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.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
6.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
8.Serum micronutrients levels and clinical features of elderly asthmatics.
So Hee LEE ; Woo Jung SONG ; Heung Woo PARK ; Sae Hoon KIM ; Hye Kyung PARK ; Sang Heon KIM ; Yong Eun KWON ; Tae Bum KIM ; Byung Jae LEE ; Young Koo JEE ; Byoung Whui CHOI ; Sang Heon CHO ; Sun Sin KIM
Allergy, Asthma & Respiratory Disease 2017;5(4):223-227
PURPOSE: The prevalence of asthma in the elderly is rapidly increasing. However, we do not fully understand the pathogenesis of elderly asthma, especially for the roles of micronutrients. This study aimed to evaluate the associations between serum levels of micronutrients, including several vitamins and minerals, and clinical features of the elderly asthmatics. METHODS: A total of 317 asthmatics aged 65 or older were enrolled. Serum levels of vitamin D, vitamin B₁₂, folate, Mg, and Se were measured and then the associations between serum micronutrient levels and clinical features of elderly asthmatics were evaluated. RESULTS: Positive correlations with significance among serum levels of vitamin B₁₂, vitamin D, and folate were found. Serum micronutrients levels showed no difference according to the atopic status and symptom severity. The serum folate level was significantly associated with forced expiratory volume in 1 second, and serum vitamin B₁₂ and folate levels were significantly associated with serum total IgE level. Interestingly, elderly asthmatics with exacerbation history showed significantly lower serum levels of vitamin D and Mg, but significantly higher serum levels of Se. CONCLUSION: Serum levels of micronutrients, such as vitamin D, vitamin B₁₂, Mg, folate, and Se, were significantly associated with some clinical features of elderly asthmatics. Clinical meanings of these associations need to be investigated further.
Aged*
;
Asthma
;
Folic Acid
;
Forced Expiratory Volume
;
Humans
;
Immunoglobulin E
;
Micronutrients*
;
Minerals
;
Miners
;
Prevalence
;
Vitamin D
;
Vitamins
9.Effects of Lobeglitazone, a Novel Thiazolidinedione, on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus over 52 Weeks.
Soo LIM ; Kyoung Min KIM ; Sin Gon KIM ; Doo Man KIM ; Jeong Taek WOO ; Choon Hee CHUNG ; Kyung Soo KO ; Jeong Hyun PARK ; Yongsoo PARK ; Sang Jin KIM ; Hak Chul JANG ; Dong Seop CHOI
Diabetes & Metabolism Journal 2017;41(5):377-385
BACKGROUND: The aim of this multicenter, randomized, double-blind study was to examine the effect of lobeglitazone, a novel thiazolidinedione, on the changes in bone mineral density (BMD) in patients with type 2 diabetes mellitus. METHODS: A 24-week, double-blinded phase was followed by a 28-week, open-label phase, in which the placebo group also started to receive lobeglitazone. A total of 170 patients aged 34 to 76 years were randomly assigned in a 2:1 ratio to receive lobeglitazone 0.5 mg or a matching placebo orally, once daily. BMD was assessed using dual-energy X-ray absorptiometry at week 24 and at the end of the study (week 52). RESULTS: During the double-blinded phase, the femur neck BMD showed decreasing patterns in both groups, without statistical significance (−0.85%±0.36% and −0.78%±0.46% in the lobeglitazone and placebo groups, respectively). The treatment difference between the groups was 0.07%, which was also not statistically significant. Further, minimal, nonsignificant decreases were observed in both groups in the total hip BMD compared to values at baseline, and these differences also did not significantly differ between the groups. During the open-label phase, the BMD was further decreased, but not significantly, by −0.32% at the femur neck and by −0.60% at the total hip in the lobeglitazone group, and these changes did not significantly differ compared with the original placebo group switched to lobeglitazone. CONCLUSION: Our results indicate that treatment with lobeglitazone 0.5 mg over 52 weeks showed no detrimental effect on the BMD compared to the placebo.
Absorptiometry, Photon
;
Bone Density*
;
Diabetes Mellitus, Type 2*
;
Double-Blind Method
;
Femur Neck
;
Hip
;
Humans
;
Thiazolidinediones
10.Korean Patients Undergoing Deceased Donor Liver Transplantation for Alcoholic Liver Disease Have Non-Inferior Survival Outcomes than for Hepatitis B Virus: a Real-World Experience without Minimum Abstinence before Transplantation.
Suk Kyun HONG ; Nam Joon YI ; Hyo Sin KIM ; Sung Woo AHN ; Kyung Chul YOON ; Hyeyoung KIM ; Kwang Woong LEE ; Kyung Suk SUH
Journal of Korean Medical Science 2017;32(6):919-925
Few studies have compared outcomes in patients undergoing liver transplantation (LT) for hepatitis B virus (HBV) and alcoholic liver disease (ALD) in Asian countries in which living donor LT (LDLT) is dominant, where HBV is endemic and where there are no strict regulations on pre-transplant abstinence for ALD. This study compared post-LT outcomes of deceased donor LT (DDLT) in patients with ALD and HBV. Data from 220 patients who underwent primary DDLT at Seoul National University Hospital from January 2010 to December 2014, including 107 with HBV and 38 with ALD, were retrospectively analyzed. Seventy-four patients (69.2%) in the HBV group and 30 (78.9%) in the ALD group had United Network for Organ Sharing (UNOS) status 2A (P = 0.250). There were no significant differences in their 1-year (90.7% vs. 92.1%) and 3-year (82.1% vs. 82.3%) overall survival rates (P = 1.000). Multivariate analysis showed that high serum gamma glutamyltransferase concentration (≥ 70 IU/L) was independently prognostic of 1-year post-LT overall survival. Survival outcomes following DDLT were similar in Korean patients with ALD and HBV, even in the absence of strict pre-transplant abstinence from alcohol as a selection criterion.
Alcoholics*
;
Asian Continental Ancestry Group
;
gamma-Glutamyltransferase
;
Hepatitis B virus*
;
Hepatitis B*
;
Hepatitis*
;
Humans
;
Liver Cirrhosis
;
Liver Diseases, Alcoholic*
;
Liver Transplantation*
;
Liver*
;
Living Donors
;
Multivariate Analysis
;
Retrospective Studies
;
Seoul
;
Social Control, Formal
;
Survival Rate
;
Tissue Donors*

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