1.Efficacy and Safety of Metformin and Atorvastatin Combination Therapy vs. Monotherapy with Either Drug in Type 2 Diabetes Mellitus and Dyslipidemia Patients (ATOMIC): Double-Blinded Randomized Controlled Trial
Jie-Eun LEE ; Seung Hee YU ; Sung Rae KIM ; Kyu Jeung AHN ; Kee-Ho SONG ; In-Kyu LEE ; Ho-Sang SHON ; In Joo KIM ; Soo LIM ; Doo-Man KIM ; Choon Hee CHUNG ; Won-Young LEE ; Soon Hee LEE ; Dong Joon KIM ; Sung-Rae CHO ; Chang Hee JUNG ; Hyun Jeong JEON ; Seung-Hwan LEE ; Keun-Young PARK ; Sang Youl RHEE ; Sin Gon KIM ; Seok O PARK ; Dae Jung KIM ; Byung Joon KIM ; Sang Ah LEE ; Yong-Hyun KIM ; Kyung-Soo KIM ; Ji A SEO ; Il Seong NAM-GOONG ; Chang Won LEE ; Duk Kyu KIM ; Sang Wook KIM ; Chung Gu CHO ; Jung Han KIM ; Yeo-Joo KIM ; Jae-Myung YOO ; Kyung Wan MIN ; Moon-Kyu LEE
Diabetes & Metabolism Journal 2024;48(4):730-739
Background:
It is well known that a large number of patients with diabetes also have dyslipidemia, which significantly increases the risk of cardiovascular disease (CVD). This study aimed to evaluate the efficacy and safety of combination drugs consisting of metformin and atorvastatin, widely used as therapeutic agents for diabetes and dyslipidemia.
Methods:
This randomized, double-blind, placebo-controlled, parallel-group and phase III multicenter study included adults with glycosylated hemoglobin (HbA1c) levels >7.0% and <10.0%, low-density lipoprotein cholesterol (LDL-C) >100 and <250 mg/dL. One hundred eighty-five eligible subjects were randomized to the combination group (metformin+atorvastatin), metformin group (metformin+atorvastatin placebo), and atorvastatin group (atorvastatin+metformin placebo). The primary efficacy endpoints were the percent changes in HbA1c and LDL-C levels from baseline at the end of the treatment.
Results:
After 16 weeks of treatment compared to baseline, HbA1c showed a significant difference of 0.94% compared to the atorvastatin group in the combination group (0.35% vs. −0.58%, respectively; P<0.0001), whereas the proportion of patients with increased HbA1c was also 62% and 15%, respectively, showing a significant difference (P<0.001). The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (−55.20% vs. −7.69%, P<0.001) without previously unknown adverse drug events.
Conclusion
The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or atorvastatin alone in diabetes and dyslipidemia patients. This study also suggested metformin’s preventive effect on the glucose-elevating potential of atorvastatin in patients with type 2 diabetes mellitus and dyslipidemia, insufficiently controlled with exercise and diet. Metformin and atorvastatin combination might be an effective treatment in reducing the CVD risk in patients with both diabetes and dyslipidemia because of its lowering effect on LDL-C and glucose.
2.Differences in Depressive Symptom Profile by Age Group in Koreans With Major Depressive Disorder: Results From Nationwide General Population Surveys
Jimin LEE ; Byung-Soo KIM ; Seong-Jin CHO ; Jun-Young LEE ; Jee Eun PARK ; Su Jeong SEONG ; Sung Man CHANG
Psychiatry Investigation 2024;21(9):1025-1032
Objective:
This study investigated to what extent a range of depressive symptoms was differentially present depending on age group in Korean population.
Methods:
Data was pooled from five nationally representative surveys in which 29,418 respondents aged at least 18 years were interviewed face-to-face using the Korean version of the Composite International Diagnostic Interview. A total of 691 (2.1%) respondents were found to have had at least 1 episode of major depressive disorder (MDD) within the last 12 months. Logistic regression analysis was conducted to identify the association between age groups (18–39 years, 40–59 years, and 60 years or older) and 26 depressive symptoms among the respondents with MDD.
Results:
Associations were observed between somatic symptoms—including insomnia, awakening 2 h earlier—and cognitive symptoms such as feelings of guilt, thoughts of death, and suicidal ideation with the older age group. Whereas, atypical depressive symptoms such as increased appetite, weight gain, and hypersomnia were associated with the younger age group. When adjusted for sociodemographic factors, symptoms such as depressed mood, awakening 2 h earlier, and feeling guilty in the older age group, and hypersomnia, psychomotor retardation, and worse in the morning in the younger age group still remained statistically significant. Furthermore, fatigue and decreased libido were newly associated with the younger age group.
Conclusion
The findings of this study revealed distinct patterns of symptomatology in MDD based on age groups. These differences should be considered owing to their potential relevance to treatment response and prognosis in the clinical setting.
3.Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial
Kyung Ah HAN ; Yong Hyun KIM ; Doo Man KIM ; Byung Wan LEE ; Suk CHON ; Tae Seo SOHN ; In Kyung JEONG ; Eun-Gyoung HONG ; Jang Won SON ; Jae Jin NAH ; Hwa Rang SONG ; Seong In CHO ; Seung-Ah CHO ; Kun Ho YOON
Diabetes & Metabolism Journal 2023;47(6):796-807
Background:
Enavogliflozin is a novel sodium-glucose cotransporter-2 inhibitor currently under clinical development. This study evaluated the efficacy and safety of enavogliflozin as an add-on to metformin in Korean patients with type 2 diabetes mellitus (T2DM) against dapagliflozin.
Methods:
In this multicenter, double-blind, randomized, phase 3 study, 200 patients were randomized to receive enavogliflozin 0.3 mg/day (n=101) or dapagliflozin 10 mg/day (n=99) in addition to ongoing metformin therapy for 24 weeks. The primary objective of the study was to prove the non-inferiority of enavogliflozin to dapagliflozin in glycosylated hemoglobin (HbA1c) change at week 24 (non-inferiority margin of 0.35%) (Clinical trial registration number: NCT04634500).
Results:
Adjusted mean change of HbA1c at week 24 was –0.80% with enavogliflozin and –0.75% with dapagliflozin (difference, –0.04%; 95% confidence interval, –0.21% to 0.12%). Percentages of patients achieving HbA1c <7.0% were 61% and 62%, respectively. Adjusted mean change of fasting plasma glucose at week 24 was –32.53 and –29.14 mg/dL. An increase in urine glucose-creatinine ratio (60.48 vs. 44.94, P<0.0001) and decrease in homeostasis model assessment of insulin resistance (–1.85 vs. –1.31, P=0.0041) were significantly greater with enavogliflozin than dapagliflozin at week 24. Beneficial effects of enavogliflozin on body weight (–3.77 kg vs. –3.58 kg) and blood pressure (systolic/diastolic, –5.93/–5.41 mm Hg vs. –6.57/–4.26 mm Hg) were comparable with those of dapagliflozin, and both drugs were safe and well-tolerated.
Conclusion
Enavogliflozin added to metformin significantly improved glycemic control in patients with T2DM and was non-inferior to dapagliflozin 10 mg, suggesting enavogliflozin as a viable treatment option for patients with inadequate glycemic control on metformin alone.
4.Trends in the Prevalence of Major Depressive Disorder by Sociodemographic Factors in Korea:Results from Nationwide General Population Surveys in 2001, 2006, and 2011
Jimin LEE ; Hyerim KIM ; Jin Pyo HONG ; Seong-Jin CHO ; Jun-Young LEE ; Hong Jin JEON ; Byung-Soo KIM ; Sung Man CHANG
Journal of Korean Medical Science 2021;36(39):e244-
Background:
This study investigated trends in the prevalence of major depressive disorder (MDD) by sociodemographic factors in South Korea.
Methods:
National samples of the general population aged 18 years or older collected from the nationwide Korean Epidemiologic Catchment Area surveys conducted in 2001 (n = 6,206), 2006 (n = 6,466), and 2011 (n = 5,986) were used. For MDD diagnosis, we conducted face-to-face interviews using the Korean version of the Composite International Diagnostic Interview. We performed logistic regression analyses stratified by gender, after adjusting for other sociodemographic variables, to calculate the 2006-to-2001 odds ratio (OR) and 2011-to-2001 OR by subgroups of sociodemographic factors to explore the association of MDD prevalence with sociodemographic factors over time.
Results:
The prevalence of MDD in the general population of South Korea increased steadily from 2001, to 2006, and to 2011 (1.6%, 2.5%, and 3.1%, respectively). Among the men, the prevalence of MDD continued to increase significantly in 18–29 years of age group (2006: adjusted OR [AOR], 3.32; 2011: AOR, 7.42), at-risk drinking group (2006: AOR, 3.56; 2011: AOR, 4.77), and not living with a partner group (2006: AOR, 3.24; 2011: AOR, 3.25).Meanwhile, among the women, the prevalence of MDD continued to significantly increase in the below-average household income group (2006: AOR, 2.58; 2011: AOR, 2.59), at-risk drinking group (2006: AOR, 2.02; 2011: AOR, 2.47), and unemployed group (2006: AOR, 1.48; 2011: AOR, 2.04).
Conclusion
This study may provide significant information for public policymakers to allocate sufficient health resources on MDD to vulnerable groups, particularly, men aged 18–29 years and women living in households with below-average income, and for clinicians to develop appropriate screening and treatment modalities for MDD.
5.The Association of Childhood Maltreatment with Adulthood Mental Disorders and Suicidality in Korea: a Nationwide Community Study
Jimin LEE ; Hyerim KIM ; Sung Man CHANG ; Jin Pyo HONG ; Dong-Woo LEE ; Bong-Jin HAHM ; Seong-Jin CHO ; Jong-Ik PARK ; Hong Jin JEON ; Su Jeong SEONG ; Jee Eun PARK ; Byung-Soo KIM
Journal of Korean Medical Science 2021;36(37):e240-
Background:
Although childhood maltreatment is a known risk factor for adulthood mental health, the impact of different types of childhood maltreatment on mental disorders is not yet clear. This study explored the association of each type of childhood maltreatment with adulthood mental disorders and suicidality in South Korea.
Methods:
A total of 5,102 individuals from the general populations over the age of 18 responded to the Korean version of the Composite International Diagnostic Interview and questions about childhood maltreatment (emotional neglect, psychological abuse, physical abuse, and sexual abuse). To evaluate the odds ratio for mental disorders and suicidality associated with each type of childhood maltreatment, we used logistic regression analysis.
Results:
About 17.0% of the respondents reported having experienced a type of maltreatment in childhood. According to the type, 9.4% reported physical abuse, 9.3% reported emotional neglect, 7.9% reported psychological abuse, and 3.8% reported sexual abuse. Exposure to each type of childhood maltreatment was associated with most types of mental disorders after adjusting for sociodemographic factors. Each type of childhood maltreatment victim was associated with suicidality (suicidal ideations, suicide plans, and suicide attempts).Dose-response patterns for suicide attempts were observed in all types of victims. Moreover, the respondents who experienced frequent childhood emotional neglect were 14 times more likely to have attempted suicide.
Conclusion
Childhood maltreatment was associated with mental health in adulthood.The findings show the need for early detection and intervention of victims of childhood maltreatment to minimize its negative impact on adult mental health.
6.Trends in the Prevalence of Major Depressive Disorder by Sociodemographic Factors in Korea:Results from Nationwide General Population Surveys in 2001, 2006, and 2011
Jimin LEE ; Hyerim KIM ; Jin Pyo HONG ; Seong-Jin CHO ; Jun-Young LEE ; Hong Jin JEON ; Byung-Soo KIM ; Sung Man CHANG
Journal of Korean Medical Science 2021;36(39):e244-
Background:
This study investigated trends in the prevalence of major depressive disorder (MDD) by sociodemographic factors in South Korea.
Methods:
National samples of the general population aged 18 years or older collected from the nationwide Korean Epidemiologic Catchment Area surveys conducted in 2001 (n = 6,206), 2006 (n = 6,466), and 2011 (n = 5,986) were used. For MDD diagnosis, we conducted face-to-face interviews using the Korean version of the Composite International Diagnostic Interview. We performed logistic regression analyses stratified by gender, after adjusting for other sociodemographic variables, to calculate the 2006-to-2001 odds ratio (OR) and 2011-to-2001 OR by subgroups of sociodemographic factors to explore the association of MDD prevalence with sociodemographic factors over time.
Results:
The prevalence of MDD in the general population of South Korea increased steadily from 2001, to 2006, and to 2011 (1.6%, 2.5%, and 3.1%, respectively). Among the men, the prevalence of MDD continued to increase significantly in 18–29 years of age group (2006: adjusted OR [AOR], 3.32; 2011: AOR, 7.42), at-risk drinking group (2006: AOR, 3.56; 2011: AOR, 4.77), and not living with a partner group (2006: AOR, 3.24; 2011: AOR, 3.25).Meanwhile, among the women, the prevalence of MDD continued to significantly increase in the below-average household income group (2006: AOR, 2.58; 2011: AOR, 2.59), at-risk drinking group (2006: AOR, 2.02; 2011: AOR, 2.47), and unemployed group (2006: AOR, 1.48; 2011: AOR, 2.04).
Conclusion
This study may provide significant information for public policymakers to allocate sufficient health resources on MDD to vulnerable groups, particularly, men aged 18–29 years and women living in households with below-average income, and for clinicians to develop appropriate screening and treatment modalities for MDD.
7.The Association of Childhood Maltreatment with Adulthood Mental Disorders and Suicidality in Korea: a Nationwide Community Study
Jimin LEE ; Hyerim KIM ; Sung Man CHANG ; Jin Pyo HONG ; Dong-Woo LEE ; Bong-Jin HAHM ; Seong-Jin CHO ; Jong-Ik PARK ; Hong Jin JEON ; Su Jeong SEONG ; Jee Eun PARK ; Byung-Soo KIM
Journal of Korean Medical Science 2021;36(37):e240-
Background:
Although childhood maltreatment is a known risk factor for adulthood mental health, the impact of different types of childhood maltreatment on mental disorders is not yet clear. This study explored the association of each type of childhood maltreatment with adulthood mental disorders and suicidality in South Korea.
Methods:
A total of 5,102 individuals from the general populations over the age of 18 responded to the Korean version of the Composite International Diagnostic Interview and questions about childhood maltreatment (emotional neglect, psychological abuse, physical abuse, and sexual abuse). To evaluate the odds ratio for mental disorders and suicidality associated with each type of childhood maltreatment, we used logistic regression analysis.
Results:
About 17.0% of the respondents reported having experienced a type of maltreatment in childhood. According to the type, 9.4% reported physical abuse, 9.3% reported emotional neglect, 7.9% reported psychological abuse, and 3.8% reported sexual abuse. Exposure to each type of childhood maltreatment was associated with most types of mental disorders after adjusting for sociodemographic factors. Each type of childhood maltreatment victim was associated with suicidality (suicidal ideations, suicide plans, and suicide attempts).Dose-response patterns for suicide attempts were observed in all types of victims. Moreover, the respondents who experienced frequent childhood emotional neglect were 14 times more likely to have attempted suicide.
Conclusion
Childhood maltreatment was associated with mental health in adulthood.The findings show the need for early detection and intervention of victims of childhood maltreatment to minimize its negative impact on adult mental health.
8.Golden Hour Thrombolysis in Acute Ischemic Stroke: The Changing Pattern in South Korea
Hyunsoo KIM ; Joon-Tae KIM ; Ji Sung LEE ; Beom Joon KIM ; Jong-Moo PARK ; Kyusik KANG ; Soo Joo LEE ; Jae Guk KIM ; Jae-Kwan CHA ; Dae-Hyun KIM ; Tai Hwan PARK ; Sang-Soon PARK ; Kyung Bok LEE ; Jun LEE ; Keun-Sik HONG ; Yong-Jin CHO ; Hong-Kyun PARK ; Byung-Chul LEE ; Kyung-Ho YU ; Mi Sun OH ; Dong-Eog KIM ; Wi-Sun RYU ; Jay Chol CHOI ; Jee-Hyun KWON ; Wook-Joo KIM ; Dong-Ick SHIN ; Sung Il SOHN ; Jeong-Ho HONG ; Man-Seok PARK ; Kang-Ho CHOI ; Ki-Hyun CHO ; Juneyoung LEE ; Hee-Joon BAE
Journal of Stroke 2021;23(1):135-138
9.Severe Disease Activity Based on the Paris Classification Is Associated with the Development of Extraintestinal Manifestations in Korean Children and Adolescents with Ulcerative Colitis
Hyo-Jeong JANG ; Hyo Rim SUH ; Sujin CHOI ; Suk Jin HONG ; Seung-Man CHO ; Kwang-Hae CHOI ; Byung-Ho CHOE ; Ben KANG ;
Journal of Korean Medical Science 2021;36(44):e278-
Background:
There are limited data regarding the extraintestinal manifestations (EIMs) associated with pediatric inflammatory bowel disease (IBD) in Korea. We aimed to investigate the clinical features and factors associated with the development of EIMs in Korean children and adolescents with IBD.
Methods:
This multicenter, retrospective study was conducted from 2010 to 2017. Baseline clinicodemographic, laboratory findings, disease activity, disease phenotypes, and EIMs were investigated.
Results:
A total of 172 patients were included. One-hundred thirty-seven (79.7%) had Crohn's disease (CD), and 35 (20.3%) had ulcerative colitis (UC). EIMs occurred in 42 patients (24.4%). EIMs developed in 34/137 diagnosed with CD (24.8%), and in 8/35 diagnosed with UC (22.9%), during a median follow-up duration of 3.2 (interquartile range, 1.9–5.4) years for CD and 3.0 (1.0–4.0) years for UC, respectively. Arthritis/arthralgia was most commonly observed (n = 15, 35.7%), followed by stomatitis/oral ulcer (n = 10, 23.8%), hepatitis (n = 5, 11.9%), nephritis (n = 4, 9.5%), pancreatitis (n = 2, 4.8%), erythema nodosum (n = 2, 4.8%), pyoderma gangrenosum (n = 1, 2.4%), primary sclerosing cholangitis (n = 1, 2.4%), uveitis (n = 1, 2.4%), and ankylosing spondylitis (n = 1, 2.4%). A significant difference in disease severity based on the Paris classification (P = 0.011) and ESR at diagnosis (P = 0.043) was observed between the EIM positive and negative group in patients with UC. According to logistic regression analyses, S1 disease severity based on the Paris classification was the only factor that was significantly associated with the development of EIMs (odds ratio, 16.57; 95% confidence interval, 2.18–287.39; P = 0.017).
Conclusion
Severe disease activity based on the Paris classification in pediatric patients with UC was significantly associated with EIM development. As disease severity in the Paris classification is a dynamic parameter, treatment should be focused on disease control to minimize the occurrence of EIMs in Korean children and adolescents with UC.
10.Impacts of Remaining Single above the Mean Marriage Age on Mental Disorders and Suicidality:a Nationwide Study in Korea
Jimin LEE ; Hyerim KIM ; Jungmin WOO ; Sung Man CHANG ; Jin Pyo HONG ; Dong-Woo LEE ; Bong-Jin HAHM ; Seong-Jin CHO ; Jong-Ik PARK ; Hong Jin JEON ; Su Jeong SEONG ; Jee Eun PARK ; Byung-Soo KIM
Journal of Korean Medical Science 2020;35(37):e319-
Background:
This study investigated the impact of getting older than the mean marriage age on mental disorders and suicidality among never-married people.
Methods:
We performed an epidemiological survey, a nationwide study of mental disorders, in 2016. In this study, a multi-stage cluster sampling was adopted. The Korean version of the Composite International Diagnostic Interview was conducted with 5,102 respondents aged 18 years or above. The associations between never-married status, mental disorders, and suicidality were explored according to whether the mean age of first marriage (men = 32.8 years; women = 30.1 years) had passed.
Results:
Never-married status over the mean marriage age was associated with agoraphobia, obsessive–compulsive disorder, mood disorders, and major depressive disorder after adjusting for sociodemographic factors. Respondents with never-married status above the mean marriage age were associated with suicide attempts (adjusted odds ratio [aOR], 3.21;95% confidence interval [CI], 1.36–7.60) after controlling for sociodemographic factors and lifetime prevalence of mental disorders, while respondents with never-married status under the mean marriage age were not. Moreover, in respondents with never-married status, getting older than the mean marriage age was associated with suicidal ideations (aOR, 1.49;95% CI, 1.04–2.15) and suicide attempts (aOR, 3.38; 95% CI, 1.46–7.84) after controlling for sociodemographic factors and lifetime prevalence of mental disorders.
Conclusion
Never-married status above the mean first marriage age was associated with mental disorders and suicidality. These findings suggest the need for a national strategy to develop an environment where people with never-married status do not suffer even if their marriage is delayed.

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