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.Comprehensive management of polypharmacy in older patients with diabetes
Journal of the Korean Medical Association 2024;67(7):449-460
Diabetes mellitus is a complex group of chronic metabolic conditions. The incidence of frailty, sarcopenia, geriatric syndrome, and multiple chronic conditions is high in older patients with diabetes, who often require multiple medications for optimal glucose control and treatment of associated chronic complications. Unfortunately, polypharmacy is associated with a high risk of adverse outcomes, such as hypoglycemia, drug-drug interactions, and an increased socioeconomic burden in older adults with diabetes.Current Concepts: Elderly patients with diabetes are at a high risk for polypharmacy and consequently, a high risk of adverse drug reactions. Polypharmacy is defined as the cumulative use of five or more medications. Comprehensive management and deprescribing are the most important approaches to reduce polypharmacy. Deprescription refers to reduction in or cessation of inappropriate medications.Discussion and Conclusion: Polypharmacy continues to increase the risk of morbidity and mortality among older adults with diabetes. A comprehensive polypharmacy management and deprescription plan is warranted for significant risk reduction in elderly patients with diabetes.
3.The incidence and risk factors of extrapulmonary manifestations in Mycoplasma pneumoniae pneumonia
Yoo Kyung PARK ; You Na PARK ; Ji Eun MOON ; Hyo-Bin KIM ; Meeyong SHIN ; Eun LEE ; Chul-Hong KIM ; Ju Suk LEE ; Yong Ju LEE ; Bong-Seong KIM ; Hyung Young KIM ; Sungsu JUNG ; Yunsun KIM ; Sangyoung KIM ; Chorong PARK ; Ju-Hee SEO ; Jung Yeon SHIM ; In Suk SOL ; Myongsoon SUNG ; Dae Jin SONG ; Young Min AHN ; Hea Lin OH ; Jinho YU ; Kyung Suk LEE ; Gwang Cheon JANG ; Yoon-Young JANG ; Hai Lee CHUNG ; Eun Hee CHUNG ; Sung-Min CHOI ; Yun Jung CHOI ; Man Yong HAN ; Jin Tack KIM ; Chang-Keun KIM ; Hyeon-Jong YANG
Allergy, Asthma & Respiratory Disease 2022;10(4):207-214
Purpose:
Mycoplasma pneumoniae pneumonia (MP) is a major cause of community-acquired pneumonia (CAP) in children and is associated with extrapulmonary manifestations (EPM). The incidence and risk factors for EPM in children are unknown.
Methods:
This was a retrospective study involving 65,243 pediatric patients with CAP between 2010 and 2015 at 23 nationwide hospitals in South Korea. Medical records were reviewed to collect information regarding the clinical characteristics, radiological results, and laboratory findings. Logistic regression with multivariate analysis was performed to evaluate the risk factors associated with EPM in MP.
Results:
The incidence of EPM was 23.9%, including elevation of liver enzymes (18.1%), mucocutaneous manifestations (4.4%), proteinuria (4.1%), cardiovascular and neurological manifestations (0.4%), hematologic manifestations (0.2%), and arthritis (0.2%). Statistical analysis showed that mucocutaneous manifestations significantly increased with elevated alanine aminotransferase (adjusted odds ratio [aOR], 3.623; 95% confidence interval [CI], 1.933-6.790) and atopic sensitization (aOR, 2.973; 95% CI, 1.615–5.475) and decreased with respiratory virus coinfection (aOR, 0.273; 95% CI, 0.084–0.887). Elevated liver enzymes were significantly associated with elevated lactate dehydrogenase (aOR, 3.055; 95% CI, 2.257–4.137), presence of pleural effusion (aOR, 2.635; 95% CI, 1.767–3.930), and proteinuria with respiratory virus coinfection (aOR, 2.245; 95% CI, 1.113–4.527).
Conclusion
Approximately 24% of pediatric patients with MP had various EPM. As the risk factors associated with each EPM were different, it is necessary to evaluate the various clinical aspects and findings of MP to predict and prepare for the occurrence of EPM.
4.Comparison of the Efficacy and Safety of Insulin Detemir Administered Once Daily According to Two Titration Algorithms (3-0-3 and 2-4-6-8) in Patients with Type 2 Diabetes Mellitus
Hea Min YU ; Kang Seo PARK ; Jun Hwa HONG ; Keun Yong PARK ; Jong Min LEE ; Bon Jeong KU ; Yeo Joo KIM ; Tae Kun OH
Endocrinology and Metabolism 2020;35(1):142-148
BACKGROUND:
This study was conducted to compare glycaemic control with insulin detemir administered according to two titration algorithms (3-0-3 and 2-4-6-8) after 20 weeks of treatment in subjects with type 2 diabetes mellitus inadequately controlled on metformin.
METHODS:
This was a 20-week, randomised, multicentre, open-labelled, treat-to-target trial. Forty-six patients were randomised in a 1:1 manner to either the 3-0-3 (G3, n=23) or 2-4-6-8 (G2, n=23) algorithm. The primary endpoint was change of haemoglobin A1c (HbA1c), and the secondary safety endpoint included hypoglycaemic events.
RESULTS:
After 20 weeks, HbA1c decreased similarly in the G3 and G2 groups, with a mean change of −0.9% from baseline. The mean change in fasting plasma glucose was numerically similar in both groups. The hypoglycaemia event rate per 100-patient-years of exposure (r) in the G2 group (r=1,427) was higher than that in the G3 group (r=807).
CONCLUSION
Both treatment groups had numerically similar HbA1c reductions. A trend towards fewer hypoglycaemia episodes after dose stabilisation was seen with the simpler G3. Clinically, this may be an important observation, as a simpler titration algorithm may support self-management and maintenance of insulin therapy.
5.Seasonal patterns and etiologies of croup in children during the period 2010–2015: A multicenter retrospective study
Yong Ju LEE ; Hyo Bin KIM ; Bong Seong KIM ; Chang Keun KIM ; Cheol Hong KIM ; Hyung Young KIM ; Sangyoung KIM ; Yunsun KIM ; Chorong PARK ; Ju Hee SEO ; In Suk SOL ; Myongsoon SUNG ; Min Seob SONG ; Dae Jin SONG ; Young Min AHN ; Hea Lin OH ; Jinho YU ; Kyung Suk LEE ; Eun LEE ; Ju Suk LEE ; Gwang Cheon JANG ; Yoon Young JANG ; Eun Hee CHUNG ; Hai Lee CHUNG ; Sung Min CHOI ; Yun Jung CHOI ; Man Yong HAN ; Hyeon Jong YANG ; Jung Yeon SHIM ; Jin Tack KIM ;
Allergy, Asthma & Respiratory Disease 2019;7(2):78-85
PURPOSE: Croup is known to have epidemics in seasonal and biennial trends, and to be strongly associated with epidemics of parainfluenza virus. However, seasonal and annual epidemics of croup have not been clearly reported in Korea. This study aimed to examine the seasonal/annual patterns and etiologies of childhood croup in Korea during a consecutive 6-year period. METHODS: Pediatric croup data were collected from 23 centers in Korea from 1 January 2010 to 31 December 2015. Electronic medical records, including multiplex reverse transcription polymerase chain reaction (RT-PCR) results, demographics and clinical information were cross-sectionally reviewed and analyzed. RESULTS: Overall, 2,598 childhood croup patients requiring hospitalization were identified during the study period. Among them, a total of 927 who underwent RT-PCR were included in the analysis. Males (61.5%) predominated, and most (63.0%) of them were younger than 2 years of age (median, 19 months; interquartile range, 11–31 months). Peak hospitalization occurred in 2010 and 2012 in even-numbered years, and parainfluenza virus (PIV, 39.7%) was the most common cause of childhood croup requiring hospitalization, followed by respiratory syncytial virus (14.9%), human rhinovirus (12.5%), Mycoplasma pneumonaie (10.6%), and human coronavirus (7.3%). CONCLUSION: It is concluded that croup hospitalization has a biennial pattern in even-numbered years. PIV may be the most common cause of childhood croup; however, croup epidemics could be attributed to other viruses.
Child
;
Coronavirus
;
Croup
;
Demography
;
Electronic Health Records
;
Hospitalization
;
Humans
;
Korea
;
Male
;
Mycoplasma
;
Paramyxoviridae Infections
;
Polymerase Chain Reaction
;
Respiratory Syncytial Viruses
;
Retrospective Studies
;
Reverse Transcription
;
Rhinovirus
;
Seasons
6.Identification of LEF1 as a Susceptibility Locus for Kawasaki Disease in Patients Younger than 6 Months of Age.
Hea Ji KIM ; Sin Weon YUN ; Jeong Jin YU ; Kyung Lim YOON ; Kyung Yil LEE ; Hong Ryang KIL ; Gi Beom KIM ; Myung Ki HAN ; Min Seob SONG ; Hyoung Doo LEE ; Kee Soo HA ; Sejung SOHN ; Ryota EBATA ; Hiromichi HAMADA ; Hiroyuki SUZUKI ; Yoichiro KAMATANI ; Michiaki KUBO ; Kaoru ITO ; Yoshihiro ONOUCHI ; Young Mi HONG ; Gi Young JANG ; Jong Keuk LEE
Genomics & Informatics 2018;16(2):36-41
Kawasaki disease (KD) is an acute febrile vasculitis predominately affecting infants and children. The dominant incidence age of KD is from 6 months to 5 years of age, and the incidence is unusual in those younger than 6 months and older than 5 years of age. We tried to identify genetic variants specifically associated with KD in patients younger than 6 months or older than 5 years of age. We performed an age-stratified genome-wide association study using the Illumina HumanOmni1-Quad BeadChip data (296 cases vs. 1,000 controls) and a replication study (1,360 cases vs. 3,553 controls) in the Korean population. Among 26 candidate single nucleotide polymorphisms (SNPs) tested in replication study, only a rare nonsynonymous SNP (rs4365796: c.1106C>T, p.Thr369Met) in the lymphoid enhancer binding factor 1 (LEF1) gene was very significantly associated with KD in patients younger than 6 months of age (odds ratio [OR], 3.07; p(combined) = 1.10 × 10⁻⁵), whereas no association of the same SNP was observed in any other age group of KD patients. The same SNP (rs4365796) in the LEF1 gene showed the same direction of risk effect in Japanese KD patients younger than 6 months of age, although the effect was not statistically significant (OR, 1.42; p = 0.397). This result indicates that the LEF1 gene may play an important role as a susceptibility gene specifically affecting KD patients younger than 6 months of age.
Asian Continental Ancestry Group
;
Child
;
Genome-Wide Association Study
;
Humans
;
Incidence
;
Infant
;
Lymphoid Enhancer-Binding Factor 1
;
Mucocutaneous Lymph Node Syndrome*
;
Polymorphism, Single Nucleotide
;
Vasculitis
7.Clinical Outcomes of Argon Plasma Coagulation Therapy for Early Gastric Neoplasms.
Kyu Young KIM ; Seong Woo JEON ; Hea Min YANG ; Yu Rim LEE ; Eun Jeong KANG ; Hyun Seok LEE ; Sung Kook KIM
Clinical Endoscopy 2015;48(2):147-151
BACKGROUND/AIMS: Argon plasma coagulation (APC) has some merits in the treatment of gastric neoplasms including a shorter operative time and fewer complications compared with endoscopic mucosal resection or endoscopic submucosal dissection. However, there are few reports on the outcomes of gastric neoplasms treated using APC. The aim of this study was to evaluate APC in the treatment of early gastric neoplasms in terms of clinical efficacy, safety, and local recurrence. METHODS: We enrolled 28 patients who received APC therapy at the Kyungpook National University Hospital between May 2007 and April 2013. Clinical outcomes were analyzed. RESULTS: The median follow-up period was 24.8 months (range, 2 to 78). Among the 28 lesions treated using the APC procedure, tumor recurrence was encountered in seven lesions (25.0%). Recurrence was found in 50% (5/10) of single APC cases and 11% (2/18) of rescue APC cases. The mean time to recurrence was 16.1 months (range, 2 to 78). There were no serious APC-related complications such as perforation, bleeding, or infection. CONCLUSIONS: APC therapy can be a useful treatment with a favorable safety profile for patients with early gastric neoplasms. However, further studies are necessary to determine the long-term prognosis of patients undergoing this treatment.
Argon Plasma Coagulation*
;
Follow-Up Studies
;
Gyeongsangbuk-do
;
Hemorrhage
;
Humans
;
Operative Time
;
Prognosis
;
Recurrence
;
Stomach Neoplasms*
8.Case of Recurrent Diabetic Muscle Infarction Related to Strict Blood Glucose Control.
Hea Min YU ; Heung Young JIN ; Tae Sun PARK
Korean Journal of Medicine 2013;84(5):737-741
Diabetic muscle infarction (DMI) is an uncommon complication in patients with diabetes and it tends to be underdiagnosed, or misdiagnosed, clinically. Recently, we experienced a case of recurrent diabetic muscle infarction that was unusual in that the patient was younger than other patients. The patient was a 21-year-old woman with a 9-year history of maturity-onset diabetes of the young (MODY) who was referred to our department complaining of pain and edema in her right thigh. Magnetic resonance imaging (MRI) showed an increased T2-weighted signal and edema in the affected muscle. The final diagnosis was DMI. However, when the patient had partially recovered and was receiving supportive care, she had a second attack on the other side of the same leg during her hospitalization, in spite of her blood glucose level being strictly controlled. We report the clinical characteristics and imaging findings of this patient with recurrent DMI.
Blood Glucose
;
Diabetes Complications
;
Diabetes Mellitus, Type 2
;
Edema
;
Female
;
Hospitalization
;
Humans
;
Infarction
;
Leg
;
Magnetic Resonance Imaging
;
Muscles
;
Recurrence
;
Thigh
9.Effect of Granulocyte Colony-Stimulating Factor on the Peripheral Nerves in Streptozotocin-Induced Diabetic Rat.
Kyung Ae LEE ; Kyung Taek PARK ; Hea Min YU ; Heung Yong JIN ; Hong Sun BAEK ; Tae Sun PARK
Diabetes & Metabolism Journal 2013;37(4):286-290
There are controversial reports about the effect of granulocyte colony-stimulating factor (G-CSF) in peripheral nerve protection. Therefore, the present study aimed to investigate the effect of G-CSF on peripheral nerves in streptozotocin (STZ) induced diabetic rats. After STZ or vehicle injection, rats were divided into five groups (n=6) as follows: normal+vehicle, normal+G-CSF (50 microg/kg for 5 days), diabetes mellitus (DM)+vehicle, DM+G-CSF (50 microg/kg for 5 days), and DM+G-CSF extension (50 microg/kg for 5 days and followed by two injections per week up to 24 weeks). Our results showed that the current perception threshold was not significantly different among experimental groups. G-CSF treatment inhibited the loss of cutaneous nerves and gastric mucosal small nerve fibers in morphometric comparison, but statistical significance was not observed. The present results demonstrated that G-CSF has no harmful but minimal beneficial effects with respect to peripheral nerve preservation in diabetic rats.
Animals
;
Diabetes Mellitus
;
Granulocyte Colony-Stimulating Factor
;
Granulocytes
;
Nerve Fibers
;
Peripheral Nerves
;
Rats
;
Streptozocin
10.Graves' Disease that Developed Shortly after Surgery for Thyroid Cancer.
Hea Min YU ; Soon Hyun PARK ; Jae Min LEE ; Kang Seo PARK
Endocrinology and Metabolism 2013;28(3):226-230
Graves' disease is an autoimmune disorder that may present with various clinical manifestations of hyperthyroidism. Patients with Graves' disease have a greater number of thyroid nodules and a higher incidence of thyroid cancer compared with patients with normal thyroid activity. However, cases in which patients are diagnosed with recurrence of Graves' disease shortly after partial thyroidectomy for thyroid cancer are very rare. Here we report a case of hyperthyroid Graves' disease that occurred after partial thyroidectomy for papillary thyroid cancer. In this case, the patient developed hyperthyroidism 9 months after right hemithyroidectomy, and antithyroglobulin autoantibody and thyroid stimulating hormone receptor stimulating autoantibody were positive. Therefore, we diagnosed Graves' disease on the basis of the laboratory test results and thyroid ultrasonography findings. The patient was treated with and maintained on antithyroid drugs. The mechanism of the recurrence of Graves' disease in this patient is still unclear. The mechanism may have been the improper response of the immune system after partial thyroidectomy. To precisely determine the mechanisms in Graves' disease after partial thyroidectomy, further studies based on a greater number of cases are needed.
Antithyroid Agents
;
Autoantibodies
;
Carcinoma
;
Graves Disease
;
Humans
;
Hyperthyroidism
;
Immune System
;
Incidence
;
Receptors, Thyrotropin
;
Recurrence
;
Thyroid Gland
;
Thyroid Neoplasms
;
Thyroid Nodule
;
Thyroidectomy

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