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.Clinical Efficacy of Rebamipide Eyedrops in Patients with Sjögren’s Syndrome Accompanied by Meibomian Gland Dysfunction
Hyo Ju JANG ; Ja Young MOON ; Hyeon Jeong YOON ; Kyung Chul YOON
Journal of the Korean Ophthalmological Society 2025;66(1):8-16
Purpose:
To investigate the clinical efficacy of rebamipide eyedrops in patients with meibomian gland dysfunction (MGD) associated with Sjögren’s syndrome.
Methods:
The study included 50 patients with Sjögren’s syndrome accompanied by MGD treated with 0.05% (w/v) cyclosporine and 0.15% (w/v) sodium hyaluronate eyedrops. They were divided into two groups: 25 who added rebamipide eyedrops to their existing treatments and a control group of 25 whose treatments did not change. We evaluated the tear breakup time, the Schirmer test and conjunctival staining scores, meibomian gland quality and function, and eyelid margin irregularity before prescribing rebamipide eyedrops and 1 and 3 months after prescription. Additionally, before eyedrops use and 3 months later, meibographic scores were assessed via imaging of the meibomian gland and ocular surface disease index values also were assessed.
Results:
The rebamipide group exhibited significant improvements in the tear breakup time, conjunctival staining score, and ocular surface disease index compared to before treatment (all p < 0.05). However, the Schirmer test result, meibomian gland quality and function, and eyelid margin irregularity did not differ between either groups before or after treatment. After 3 months of eyedrop use, the rebamipide group exhibited a significantly higher tear breakup time (p < 0.01) and Schirmer test score (p < 0.01) than the control group (p = 0.01), and significantly lower ocular surface disease index and conjunctival staining scores (p < 0.01).
Conclusions
Addition of rebamipide eyedrops to the conventional treatment of patients with Sjögren’s syndrome accompanied by MGD effectively improves dry eye symptoms and the ocular surface parameters.
3.Eligibility for Lecanemab Treatment in the Republic of Korea:Real-World Data From Memory Clinics
Sung Hoon KANG ; Jee Hyang JEONG ; Jung-Min PYUN ; Geon Ha KIM ; Young Ho PARK ; YongSoo SHIM ; Seong-Ho KOH ; Chi-Hun KIM ; Young Chul YOUN ; Dong Won YANG ; Hyuk-je LEE ; Han LEE ; Dain KIM ; Kyunghwa SUN ; So Young MOON ; Kee Hyung PARK ; Seong Hye CHOI
Journal of Clinical Neurology 2025;21(3):182-189
Background:
and Purpose We aimed to determine the proportion of Korean patients with early Alzheimer’s disease (AD) who are eligible to receive lecanemab based on the United States Appropriate Use Recommendations (US AUR), and also identify the barriers to this treatment.
Methods:
We retrospectively enrolled 6,132 patients with amnestic mild cognitive impairment or mild amnestic dementia at 13 hospitals from June 2023 to May 2024. Among them, 2,058 patients underwent amyloid positron emission tomography (PET) and 1,199 (58.3%) of these patients were amyloid-positive on PET. We excluded 732 patients who did not undergo brain magnetic resonance imaging between June 2023 and May 2024. Finally, 467 patients were included in the present study.
Results:
When applying the criteria of the US AUR, approximately 50% of patients with early AD were eligible to receive lecanemab treatment. Among the 467 included patients, 36.8% did not meet the inclusion criterion of a Mini-Mental State Examination (MMSE) score of ≥22.
Conclusions
Eligibility for lecanemab treatment was not restricted to Korean patients with early AD except for those with an MMSE score of ≥22. The MMSE criteria should therefore be reconsidered in areas with a higher proportion of older people, who tend to have lower levels of education.
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.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.
6.Eligibility for Lecanemab Treatment in the Republic of Korea:Real-World Data From Memory Clinics
Sung Hoon KANG ; Jee Hyang JEONG ; Jung-Min PYUN ; Geon Ha KIM ; Young Ho PARK ; YongSoo SHIM ; Seong-Ho KOH ; Chi-Hun KIM ; Young Chul YOUN ; Dong Won YANG ; Hyuk-je LEE ; Han LEE ; Dain KIM ; Kyunghwa SUN ; So Young MOON ; Kee Hyung PARK ; Seong Hye CHOI
Journal of Clinical Neurology 2025;21(3):182-189
Background:
and Purpose We aimed to determine the proportion of Korean patients with early Alzheimer’s disease (AD) who are eligible to receive lecanemab based on the United States Appropriate Use Recommendations (US AUR), and also identify the barriers to this treatment.
Methods:
We retrospectively enrolled 6,132 patients with amnestic mild cognitive impairment or mild amnestic dementia at 13 hospitals from June 2023 to May 2024. Among them, 2,058 patients underwent amyloid positron emission tomography (PET) and 1,199 (58.3%) of these patients were amyloid-positive on PET. We excluded 732 patients who did not undergo brain magnetic resonance imaging between June 2023 and May 2024. Finally, 467 patients were included in the present study.
Results:
When applying the criteria of the US AUR, approximately 50% of patients with early AD were eligible to receive lecanemab treatment. Among the 467 included patients, 36.8% did not meet the inclusion criterion of a Mini-Mental State Examination (MMSE) score of ≥22.
Conclusions
Eligibility for lecanemab treatment was not restricted to Korean patients with early AD except for those with an MMSE score of ≥22. The MMSE criteria should therefore be reconsidered in areas with a higher proportion of older people, who tend to have lower levels of education.
7.Clinical Efficacy of Rebamipide Eyedrops in Patients with Sjögren’s Syndrome Accompanied by Meibomian Gland Dysfunction
Hyo Ju JANG ; Ja Young MOON ; Hyeon Jeong YOON ; Kyung Chul YOON
Journal of the Korean Ophthalmological Society 2025;66(1):8-16
Purpose:
To investigate the clinical efficacy of rebamipide eyedrops in patients with meibomian gland dysfunction (MGD) associated with Sjögren’s syndrome.
Methods:
The study included 50 patients with Sjögren’s syndrome accompanied by MGD treated with 0.05% (w/v) cyclosporine and 0.15% (w/v) sodium hyaluronate eyedrops. They were divided into two groups: 25 who added rebamipide eyedrops to their existing treatments and a control group of 25 whose treatments did not change. We evaluated the tear breakup time, the Schirmer test and conjunctival staining scores, meibomian gland quality and function, and eyelid margin irregularity before prescribing rebamipide eyedrops and 1 and 3 months after prescription. Additionally, before eyedrops use and 3 months later, meibographic scores were assessed via imaging of the meibomian gland and ocular surface disease index values also were assessed.
Results:
The rebamipide group exhibited significant improvements in the tear breakup time, conjunctival staining score, and ocular surface disease index compared to before treatment (all p < 0.05). However, the Schirmer test result, meibomian gland quality and function, and eyelid margin irregularity did not differ between either groups before or after treatment. After 3 months of eyedrop use, the rebamipide group exhibited a significantly higher tear breakup time (p < 0.01) and Schirmer test score (p < 0.01) than the control group (p = 0.01), and significantly lower ocular surface disease index and conjunctival staining scores (p < 0.01).
Conclusions
Addition of rebamipide eyedrops to the conventional treatment of patients with Sjögren’s syndrome accompanied by MGD effectively improves dry eye symptoms and the ocular surface parameters.
8.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.
9.Eligibility for Lecanemab Treatment in the Republic of Korea:Real-World Data From Memory Clinics
Sung Hoon KANG ; Jee Hyang JEONG ; Jung-Min PYUN ; Geon Ha KIM ; Young Ho PARK ; YongSoo SHIM ; Seong-Ho KOH ; Chi-Hun KIM ; Young Chul YOUN ; Dong Won YANG ; Hyuk-je LEE ; Han LEE ; Dain KIM ; Kyunghwa SUN ; So Young MOON ; Kee Hyung PARK ; Seong Hye CHOI
Journal of Clinical Neurology 2025;21(3):182-189
Background:
and Purpose We aimed to determine the proportion of Korean patients with early Alzheimer’s disease (AD) who are eligible to receive lecanemab based on the United States Appropriate Use Recommendations (US AUR), and also identify the barriers to this treatment.
Methods:
We retrospectively enrolled 6,132 patients with amnestic mild cognitive impairment or mild amnestic dementia at 13 hospitals from June 2023 to May 2024. Among them, 2,058 patients underwent amyloid positron emission tomography (PET) and 1,199 (58.3%) of these patients were amyloid-positive on PET. We excluded 732 patients who did not undergo brain magnetic resonance imaging between June 2023 and May 2024. Finally, 467 patients were included in the present study.
Results:
When applying the criteria of the US AUR, approximately 50% of patients with early AD were eligible to receive lecanemab treatment. Among the 467 included patients, 36.8% did not meet the inclusion criterion of a Mini-Mental State Examination (MMSE) score of ≥22.
Conclusions
Eligibility for lecanemab treatment was not restricted to Korean patients with early AD except for those with an MMSE score of ≥22. The MMSE criteria should therefore be reconsidered in areas with a higher proportion of older people, who tend to have lower levels of education.
10.Clinical Efficacy of Rebamipide Eyedrops in Patients with Sjögren’s Syndrome Accompanied by Meibomian Gland Dysfunction
Hyo Ju JANG ; Ja Young MOON ; Hyeon Jeong YOON ; Kyung Chul YOON
Journal of the Korean Ophthalmological Society 2025;66(1):8-16
Purpose:
To investigate the clinical efficacy of rebamipide eyedrops in patients with meibomian gland dysfunction (MGD) associated with Sjögren’s syndrome.
Methods:
The study included 50 patients with Sjögren’s syndrome accompanied by MGD treated with 0.05% (w/v) cyclosporine and 0.15% (w/v) sodium hyaluronate eyedrops. They were divided into two groups: 25 who added rebamipide eyedrops to their existing treatments and a control group of 25 whose treatments did not change. We evaluated the tear breakup time, the Schirmer test and conjunctival staining scores, meibomian gland quality and function, and eyelid margin irregularity before prescribing rebamipide eyedrops and 1 and 3 months after prescription. Additionally, before eyedrops use and 3 months later, meibographic scores were assessed via imaging of the meibomian gland and ocular surface disease index values also were assessed.
Results:
The rebamipide group exhibited significant improvements in the tear breakup time, conjunctival staining score, and ocular surface disease index compared to before treatment (all p < 0.05). However, the Schirmer test result, meibomian gland quality and function, and eyelid margin irregularity did not differ between either groups before or after treatment. After 3 months of eyedrop use, the rebamipide group exhibited a significantly higher tear breakup time (p < 0.01) and Schirmer test score (p < 0.01) than the control group (p = 0.01), and significantly lower ocular surface disease index and conjunctival staining scores (p < 0.01).
Conclusions
Addition of rebamipide eyedrops to the conventional treatment of patients with Sjögren’s syndrome accompanied by MGD effectively improves dry eye symptoms and the ocular surface parameters.

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