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.Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study
Jun Sung MOON ; Sunghwan SUH ; Sang Soo KIM ; Heung Yong JIN ; Jeong Mi KIM ; Min Hee JANG ; Kyung Ae LEE ; Ju Hyung LEE ; Seung Min CHUNG ; Young Sang LYU ; Jin Hwa KIM ; Sang Yong KIM ; Jung Eun JANG ; Tae Nyun KIM ; Sung Woo KIM ; Eonju JEON ; Nan Hee CHO ; Mi-Kyung KIM ; Hye Soon KIM ; Il Seong NAM-GOONG ; Eun Sook KIM ; Jin Ook CHUNG ; Dong-Hyeok CHO ; Chang Won LEE ; Young Il KIM ; Dong Jin CHUNG ; Kyu Chang WON ; In Joo KIM ; Tae Sun PARK ; Duk Kyu KIM ; Hosang SHON
Diabetes & Metabolism Journal 2021;45(5):675-683
Only few studies have shown the efficacy and safety of glucose-control strategies using the quadruple drug combination. Therefore, the aim of the present study was to investigate the usefulness of the quadruple combination therapy with oral hypoglycemic agents (OHAs) in patients with uncontrolled type 2 diabetes mellitus (T2DM). From March 2014 to December 2018, data of patients with T2DM, who were treated with quadruple hypoglycemic medications for over 12 months in 11 hospitals in South Korea, were reviewed retrospectively. We compared glycosylated hemoglobin (HbA1c) levels before and 12 months after quadruple treatment with OHAs. The safety, maintenance rate, and therapeutic patterns after failure of the quadruple therapy were also evaluated. In total, 357 patients were enrolled for quadruple OHA therapy, and the baseline HbA1c level was 9.0%±1.3% (74.9±14.1 mmol/mol). After 12 months, 270 patients (75.6%) adhered to the quadruple therapy and HbA1c was significantly reduced from 8.9%±1.2% to 7.8%±1.3% (mean change, −1.1%±1.2%; This study shows the therapeutic efficacy of the quadruple OHA regimen T2DM and demonstrates that it can be an option for the management of T2DM patients who cannot use insulin or reject injectable therapy.
3.Association between Bone Mineral Density and Fracture Characteristics in the 5th Metatarsal Bone Base Fracture in Elderly for Prediction of Osteoporotic Fracture
Dong-Il CHUN ; Tae-Hong MIN ; Jae-Ho CHO ; Sung-Hun WON ; Jeong-In SHON ; Young YI
Journal of Bone Metabolism 2021;28(3):231-237
Background:
This study aimed to analyze the correlation between bone mineral density (BMD) and the type of 5th metatarsal fracture, as well as to demonstrate whether there is a difference in radiological findings (heel alignment angle [HAA], heel moment arm [HMA], and metatarsus angle) between fracture types.
Methods:
A total of 87 patients were enrolled in the study and allocated into 3 groups: the Zone 1 group (N=36), the Zone 2 group (N=33), and the Zone 3 group (N=18). The participants’ demographic data, T-scores, existing fracture or osteoporosis medications, and radiologic parameters including HAA, HMA, and metatarsus adductus angle were analyzed and compared.
Results:
There was a significant difference between the mean age of the participants, with the highest age in the Zone 1 group and the lowest in the Zone 3 group. Regarding the history of concurrent fracture or osteoporosis medications, there was no significant difference between the 3 groups. Similarly, no significant difference was observed between the 3 groups about the BMD values. In contrast, the HAA was statistically significant in all groups with a positive correlation of -8.9 in the Zone 1 group, a negative correlation of 3.55 in the Zone 2 group, and an inverse relationship of 6.1 in the Zone 3 group. The metatarsus adductus angle was significantly higher in the Zone 3 group than the Zone 1 and Zone 2 groups.
Conclusions
The location of a 5th metatarsal bone fracture is not significantly associated with BMD. However, mechanical influences, such as hindfoot varus or forefoot adductus, have a significant correlation with fracture types.
4.Clinical Characteristics Associated with Suicidal Attempt and Non-Suicidal Self-Injury in Korean Adolescents
Han-Sung LEE ; Kee Jeong PARK ; Yejin KWON ; Seung-Hyun SHON ; Eric A. YOUNGSTROM ; Hyo-Won KIM
Psychiatry Investigation 2021;18(6):561-569
Objective:
This study evaluated the association between mood and anxiety symptoms and suicidal attempt (SA) and/or non-suicidal self-injury (NSSI) in adolescents seeking mental health services. We also tested predictors of SA and NSSI.
Methods:
We retrospectively reviewed the medical records of 220 adolescents who completed psychological assessment in clinical sample. Participants did the Adolescent General Behavior Inventory (A-GBI) and Children’s Depression Inventory (CDI). SA and NSSI were assessed retrospectively by interview. The caregiver of participants completed the Beck Depression Inventory (BDI) for themselves.
Results:
17% of total participants had a history of SA, and 24% experienced NSSI. Both SA and NSSI were more common in girls. The score of depressive subscale on A-GBI was higher in adolescents with SA than those without. The participants with NSSI showed higher scores on CDI and depressive subscale on A-GBI than those without. SA was associated with maternal BDI and history of NSSI; female sex, depressive subscale on A-GBI, and history of SA with NSSI.
Conclusion
Our study found that NSSI and SA are strongly associated in adolescents. Female sex and depressive symptoms of the adolescents were also significantly associated with NSSI in Korean adolescent. Findings are consistent with patterns in other countries.
5.Usefulness of Synthetic Osteoconductive Bone Graft Substitute with Zeta Potential Control for Intramedullary Fixation with Proximal Femur Nail Antirotation in Osteoporotic Unstable Femoral Intertrochanteric Fracture
Tae-Woo SUNG ; Ein-Seong LEE ; Ok-Gul KIM ; Ki-Seong HEO ; Won Yong SHON
Hip & Pelvis 2021;33(4):211-218
Purpose:
This study was conducted in order to examine the usefulness of osteoconductive bone substitutes with zeta potential control (geneX® ds; Biocomposites, England) by comparing the complications and radiographic evaluation with or without geneX® ds augmentation for internal fixation with proximal femur nail antirotation (PFNA) for treatment of osteoporotic unstable intertrochanteric fractures.
Materials and Methods:
A retrospective study of 101 patients who underwent fixation with PFNA in osteoporotic unstable intertrochanteric fractures was conducted from December 2015 to August 2020. The radiographic evaluation and complication rates were compared between patients with geneX® ds (Group A: 41 cases) and those without geneX® ds (Group B: 60 cases).
Results:
In radiological valuation, the degree of blade sliding from the time immediately after surgery to one year after surgery was 1.4±1.2 mm and 5.8±2.7 mm in Group A and Group B, respectively (P<0.001). During the same time frame, a significant difference of 2.3±2.2° and 7.4±3.1° , respectively (P<0.001), in varus collapse, was observed for Group A and Group B.
Conclusion
Among patients fixed with PFNA for treatment of unstable intertrochanteric fractures, less blade sliding and varus collapse was observed for those with geneX® ds augmentation compared to those without it. In addition, there was no increase in the incidence of complications. The authors believe it can be regarded as a safe and effective additive for intramedullary fixation for treatment of unstable intertrochanteric fractures.
6.Clinical Characteristics Associated with Suicidal Attempt and Non-Suicidal Self-Injury in Korean Adolescents
Han-Sung LEE ; Kee Jeong PARK ; Yejin KWON ; Seung-Hyun SHON ; Eric A. YOUNGSTROM ; Hyo-Won KIM
Psychiatry Investigation 2021;18(6):561-569
Objective:
This study evaluated the association between mood and anxiety symptoms and suicidal attempt (SA) and/or non-suicidal self-injury (NSSI) in adolescents seeking mental health services. We also tested predictors of SA and NSSI.
Methods:
We retrospectively reviewed the medical records of 220 adolescents who completed psychological assessment in clinical sample. Participants did the Adolescent General Behavior Inventory (A-GBI) and Children’s Depression Inventory (CDI). SA and NSSI were assessed retrospectively by interview. The caregiver of participants completed the Beck Depression Inventory (BDI) for themselves.
Results:
17% of total participants had a history of SA, and 24% experienced NSSI. Both SA and NSSI were more common in girls. The score of depressive subscale on A-GBI was higher in adolescents with SA than those without. The participants with NSSI showed higher scores on CDI and depressive subscale on A-GBI than those without. SA was associated with maternal BDI and history of NSSI; female sex, depressive subscale on A-GBI, and history of SA with NSSI.
Conclusion
Our study found that NSSI and SA are strongly associated in adolescents. Female sex and depressive symptoms of the adolescents were also significantly associated with NSSI in Korean adolescent. Findings are consistent with patterns in other countries.
7.Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study
Jun Sung MOON ; Sunghwan SUH ; Sang Soo KIM ; Heung Yong JIN ; Jeong Mi KIM ; Min Hee JANG ; Kyung Ae LEE ; Ju Hyung LEE ; Seung Min CHUNG ; Young Sang LYU ; Jin Hwa KIM ; Sang Yong KIM ; Jung Eun JANG ; Tae Nyun KIM ; Sung Woo KIM ; Eonju JEON ; Nan Hee CHO ; Mi-Kyung KIM ; Hye Soon KIM ; Il Seong NAM-GOONG ; Eun Sook KIM ; Jin Ook CHUNG ; Dong-Hyeok CHO ; Chang Won LEE ; Young Il KIM ; Dong Jin CHUNG ; Kyu Chang WON ; In Joo KIM ; Tae Sun PARK ; Duk Kyu KIM ; Hosang SHON
Diabetes & Metabolism Journal 2021;45(5):675-683
Only few studies have shown the efficacy and safety of glucose-control strategies using the quadruple drug combination. Therefore, the aim of the present study was to investigate the usefulness of the quadruple combination therapy with oral hypoglycemic agents (OHAs) in patients with uncontrolled type 2 diabetes mellitus (T2DM). From March 2014 to December 2018, data of patients with T2DM, who were treated with quadruple hypoglycemic medications for over 12 months in 11 hospitals in South Korea, were reviewed retrospectively. We compared glycosylated hemoglobin (HbA1c) levels before and 12 months after quadruple treatment with OHAs. The safety, maintenance rate, and therapeutic patterns after failure of the quadruple therapy were also evaluated. In total, 357 patients were enrolled for quadruple OHA therapy, and the baseline HbA1c level was 9.0%±1.3% (74.9±14.1 mmol/mol). After 12 months, 270 patients (75.6%) adhered to the quadruple therapy and HbA1c was significantly reduced from 8.9%±1.2% to 7.8%±1.3% (mean change, −1.1%±1.2%; This study shows the therapeutic efficacy of the quadruple OHA regimen T2DM and demonstrates that it can be an option for the management of T2DM patients who cannot use insulin or reject injectable therapy.
8.Association between Bone Mineral Density and Fracture Characteristics in the 5th Metatarsal Bone Base Fracture in Elderly for Prediction of Osteoporotic Fracture
Dong-Il CHUN ; Tae-Hong MIN ; Jae-Ho CHO ; Sung-Hun WON ; Jeong-In SHON ; Young YI
Journal of Bone Metabolism 2021;28(3):231-237
Background:
This study aimed to analyze the correlation between bone mineral density (BMD) and the type of 5th metatarsal fracture, as well as to demonstrate whether there is a difference in radiological findings (heel alignment angle [HAA], heel moment arm [HMA], and metatarsus angle) between fracture types.
Methods:
A total of 87 patients were enrolled in the study and allocated into 3 groups: the Zone 1 group (N=36), the Zone 2 group (N=33), and the Zone 3 group (N=18). The participants’ demographic data, T-scores, existing fracture or osteoporosis medications, and radiologic parameters including HAA, HMA, and metatarsus adductus angle were analyzed and compared.
Results:
There was a significant difference between the mean age of the participants, with the highest age in the Zone 1 group and the lowest in the Zone 3 group. Regarding the history of concurrent fracture or osteoporosis medications, there was no significant difference between the 3 groups. Similarly, no significant difference was observed between the 3 groups about the BMD values. In contrast, the HAA was statistically significant in all groups with a positive correlation of -8.9 in the Zone 1 group, a negative correlation of 3.55 in the Zone 2 group, and an inverse relationship of 6.1 in the Zone 3 group. The metatarsus adductus angle was significantly higher in the Zone 3 group than the Zone 1 and Zone 2 groups.
Conclusions
The location of a 5th metatarsal bone fracture is not significantly associated with BMD. However, mechanical influences, such as hindfoot varus or forefoot adductus, have a significant correlation with fracture types.
9.Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study
Jun Sung MOON ; Sunghwan SUH ; Sang Soo KIM ; Heung Yong JIN ; Jeong Mi KIM ; Min Hee JANG ; Kyung Ae LEE ; Ju Hyung LEE ; Seung Min CHUNG ; Young Sang LYU ; Jin Hwa KIM ; Sang Yong KIM ; Jung Eun JANG ; Tae Nyun KIM ; Sung Woo KIM ; Eonju JEON ; Nan Hee CHO ; Mi-Kyung KIM ; Hye Soon KIM ; Il Seong NAM-GOONG ; Eun Sook KIM ; Jin Ook CHUNG ; Dong-Hyeok CHO ; Chang Won LEE ; Young Il KIM ; Dong Jin CHUNG ; Kyu Chang WON ; In Joo KIM ; Tae Sun PARK ; Duk Kyu KIM ; Hosang SHON
Diabetes & Metabolism Journal 2020;44(S1):e46-
Background:
Only few studies have shown the efficacy and safety of glucose-control strategies using the quadruple drug combination. Therefore, the aim of the present study was to investigate the usefulness of the quadruple combination therapy with oral hypoglycemic agents (OHAs) in patients with uncontrolled type 2 diabetes mellitus (T2DM).
Methods:
From March 2014 to December 2018, data of patients with T2DM, who were treated with quadruple hypoglycemic medications for over 12 months in 11 hospitals in South Korea, were reviewed retrospectively. We compared glycosylated hemoglobin (HbA1c) levels before and 12 months after quadruple treatment with OHAs. The safety, maintenance rate, and therapeutic patterns after failure of the quadruple therapy were also evaluated.
Results:
In total, 357 patients were enrolled for quadruple OHA therapy, and the baseline HbA1c level was 9.0%±1.3% (74.9± 14.1 mmol/mol). After 12 months, 270 patients (75.6%) adhered to the quadruple therapy and HbA1c was significantly reduced from 8.9%±1.2% to 7.8%±1.3% (mean change, –1.1%±1.2%; P<0.001). The number of patients with HbA1c <7% increased significantly from 5 to 68 (P<0.005). In addition, lipid profiles and liver enzyme levels were also improved whereas no changes in body weight. There was no significant safety issue in patients treated with quadruple OHA therapy.
Conclusion
This study shows the therapeutic efficacy of the quadruple OHA regimen T2DM and demonstrates that it can be an option for the management of T2DM patients who cannot use insulin or reject injectable therapy.
10.Methylation Signature for Prediction of Progression Free Survival in Surgically Treated Clear Cell Renal Cell Carcinoma
Ho Won KANG ; Hongyong PARK ; Sung Pil SEO ; Young Joon BYUN ; Xuan Mei PIAO ; Sung Min KIM ; Won Tae KIM ; Seok Joong YUN ; Wooyeong JANG ; Ho Sun SHON ; Keun Ho RYU ; Sang Cheol LEE ; Wun Jae KIM ; Yong June KIM
Journal of Korean Medical Science 2019;34(19):e144-
BACKGROUND: Little is known about epigenetic silencing of genes by promoter hypermethylation in renal cell carcinoma (RCC). The aim of this study was to identify prognostic methylation markers in surgically treated clear cell RCC (ccRCC). METHODS: Methylation patterns were assayed using the Infinium HumanMethylation450 BeadChip array on pairs of ccRCC and normal tissue from 12 patients. Using quantitative PSQ analysis, tumor-specific hypermethylated genes were validated in 25 independent cohorts and their clinical relevance was also verified in 152 independent cohorts. RESULTS: Using genome-wide methylation array, Zinc finger protein 278 (ZNF278), Family with sequence similarity 155 member A (FAM155A) and Dipeptidyl peptidase 6 (DPP6) were selected for tumor-specific hypermethylated genes in primary ccRCC. The promoter methylation of these genes occurred more frequently in ccRCC than normal kidney in independent validation cohort. The hypermethylation of three genes were associated with advanced tumor stage and high grade tumor in ccRCC. During median follow-up of 39.2 (interquartile range, 15.4–79.1) months, 22 (14.5%) patients experienced distant metastasis. Multivariate analysis identified the methylation status of these three genes, either alone, or in a combined risk score as an independent predictor of distant metastasis. CONCLUSION: The promoter methylation of ZNF278, FAM155A and DPP6 genes are associated with aggressive tumor phenotype and early development of distant metastasis in patients with surgically treated ccRCC. These potential methylation markers, either alone, or in combination, could provide novel targets for development of individualized therapeutic and prevention regimens.
Carcinoma, Renal Cell
;
Cohort Studies
;
Disease-Free Survival
;
Epigenomics
;
Follow-Up Studies
;
Humans
;
Kidney
;
Methylation
;
Multivariate Analysis
;
Neoplasm Metastasis
;
Phenotype
;
Zinc Fingers

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