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.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
3.An Automated Draft Report Generator for Peripheral Blood Smear Examinations Based on Complete Blood Count Parameters.
Young gon KIM ; Jung Ah KWON ; Yeonsook MOON ; Seong Jun PARK ; Sangwook KIM ; Hyun A LEE ; Sun Young KO ; Eun Ah CHANG ; Myung Hyun NAM ; Chae Seung LIM ; Soo Young YOON
Annals of Laboratory Medicine 2018;38(6):512-517
BACKGROUND: Complete blood count (CBC) results play an important role in peripheral blood smear (PBS) examinations. Many descriptions in PBS reports may simply be translated from CBC parameters. We developed a computer program that automatically generates a PBS draft report based on CBC parameters and age- and sex-matched reference ranges. METHODS: The Java programming language was used to develop a computer program that supports a graphical user interface. Four hematology analyzers from three different laboratories were tested: Sysmex XE-5000 (Sysmex, Kobe, Japan), Sysmex XN-9000 (Sysmex), DxH800 (Beckman Coulter, Brea, CA, USA), and ADVIA 2120i (Siemens Healthcare Diagnostics, Eschborn, Germany). Input data files containing 862 CBC results were generated from hematology analyzers, middlewares, or laboratory information systems. The draft reports were compared with the content of input data files. RESULTS: We developed a computer program that reads CBC results from a data file and automatically writes a draft PBS report. Age- and sex-matched reference ranges can be automatically applied. After examining PBS, users can modify the draft report based on microscopic findings. Recommendations such as suggestions for further evaluations are also provided based on morphological findings, and they can be modified by users. The program was compatible with all four hematology analyzers tested. CONCLUSIONS: Our program is expected to reduce the time required to manually incorporate CBC results into PBS reports. Systematic inclusion of CBC results could help improve the reliability and sensitivity of PBS examinations.
Blood Cell Count*
;
Clinical Laboratory Information Systems
;
Delivery of Health Care
;
Hematology
;
Indonesia
;
Information Storage and Retrieval
;
Programming Languages
;
Reference Values
4.Evaluation of the Abuse Potential of Novel Amphetamine Derivatives with Modifications on the Amine (NBNA) and Phenyl (EDA, PMEA, 2-APN) Sites.
Raly James Perez CUSTODIO ; Chrislean Jun BOTANAS ; Seong Shoon YOON ; June Bryan DE LA PEÑA ; Irene Joy DELA PEÑA ; Mikyung KIM ; Taeseon WOO ; Joung Wook SEO ; Choon Gon JANG ; Yong Ho KWON ; Nam Yong KIM ; Yong Sup LEE ; Hee Jin KIM ; Jae Hoon CHEONG
Biomolecules & Therapeutics 2017;25(6):578-585
Recently, there has been a rise in the number of amphetamine derivatives that serve as substitutes for controlled substances (e.g. amphetamine and methamphetamine) on the global illegal drug market. These substances are capable of producing rewarding effects similar to their parent drug. In anticipation of the future rise of new and similar psychoactive substances, we designed and synthesized four novel amphetamine derivatives with N-benzyl, N-benzylamphetamine HCl (NBNA) substituent on the amine region, 1,4-dioxane ring, ethylenedioxy-amphetamine HCl (EDA), methyl, para-methylamphetamine HCl (PMEA), and naphthalene, 2-(aminopropyl) naphthalene HCl (2-APN) substituents on the phenyl site. Then, we evaluated their abuse potential in the conditioned place preference (CPP) test in mice and self-administration (SA) test in rats. We also investigated the psychostimulant properties of the novel drugs using the locomotor sensitization test in mice. Moreover, we performed qRT-PCR analyses to explore the effects of the novel drugs on the expression of D1 and D2 dopamine receptor genes in the striatum. NBNA, but not EDA, PMEA, and 2-APN, induced CPP and SA in rodents. None of the test drugs have produced locomotor sensitization. qRT-PCR analyses demonstrated that NBNA increased the expression of striatal D1 dopamine receptor genes. These data indicate that NBNA yields rewarding effects, suggesting potential for abuse. Continual observation for the rise of related substances is thus strongly encouraged.
Amphetamine*
;
Animals
;
Controlled Substances
;
Humans
;
Mice
;
Parents
;
Rats
;
Receptors, Dopamine
;
Reward
;
Rodentia
5.The safety and efficacy of percutaneous transhepatic gallbladder drainage in elderly patients with acute cholecystitis before laparoscopic cholecystectomy.
Byung Gon NA ; Young Sun YOO ; Seong Pyo MUN ; Seong Hwan KIM ; Hyun Young LEE ; Nam Kyu CHOI
Annals of Surgical Treatment and Research 2015;89(2):68-73
PURPOSE: Laparoscopic cholecystectomy (LC) is the standard management for acute cholecystitis. Percutaneous transhepatic gallbladder drainage (PTGBD) may be an alternative interim strategy before surgery in elderly patients with comorbidities. This study was designed to evaluate the safety and efficacy of PTGBD for elderly patients (>60 years) with acute cholecystitis. METHODS: We reviewed consecutive patients diagnosed with acute cholecystitis between January 2009 and December 2013. Group I included patients who underwent PTGBD, and patients of group II did not undergo PTGBD before LC. RESULTS: All 116 patients (72.7 +/- 7.1 years) were analyzed. The preoperative details of group I (n = 39) and group II (n = 77) were not significantly different. There was no significant difference in operative time (P = 0.057) and intraoperative estimated blood loss (P = 0.291). The rate of conversion to open operation of group I was significantly lower than that of group II (12.8% vs. 32.5%, P < 0.050). No significant difference of postoperative morbidity was found between the two groups (25.6% vs. 26.0%, P = 0.969). In addition, perioperative mortality was not significantly different. Preoperative hospital stay of group I was significantly longer than that of group II (10.3 +/- 5.7 days vs. 4.4 +/- 2.8 days, P < 0.050). However, two groups were not significantly different in total hospital stay (16.3 +/- 9.0 days vs. 13.4 +/- 6.5 days, P = 0.074). CONCLUSION: PTGBD is a proper preoperative management before LC for elderly patients with acute cholecystitis.
Aged*
;
Cholecystectomy, Laparoscopic*
;
Cholecystitis, Acute*
;
Comorbidity
;
Drainage*
;
Gallbladder*
;
Humans
;
Length of Stay
;
Mortality
;
Operative Time
6.Clinical outcome for laparoscopic cholecystectomy in extremely elderly patients.
Sang Ill LEE ; Byung Gon NA ; Young Sun YOO ; Seong Pyo MUN ; Nam Kyu CHOI
Annals of Surgical Treatment and Research 2015;88(3):145-151
PURPOSE: Extremely elderly patients who present with complicated gallstone disease are less likely to undergo definitive treatment. The use of laparoscopic cholecystectomy (LC) in older patients is complicated by comorbid conditions that are concomitant with advanced age and may increase postoperative complications and the frequency of conversion to open surgery. We aimed to evaluate the results of LC in patients (older than 80 years). METHODS: We retrospectively analyzed 302 patients who underwent LC for acute cholecystitis between January 2011 and December 2013. Total patients were divided into three groups: group 1 patients were younger than 65 years, group 2 patients were between 65 and 79 years, and group 3 patients were older than 80 years. Patient characteristics were compared between the different groups. RESULTS: The conversion rate was significantly higher in group 3 compared to that in the other groups. Hematoma in gallbladder fossa and intraoperative bleeding were higher in group 3, the difference was not significant. Wound infection was not different between the three groups. Operating time and postoperative hospital stay were significantly higher in group 3 compared to those in the other groups. There was no reported bile leakage and operative mortality. Preoperative percutaneous transhepatic gallbladder drainage and endoscopic retrograde cholangiopancreatography were performed more frequently in group 3 than in the other groups. CONCLUSION: LC is safe and feasible. It should be the gold-standard approach for extremely elderly patients with acute cholecystitis.
Aged*
;
Bile
;
Cholangiopancreatography, Endoscopic Retrograde
;
Cholecystectomy, Laparoscopic*
;
Cholecystitis, Acute
;
Conversion to Open Surgery
;
Drainage
;
Gallbladder
;
Gallstones
;
Hematoma
;
Hemorrhage
;
Humans
;
Length of Stay
;
Mortality
;
Postoperative Complications
;
Retrospective Studies
;
Treatment Outcome
;
Wound Infection
7.The effect of silk fibroin and rhBMP-2 on bone regeneration in rat calvarial defect model.
Jeong Hun NAM ; Kyung Lok NOH ; Eun O PANG ; Woo Geun YU ; Eung Sun KANG ; Hae Yong KWEON ; Seong Gon KIM ; Young Ju PARK
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2010;36(5):366-374
INTRODUCTION: This study evaluated the capability of silk fibroin (SF) and recombinant human bone morphogenetic protein-2 loaded SF (SF-BMP) as a bone defect replacement matrix when grafted in a calvarial bone defect of rats in vivo. MATERIALS AND METHODS: A total 70 calvarial critical size defects (5.0 mm in diameter) made on 35 adult female Sprague-Dawley rats were used in this study. The defects were transplanted with (1) rhBMP-2 loaded silk fibroin graft (SF-BMP: 0.8+10 microg), (2) Silk fibroin (SF: 10 microg), and (3) no graft material (Raw). The samples were evaluated with soft x-rays, alkaline phosphatase activity, calcium/phosphate quantification, histological and histomorphometric analysis at postoperative 4 and 8 weeks. RESULTS: The SF-BMP group (48.86+/-14.92%) had a significantly higher mean percentage bone area than the SF group (24.96+/-11.01%) at postoperative 4 weeks.(P<0.05) In addition, the SF-BMP group (40.01+/-12.43%) had a higher % bone area at postoperative 8 weeks than the SF group (33.26+/-5.15%). The mean ratio of gray scale levels to the host bone showed that the SF-BMP group (0.67+/-0.08) had a higher mean ratio level than the SF group (0.61+/-0.09) at postoperative 8 weeks. These differences were not statistically significant.(P=0.168 and P=0.243, respectively) CONCLUSION: The rhBMP-2 loaded silk fibroin graft revealed fewer immunoreactions and inflammation as well as more new bone formation than the pure silk fibroin graft. Therefore, silk fibroin may be a candidate scaffold for tissue engineered bone regeneration.
Adult
;
Alkaline Phosphatase
;
Animals
;
Bone Morphogenetic Protein 2
;
Bone Regeneration
;
Female
;
Fibroins
;
Humans
;
Inflammation
;
Osteogenesis
;
Rats
;
Rats, Sprague-Dawley
;
Recombinant Proteins
;
Silk
;
Tissue Scaffolds
;
Transforming Growth Factor beta
;
Transplants
8.Study of Facts and Problems of Reports for Court about Traumatic Mental and Behavioral Disabilities.
Seong Gon RYU ; Hanyong JUNG ; Boung Chul LEE ; Kyung Nam AHN
Journal of Korean Neuropsychiatric Association 2008;47(6):561-567
Traumatic injury can result not only in physical disability but also in mental and behavioral sequelae. It is very important to properly judge the severity of disability as well as the need for assistance and future medical treatment. It is very difficult to establish objective guidelines for assessing mental and behavioral disabilities due to the inherent peculiarity of the disabilities. This study uses reports generated for court because they need to be more judicious than reports for other types of evaluation. We analyzed reports concerning the facts and problems associated with evaluation of mental and behavioral disabilities. We hope this study will help further our understanding of mental and behavioral disabilities.
9.The prevalence of microalbuminuria and associated factors in newly diagnosed type 2 diabetes mellitus in Korea.
Dong Jin KIM ; Seong Jin RYU ; Young Jin SEO ; Nam Hoon KIM ; Hye Soo CHUNG ; Chai Ryoung EUN ; Hye Jung CHOI ; Hye Sook KIM ; Sae Jeong YANG ; Juri PARK ; Hye Jin YOO ; Soo Yeon PARK ; Yun Jeong LEE ; Ohk Hyun RYU ; Kye Won LEE ; Hee Young KIM ; Ji A SEO ; Sin Gon KIM ; Nan Hee KIM ; Kyung Mook CHOI ; Sei Hyun BAIK ; Dong Seop CHOI
Korean Journal of Medicine 2007;73(5):503-511
BACKGROUND: To determine the prevalence and the associated factors of microalbuminuria in Korean subjects with newly diagnosed type 2 diabetes mellitus. METHODS: A total of 304 patients with newly diagnosed type 2 diabetes mellitus that visited Anam Hospital, Korea University Medical Center, were studied cross-sectionally for the presence of microalbuminuria and other micro- and macrovascular complications. Microalbuminuria was calculated by the amount of albumin excretion in the urine for 24 hrs (30-299 mg/24hr) or by the albumin creatinine ratio in a spot urine sample (30-299 mg/g creatinine). Subjects were divided into two groups: the normoalbuminuria group and the microalbuminuria group. RESULTS: The prevalence of microalbuminuria, normoalbuminuria and overt proteinuria in patients with newly diagnosed type 2 diabetes mellitus was 17.1%, 80.3% and 2.6%. respectively. Microalbuminuria was significantly correlated with the body mass index (BMI), fasting insulin level, fasting C-peptide level and triglyceride level. The number of metabolic syndrome components was significantly correlated with the amount of microalbuminuria. In patients with microalbuminuria and without retinopathy, the correlation of microalbuminuria and the presence of metabolic syndrome was also significant. CONCLUSIONS: The prevalence of microalbuminuria in 304 Korean patients with newly diagnosed type 2 diabetes mellitus was 17.1%, and microalbuminuria had a correlation with the BMI, fasting insulin level, fasting C-peptide level, HOMA level, triglyceride level and the presence of metabolic syndrome.
Academic Medical Centers
;
Body Mass Index
;
C-Peptide
;
Creatinine
;
Diabetes Mellitus
;
Diabetes Mellitus, Type 2*
;
Fasting
;
Humans
;
Insulin
;
Korea*
;
Prevalence*
;
Proteinuria
;
Triglycerides
10.The therapeutic effect of silver nanocrystalline ointment on TMJ capsulitis.
Chang Hoon CHAE ; Jwa Young KIM ; Mi Ja KIM ; Hoon CHUNG ; Seung Ho KIM ; Hyun Woo OH ; Young Nam KIM ; Young Il KIM ; Byung Ho YANG ; Seong Gon KIM
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2006;32(3):262-266
The silver nanocrystalline is widely used for biological field because of its biocompatibility and anti-microbial effect. The objective of this study was to evaluate the therapeutic efficacy of the silver nanocrystalline ointment on the temporomandibular joint (TMJ) capsulitis. Total 39 patients were included in this study and all patients were received single topical application of the silver nanocrystalline ointment (group A, n=30) or placebo ointment (group B, n=19). Measured variables were maximum mouth opening (MMO), visual analog scale (VAS) for pain, and VAS for function. In results, we could not assess any therapeutic efficacy of single application in the chronic TMJ capsulitis (p>0.05). However, the single application of silver nanocrystalline ointment showed significant improvement in MMO and VAS for pain compared to placebo effect in the acute TMJ capsulitis (p<0.05). We could not find any complications related to ointment application in both groups. In conclusion, the single application of silver nanocrystalline ointment was effective in improving patient's symptom in acute TMJ capsulitis without any noticing complications.
Humans
;
Mouth
;
Placebo Effect
;
Silver*
;
Temporomandibular Joint*
;
Visual Analog Scale

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