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.Clinical Course and Outcomes of 3,060 Patients with Coronavirus Disease 2019 in Korea, January–May 2020
Ho Kyung SUNG ; Jin Yong KIM ; Jeonghun HEO ; Haesook SEO ; Young soo JANG ; Hyewon KIM ; Bo Ram KOH ; Neungsun JO ; Hong Sang OH ; Young Mi BAEK ; Kyung-Hwa PARK ; Jeung A SHON ; Min-Chul KIM ; Joon Ho KIM ; Hyun-Ha CHANG ; Yukyung PARK ; Yu Min KANG ; Dong Hyun LEE ; Dong Hyun OH ; Hyun Jung PARK ; Kyoung-Ho SONG ; Eun Kyoung LEE ; Hyeongseok JEONG ; Ji Yeon LEE ; Ja-Young KO ; Jihee CHOI ; Eun Hwa RYU ; Ki-hyun CHUNG ; Myoung-don OH ;
Journal of Korean Medical Science 2020;35(30):e280-
Background:
The fatality rate of patients with coronavirus disease 2019 (COVID-19) varies among countries owing to demographics, patient comorbidities, surge capacity of healthcare systems, and the quality of medical care. We assessed the clinical outcomes of patients with COVID-19 during the first wave of the epidemic in Korea.
Methods:
Using a modified World Health Organization clinical record form, we obtained clinical data for 3,060 patients with COVID-19 treated at 55 hospitals in Korea. Disease severity scores were defined as: 1) no limitation of daily activities; 2) limitation of daily activities but no need for supplemental oxygen; 3) supplemental oxygen via nasal cannula; 4) supplemental oxygen via facial mask; 5) non-invasive mechanical ventilation; 6) invasive mechanical ventilation; 7) multi-organ failure or extracorporeal membrane oxygenation therapy; and 8) death. Recovery was defined as a severity score of 1 or 2, or discharge and release from isolation.
Results:
The median age of the patients was 43 years of age; 43.6% were male. The median time from illness onset to admission was 5 days. Of the patients with a disease severity score of 3–4 on admission, 65 (71.5%) of the 91 patients recovered, and 7 (7.7%) died due to illness by day 28. Of the patients with disease severity scores of 5–7, 7 (19.5%) of the 36 patients recovered, and 8 (22.2%) died due to illness by day 28. None of the 1,324 patients who were < 50 years of age died; in contrast, the fatality rate due to illness by day 28 was 0.5% (2/375), 0.9% (2/215), 5.8% (6/104), and 14.0% (7/50) for the patients aged 50–59, 60–69, 70–79, and ≥ 80 years of age, respectively.
Conclusion
In Korea, almost all patients of < 50 years of age with COVID-19 recovered without supplemental oxygen. In patients of ≥ 50 years of age, the fatality rate increased with age, reaching 14% in patients of ≥ 80 years of age.
6.Is the Incidence Rate of Hip Fractures still Increasing in Korea?: An Epidemiologic Study Based on National Health Insurance Database.
Eui Sung CHOI ; Hyun Chul SHON ; Yong Min KIM ; Dong Soo KIM ; Kyoung Jin PARK ; Chae Ouk LIM ; Hyung Ki LEE
The Journal of the Korean Orthopaedic Association 2016;51(6):447-454
PURPOSE: A retrospective study was conducted to examine the current trend in incidence rates of hip fractures among patients aged 50 years and older in Korea. MATERIALS AND METHODS: A retrospective study was conducted using data on the population, collected by Statistics Korea within the different gender and age groups in total population of Korea from 2007 to 2012. The International Classification of Diseases-10 classification method from the Health Insurance Review and Assessment Service was used to investigate the number of patients with hip fractures, and determine the crude incidence rate (CR) and the age-adjusted incidence rate (AR) for comparison. RESULTS: The CR of hip fractures for patients aged 50 years and older was 178 per 100,000 for men and 350 per 100,000 for women in 2007. In 2012, the CR was 194 per 100,000 for men, and 418 per 100,000 for women. The AR was 197 per 100,000 for men and 281 per 100,000 for women in 2007. In 2012, the AR was 206 per 100,000 for men, and 310 per 100,000 for women. During the observation period, the AR and the CR of hip fractures showed a statistically significant increase. However, the increasing trend has been slowing since its peak in 2010. Comparison of the AR of men and women, showed statistical significance only for women. CONCLUSION: In Korea, the incidence of hip fractures increased significantly from 2007 to 2012. The AR showed statistical significance only for women and the increasing trend is slowing down from 2010.
Classification
;
Epidemiologic Studies*
;
Female
;
Hip Fractures*
;
Hip*
;
Humans
;
Incidence*
;
Insurance, Health
;
Korea*
;
Male
;
Methods
;
National Health Programs*
;
Retrospective Studies
7.Psoas and Thigh Abscess Caused by Perforated Retrocecal Appendicitis: A Case Report.
Dong Soo KIM ; Yong Min KIM ; Eui Sung CHOI ; Hyun Chul SHON ; Suri CHONG ; Seung Myung CHOI ; Sang Jun PARK
Journal of Korean Society of Spine Surgery 2015;22(1):31-35
STUDY DESIGN: A case report. SUMMARY OF LITERATURE REVIEW: The symptoms of psoas abscess are fever, low back pain, and spasm of the psoas muscle. OBJECTIVES: To report a case of psoas and thigh abscess caused by ruptured appendicitis. MATERIALS AND METHODS: A 53- year old male patient visited the complaining of fever, low back pain and thigh pain. Imaging studies revealed psoas abscess and thigh abscess, accompanied by ruptured appendicitis. Therefore, surgical treatment with percutaneous drainage was performed. RESULTS: The patient recovered and returned to his normal life after 2 months. CONCLUSIONS: It is necessary to identify the cause of the infection using physical examination as well as abdominal and pelvis computed tomography when a patient has fever, psoas abscess and thigh abscess. It is also important to be aware that the cause of psoas abscess may also be gastrointestinal tract disease with non specific symptoms.
Abscess*
;
Appendicitis*
;
Drainage
;
Fever
;
Gastrointestinal Tract
;
Humans
;
Low Back Pain
;
Male
;
Pelvis
;
Physical Examination
;
Psoas Abscess
;
Psoas Muscles
;
Spasm
;
Thigh*
8.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
9.Coracoclavicular Ligament Suture Augmentation with Anatomical Locking Plate Fixation for Distal Clavicle Fracture.
Tae Kang LIM ; Min Soo SHON ; Hyung Gon RYU ; Jae Sung SEO ; Jae Hyun PARK ; Young KO ; Kyoung Hwan KOH
Clinics in Shoulder and Elbow 2014;17(4):175-180
BACKGROUND: For Neer type IIB fracture of distal clavicle with coracoclavicular ligament injury, various surgical treatments have been used in literatures. However, there was no consensus on the optimal treatment. The aim of this study is to report the clinical and radiological results of open reduction and internal fixation of unstable distal clavicle fracture and suture augmentation of disrupted coracoclavicular ligament. METHODS: A prospective study was performed in 23 patients with Neer type IIB distal clavicle fracture in Seoul Medical Center, Eulji Hospital, and National Medical Center. Firstly, suture anchors are inserted in the base of coracoid process and preliminary reduction was achieved by tie-off of three suture limbs around the clavicle. Then, the final fixation was completed with anatomical locking plate. Bony union and the distance between coracoclavicular ligaments were evaluated. Clinical results and complications including stiffness and secondary procedures were evaluated. RESULTS: Bony union was achieved in all cases except one (22 of 23). At mean 14.9 months, no significant difference in the mean coracoclavicular distance was observed compared to uninjured shoulder (8.2 +/- 7.9 mm versus 7.3 +/- 3.4 mm, p=0.14). Pain visual analogue scale, American Shoulder and Elbow Surgeons score, Constant score, and Disabilities of the Arm, Shoulder and Hand score were 0.5, 83.4, 78.5, and 6.2, respectively. Revision surgery was performed in one case of nonunion. Four patients who complained of skin irritation underwent implant removal. CONCLUSIONS: In cases of an unstable distal clavicle fracture with coracoclavicular ligament disruption, satisfactory clinical results were obtained by locking plate fixation and coracoclavicular ligament suture augmentation concurrently.
Arm
;
Clavicle*
;
Consensus
;
Elbow
;
Extremities
;
Hand
;
Humans
;
Ligaments*
;
Prospective Studies
;
Seoul
;
Shoulder
;
Shoulder Fractures
;
Skin
;
Suture Anchors
;
Sutures*
10.Subsidence of Polyetheretherketone Cage after Anterior Cervical Fusion.
Yong Min KIM ; Kyu Won OH ; Dong Soo KIM ; Eui Sung CHOI ; Hyun Chul SHON ; Kyung Jin PARK ; Byung Ki CHO ; Ji Kang PARK ; Ho Seung JEONG ; Jung Wook OH
The Journal of the Korean Orthopaedic Association 2014;49(3):185-194
PURPOSE: The purpose of this study is to evaluate the rate and direction of subsidence that occurred after anterior cervical discectomy and fusion using the polyetheretherketone (PEEK) cage and to analyze the risk factors of subsidence. MATERIALS AND METHODS: Thirty two patients (36 segments) who underwent anterior cervical discectomy and fusion using the PEEK cage and autologous cancellous iliac bone graft from July 2003 to November 2011 were enrolled in this study. anterior segmental height (ASH), posterior segmental height (PSH) and cage corner distance (CCD) were measured on plain radiographs. Subsidence was defined as > or =2 mm decrease in the average of ASH and PSH at the final follow up compared to that measured in the immediate postoperative period. A decrease of more than 3 mm was defined as severe subsidence for further statistical analysis. RESULTS: Subsidence of more than 2 mm was observed in 14 segments (38.9%) and severe subsidence (> or =3 mm) was observed in seven segments (19.4%). The direction of subsidence was examined by comparison of means of decreased ASH and PSH and anterior subsidence outweighed posterior subsidence (p<0.001). Examination of CCD showed that inferior subsidence was more frequent than superior subsidence (p<0.001, p=0.047). Among the suspicious risk factors for subsidence, intraoperative disc space distraction (anterior distraction: p=0.031, posterior distraction: p=0.007) and height of inserted cage (p=0.032) showed statistical significance. CONCLUSION: Considerable incidence of subsidence was observed after use of the cage. Using a cage of appropriate height and prevention of intraoperative over-distraction of disc space will be helpful to prevention of subsidence of the cage after anterior cervical discectomy and fusion using the PEEK cage.
Diskectomy
;
Follow-Up Studies
;
Humans
;
Incidence
;
Postoperative Period
;
Risk Factors
;
Transplants

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