1.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.
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.Characteristics and Prognosis of Breast Cancer Patients With Prior Hormone Replacement Therapy: Insights From the Korean Breast Cancer Society Registry
Chai Won KIM ; Yongsik JUNG ; Joon JEONG ; Hee Jeong KIM ; Jung Eun CHOI ; Young Jin SUH ; Ku Sang KIM ; Woo Chan PARK ; Chang Ik YOON ; Young Joo LEE ; Dooreh KIM ; Soo Youn BAE ;
Journal of Breast Cancer 2024;27(6):383-394
By investigating the characteristics and prognosis of breast cancer (BC) patients who have undergone hormone replacement therapy (HRT), this study addresses a gap in the existing literature. A total of 17,355 postmenopausal patients with BC were analyzed using data from the Korea Breast Cancer Society database (2000–2014). Among them, 3,585 (20.7%) had a history of HRT before BC diagnosis (HRT group), while 13,770 (79.3%) never received HRT (non-HRT group). The HRT group exhibited an earlier pathologic stage, lower histologic and nuclear grades, and a higher rate of breast conservation surgery compared to the non-HRT group. Furthermore, this group had a higher rate of screening participation and a greater proportion of patients with a normal or overweight body mass index (BMI). The prognosis of the HRT group was better than that of the non-HRT group, with a 5-year overall survival rate of 93.9% versus 91.7% (p < 0.001). The hazard ratio for the HRT group was 0.7 (95% confidence interval, 0.608–0.805; p < 0.001). Increased screening participation, longer HRT duration, and a normal or overweight BMI were associated with a better prognosis in the HRT group. Patients with BC who underwent HRT showed better clinicopathological characteristics and prognosis than those who did not receive HRT. The results highlighted significant differences in patients who underwent screening and those with a normal or overweight BMI. Furthermore, a longer HRT duration was associated with a better prognosis.
6.Single-Dose Versus Multiple-Dose Prophylactic Antibiotics in Minimally Invasive Colorectal Surgery:A Propensity Score Matched Analysis
Ga Yoon KU ; Beom-jin KIM ; Ji Won PARK ; Min Jung KIM ; Seung-Bum RYOO ; Seung-Yong JEONG ; Kyu Joo PARK
Journal of Korean Medical Science 2024;39(47):e305-
Background:
Recent guidelines about preventing surgical site infections (SSIs) recommend against the administration of prophylactic antibiotics after surgery. However, many colorectal surgeons still prefer prolonged use of prophylactic antibiotics. While minimally invasive surgery (MIS) has become the standard for colorectal cancer surgery, there were few studies about proper dose of prophylactic antibiotics in minimally invasive colorectal surgery.
Methods:
This is a retrospective study. All patients underwent elective colorectal cancer surgery using MIS. Intravenous cefotetan was administered as a prophylactic antibiotic.Two groups were classified according to the dose of prophylactic antibiotics: a group using a single dose preoperatively (single-dose group) and a group using a preoperative single dose plus additional doses within 24 hours after surgery (multiple-dose group). The SSI rates between the two groups were compared before and after propensity score matching (PSM).Risk factors of SSIs were assessed using univariate and multivariable analysis.
Results:
There were 902 patients in the single-dose group and 330 patients in the multipledose group. After PSM, 320 patients were included in each group. There were no differences in baseline characteristics and surgical outcomes except the length of hospital stay. SSI rates were not different between the two groups before and after PSM (before 2.0% vs. 2.1%, P = 0.890; after 0.9% vs. 1.9%, P = 0.505). In multivariable analysis, American Society of Anesthesiologists class 3, rectal surgery, intraoperative transfusion, and larger tumor size were identified as independent factors associated with SSI incidence.
Conclusion
A single preoperative dose of prophylactic antibiotics may be sufficient to prevent SSIs in elective MIS for colorectal cancer.
7.Single-Dose Versus Multiple-Dose Prophylactic Antibiotics in Minimally Invasive Colorectal Surgery:A Propensity Score Matched Analysis
Ga Yoon KU ; Beom-jin KIM ; Ji Won PARK ; Min Jung KIM ; Seung-Bum RYOO ; Seung-Yong JEONG ; Kyu Joo PARK
Journal of Korean Medical Science 2024;39(47):e305-
Background:
Recent guidelines about preventing surgical site infections (SSIs) recommend against the administration of prophylactic antibiotics after surgery. However, many colorectal surgeons still prefer prolonged use of prophylactic antibiotics. While minimally invasive surgery (MIS) has become the standard for colorectal cancer surgery, there were few studies about proper dose of prophylactic antibiotics in minimally invasive colorectal surgery.
Methods:
This is a retrospective study. All patients underwent elective colorectal cancer surgery using MIS. Intravenous cefotetan was administered as a prophylactic antibiotic.Two groups were classified according to the dose of prophylactic antibiotics: a group using a single dose preoperatively (single-dose group) and a group using a preoperative single dose plus additional doses within 24 hours after surgery (multiple-dose group). The SSI rates between the two groups were compared before and after propensity score matching (PSM).Risk factors of SSIs were assessed using univariate and multivariable analysis.
Results:
There were 902 patients in the single-dose group and 330 patients in the multipledose group. After PSM, 320 patients were included in each group. There were no differences in baseline characteristics and surgical outcomes except the length of hospital stay. SSI rates were not different between the two groups before and after PSM (before 2.0% vs. 2.1%, P = 0.890; after 0.9% vs. 1.9%, P = 0.505). In multivariable analysis, American Society of Anesthesiologists class 3, rectal surgery, intraoperative transfusion, and larger tumor size were identified as independent factors associated with SSI incidence.
Conclusion
A single preoperative dose of prophylactic antibiotics may be sufficient to prevent SSIs in elective MIS for colorectal cancer.
8.Single-Dose Versus Multiple-Dose Prophylactic Antibiotics in Minimally Invasive Colorectal Surgery:A Propensity Score Matched Analysis
Ga Yoon KU ; Beom-jin KIM ; Ji Won PARK ; Min Jung KIM ; Seung-Bum RYOO ; Seung-Yong JEONG ; Kyu Joo PARK
Journal of Korean Medical Science 2024;39(47):e305-
Background:
Recent guidelines about preventing surgical site infections (SSIs) recommend against the administration of prophylactic antibiotics after surgery. However, many colorectal surgeons still prefer prolonged use of prophylactic antibiotics. While minimally invasive surgery (MIS) has become the standard for colorectal cancer surgery, there were few studies about proper dose of prophylactic antibiotics in minimally invasive colorectal surgery.
Methods:
This is a retrospective study. All patients underwent elective colorectal cancer surgery using MIS. Intravenous cefotetan was administered as a prophylactic antibiotic.Two groups were classified according to the dose of prophylactic antibiotics: a group using a single dose preoperatively (single-dose group) and a group using a preoperative single dose plus additional doses within 24 hours after surgery (multiple-dose group). The SSI rates between the two groups were compared before and after propensity score matching (PSM).Risk factors of SSIs were assessed using univariate and multivariable analysis.
Results:
There were 902 patients in the single-dose group and 330 patients in the multipledose group. After PSM, 320 patients were included in each group. There were no differences in baseline characteristics and surgical outcomes except the length of hospital stay. SSI rates were not different between the two groups before and after PSM (before 2.0% vs. 2.1%, P = 0.890; after 0.9% vs. 1.9%, P = 0.505). In multivariable analysis, American Society of Anesthesiologists class 3, rectal surgery, intraoperative transfusion, and larger tumor size were identified as independent factors associated with SSI incidence.
Conclusion
A single preoperative dose of prophylactic antibiotics may be sufficient to prevent SSIs in elective MIS for colorectal cancer.
9.Characteristics and Prognosis of Breast Cancer Patients With Prior Hormone Replacement Therapy: Insights From the Korean Breast Cancer Society Registry
Chai Won KIM ; Yongsik JUNG ; Joon JEONG ; Hee Jeong KIM ; Jung Eun CHOI ; Young Jin SUH ; Ku Sang KIM ; Woo Chan PARK ; Chang Ik YOON ; Young Joo LEE ; Dooreh KIM ; Soo Youn BAE ;
Journal of Breast Cancer 2024;27(6):383-394
By investigating the characteristics and prognosis of breast cancer (BC) patients who have undergone hormone replacement therapy (HRT), this study addresses a gap in the existing literature. A total of 17,355 postmenopausal patients with BC were analyzed using data from the Korea Breast Cancer Society database (2000–2014). Among them, 3,585 (20.7%) had a history of HRT before BC diagnosis (HRT group), while 13,770 (79.3%) never received HRT (non-HRT group). The HRT group exhibited an earlier pathologic stage, lower histologic and nuclear grades, and a higher rate of breast conservation surgery compared to the non-HRT group. Furthermore, this group had a higher rate of screening participation and a greater proportion of patients with a normal or overweight body mass index (BMI). The prognosis of the HRT group was better than that of the non-HRT group, with a 5-year overall survival rate of 93.9% versus 91.7% (p < 0.001). The hazard ratio for the HRT group was 0.7 (95% confidence interval, 0.608–0.805; p < 0.001). Increased screening participation, longer HRT duration, and a normal or overweight BMI were associated with a better prognosis in the HRT group. Patients with BC who underwent HRT showed better clinicopathological characteristics and prognosis than those who did not receive HRT. The results highlighted significant differences in patients who underwent screening and those with a normal or overweight BMI. Furthermore, a longer HRT duration was associated with a better prognosis.
10.Characteristics and Prognosis of Breast Cancer Patients With Prior Hormone Replacement Therapy: Insights From the Korean Breast Cancer Society Registry
Chai Won KIM ; Yongsik JUNG ; Joon JEONG ; Hee Jeong KIM ; Jung Eun CHOI ; Young Jin SUH ; Ku Sang KIM ; Woo Chan PARK ; Chang Ik YOON ; Young Joo LEE ; Dooreh KIM ; Soo Youn BAE ;
Journal of Breast Cancer 2024;27(6):383-394
By investigating the characteristics and prognosis of breast cancer (BC) patients who have undergone hormone replacement therapy (HRT), this study addresses a gap in the existing literature. A total of 17,355 postmenopausal patients with BC were analyzed using data from the Korea Breast Cancer Society database (2000–2014). Among them, 3,585 (20.7%) had a history of HRT before BC diagnosis (HRT group), while 13,770 (79.3%) never received HRT (non-HRT group). The HRT group exhibited an earlier pathologic stage, lower histologic and nuclear grades, and a higher rate of breast conservation surgery compared to the non-HRT group. Furthermore, this group had a higher rate of screening participation and a greater proportion of patients with a normal or overweight body mass index (BMI). The prognosis of the HRT group was better than that of the non-HRT group, with a 5-year overall survival rate of 93.9% versus 91.7% (p < 0.001). The hazard ratio for the HRT group was 0.7 (95% confidence interval, 0.608–0.805; p < 0.001). Increased screening participation, longer HRT duration, and a normal or overweight BMI were associated with a better prognosis in the HRT group. Patients with BC who underwent HRT showed better clinicopathological characteristics and prognosis than those who did not receive HRT. The results highlighted significant differences in patients who underwent screening and those with a normal or overweight BMI. Furthermore, a longer HRT duration was associated with a better prognosis.

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