear.
Methods:
Patients from 14 South Korean centers were analyzed separately. Patients with ischemic stroke or transient ischemic attack with evidence of atherosclerosis were randomized into LT and HT groups. The primary endpoint was a composite of ischemic stroke, myocardial infarction, coronary or cerebral revascularization, and cardiovascular death.
Results:
Among 712 enrolled patients, the mean LDL-C level was 71.0 mg/dL in 357 LT patients and 86.1 mg/dL in 355 HT patients. The primary endpoint occurred in 24 (6.7%) of LT and in 31 (8.7%) of HT group patients (adjusted hazard ratio [HR]=0.78; 95% confidence interval [CI]=0.45–1.33, P=0.353). Cardiovascular events alone occurred significantly less frequently in the LT than in the HT group (HR 0.26, 95% CI 0.09–0.80, P=0.019), whereas there were no significant differences in ischemic stroke events (HR 1.12, 95% CI 0.60–2.10, P=0.712). The benefit of LT was less apparent in patients with small vessel disease and intracranial atherosclerosis than in those with extracranial atherosclerosis.
Conclusion
In contrast to the French TST, the outcomes in Korean patients were neutral. Although LT was more effective in preventing cardiovascular diseases, it was not so in stroke prevention, probably attributed to the differences in stroke subtypes. Further studies are needed to elucidate the efficacy of statins and appropriate LDL-C targets in Asian patients with stroke.
6.Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
Nam Hoon KIM ; Soo LIM ; In-Kyung JEONG ; Eun-Jung RHEE ; Jun Sung MOON ; Ohk-Hyun RYU ; Hyuk-Sang KWON ; Jong Chul WON ; Sang Soo KIM ; Sang Yong KIM ; Bon Jeong KU ; Heung Yong JIN ; Sin Gon KIM ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2025;49(2):225-234
Background:
The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated.
Methods:
This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243).
Conclusion
This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.
7.Low-Density Lipoprotein Cholesterol Level, the Lower the Better? Analysis of Korean Patients in the Treat Stroke to Target Trial
Hanim KWON ; Jae-Chan RYU ; Jae-Kwan CHA ; Sang Min SUNG ; Tae-Jin SONG ; Kyung Bok LEE ; Eung-Gyu KIM ; Yong-Won KIM ; Ji Hoe HEO ; Man Seok PARK ; Kyusik KANG ; Byung-Chul LEE ; Keun-Sik HONG ; Oh Young BANG ; Jei KIM ; Jong S. KIM
Journal of Stroke 2025;27(2):228-236
Background:
and Purpose The Treat Stroke to Target (TST) was a randomized clinical trial involving French and Korean patients demonstrating that a lower low-density lipoprotein cholesterol (LDL-C, <70 mg/dL) target group (LT) experienced fewer cerebro-cardiovascular events than a higher target (90–110 mg/dL) group (HT). However, whether these results can be applied to Asian patients with different ischemic stroke subtypes remains unclear.
Methods:
Patients from 14 South Korean centers were analyzed separately. Patients with ischemic stroke or transient ischemic attack with evidence of atherosclerosis were randomized into LT and HT groups. The primary endpoint was a composite of ischemic stroke, myocardial infarction, coronary or cerebral revascularization, and cardiovascular death.
Results:
Among 712 enrolled patients, the mean LDL-C level was 71.0 mg/dL in 357 LT patients and 86.1 mg/dL in 355 HT patients. The primary endpoint occurred in 24 (6.7%) of LT and in 31 (8.7%) of HT group patients (adjusted hazard ratio [HR]=0.78; 95% confidence interval [CI]=0.45–1.33, P=0.353). Cardiovascular events alone occurred significantly less frequently in the LT than in the HT group (HR 0.26, 95% CI 0.09–0.80, P=0.019), whereas there were no significant differences in ischemic stroke events (HR 1.12, 95% CI 0.60–2.10, P=0.712). The benefit of LT was less apparent in patients with small vessel disease and intracranial atherosclerosis than in those with extracranial atherosclerosis.
Conclusion
In contrast to the French TST, the outcomes in Korean patients were neutral. Although LT was more effective in preventing cardiovascular diseases, it was not so in stroke prevention, probably attributed to the differences in stroke subtypes. Further studies are needed to elucidate the efficacy of statins and appropriate LDL-C targets in Asian patients with stroke.
8.Helicobacter pylori Isolation and Antibiotic Susceptibility Testing Using Rapidly Frozen Biopsy Samples
Kee Don CHOI ; Jung Mogg KIM ; Gwang Ho BAIK ; Jun Chul PARK ; Hye-Kyung JUNG ; Han Seung RYU ; Soo-Jeong CHO ; Cheol Min SHIN ; Hwoon-Yong JUNG ;
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2024;24(4):360-364
Objectives:
To involve institutions without the ability to perform susceptibility testing, long-term storage of tissue sample is critical to isolate the bacteria in a central laboratory. The aim of the study was to investigate the feasibility of H. pylori isolation and antibiotic susceptibility testing using rapidly frozen biopsy specimens collected from various institutions.
Methods:
Eight institutions located in various regions of Korea participated in the study. Patients requiring upper endoscopy and H. pylori testing were screened. Two biopsy samples were taken from the stomach. One was placed in a sterile Eppendorf tube and then immediately placed in a vacuum bottle containing dry ice, which was stored at -80°C. The other was used in a rapid urease test. Collected samples were delivered to a central laboratory. The bacteria were isolated from the frozen samples under microaerophilic conditions. The agar dilution method was used to determine the minimum inhibitory concentration (MIC) of amoxicillin, clarithromycin, metronidazole, tetracycline, ciprofloxacin, and levofloxacin for each H. pylori isolate.
Results:
Patients with a positive rapid urease test result (n=113) were enrolled. The mean age was 56.6±12.3 years. The male:female ratio was 64:49. The overall culture success rate was 77.0% (87/113). MIC values were determined using isolated 87 H. pylori strains. Rates of resistance to amoxicillin, clarithromycin, metronidazole, tetracycline, levofloxacin, and ciprofloxacin were 23.0%, 25.3%, 28.7%, 1.1%, 33.3%, and 34.5%, respectively.
Conclusions
It is feasible to perform H. pylori isolation and antimicrobial susceptibility testing using rapidly frozen and transported biopsy specimens.
9.Helicobacter pylori Isolation and Antibiotic Susceptibility Testing Using Rapidly Frozen Biopsy Samples
Kee Don CHOI ; Jung Mogg KIM ; Gwang Ho BAIK ; Jun Chul PARK ; Hye-Kyung JUNG ; Han Seung RYU ; Soo-Jeong CHO ; Cheol Min SHIN ; Hwoon-Yong JUNG ;
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2024;24(4):360-364
Objectives:
To involve institutions without the ability to perform susceptibility testing, long-term storage of tissue sample is critical to isolate the bacteria in a central laboratory. The aim of the study was to investigate the feasibility of H. pylori isolation and antibiotic susceptibility testing using rapidly frozen biopsy specimens collected from various institutions.
Methods:
Eight institutions located in various regions of Korea participated in the study. Patients requiring upper endoscopy and H. pylori testing were screened. Two biopsy samples were taken from the stomach. One was placed in a sterile Eppendorf tube and then immediately placed in a vacuum bottle containing dry ice, which was stored at -80°C. The other was used in a rapid urease test. Collected samples were delivered to a central laboratory. The bacteria were isolated from the frozen samples under microaerophilic conditions. The agar dilution method was used to determine the minimum inhibitory concentration (MIC) of amoxicillin, clarithromycin, metronidazole, tetracycline, ciprofloxacin, and levofloxacin for each H. pylori isolate.
Results:
Patients with a positive rapid urease test result (n=113) were enrolled. The mean age was 56.6±12.3 years. The male:female ratio was 64:49. The overall culture success rate was 77.0% (87/113). MIC values were determined using isolated 87 H. pylori strains. Rates of resistance to amoxicillin, clarithromycin, metronidazole, tetracycline, levofloxacin, and ciprofloxacin were 23.0%, 25.3%, 28.7%, 1.1%, 33.3%, and 34.5%, respectively.
Conclusions
It is feasible to perform H. pylori isolation and antimicrobial susceptibility testing using rapidly frozen and transported biopsy specimens.
10.Helicobacter pylori Isolation and Antibiotic Susceptibility Testing Using Rapidly Frozen Biopsy Samples
Kee Don CHOI ; Jung Mogg KIM ; Gwang Ho BAIK ; Jun Chul PARK ; Hye-Kyung JUNG ; Han Seung RYU ; Soo-Jeong CHO ; Cheol Min SHIN ; Hwoon-Yong JUNG ;
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2024;24(4):360-364
Objectives:
To involve institutions without the ability to perform susceptibility testing, long-term storage of tissue sample is critical to isolate the bacteria in a central laboratory. The aim of the study was to investigate the feasibility of H. pylori isolation and antibiotic susceptibility testing using rapidly frozen biopsy specimens collected from various institutions.
Methods:
Eight institutions located in various regions of Korea participated in the study. Patients requiring upper endoscopy and H. pylori testing were screened. Two biopsy samples were taken from the stomach. One was placed in a sterile Eppendorf tube and then immediately placed in a vacuum bottle containing dry ice, which was stored at -80°C. The other was used in a rapid urease test. Collected samples were delivered to a central laboratory. The bacteria were isolated from the frozen samples under microaerophilic conditions. The agar dilution method was used to determine the minimum inhibitory concentration (MIC) of amoxicillin, clarithromycin, metronidazole, tetracycline, ciprofloxacin, and levofloxacin for each H. pylori isolate.
Results:
Patients with a positive rapid urease test result (n=113) were enrolled. The mean age was 56.6±12.3 years. The male:female ratio was 64:49. The overall culture success rate was 77.0% (87/113). MIC values were determined using isolated 87 H. pylori strains. Rates of resistance to amoxicillin, clarithromycin, metronidazole, tetracycline, levofloxacin, and ciprofloxacin were 23.0%, 25.3%, 28.7%, 1.1%, 33.3%, and 34.5%, respectively.
Conclusions
It is feasible to perform H. pylori isolation and antimicrobial susceptibility testing using rapidly frozen and transported biopsy specimens.

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