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.Preventable Trauma Death Rate in Daegu, South Korea.
Sungbae MOON ; Suk Hee LEE ; Hyun Wook RYOO ; Jong Kun KIM ; Jae Yun AHN ; Sung Jin KIM ; Jae Cheon JEON ; Kyung Woo LEE ; Ae Jin SUNG ; Yun Jeong KIM ; Dae Ro LEE ; Byung Soo DO ; Sin Ryul PARK ; Jin Seok LEE
Journal of the Korean Society of Emergency Medicine 2016;27(5):404-413
PURPOSE: This study was performed to investigate the preventable death rate (PDR) in Daegu, South Korea, and to assess both its affecting- and preventable-factors to improve the treatment of regional trauma patients. METHODS: All cases of traumatic death that occurred between January 2012 and December 2012 in five hospitals in Daegu were analyzed retrospectively by a panel review. Cases were classified into preventable (P) and non-preventable deaths (NP). We determined the affecting factors of trauma deaths and preventable factors during trauma care. RESULTS: The PDR was 25.2%. Significant differences by mode of arrival, day of injury, cause of death, and time of emergency department (ED) arrival were observed between P and NP groups. According to the logistic regression analysis, preventability was associated with patients transferred from other hospitals, ED arrival at night and dawn, and non-head injuries. A total of 145 preventable factors were discovered in 59 preventable trauma deaths. When we categorized by location, the ED was the most common, with 71 cases, followed by 57 prehospital preventable factors. When we classified the preventable factors by process, 76.8% were process-related and 23.4% were structure-related. CONCLUSION: Our study is valuable to build an adequate trauma system in Daegu as it provides the baseline quality control data. Efforts to mediate the preventable factors were revealed in this study, and continuous reviews to calculate and track the PDR are needed to evaluate the local trauma system and establish a system specific to Daegu.
Cause of Death
;
Daegu*
;
Emergency Service, Hospital
;
Humans
;
Korea*
;
Logistic Models
;
Mortality*
;
Outcome and Process Assessment (Health Care)
;
Quality Control
;
Retrospective Studies
4.Comparison of Clinical Manifestation and Prognosis of Preterm and Full-Term Infants with Down Syndrome.
Hye Seon KIM ; Ji Suk KIM ; Yo Han HO ; Ka Young PARK ; Sin Ae YOUN ; Ji Young JEON ; So Youn AN ; Hye Soo YOO ; Sei In SEONG ; Yun Sil CHANG ; Won Soon PARK
Neonatal Medicine 2015;22(2):105-111
PURPOSE: To investigate and compare the clinical manifestation and prognosis of preterm and full-term infants with Down syndrome (DS). METHODS: We retrospectively reviewed 80 patients diagnosed with DS and confirmed by chromosomal study at the Samsung Medical Center between January 1994 and July 2014. Data on demographic characteristics, associated anomalies, treatment, prognosis and cause of death were compared between preterm and full-term DS infants. RESULTS: Of the 80 confirmed DS patients, there were 49 (61%) full-term and 31 (38%) preterm DS infants. The mean gestational age of full-term DS infants was 38(+1)+/-0(+2) weeks (range, 37(+0)-40(+0) weeks) and the mean birth weight was 3,007+/-418 g (range, 1,930-4,100 g). The mean gestational age of preterm infants was 34(+1)+/-2(+1) weeks (range, 29(+1)-36(+6) weeks) and the mean birth weight was 2,181+/-598 g (range, 890-3,500 g). There were no differences in demographics, associated anomalies, mortality or related factors, or the rate of active treatment between full-term and preterm DS infants. CONCLUSION: In this single center study, the mortality rate of preterm DS infants was comparable to that of full-term DS infants. Larger national cohort studies might be needed to further investigate the prognosis of preterm DS infants.
Birth Weight
;
Cause of Death
;
Cohort Studies
;
Demography
;
Down Syndrome*
;
Gestational Age
;
Humans
;
Infant*
;
Infant, Newborn
;
Infant, Premature
;
Mortality
;
Prognosis*
;
Retrospective Studies
5.Effect of Continuous Urethro-Vesical Anastomosis Technique in Incontinence After Radical Retropubic Prostatectomy, 1:1 Matching Study.
Sin Woo LEE ; Deok Hyun HAN ; Kyu Sung LEE ; Seong Soo JEON
International Neurourology Journal 2015;19(2):113-119
PURPOSE: Vesicourethral anastomosis (VUA) is an important step in radical prostatectomy and can affect clinical course in hospital. However, few studies comparing VUA by standard interrupted and continuous suturing techniques in radical retropubicprostatectomy (RRP) have been reported. We compared the postoperative outcomes and continence recovery rates of patients undergoing these two variations of VUA using 1:1 propensity score matching. METHODS: From January 2008 to January 2014, a total of 188 patients underwent RRP. We conducted 1:1 propensity score matching based on age, prostate volume, pathological stage, status of nerve sparing, and two baseline characteristics (preoperative prostate-specific antigen [PSA] level and Gleason score determined by pathology). Patients were assigned to two groups based on the suturing method used (interrupted or continuous). After RRP, incontinence levels were assessed at 1, 3, 6, and 12months based on pad usage per day (0, dry; < or =1, social continence; > or =2, incontinence). RESULTS: Each group consisted of 47 patients. The continuous group had a lower incidence of VUA site leakage (0% vs. 10.6%, P=0.022), but there were no significant differences in the rates of postoperative urethral stricture (6.4% vs. 6.4%, P=1.00) andpyuria (43.6% vs. 45.0%, P=0.770) between the two groups. The rate of recovery to social continence was greater in the continuous group at postoperative 3 months (85.1% vs. 66.0%, P=0.031). About 50% of patients had no incontinence (pad perday=0) after 6 months (59.6% in the continuous group and 51.1% in the interrupted group, P=0.407) and at postoperative 12 months, the dry rate 61.7% in the interrupted group and 80.4% in the continuous group (P=0.047). The times required toreach social continence (3.21 months vs. 3.77 months, P=0.056) and no incontinence (7.23 months vs. 7.63 months, P=0.132) were also shorter in the continuous group, but these differences were not statistically significant. CONCLUSIONS: The results of this study suggest that earlier recovery to social continence and a higher rate of complete recovery (dry) could be expected with VUA by continuous suturing. Furthermore, if adequate surgical experience is accumulated, VUAwith continuous suturing could be performed without difficulty.
Anastomosis, Surgical
;
Humans
;
Incidence
;
Neoplasm Grading
;
Propensity Score
;
Prostate
;
Prostate-Specific Antigen
;
Prostatectomy*
;
Urethral Stricture
;
Urinary Incontinence, Stress
6.Laparoscopic Partial Nephrectomy Using a Water (Hydro)-Jet System: A Case Report.
Sin Woo LEE ; Hyun Hwan SUNG ; Hwang Gyun JEON ; Byong Chang JEONG ; Seong Soo JEON ; Hyun Moo LEE ; Han Yong CHOI ; Seong Il SEO
Korean Journal of Urological Oncology 2015;13(3):138-142
The water-jet system (WJS) can be used for selective dissection of kidney parenchyma without renal artery clamping in laparoscopic partial nephrectomy (LPN). We report our experiences regarding LPN with a WJS. The first case was a 59 year old male with a 1.8 cm solid mass in the Rt. mid-lateral area (R.E.N.A.L score: 5a). The second case was a 24 year old female with a 2.3cm solid mass in the Lt. mid-lateral area (R.E.N.A.L score: 7x). We successfully finished non-clamping LPN using a WJS without perioperative complications. Surgical margins were negative (7mm and 1mm for cases 1 and 2, respectively). Post-operative renal function was not decreased significantly. LPN using a WJS is a feasible and safe technique which can be performed for small renal masses without ischemic damage.
Constriction
;
Female
;
Humans
;
Kidney
;
Laparoscopy
;
Male
;
Nephrectomy*
;
Renal Artery
;
Water*
7.Granulocyte Colony Stimulating Factor Attenuates Hyperoxia-Induced Lung Injury by Down-Modulating Inflammatory Responses in Neonatal Rats.
Ga Won JEON ; Dong Kyung SUNG ; Yu Jin JUNG ; Soo Hyun KOO ; Seo Heui CHOI ; Yun Sil CHANG ; Jong Beom SIN ; Won Soon PARK
Yonsei Medical Journal 2011;52(1):65-73
PURPOSE: Granulocyte colony stimulating factor (G-CSF) has been known to increase neutrophil production and have anti-inflammatory properties, but the effect of G-CSF on pulmonary system is in controversy. We investigated whether G-CSF treatment could attenuate hyperoxia-induced lung injury, and whether this protective effect is mediated by the down-modulation of inflammatory responses in a neonatal rat model. MATERIALS AND METHODS: Newborn Sprague-Dawley rats (Orient Co., Seoul, Korea) were subjected to 14 days of hyperoxia (90% oxygen) beginning within 10 h after birth. G-CSF (20 microg/kg) was administered intraperitoneally on the fourth, fifth, and sixth postnatal days. RESULTS: This treatment significantly improved hyperoxia-induced reduction in body weight gain and lung pathology such as increased mean linear intercept, mean alveolar volume, terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate nick end labeling positive cells. Hyperoxia-induced activation of nicotinamide adenine dinucleotide phosphate oxidase, which is responsible for superoxide anion production, as evidenced by upregulation and membrane translocation of p67phox was significantly attenuated after G-CSF treatment, as were inflammatory responses such as increased myeloperoxidase activity and mRNA expression of transforming growth factor-beta. However, the attenuation of other proinflammatory cytokines such as tumor necrosis factor-alpha and interleukin-6 was not significant. CONCLUSION: In sum, G-CSF treatment significantly attenuated hyperoxia-induced lung injury by down-modulating the inflammatory responses in neonatal rats.
Animals
;
Animals, Newborn
;
Blotting, Western
;
Female
;
Granulocyte Colony-Stimulating Factor/*therapeutic use
;
Hyperoxia/*complications
;
In Situ Nick-End Labeling
;
Interleukin-6/genetics
;
Lung/*drug effects/*metabolism
;
Lung Injury/*drug therapy/etiology/genetics/metabolism
;
NADPH Oxidase/metabolism
;
Peroxidase/metabolism
;
Pregnancy
;
Random Allocation
;
Rats
;
Rats, Sprague-Dawley
;
Reverse Transcriptase Polymerase Chain Reaction
;
Transforming Growth Factor beta/genetics
;
Tumor Necrosis Factor-alpha/genetics
;
Weight Gain/drug effects
8.The Clinical Effects of Early Trophic Feeding in Extremely Low Birth Weight Infants.
Ji Mi JUNG ; Seong Woo HAN ; Mi Lim CHUNG ; Soo Hyun KOO ; Ga Won JEON ; Jong Beom SIN
Korean Journal of Perinatology 2011;22(2):122-128
PURPOSE: This study investigated the effects of early enteral feeding on the morbidities of extremely low birth weight infants (ELBWI) weighing less than 1,000 g. METHODS: We conducted a retrospective review of the medical records of sixty one ELBWI who were admitted to the neonatal intensive care unit of Inje University Busan Paik Hospital from January 2007 to October 2009. ELBWI were divided into two groups; the control group included ELBWI from January 2007 to March 2008, for whom enteral feeding was started beyond 3 days and the early feeding group included ELBWI from April 2008 to October 2009, for whom enteral feeding was started within 3 days. RESULTS: Gestational age and birth weight did not differ between the two groups. In the early feeding group, start day of enteral feeding (control group vs. early feeding group; 7+/-2days vs. 2+/-1days), time to achieve full enteral feeding (68+/-6 days vs. 22+/-2 days), and the duration of parenteral nutrition (58+/-6 days vs. 22+/-2 days) were significantly shorter, and weight gain at postnatal day 28 was significantly higher than that of the control group (P<0.001). No differences were observed in the incidence of sepsis and necrotizing enterocolitis and duration of hospitalization; however, the incidence of total parenteral nutrition induced cholestasis (44% vs. 7%) and bronchopulmonary dysplsia (78% vs. 24%) was significantly lower in the early feeding group. CONCLUSION: Early enteral feeding in ELBWI shortened the time to achieve full enteral feeding, improved weight gain, and decreased the incidence of brochopulmonay dysplasia and cholestasis.
Birth Weight
;
Cholestasis
;
Enteral Nutrition
;
Enterocolitis, Necrotizing
;
Gestational Age
;
Humans
;
Incidence
;
Infant
;
Infant, Low Birth Weight
;
Infant, Newborn
;
Intensive Care, Neonatal
;
Medical Records
;
Parenteral Nutrition
;
Parenteral Nutrition, Total
;
Retrospective Studies
;
Sepsis
;
Weight Gain
9.Korean Ginseng-Induced Occupational Asthma and Determination of IgE Binding Components.
Kyung Mook KIM ; Hyouk Soo KWON ; Sung Gyu JEON ; Chang Han PARK ; Seong Wook SOHN ; Duck In KIM ; Sun Sin KIM ; Yoon Seok CHANG ; Yoon Keun KIM ; Sang Heon CHO ; Kyung Up MIN ; You Young KIM
Journal of Korean Medical Science 2008;23(2):232-235
A number of case reports on occupational asthma caused by herbal medicines have been issued, for example, on Sanyak, Chunkung, Banha, and Brazilian ginseng. Recently, cases of occupational asthma induced by Sanyak and Korean ginseng have been reported, but the pathogenic mechanisms involved are unknown. This study was carried out to evaluate the immunologic mechanism underlying Korean ginseng-induced occupational asthma. A patient engaged in Korean ginseng wholesale was referred for recurrent dyspnea, wheezing, and nasal symptoms, which were aggravated at work. Allergen bronchial provocation testing to Korean ginseng extract showed a typical immediate response, and skin prick testing to Korean ginseng extract also showed a strong positive response. Moreover, serum-specific IgE levels to Korean ginseng extract were significantly higher than in controls. Enzymelinked immunosorbent assay (ELISA) inhibition tests showed a dose-dependent inhibition by Korean ginseng, but not by Dermatophagoides farinae, wheat flour, or Chinese balloon flower. Sodium dodecylsulfate-poly-acrylamide gel electrophoresis (SDS-PAGE) and immunoblotting revealed four specific Immunoglobulin E (IgE) binding components at 26, 30, 47, and 60 kDa, which were not bound by control sera. These results strongly suggest that occupation asthma induced by Korean ginseng is induced via an IgE-mediated mechanism.
Animals
;
Asthma/diagnosis/*etiology/*immunology
;
Bronchi/metabolism
;
Electrophoresis, Polyacrylamide Gel
;
Enzyme-Linked Immunosorbent Assay/methods
;
Flour
;
Flowers
;
Humans
;
Hypersensitivity/*diagnosis
;
Immunoglobulin E/analysis/*chemistry
;
Korea
;
Occupational Diseases/diagnosis/*etiology/*immunology
;
Panax/*adverse effects
;
Pyroglyphidae/metabolism
;
*Skin Tests
10.The clinical outcome of renal transplantation with a poor HLA matched living kidney donors.
Yong Hun SIN ; Hyun Ju KIM ; Hwa Mok LEE ; Joon Seok OH ; Hyun Cheol HWANG ; Dong Han IM ; Ji Hwan KIM ; Chang Soo PARK ; Mi Jeong PARK ; Hoe Joo OH ; Yong Ki PARK ; Joong Kyung KIM ; Gun Ung JEON
Korean Journal of Medicine 2005;69(4):402-409
BACKGROUND: Poor HLA matched donors may become an additional organ source for renal transplantation. This study is conducted to predict the clinical outcomes of renal transplantation in a poor HLA matched group (0 or 1 or 2 HLA matching) by comparing them with those of HLA haploidentical group. METHODS: This study compared a poor HLA matched group (N=89) with HLA haploidentical group (N=79) to analyze differences between two groups in graft survival, incidence of acute rejection, cause of graft failure, posttransplant serum creatinine at 1, 2, 3, 5 years. Total 168 cases, appeared in the medical records for more than six months in Bong-Saeng Hospital, from December, 1984 to March, 2004 were traced and identified as relevant cases for this study. RESULTS: Allograft survival rate at 1, 3, 5, 10 years for poor HLA matched group and HLA haploidentical group were 100%, 98.6%, 95.4%, 72.5% and 100%, 100%, 96.1%, 86.2% (p=not significant) respectively. Acute rejection developed in 25.8% of poor HLA matched group versus 18.9% of HLA haploidentical group (p=not significant). The most common causes of graft failure in both groups were chronic rejection. CONCLUSIONS: It should be actively encouraged to consider renal transplantation in a poor HLA matched group as the results of this study support that the clinical outcomes of renal transplantation in a poor HLA matched group are equivalent to those of HLA haploidentical group.
Allografts
;
Creatinine
;
Graft Survival
;
Humans
;
Incidence
;
Kidney Transplantation*
;
Kidney*
;
Medical Records
;
Research Design
;
Survival Rate
;
Tissue Donors*
;
Transplants

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