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.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.
4.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.
5.Comparison of sleep quality based on direction of shift rotation in electronics workers.
Youil SHON ; Seungho RYU ; Byung Seong SUH ; Soo Geun KIM ; Won Sool KIM ; Hee Seung SON ; Hee Yun KIM ; Han Seur JEONG
Annals of Occupational and Environmental Medicine 2016;28(1):37-
BACKGROUND: Previous studies have reported the effects of direction of shift rotation on sleep, however, the findings are inconsistent. In this study, we investigated sleep quality related to direction of shift rotation using large-scale data from shiftwork-specific health examinations of electronics workers. METHODS: This study included 4750 electronics workers working in a rotating 3-shift system who completed a medical examination for shift workers survey from January 1 to December 31, 2014, at a general hospital. The subjects were categorized into one of two groups according to direction of shift rotation. We compared sleep quality index between the subjects who worked in forward rotation and backward rotation systems. RESULTS: Backward rotation was positively associated with prevalence of poor sleep quality. In the multivariable-adjusted model, when comparing backward rotation to forward rotation, the odds ratio (OR) with 95 % confidence interval (95 % CI) for poor sleep quality was 1.95 (1.58–2.41). After stratifying by gender, the ORs (95 % CIs) for poor sleep quality in male and female was 1.92 (1.47–2.49) and 2.13 (1.47–3.08), respectively. In subgroup analyses, backward rotation was significantly associated with poor sleep quality in workers ≥30 years of age compared with workers <30 years of age (adjusted OR 2.60 vs. 1.89, respectively; P for interaction <0.001). CONCLUSIONS: Our study supports that a backward rotation system is associated with poor sleep quality. Forward rotation systems should be considered to reduce sleep problems.
Female
;
Hospitals, General
;
Humans
;
Male
;
Odds Ratio
;
Prevalence
6.Effects of Teriparatide Administration on Fracture Healing after Intramedullary Nailing in Atypical Femoral Fractures.
Chul Hyun PARK ; Oog Jin SHON ; Jeong Jae MOON ; Bum Jin SHIM ; Jae Hee HEO
The Journal of the Korean Orthopaedic Association 2016;51(3):231-237
PURPOSE: The purpose of this study is to evaluate the effects of teriparatide administration on fracture healing after intramedullary nailing in atypical femoral fractures. MATERIALS AND METHODS: We retrospectively reviewed 26 patients (26 cases) with atypical femoral fracture who were treated using intramedullary nailing between January 2009 and December 2013. Teriparatide was not administered to 15 patients (non-injection group) and was administered to 11 patients after surgery (injection group). Clinical results were assessed using the Nakajima score and the visual analogue scale (VAS). Radiographic results were compared for the time of callus formation, callus bridge formation, and bone union between the groups. RESULTS: Time to recover walking ability and to decrease pain in the surgery region (VAS≤2) were significantly shorter in the injection group than in the non-injection group. The time of callus formation, callus bridge formation, and bone union was significantly shorter in the injection group than in the non-injection group. There were 5 cases of delayed bone union (33.3%) and 1 case of none union (6.7%) in the non-injection group and all cases obtained bone union in injection group. CONCLUSION: The injection group showed better clinical and radiographic results than the non-injection group after intramedullary nailing in atypical femoral fracture. Therefore, we think that teriparatide administration after intramedullary nailing could be a useful treatment option to promote bone union.
Bony Callus
;
Femoral Fractures*
;
Fracture Fixation, Intramedullary*
;
Fracture Healing*
;
Humans
;
Parathyroid Hormone
;
Retrospective Studies
;
Teriparatide*
;
Walking
7.Pre-Clinical Efficacy and Safety Evaluation of Human Amniotic Fluid-Derived Stem Cell Injection in a Mouse Model of Urinary Incontinence.
Jae Young CHOI ; So Young CHUN ; Bum Soo KIM ; Hyun Tae KIM ; Eun Sang YOO ; Yun Hee SHON ; Jeong Ok LIM ; Seok Joong YUN ; Phil Hyun SONG ; Sung Kwang CHUNG ; James J YOO ; Tae Gyun KWON
Yonsei Medical Journal 2015;56(3):648-657
PURPOSE: Stem cell-based therapies represent new promises for the treatment of urinary incontinence. This study was performed to assess optimized cell passage number, cell dose, therapeutic efficacy, feasibility, toxicity, and cell trafficking for the first step of the pre-clinical evaluation of human amniotic fluid stem cell (hAFSC) therapy in a urinary incontinence animal model. MATERIALS AND METHODS: The proper cell passage number was analyzed with hAFSCs at passages 4, 6, and 8 at week 2. The cell dose optimization included 1x10(4), 1x10(5), and 1x10(6) cells at week 2. The in vivo cell toxicity was performed with 0.25x10(6), 0.5x10(6), and 1x10(6) cells at weeks 2 and 4. Cell tracking was performed with 1x10(6) cells at weeks 2 and 4. RESULTS: The selected optimal cell passage number was smaller than 6, and the optimal cell dose was 1x10(6) for the mouse model. In our pre-clinical study, hAFSC-injected animals showed normal values for several parameters. Moreover, the injected cells were found to be non-toxic and non-tumorigenic. Furthermore, the injected hAFSCs were rarely identified by in vivo cell trafficking in the target organs at week 2. CONCLUSION: This study demonstrates for the first time the pre-clinical efficacy and safety of hAFSC injection in the urinary incontinence animal model and provides a basis for future clinical applications.
Amniotic Fluid/*cytology
;
Animals
;
Cell Movement
;
Disease Models, Animal
;
Humans
;
Injections
;
Mice
;
Stem Cell Transplantation/*methods
;
Stem Cells/*cytology
;
Treatment Outcome
;
Urinary Incontinence/*therapy
8.Comparison of clinical outcomes between culprit vessel only and multivessel percutaneous coronary intervention for ST-segment elevation myocardial infarction patients with multivessel coronary diseases
Ryu Sun Kwang ; Park Woo Hyun ; Park Ho Soo ; Shon Sun Ho ; Ryu Ho Keun ; Lee Gyu Dong ; Bashir EA Mohamed ; Lee Hee Ju ; Kim Min Sang ; Lee Yeub Sang ; Bae Whan Jang ; Hwang Kuk Kyung ; Kim Woon Dong ; Cho Chan Myeong ; Ahn Keun Young ; Jeong Ho Myung ; Kim Jin Chong ; P
Journal of Geriatric Cardiology 2015;(3):208-217
Background The clinical significance of complete revascularization for ST segment elevation myocardial infarction (STEMI) pa-tients during admission is still debatable. Methods A total of 1406 STEMI patients from the Korean Myocardial Infarction Registry with multivessel diseases without cardiogenic shock who underwent primary percutaneous coronary intervention (PPCI) were analyzed. We used propensity score matching (PSM) to control differences of baseline characteristics between culprit only intervention (CP) and multivessel percutaneous coronary interventions (MP), and between double vessel disease (DVD) and triple vessel disease (TVD). The major adverse cardiac event (MACE) was analyzed for one year after discharge. Results TVD patients showed higher incidence of MACE (14.2%vs. 8.6%, P=0.01), any cause of revascularization (10.6%vs. 5.9%, P=0.01), and repeated PCI (9.5%vs. 5.7%, P=0.02), as compared to DVD patients during one year after discharge. MP reduced MACE effectively (7.3%vs. 13.8%, P=0.03), as compared to CP for one year, but all cause of death (1.6%vs. 3.2%, P=0.38), MI (0.4%vs. 0.8%, P=1.00), and any cause of revascularization (5.3%vs. 9.7%, P=0.09) were comparable in the two treatment groups. Conclusions STEMI patients with TVD showed higher rate of MACE, as compared to DVD. MP performed during PPCI or ad hoc during admission for STEMI patients without cardiogenic shock showed lower rate of MACE in this large scaled database. Therefore, MP could be considered as an effective treatment option for STEMI patients without cardiogenic shock.
9.Correlations between the prevalence of colonic neoplasia and Helicobacter pylori infection.
Eun Jung HONG ; Dong Il PARK ; Hee Jung SOHN ; Mun Hee BAE ; Hwa Mock KIM ; Yong Sung KIM ; Sun Jeong BYUN ; Jung Ho PARK ; Hong Joo KIM ; Yong Kyun CHO ; Chong Il SHON ; Woo Kyu JEON ; Byung Ik KIM
Korean Journal of Medicine 2008;74(6):605-610
BACKGROUND/AIMS: Helicobacter pylori infection is a recognized cause of chronic gastritis, peptic ulcer and gastric adenocarcinoma. However, both positive and negative associations with colorectal neoplasia have been reported. The aim of this study was to determine whether H. pylori infection is associated with an increased risk of colonic neoplasia in a Korean population. METHODS: We examined 1,590 subjects (1,297 men and 293 women) who underwent colonoscopy and serologic testing for IgG antibodies against H. pylori at the Health promotion Center in Kangbuk Samsung Hospital and at Samsung Medical Center. We compared the prevalence of colonic neoplasia in the seropositive subjects with that of the seronegative subjects. RESULTS: The overall prevalence of H. pylori in our study population was 56.2%. There were no significant differences of the baseline characteristics between the two groups. There was no statistically significant difference in the prevalence of colonic neoplasia between the seropositive group and the seronegative group (p=0.090). CONCLUSIONS: These findings suggest that there is no significant association between H. pylori infection and colonic neoplasia.
Adenocarcinoma
;
Antibodies
;
Colon
;
Colonoscopy
;
Gastritis
;
Health Promotion
;
Helicobacter
;
Helicobacter pylori
;
Humans
;
Immunoglobulin G
;
Male
;
Peptic Ulcer
;
Prevalence
;
Serologic Tests
10.Three Cases Treated with High-dose Cytarabine and Etoposide followed by Autologous Stem Cell Transplantation for Relapsed Primary CNS Lymphoma.
Ja Eun KOO ; Min Hee RYU ; Hee Jeong SHON ; Hye Jin KANG ; Woo Kun KIM ; Cheolwon SUH ; Jung Shin LEE ; Yoon Koo KANG
Korean Journal of Hematology 2005;40(3):172-176
The treatment outcomes with conventional second-line chemotherapy or radiotherapy aregenerally very poor for patients with relapsed primary CNS lymphoma (PCNSL). We treated three relapsed PCNSL patients with high-dose cytarabine plus etoposide (CYVE) chemotherapy, and this was followed by autologous stem cell transplantation (ASCT). The salvage CYVE chemotherapy consisted of cytarabine 2g/m2/d on days 2 to 5 in a 3-hour infusion and 50mg/m2/d on days 1 to 5 in a 12-hourinfusion, and etoposide 200mg/m2/d on days 2 to 5 in a 2-hour infusion. After two cycles of CYVE chemotherapy, two patients achieved a complete response (CR), and one patient achieved a partial response (PR). All three patients experienced febrile neutropenia and grade 4 thrombocytopenia with the CYVE chemotherapy. However, the hematologic toxicities were well managed without any complications. The conditioning regimen for ASCT consisted of BCNU 300mg/m2 on day -7, etoposide 100mg/m2 on days -6 to -3, cytarabine 100mg/m2 on days -6 to -3, and cyclophosphamide 35mg/kg on days -6 to -3 (BEAC). After ASCT, the patient who initially showed a PR with CYVE chemotherapy then achieved a CR. At the time of this report, one patient remained alive in CR for 41 months after CYVE chemotherapy. The remaining two patients experienced relapse 5 months and 4 months after ASCT, respectively, and they ultimately died of disease progression 18 months and 8 months after ASCT, respectively. In our cases, the CYVE chemotherapy+ASCT was well tolerated, and this induced the complete disappearance of the tumor, and one patient showed prolonged disease-free survival. CYVE chemotherapy+ASCT could be a treatment option for relapsed PCNSL.
Anemia, Hemolytic, Autoimmune
;
Carmustine
;
Cyclophosphamide
;
Cytarabine*
;
Disease Progression
;
Disease-Free Survival
;
Drug Therapy
;
Etoposide*
;
Febrile Neutropenia
;
Humans
;
Lymphoma*
;
Radiotherapy
;
Recurrence
;
Stem Cell Transplantation*
;
Stem Cells*
;
Thrombocytopenia
;
Waldenstrom Macroglobulinemia

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