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.Developmental Delay and Rehabilitation in an Infant with Partial Trisomy 1q32.1 to 1q44: A Case Report
Woo Kyung KIM ; Na Mi LEE ; In Seok LIM ; Soo Ahn CHAE ; Sin Weon YUN ; Dae Yong YI ; Su Yeong KIM
Neonatal Medicine 2022;29(2):91-95
Partial trisomy 1q is a rare chromosomal disorder characterized by ventriculomegaly with craniofacial, renal, cardiac, and finger and toe anomalies. Most reported cases of partial trisomy1q have involved stillborn or premature deaths due to cardiac or liver failure. This case report describes an 18-month-old patient with partial duplication of the 1q32-44 segments and consequent developmental delays who exhibited improvement in developmental status with rehabilitation. Prenatal ultrasonography and magnetic resonance imaging of the mother revealed ventriculomegaly and atrophic changes in the left cerebral hemisphere of the fetus. The infant was born with micrognathia, microphthalmia, macrocephaly, low-set ears, polydactyly, and long feet at 37+5 weeks of gestation. A chromosomal study revealed an abnormal male karyotype of 46,XY,rec(1)dup(1)(q32.1q44)inv(1)(p36.3q32.1)pat. In this rare case of a patient with partial trisomy, we observed improvement in developmental delays following treatment using appropriate rehabilitation techniques. Further research is required to help validate the findings of this case study and establish a standardized rehabilitation technique that can be subsequently applied to such cases.
3.Frequency and Severity of Hypoglycemia in Type 2 Diabetes Mellitus Patients Treated with a Sulfonylurea-Based Regimen at University-Affiliated Hospitals in Korea: The Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects Study
Yon Su KIM ; Be Long CHO ; Woo Sik KIM ; Sang Hyun KIM ; In Hyeon JUNG ; Won Yong SIN ; Dong Hoon CHOI ; Sang Jae LEE ; Chun Soo LIM ; Kyung Pyo KANG ; Byung Yeon YU ; Wonju JEUNG ; Chang Gyu PARK
Korean Journal of Family Medicine 2019;40(4):212-219
BACKGROUND: We assessed the frequency and severity of hypoglycemia in type 2 diabetes mellitus patients treated with sulfonylurea monotherapy or sulfonylurea+metformin. METHODS: We conducted a retrospective, observational, cross-sectional study in 2011 and 2012 including patients with type 2 diabetes mellitus aged ≥30 years who were treated with ≥6 months of sulfonylurea monotherapy or sulfonylurea+metformin at 20 university-affiliated hospitals in Korea. At enrollment, glycated hemoglobin (HbA1c) was assessed; participants completed self-reported questionnaires describing hypoglycemia incidents over the past 6 months. A review of medical records up to 12 months before enrollment provided data on demographics, disease history, comorbidities, laboratory results, and drug usage. RESULTS: Of 726 enrolled patients, 719 were included (55.6% male); 31.7% and 68.3% were on sulfonylurea monotherapy and sulfonylurea+metformin, respectively. Mean±standard deviation age was 65.9±10.0 years; mean HbA1c level was 7.0%±1.0%; 77.8% of patients had hypertension (89.4% used antihypertensive medication); 60.5% had lipid disorders (72.5% used lipid-lowering medication); and 52.0% had one or more micro- or macrovascular diseases. Among patients with A1c measurement (n=717), 56.4% achieved therapeutic goals (HbA1c <7.0%); 42.4% (305/719) experienced hypoglycemia within 6 months of enrollment; and 38.8%, 12.9%, 12.7%, and 3.9% of patients experienced mild, moderate, severe, and very severe hypoglycemia symptoms, respectively. Several reported hypoglycemia frequency as 1–2 times over the last 6 months. The mean number of very severe hypoglycemia episodes was 3.5±5.5. CONCLUSION: Among type 2 diabetes mellitus patients treated with sulfonylurea-based regimens, glycemic levels were relatively well controlled but hypoglycemia remained a prevalent side effect.
Comorbidity
;
Cross-Sectional Studies
;
Demography
;
Diabetes Mellitus, Type 2
;
Hemoglobin A, Glycosylated
;
Humans
;
Hypertension
;
Hypoglycemia
;
Korea
;
Medical Records
;
Metformin
;
Retrospective Studies
4.Upper eyelid platinum weight placement for the treatment of paralytic lagophthalmos: A new plane between the inner septum and the levator aponeurosis.
Tae Suk OH ; Kyunghyun MIN ; Sin Young SONG ; Jong Woo CHOI ; Kyung Suk KOH
Archives of Plastic Surgery 2018;45(3):222-228
BACKGROUND: The most common surgical treatment for paralytic lagophthalmos is the placement of a weight implant in the upper eyelid; however, this technique confers the risks of implant visibility, implant extrusion, and entropion. In this study, we present a new technique of placing platinum weight implants between the levator aponeurosis and inner septum to decrease such complications. METHODS: A total of 37 patients with paralytic lagophthalmos were treated between March 2014 and January 2017 with platinum weight placement (mean follow-up, 520.1 days). After dissecting through the orbicularis oculi muscle, the tarsal plate and levator aponeurosis were exposed. The platinum weights (1.0–1.4 g) were fixed to the upper margin of the tarsal plate and placed underneath the orbital septum. RESULTS: Five patients could partially close their eye after surgery. The average distance between the upper eyelid and the lower eyelid when the eyes were closed was 1.12 mm. The rest of the patients were able to close their eye completely. Three patients patient developed allergic conjunctivitis after platinum weight insertion, which was managed with medication. None of the patients complained of discomfort in the upper eyelid after surgery. Visibility or extrusion of the implant were observed in three patients. CONCLUSIONS: Postseptal weight placement is a safe and reproducible method in both primary and secondary upper eyelid surgery for patients with paralytic lagophthalmos. It is a feasible method for preventing implant visibility, implant exposure, and entropion. Moreover, platinum is a better implant material than gold because of its smaller size and greater thinness.
Conjunctivitis, Allergic
;
Entropion
;
Eyelid Diseases
;
Eyelids*
;
Facial Paralysis
;
Follow-Up Studies
;
Humans
;
Methods
;
Orbit
;
Platinum*
;
Prostheses and Implants
;
Thinness
;
Weights and Measures
5.Radiographic Progression of Osteoarthritis after Rotational Acetabular Osteotomy: Minimum 10-Year Follow-up Outcome According to the Tönnis Grade.
Byung Woo MIN ; Chang Soo KANG ; Kyung Jae LEE ; Ki Cheor BAE ; Chul Hyun CHO ; Jung Hoon CHOI ; Hyuk Joon SOHN ; Hong Kwan SIN
Clinics in Orthopedic Surgery 2018;10(3):299-306
BACKGROUND: Although satisfactory mid- to long-term results of rotational acetabular osteotomy for early osteoarthritis secondary to acetabular dysplasia have been reported, there is still controversy about the long-term effects of this surgery in more advanced osteoarthritis. The purpose of this study was to investigate the radiographic progression of osteoarthritic changes after rotational acetabular osteotomy in acetabular dysplasia according to the preoperative Tönnis grade and evaluate its effects after minimum 10-year follow-up. METHODS: We performed 71 consecutive rotational acetabular osteotomies in 64 patients with symptomatic acetabular dysplasia between November 1984 and April 2005. Of these, 46 hips (four hips with Tönnis grade 0, 30 with grade 1, and 12 with grade 2) whose clinical and radiographic findings were available after minimum 10-year follow-up were evaluated in this study. The mean age at the time of surgery was 39.0 years (range, 18 to 62 years) and the average follow-up duration was 17.3 years (range, 10.0 to 27.7 years). Clinical and radiographic evaluations were performed according to the preoperative Tönnis grade. RESULTS: The average Harris hip score improved from 71.8 (range, 58 to 89) to 85.1 (range, 62 to 98). The radiographic parameters also improved in all Tönnis grades after the index surgery. Although the improvement of radiographic parameters was not different between preoperative Tönnis grades, the incidence of osteoarthritic progression was significantly different between grades (zero in Tönnis grade 0, four in Tönnis grade 1, and 10 in Tönnis grade 2; p < 0.001). The mean age at the time of surgery was also significantly older in osteoarthritic progression patients (p < 0.002). Kaplan-Meier survivorship analysis, with radiographic progression of osteoarthritis as the endpoint, predicted a 10-year survival rate of 100% in Tönnis grade 0, 85.7% in Tönnis grade 1, and 14.3% in Tönnis grade 2 (p < 0.001). CONCLUSIONS: The outcome of rotational acetabular osteotomy in most hips with Tönnis grade 0 and 1 was satisfactory after an average of 17 years of follow-up. The incidence of osteoarthritic progression was higher in Tönnis grade 2 and older age. Our results support that early joint preserving procedure is essential in the case of symptomatic dysplastic hips.
Acetabulum*
;
Follow-Up Studies*
;
Hip
;
Humans
;
Incidence
;
Joints
;
Osteoarthritis*
;
Osteotomy*
;
Survival Rate
7.Multifaceted interventions to reduce acute exacerbations in elderly asthmatics
So Hee LEE ; Woo Jung SONG ; Heung Woo PARK ; Min Gyu KANG ; Sae Hoon KIM ; Hye Kyung PARK ; Sang Heon KIM ; Yong Eun KWON ; Tae Bum KIM ; Byung Jae LEE ; Young Koo JEE ; Byung Whui CHOI ; Sang Heon CHO ; Sun Sin KIM
Asia Pacific Allergy 2018;8(1):e1-
BACKGROUND: Although many risk factors are known to be associated with poor asthma outcomes in the elderly, the literature on the effect of risk factor control on asthma outcomes in the elderly is very sparse. OBJECTIVE: To evaluate the role of multifaceted interventions in reducing acute exacerbations in elderly asthmatics. METHODS: A total of 100 subjects were randomly selected from our prospective cohort of elderly asthmatics aged 65 years or older and were provided multifaceted intervention for 1 year. Our multifaceted interventions included repeated education on asthma and inhaler technique for patients and their caregivers, provision of an action plan to cope with acute exacerbations, short message service to prevent follow-up losses, and oral replacement of magnesium. The primary outcome was an acute asthma exacerbation rate compared to the previous year. RESULTS: Ninety-two subjects completed this study, although only 58 subjects continued to take magnesium. Compared to the previous year, the acute asthma exacerbation rate showed a significant reduction from 67% to 50% (p = 0001) and significant improvement was observed in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) (p = 0.04, p = 0.036 for each). Interestingly, a subgroup analysis revealed that predicted value of FEV1 increased significantly in subjects who continued to take magnesium from 79.6% to 87.1% (p = 0.008). CONCLUSION: To reduce acute exacerbations in elderly asthmatics, a multifaceted approach in increase medical awareness, proficiency and adherence to inhaler, assistance of caregivers and correction of micronutrients deficiency is likely to be effective. In addition, a continuous oral replacement of magnesium may increase FEV1 in elderly asthmatics.
Aged
;
Asthma
;
Caregivers
;
Cohort Studies
;
Education
;
Follow-Up Studies
;
Forced Expiratory Volume
;
Humans
;
Magnesium
;
Micronutrients
;
Nebulizers and Vaporizers
;
Prospective Studies
;
Risk Factors
;
Text Messaging
;
Vital Capacity
8.Sirolimus and Metformin Synergistically Inhibits Colon Cancer In Vitro and In Vivo.
Nadiar MUSSIN ; Seung Cheol OH ; Kwang Woong LEE ; Min Young PARK ; Sooin SEO ; Nam Joon YI ; Hyeyoung KIM ; Kyung Chul YOON ; Sung Woo AHN ; Hyo Sin KIM ; Suk Kyun HONG ; Dong Kyu OH ; Kyung Suk SUH
Journal of Korean Medical Science 2017;32(9):1385-1395
We estimated the effect of various immunosuppressants (ISs) and metformin (M) to provide theoretical background of optimal therapeutic strategy for de novo colon cancer after liver transplantation (LT). Three colon cancer cell lines (HT29, SW620, and HCT116) were used in in vitro studies. HT29 was also used in BALB/c-nude mice animal models. Following groups were used in both in vitro and in vivo studies: sirolimus (S), tacrolimus (T), cyclosporin A (CsA), M, metformin/sirolimus (Met/S), metformin/tacrolimus (Met/T), and metformin/cyclosporin A (Met/CsA). 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay was performed and western blot analyses were performed for mTOR pathway proteins, apoptosis proteins, and epithelial-mesenchymal-transition (EMT) proteins. Tumor volume was measured for 4 weeks after inoculation. MTT-assay revealed significant cell viability inhibition in all 3 colon cancer cell lines in groups of S, M, and Met/S. Of note, group Met/S showed synergistic effect compare to M or S group. Western blot analysis showed significant low levels of all investigated proteins in groups of S and Met/S in both in vitro and in vivo experiment. Tumor growth was significantly inhibited only in the Met/S group. Combination of Met and S showed the most potent inhibition in all colon cancer cell lines. This finding might have application for de novo colon cancer.
Animals
;
Apoptosis
;
Blotting, Western
;
Cell Line
;
Cell Survival
;
Colon*
;
Colonic Neoplasms*
;
Cyclosporine
;
Immunosuppression
;
Immunosuppressive Agents
;
In Vitro Techniques*
;
Liver Transplantation
;
Metformin*
;
Mice
;
Models, Animal
;
Sirolimus*
;
Tacrolimus
;
Tumor Burden
9.The Correlation between Body Mass Index and Routine Parameters in Men Over Fifty.
Deok Ha SEO ; Sol YOON ; Jae Hwi CHOI ; Jungmo DO ; Sin Woo LEE ; Chunwoo LEE ; Seong Uk JEH ; See Min CHOI ; Sung Chul KAM ; Jeong Seok HWA ; Ky Hyun CHUNG ; Sung Won KWON ; Sae Chul KIM ; Dong Soo PARK ; Jae Mann SONG ; Kyung Seop LEE ; Jae Seog HYUN
The World Journal of Men's Health 2017;35(3):178-185
PURPOSE: This study aimed to investigate the relationships between body mass index (BMI) and prostate-specific antigen (PSA) levels, international prostate symptom score (IPSS), quality of life (QoL), and prostate volume (PV). MATERIALS AND METHODS: Height, weight, PSA levels, PV, and IPSS were analyzed in 15,435 patients who underwent a prostate examination between 2001 and 2014. Patients aged <50 years or with a PSA level ≥10 ng/mL were excluded. The relationships between BMI and PSA, IPSS, QoL, and PV were analyzed by a scatter plot, one-way analysis of variance, and the Pearson correlation coefficient. RESULTS: The mean age was 71.95±7.63 years, the mean BMI was 23.59±3.08 kg/m2, the mean PSA level was 1.45±1.45 ng/mL, the mean IPSS was 15.53±8.31, the mean QoL score was 3.48±1.25, and the mean PV was 29.72±14.02 mL. PSA, IPSS, and QoL showed a tendency to decrease with increasing BMI, and there were statistically significant differences for each parameter (p≤0.001). PV showed a significant tendency to increase with BMI (p < 0.001). In the correlation analysis, BMI showed a statistically significant correlation (p < 0.001) with PSA, IPSS, and QoL, although the correlations were very weak. In contrast, BMI showed a significant correlation with PV (p < 0.001), with a meaningful Pearson correlation coefficient of 0.124. CONCLUSIONS: Higher BMI was associated with lower PSA levels and higher IPSS and QoL scores. Meanwhile, PV increased with BMI. Although obese individuals had a greater PV, obesity did not aggravate lower urinary tract symptoms.
Body Mass Index*
;
Humans
;
Lower Urinary Tract Symptoms
;
Male
;
Obesity
;
Prostate
;
Prostate-Specific Antigen
;
Prostatic Hyperplasia
;
Quality of Life
10.False Positive Diagnosis of Hepatocellular Carcinoma in Liver Resection Patients.
Hongeun LEE ; Jeong Hee YOON ; Hyeyoung KIM ; Nam Joon YI ; Suk Kyun HONG ; Kyung Chul YOON ; Hyo Sin KIM ; Sung Woo AHN ; Jin Young CHOI ; YoungRok CHOI ; Hae Won LEE ; Ju Yeon YI ; Kyoung Bun LEE ; Kwang Woong LEE ; Kyung Suk SUH
Journal of Korean Medical Science 2017;32(2):315-320
The diagnosis of hepatocellular carcinoma (HCC) is based on imaging studies particularly in high-risk patients without histologic confirmation. This study evaluated the prevalence and characteristics of false-positively diagnosed HCC in a liver resection cohort for HCC. A retrospective review was performed of 837 liver resection cases for clinically diagnosed HCC between 2005 and 2010 at our institute. High-risk patients with tumors > 1 cm with one or two image findings consistent with HCC and tumors < 1 cm with two or more image findings consistent with HCC with persistently increased serum alpha-fetoprotein (AFP) levels above the normal range with underlying inhibited hepatitis activity underwent liver resection. The false-positive rate was 2.2% (n = 18). Of the 18 patients, 7 patients (0.8%) were diagnosed with benign conditions (one each of hemangioma, inflammation, cortical adenoma, dysplastic nodule, angiomyolipoma, bile duct adenoma, and non-neoplastic liver parenchyme) and 11 patients (1.3%) were diagnosed with malignancies (cholangiocarcinoma [n = 6], hepatoblastoma [n = 2], and one each of lymphoepithelioma-like carcinoma, ovarian cystadenocarcinoma, and nasopharynx carcinoma metastasis). The clinical characteristics of pathologically diagnosed HCC patients were similar (P > 0.05) compared to non-HCC patients except for higher rate of history of alcoholism (P < 0.05) observed in non-HCC patients. Four of 18 non-HCC patients (22.2%) showed diagnostic discordance on the dynamic imaging study. Despite the recent progression in diagnostic imaging techniques, 2.2% of cases were false-positively diagnosed as HCC in a liver resection patient cohort; and the final diagnosis was benign disease in 0.8% of liver resection patients clinically diagnosed with HCC.
Adenoma
;
Adenoma, Bile Duct
;
Alcoholism
;
alpha-Fetoproteins
;
Angiomyolipoma
;
Carcinoma, Hepatocellular*
;
Cohort Studies
;
Cystadenocarcinoma
;
Diagnosis*
;
Diagnostic Imaging
;
Hemangioma
;
Hepatitis
;
Hepatoblastoma
;
Humans
;
Inflammation
;
Liver*
;
Nasopharynx
;
Prevalence
;
Reference Values
;
Retrospective Studies

Result Analysis
Print
Save
E-mail