1.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.
2.Afatinib-Induced Acute Fatal Pneumonitis in Metastatic Lung Adenocarcinoma.
Sang Hoon YOO ; Jin Ah RYU ; Seo Ree KIM ; Su Yun OH ; Gu Sung JUNG ; Dong Jae LEE ; Bong Gyu KWAK ; Yu Hyun NAM ; Kyung Hyun KIM ; Young Jun YANG
Korean Journal of Family Medicine 2016;37(6):351-355
Afatinib is an oral tyrosine kinase inhibitor (TKI) that inhibit Endothelial Growth Factor Receptor (EGFR), Human Epidermal Growth Factor Receptor 2 (HER2), and HER4. The common side effects of EGFR TKI are rash, acne, diarrhea, stomatitis, pruritus, nausea, and loss of appetite. Drug induced pneumonitis is the less common adverse effects of EGFR TKI. Afatinib, 2nd generation EGFR TKI is anticipated to overcome drug resistance from 1st generation EGFR TKI according to preclinical study, and several studies are being conducted to compare clinical efficacy between 1st and 2nd EGFR TKI. Several cases of rug induced acute fatal pneumonitis were reported after use of erlotinib or gefitinib. However, a case of acute fatal pneumonitis associated with afatinib was note reported except drug induced pneumonitis in other clinical study. Here, we present a cases of acute severe pneumonitis related with afatinib in metastatic lung adenocarcinoma with literature review.
Acne Vulgaris
;
Adenocarcinoma*
;
Appetite
;
Clinical Study
;
Diarrhea
;
Drug Resistance
;
Erlotinib Hydrochloride
;
Exanthema
;
Humans
;
Lung*
;
Nausea
;
Pneumonia*
;
Protein-Tyrosine Kinases
;
Pruritus
;
Receptor, Epidermal Growth Factor
;
Receptors, Vascular Endothelial Growth Factor
;
Stomatitis
;
Treatment Outcome
3.Afatinib-Induced Acute Fatal Pneumonitis in Metastatic Lung Adenocarcinoma.
Sang Hoon YOO ; Jin Ah RYU ; Seo Ree KIM ; Su Yun OH ; Gu Sung JUNG ; Dong Jae LEE ; Bong Gyu KWAK ; Yu Hyun NAM ; Kyung Hyun KIM ; Young Jun YANG
Korean Journal of Family Medicine 2016;37(6):351-355
Afatinib is an oral tyrosine kinase inhibitor (TKI) that inhibit Endothelial Growth Factor Receptor (EGFR), Human Epidermal Growth Factor Receptor 2 (HER2), and HER4. The common side effects of EGFR TKI are rash, acne, diarrhea, stomatitis, pruritus, nausea, and loss of appetite. Drug induced pneumonitis is the less common adverse effects of EGFR TKI. Afatinib, 2nd generation EGFR TKI is anticipated to overcome drug resistance from 1st generation EGFR TKI according to preclinical study, and several studies are being conducted to compare clinical efficacy between 1st and 2nd EGFR TKI. Several cases of rug induced acute fatal pneumonitis were reported after use of erlotinib or gefitinib. However, a case of acute fatal pneumonitis associated with afatinib was note reported except drug induced pneumonitis in other clinical study. Here, we present a cases of acute severe pneumonitis related with afatinib in metastatic lung adenocarcinoma with literature review.
Acne Vulgaris
;
Adenocarcinoma*
;
Appetite
;
Clinical Study
;
Diarrhea
;
Drug Resistance
;
Erlotinib Hydrochloride
;
Exanthema
;
Humans
;
Lung*
;
Nausea
;
Pneumonia*
;
Protein-Tyrosine Kinases
;
Pruritus
;
Receptor, Epidermal Growth Factor
;
Receptors, Vascular Endothelial Growth Factor
;
Stomatitis
;
Treatment Outcome
4.Spinal Cord Injury Markedly Altered Protein Expression Patterns in the Affected Rat Urinary Bladder during Healing Stages.
Ji Young LEE ; Bong Jo KIM ; Gyujin SIM ; Gyu Tae KIM ; Dawon KANG ; Jae Hun JUNG ; Jeong Seok HWA ; Yeon Ju KWAK ; Yeon Jin CHOI ; Young Sook PARK ; Jaehee HAN ; Cheol Soon LEE ; Kee Ryeon KANG
Journal of Korean Medical Science 2011;26(6):814-823
The influence of spinal cord injury (SCI) on protein expression in the rat urinary bladder was assessed by proteomic analysis at different time intervals post-injury. After contusion SCI between T9 and T10, bladder tissues were processed by 2-DE and MALDI-TOF/MS at 6 hr to 28 days after SCI to identify proteins involved in the healing process of SCI-induced neurogenic bladder. Approximately 1,000 spots from the bladder of SCI and sham groups were visualized and identified. At one day after SCI, the expression levels of three protein were increased, and seven spots were down-regulated, including heat shock protein 27 (Hsp27) and heat shock protein 20 (Hsp20). Fifteen spots such as S100-A11 were differentially expressed seven days post-injury, and seven proteins including transgelin had altered expression patterns 28 days after injury. Of the proteins with altered expression levels, transgelin, S100-A11, Hsp27 and Hsp20 were continuously and variably expressed throughout the entire post-SCI recovery of the bladder. The identified proteins at each time point belong to eight functional categories. The altered expression patterns identified by 2-DE of transgelin and S100-A11 were verified by Western blot. Transgelin and protein S100-A11 may be candidates for protein biomarkers in the bladder healing process after SCI.
Animals
;
Biological Markers/metabolism
;
Electrophoresis, Gel, Two-Dimensional
;
Female
;
HSP20 Heat-Shock Proteins/metabolism
;
HSP27 Heat-Shock Proteins/metabolism
;
Microfilament Proteins/metabolism
;
Muscle Proteins/metabolism
;
Proteome/*biosynthesis
;
Proteomics
;
Rats
;
Rats, Sprague-Dawley
;
S100 Proteins/metabolism
;
Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization
;
Spinal Cord Injuries/*metabolism/pathology
;
Urinary Bladder/*metabolism
;
*Wound Healing
5.Amorphigenin inhibits Osteoclast differentiation by suppressing c-Fos and nuclear factor of activated T cells.
Bong Gyu KIM ; Han Bok KWAK ; Eun Yong CHOI ; Hun Soo KIM ; Myung Hee KIM ; Seong Hwan KIM ; Min Kyu CHOI ; Churl Hong CHUN ; Jaemin OH ; Jeong Joong KIM
Anatomy & Cell Biology 2010;43(4):310-316
Among the several rotenoids, amorphigenin is isolated from the leaves of Amopha Fruticosa and it is known that has anti-proliferative effects and anti-cnacer effects in many cell types. The main aim of this study was to investigate the effects of amorphigenin on osteoclast differentiation in vitro and on LPS treated inflammatory bone loss model in vivo. We show here that amorphigenin inhibited RANKL-induced osteoclast differentiation from bone marrow macrophages in a dose dependent manner without cellular toxicity. Anti-osteoclastogenic properties of amorphigenin were based on a down-regulation of c-fos and NFATc1. Amorphigenin markedly inhibited RANKL-induced p38 and NF-kappaB pathways, but other pathways were not affected. Micro-CT analysis of the femurs showed that amorphigenin protected the LPS-induced bone loss. We concluded that amorphigenin can prevent inflammation-induced bone loss. Thus we expect that amorphigenin could be a treatment option for bone erosion caused by inflammation.
Bone Marrow
;
Down-Regulation
;
Femur
;
Inflammation
;
Macrophages
;
NF-kappa B
;
Osteoclasts
;
Osteoporosis
;
Rotenone
;
T-Lymphocytes
6.The efficacy of MRI to diagnosis the bladder and rectal invasion in cervical cancer.
Il Jung CHOI ; Bong Gyu KWAK ; Moon Seok CHA
Korean Journal of Gynecologic Oncology 2007;18(1):26-31
OBJECTIVE: To evaluate the efficacy of MRI in bladder or rectal invasion of cervical cancer. METHODS: Between January 2000 and December 2005, 106 cervical cancer patients who underwent cystoscopy or sigmoidoscopy examination retrospectively compared with results of the MRI finding. A 5-point invasion score was used to determine bladder or rectal invasion in MRI (1 = no invasion, 3 = serosal invasion, 5 = definite mucosal invasion). Score of 3 or above was suspicious for both rectal and bladder invasion. RESULTS: Eighty one patients with negative for both rectal and bladder invasion in MRI were normal in cystoscopy and sigmoidoscopy. MRI identified 17 patients with suspected bladder invasion, 7 patients had confirmed bladder invasion in cystoscopy. MRI identified 11 patients with suspected rectal invasion, 1 patients had confirmed rectal invasion in sigmoidoscopy. The detection of rectal and bladder invasion by MRI had a negative predictive value of 100%. CONCLUSION: The use of a 5-point scoring system for predicting rectal or bladder invasion in MRI is accurate in detecting cervical cancer patients with no evidence of rectal or bladder invasion. The cervical cancer patients with no evidence of rectal or bladder invasion in MRI can obviate invasive cystoscopy and sigmoidoscopy.
Cystoscopy
;
Diagnosis*
;
Humans
;
Magnetic Resonance Imaging*
;
Retrospective Studies
;
Sigmoidoscopy
;
Urinary Bladder*
;
Uterine Cervical Neoplasms*
7.A Case of Ovarian Mucinous Borderline tumor in Postoperatively Diagnosed Dermatomyositis accompanying Colon Cancer.
Min Jung KIM ; Eunkuseul PARK ; Soo Jin KANG ; Il Jung CHOI ; Bong Gyu KWAK ; Moon Seok CHA ; Goo Hwa JE ; Hyun Ho KIM
Korean Journal of Obstetrics and Gynecology 2006;49(11):2410-2414
Dermatomyositis is rare inflammatory condition of the skin and muscles that the incidence is 5 cases per million population per year. This disease was strongly associated with malignant disease, particularly ovarian, lung, pancreatic, stomach and colorectal cancers, and non-Hodgkins lymphoma. A 56-year-old female patient had a ovarian tumor, thereafter she presented with typical skin lesions and muscle weakness. And then we found she had a colon cancer. Here we present the case with brief review of literature.
Colon*
;
Colonic Neoplasms*
;
Colorectal Neoplasms
;
Dermatomyositis*
;
Female
;
Humans
;
Incidence
;
Lung
;
Lymphoma, Non-Hodgkin
;
Middle Aged
;
Mucins*
;
Muscle Weakness
;
Muscles
;
Skin
;
Stomach
8.Efficacy of loop conization with right-angled triangular shaped excisor in patients with cervical intraepithelial neoplasia 3.
Il Jung CHOI ; Bong Gyu KWAK ; Moon Seok CHA
Korean Journal of Gynecologic Oncology 2006;17(3):222-226
OBJECTIVE: To evaluate the therapeutic value of conization using right-angled triangular shape loop cone biopsy excisor in patients with CIN 3 who want preserve the uterus. METHODS: A retrospective review of 64 patients was performed who underwent therapeutic conization for CIN 3 by using right-angled triangular shape loop cone biopsy excisor from January 2000 to August 2005. RESULTS: The mean duration of 64 follow-up patients who had conization for therapeutic purpose was 21.5 months (range 10-68). Their mean age was 41.1 years old and mean parity was 1.7. Two of 64 patients had CIN 3 on exocervix margin. During the followed up period, only one person (1/64) had relapse of CIN 3, hence, a simple hysterectomy was done. CONCLUSION: Right-angled triangular shape loop cone biopsy excisor is more effective than U-shaped loop with low rate of margin positive and recurrent rate in conservative treatment in CIN 3 patients who want to preserve uterus or fertility.
Biopsy
;
Cervical Intraepithelial Neoplasia*
;
Conization*
;
Female
;
Fertility
;
Follow-Up Studies
;
Humans
;
Hysterectomy
;
Parity
;
Recurrence
;
Retrospective Studies
;
Uterus
9.The Histologic Features of the Uterus and Adnexa Extirpated from Gender Identity Disorder Patients with Depot Androgen Injection.
Jae Chun BYUN ; Bong Gyu KWAK ; Ji Hyun SHIN ; Moon Seok CHA ; Myoung Seok HAN ; Seo Hee RHA ; Seok Kwun KIM
Korean Journal of Fertility and Sterility 2005;32(4):325-330
OBJECTIVE: To investigate the histologic features of the uterus and adnexae extirpated from gender identity disorder (GID) patients that received depot androgen injection. METHODS: We reviewed the histologic findings of the uterus and adnexae removed from sixteen GID patients, who had taken depot androgen injection for 5~168 months. RESULTS: Fourteen patients (87.5%) showed the atrophied epithelium of exocervix and all of 16 patients (100%) showed the atrophy of endometrium. Seven patients (43.7%) showed multiple cystic follicles in the ovarian cortex and 6 patients (37.5%), 3 patients (18.7%) showed corpus albicans and corpus luteum, respectively. CONCLUSIONS: Exogenous androgen induced atrophy of cervix and endometrium. This effect was more prominent in the endometrium. In addition, PCO-like histologic features were observed in the ovary.
Atrophy
;
Cervix Uteri
;
Corpus Luteum
;
Endometrium
;
Epithelium
;
Female
;
Gender Identity*
;
Humans
;
Ovary
;
Uterus*
10.Analysis of prognostic factor and survival in patients with epithelial ovarian cancer treated with combination chemotherapy.
Il Jung CHOI ; Bong Gyu KWAK ; Myoung Seok HAN ; Moon Seok CHA ; Hyun Ho KIM ; Goo Hwa JE
Korean Journal of Gynecologic Oncology 2005;16(2):154-162
OBJECTIVE: The purpose of this retrospective study is to identify and to discuss the clinical relevance of prognostic factors and survival rate in patients with epithelial ovarian cancer treated with combination chemotherapy. METHODS: A total of 98 histologically verified patients with epithelial ovarian cancer who were treated at Dong-A Medical Center between 1997 and 2002 were used for analysis. The 30 patients having borderline tumor were excluded. Kaplan-Meier survival curves were computed and tested statistically by the log rank test. A multivariable Cox proportional hazard model was applied to access the prognostic significance of the different covariates. RESULTS: The median age of the patients with epithelial ovarian cancer was 46.6 years and FIGO stage distribution was 38.2% for stage I, 5.9% for stage II, 44.1% for stage III, 11.8% for stage IV. The histopathologic type distribution were serous type (45.6%), mucinous type (36.8%), endometriod type (8.8%), clear cell type (7.4%), mixed type (1.4%). Residual tumor volume size of less than 1 cm or 1 cm was identified in 50 patients (73.5%) and more than 1 cm in 18 patients (26.5%) after primary cytoreductive surgery. The overall 5-year survival rate was 55.7%. According to univariate analysis, FIGO stage (p<0.0001), residual volume (p<0.0001), ascitic fluid volume (p=0.0001), menopause (p=0.0021), CA125 (p=0.0058), tumor size (p=0.0099), age (p=0.0113) were significant prognostic factors affecting survival. However, multivariate analysis in this study demonstrated that FIGO stage (p=0.011), residual tumor volume (p=0.026), ascitic fluid volume (p=0.031) were found to be the most significant independent prognostic factors. CONCLUSION: In this retrospective study, the overall 5-year survival rate of patients with epithelial ovarian cancer treated with combination chemotherapy was 55.7% and 5-year survival rate of stage I/II was 95.8%, stage III 28.4%, stage IV 0%. The overall survival of stage I/II were 90 months, stage III 39 months, stage IV 17 months. In multiple analysis, FIGO stage, residual volume, ascitic fluid volume were identified as three most significant independent prognostic factors.
Ascitic Fluid
;
Drug Therapy, Combination*
;
Female
;
Humans
;
Kaplan-Meier Estimate
;
Menopause
;
Mucins
;
Multivariate Analysis
;
Neoplasm, Residual
;
Ovarian Neoplasms*
;
Proportional Hazards Models
;
Residual Volume
;
Retrospective Studies
;
Survival Rate

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