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.Effects of A Stroke Education Program on Disease Acceptance and Knowledge among Acute Ischemic Senior Stroke Patients
Eun Kyung SEO ; Kyung Hee SHON ; Nam Hee KIM
Health Communication 2019;14(1):43-51
BACKGROUND: The purpose of this study was to confirm the effects of a stroke education program for disease acceptance and knowledge among acute ischemic senior stroke patients.METHODS: This study used a nonequivalent control group non-synchronized design. The study was performed from September 8 to November 2, 2014. The subjects were selected as an experiment group of 28 people and a control group of 28 people from acute ischemic senior stroke patients at D hospital in B metropolitan city. The data were analyzed using χ² test and Mann-Whitney U test using SPSS WIN 19.0 program.RESULTS: 1. Disease acceptance score in the experimental group revealed to be significantly higher(Z=−4.568, p<.001) than that of the control group. Hypothesis 1 was accepted. 2. Knowledge score in the experimental group revealed to be significantly higher(Z=−4.740, p<.001) than that of the control group. Hypothesis 2 was accepted.CONCLUSION: The stroke education program can be used for nursing intervention and evidence-based research hereafter because it has been confirmed that the program develops higher disease acceptance and improves knowledge among acute ischemic senior stroke patients.
Education
;
Humans
;
Nursing
;
Stroke
6.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
7.Whole-Genome Analysis in Korean Patients with Autoimmune Myasthenia Gravis.
Sang Jun NA ; Ji Hyun LEE ; So Won KIM ; Dae Seong KIM ; Eun Hee SHON ; Hyung Jun PARK ; Ha Young SHIN ; Seung Min KIM ; Young Chul CHOI
Yonsei Medical Journal 2014;55(3):660-668
PURPOSE: The underlying cause of myasthenia gravis (MG) is unknown, although it likely involves a genetic component. However, no common genetic variants have been unequivocally linked to autoimmune MG. We sought to identify the genetic variants associated with an increased or decreased risk of developing MG in samples from a Korean Multicenter MG Cohort. MATERIALS AND METHODS: To determine new genetic targets related to autoimmune MG, a whole genome-based single nucleotide polymorphisms (SNP) analysis was conducted using an Axiom(TM) Genome-Wide ASI 1 Array, comprising 598375 SNPs and samples from 109 MG patients and 150 neurologically normal controls. RESULTS: In total, 641 SNPs from five case-control associations showed p-values of less than 10(-5). From regional analysis, we selected seven candidate genes (RYR3, CACNA1S, SLAMF1, SOX5, FHOD3, GABRB1, and SACS) for further analysis. CONCLUSION: The present study suggests that a few genetic polymorphisms, such as in RYR3, CACNA1S, and SLAMF1, might be related to autoimmune MG. Our findings also encourage further studies, particularly confirmatory studies with larger samples, to validate and analyze the association between these SNPs and autoimmune MG.
Antigens, CD/genetics
;
Asian Continental Ancestry Group/genetics
;
Calcium Channels/genetics
;
Female
;
Genetic Predisposition to Disease/genetics
;
Genotype
;
Humans
;
Male
;
Myasthenia Gravis/*etiology
;
Polymorphism, Single Nucleotide/genetics
;
Receptors, Cell Surface/genetics
;
Ryanodine Receptor Calcium Release Channel/genetics
8.Status Epilepticus in Influenza A (H1N1) Viral Encephalitis.
Kyoung Jin HWANG ; Jae Seong LEE ; Jung Eun YUN ; Tae Hwan ROH ; Yu Jin JUNG ; Sang Hyun SHON ; Sung Hyuk HEO ; Dae Il CHANG
Journal of the Korean Neurological Association 2011;29(4):329-331
There has been a worldwide pandemic infection of influenza A (H1N1) since June 2009. A 23-year-old female presented with fever and sore throat and was diagnosed as having influenza A (H1N1) infection. After 2 days of illness, she had headache, nausea, and neck stiffness. Cerebrospinal-fluid findings were consistent with viral infection, and brain MRI revealed intense signals in both frontotemporal cortices. During her illness she developed repetitive seizures, which were considered to be status epilepticus.
Brain
;
Encephalitis
;
Encephalitis, Viral
;
Female
;
Fever
;
Headache
;
Humans
;
Influenza, Human
;
Nausea
;
Neck
;
Pandemics
;
Pharyngitis
;
Seizures
;
Status Epilepticus
;
Young Adult
9.A case of acute suppurative thyroiditis with thyrotoxicosis.
Chan Hee YOO ; Ye Na KIM ; Chang Bae SHON ; Eun Ho PARK ; Young Sik CHOI ; Yo Han PARK ; Jung Hun KIM
Korean Journal of Medicine 2008;75(2):242-245
Acute suppurative thryroiditis is a rare disease because the thyroid gland is resistant to infection. Thyroid function tests are usually normal in acute suppurative thryroiditis. We care for a patient with acute suppurative thryroiditis and associated thyrotoxicosis. A 73-year-old diabetic woman presented with pain over the thyroid gland and an elevated serum thyroid hormone level and decreased radioiodine uptake, as occurs in subacute thyroiditis. A neck computed tomography showed an abscess in the right lobe of the thyroid gland. A neutrophilic infiltration was shown in a fine needle aspiration biopsy, and Gram negative Burkholderia gladioli grew from the aspirate culture. Antibiotic treatment ameliorated the symptoms of infection, followed by normalization of thyroid function.
Abscess
;
Aged
;
Biopsy
;
Biopsy, Fine-Needle
;
Burkholderia gladioli
;
Female
;
Humans
;
Neck
;
Neutrophils
;
Rare Diseases
;
Thyroid Function Tests
;
Thyroid Gland
;
Thyroiditis, Subacute
;
Thyroiditis, Suppurative
;
Thyrotoxicosis
10.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

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