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.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
3.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
4.Clinical Effectiveness and Nephrotoxicity of Aerosolized Colistin Treatment in Multidrug-Resistant Gram-Negative Pneumonia.
Seung Yong PARK ; Mi Seon PARK ; Chi Ryang CHUNG ; Ju Sin KIM ; Seoung Ju PARK ; Heung Bum LEE
Korean Journal of Critical Care Medicine 2016;31(3):208-220
BACKGROUND: Colistin (polymyxin E) is active against multidrug-resistant Gram-negative bacteria (MDR-GNB). However, the effectiveness of inhaled colistin is unclear. This study was designed to assess the effectiveness and safety of aerosolized colistin for the treatment of ventilator-associated pneumonia (VAP) caused by MDR-GNB. METHODS: In this retrospective longitudinal study, we evaluated the medical records of 63 patients who received aerosolized colistin treatment for VAP caused by MDR-GNB in the medical intensive care unit (MICU) from February 2012 to March 2014. RESULTS: A total of 25 patients with VAP caused by MDR-GNB were included in this study. The negative conversion rate was 84.6% after treatment, and acute kidney injury (AKI) occurred in 11 patients (44%, AKI group). The average length of MICU stay and colistin treatment- related factors, such as daily and total cumulative doses and administration period, were not significantly different between groups. In-hospital mortality tended to be higher in the AKI group (p = 0.07). Multivariate analysis showed that a body mass index less than 18 was an independent risk factor of mortality (odds ratio [OR] = 21.95, 95% confidence interval [CI] 1.59-302.23; p = 0.02). Notably, AKI occurrence was closely related to the administration of more than two nephrotoxic drugs combined with aerosolized colistin (OR = 15.03, 95% CI 1.40-161.76; p = 0.025) and septic shock (OR = 8.10, 95% CI 1.40-161.76; p = 0.04). CONCLUSIONS: The use of adjunctive aerosolized colistin treatment appears to be a relatively safe and effective option for the treatment of VAP caused by MDR-GNB. However, more research on the concomitant use of nephrotoxic drugs with aerosolized colistin will be necessary, as this can be an important risk factor of development of AKI.
Acute Kidney Injury
;
Body Mass Index
;
Colistin*
;
Drug Resistance, Microbial
;
Gram-Negative Bacteria
;
Hospital Mortality
;
Humans
;
Intensive Care Units
;
Longitudinal Studies
;
Medical Records
;
Mortality
;
Multivariate Analysis
;
Pneumonia*
;
Pneumonia, Ventilator-Associated
;
Retrospective Studies
;
Risk Factors
;
Shock, Septic
;
Treatment Outcome*
5.The efficacy of single premedication with antihistamines for radiocontrast media hypersensitivity
So Hee LEE ; Heung Woo PARK ; Sang Heon CHO ; Sun Sin KIM
Asia Pacific Allergy 2016;6(3):164-167
BACKGROUND: Single premedication with antihistamines for radiocontrast media (RCM) hypersensitivity is frequently used in real world at the emergent situation although its efficacy is not proven. OBJECTIVE: To evaluate the effect of intravenous antihistamines as a premedication in general population who had experience of mild adverse reactions to iodinated RCM. METHODS: A retrospective observational study on 14,785 subjects who had RCM-enhanced computed tomography scans between January 2014 and December 2015 in Seoul National University Hospital Gangnam Healthcare Center, Seoul, South Korea. RESULTS: Among 453 subjects who had a history of mild RCM-induced hypersensitivity reactions, 273 subjects had a single premedication of intravenous antihistamine. When comparing antihistamine-premedication group and nonpremedication group, there is no protective effect of antihistamines on the incidence rate and severity of hypersensitivity (10.6% vs. 11.7%, p = 0.729). CONCLUSION: The clinical efficacy of a single premedication of antihistamines for mild RCM-induced hypersensitivity was not confirmed.
Contrast Media
;
Delivery of Health Care
;
Histamine Antagonists
;
Hypersensitivity
;
Incidence
;
Korea
;
Observational Study
;
Premedication
;
Retrospective Studies
;
Seoul
;
Treatment Outcome
6.Clinical Effectiveness and Nephrotoxicity of Aerosolized Colistin Treatment in Multidrug-Resistant Gram-Negative Pneumonia
Seung Yong PARK ; Mi Seon PARK ; Chi Ryang CHUNG ; Ju Sin KIM ; Seoung Ju PARK ; Heung Bum LEE
The Korean Journal of Critical Care Medicine 2016;31(3):208-220
BACKGROUND: Colistin (polymyxin E) is active against multidrug-resistant Gram-negative bacteria (MDR-GNB). However, the effectiveness of inhaled colistin is unclear. This study was designed to assess the effectiveness and safety of aerosolized colistin for the treatment of ventilator-associated pneumonia (VAP) caused by MDR-GNB. METHODS: In this retrospective longitudinal study, we evaluated the medical records of 63 patients who received aerosolized colistin treatment for VAP caused by MDR-GNB in the medical intensive care unit (MICU) from February 2012 to March 2014. RESULTS: A total of 25 patients with VAP caused by MDR-GNB were included in this study. The negative conversion rate was 84.6% after treatment, and acute kidney injury (AKI) occurred in 11 patients (44%, AKI group). The average length of MICU stay and colistin treatment- related factors, such as daily and total cumulative doses and administration period, were not significantly different between groups. In-hospital mortality tended to be higher in the AKI group (p = 0.07). Multivariate analysis showed that a body mass index less than 18 was an independent risk factor of mortality (odds ratio [OR] = 21.95, 95% confidence interval [CI] 1.59-302.23; p = 0.02). Notably, AKI occurrence was closely related to the administration of more than two nephrotoxic drugs combined with aerosolized colistin (OR = 15.03, 95% CI 1.40-161.76; p = 0.025) and septic shock (OR = 8.10, 95% CI 1.40-161.76; p = 0.04). CONCLUSIONS: The use of adjunctive aerosolized colistin treatment appears to be a relatively safe and effective option for the treatment of VAP caused by MDR-GNB. However, more research on the concomitant use of nephrotoxic drugs with aerosolized colistin will be necessary, as this can be an important risk factor of development of AKI.
Acute Kidney Injury
;
Body Mass Index
;
Colistin
;
Drug Resistance, Microbial
;
Gram-Negative Bacteria
;
Hospital Mortality
;
Humans
;
Intensive Care Units
;
Longitudinal Studies
;
Medical Records
;
Mortality
;
Multivariate Analysis
;
Pneumonia
;
Pneumonia, Ventilator-Associated
;
Retrospective Studies
;
Risk Factors
;
Shock, Septic
;
Treatment Outcome
7.Validation of the Korean version of the European Community Respiratory Health Survey screening questionnaire for use in epidemiologic studies for adult asthma
Woo Jung SONG ; So Hee LEE ; Min Gyu KANG ; Ju Young KIM ; Mi Young KIM ; Eun Jung JO ; Suh Young LEE ; Seung Eun LEE ; Min Hye KIM ; Min Suk YANG ; Sae Hoon KIM ; Hye Ryun KANG ; Hye Kyung PARK ; Heung Woo PARK ; Yoon Seok CHANG ; Sun Sin KIM ; Jong Myung LEE ; Kyung Up MIN ; Sang Heon CHO
Asia Pacific Allergy 2015;5(1):25-31
BACKGROUND: Standardized questionnaire is one of key instruments for general population surveys. OBJECTIVE: The present study aimed to develop and validate the Korean version of the European Community Respiratory Health Survey (ECRHS) screening questionnaire for adult asthma surveys. METHODS: The ECRHS screening questionnaire was translated into Korean language according to the international criteria. Study participants were prospectively recruited from six referral hospitals and one health check-up center. Comprehensibility of the translation was tested in a pilot study of 10 patients. The reliability was evaluated by internal consistency and test-retest repeatability. Validity was assess with regard to physician-diagnosed asthma. RESULTS: A total of 100 adult asthma patients and 134 volunteers were recruited. Reliability was examined for 10 items in 100 asthmatics; Cronbach α coefficients were 0.84, and test-retest repeatability was good (Cohen κ coefficient, 0.71-1.00). Validity was assessed for 8 items in 234 participants; in particular, 'recent wheeze' showed a high sensitivity (0.89) for physician-diagnosed asthma. 'Recent asthma attack' and 'current asthma medication' showed high specificity (0.96-0.98). CONCLUSION: The present study demonstrated that the Korean version of the ECRHS screening questionnaire was comprehensible, reliable and valid. We suggest the questionnaire to be utilized in further epidemiological studies for asthma in Korean adult populations.
Adult
;
Asthma
;
Epidemiologic Studies
;
Epidemiology
;
European Union
;
Health Surveys
;
Humans
;
Mass Screening
;
Pilot Projects
;
Prospective Studies
;
Referral and Consultation
;
Sensitivity and Specificity
;
Volunteers
8.Influence of the Adjuvants and Genetic Background on the Asthma Model Using Recombinant Der f 2 in Mice.
Yoon Seok CHANG ; Yoon Keun KIM ; Seong Gyu JEON ; Sae Hoon KIM ; Sun Sin KIM ; Heung Woo PARK ; Kyung Up MIN ; You Young KIM ; Sang Heon CHO
Immune Network 2013;13(6):295-300
Der f 2 is the group 2 major allergen of a house dust mite (Dermatophagoides farinae) and its function has been recently suggested. To determine the optimal condition of sensitization to recombinant Der f 2 (rDer f 2) in murine model of asthma, we compared the effectiveness with different adjuvants in BALB/c and C57BL/6 mice. Mice from both strains sensitized with rDer f 2 by intraperitoneal injection or subcutaneous injection on days 1 and 14. The dosage was 20 microg. Freund's adjuvants with pertussis toxin (FP) or alum alone were used as adjuvants. On days 28, 29, and 30, mice were challenged intranasally with 0.1% rDer f 2. We evaluated airway hyperresponsivenss, eosinophil proportion in lung lavage, airway inflammation, and serum allergen specific antibody responses. Naive mice were used as controls. Airway hyperresponsiveness was increased in C57BL/6 with FP, and BALB/c with alum (PC200: 13.5+/-6.3, 13.2+/-6.7 vs. >50 mg/ml, p<0.05). The eosinophil proportion was increased in all groups; C57BL/6 with FP, BALB/c with FP, C57BL/6 with alum, BALB/c with alum (24.8+/-3.6, 20.3+/-10.3, 11.0+/-6.9, 5.7+/-2.8, vs. 0.0+/-0.0%, p<0.05). The serum allergen specific IgE levels were increased in C57BL/6 with FP or alum (OD: 0.8+/-1.4, 1.1+/-0.8, vs. 0.0+/-0.0). C57BL/6 mice were better responders to rDer f 2 and as for adjuvants, Freund's adjuvant with pertussis toxin was better.
Animals
;
Antibody Formation
;
Asthma*
;
Bronchoalveolar Lavage
;
Eosinophils
;
Freund's Adjuvant
;
Hypersensitivity
;
Immunoglobulin E
;
Inflammation
;
Injections, Intraperitoneal
;
Injections, Subcutaneous
;
Mice*
;
Pertussis Toxin
;
Pyroglyphidae
;
Rodentia
9.Clinical characteristics and long-term outcomes related to sputum eosinophilia in Korean asthmatics
Jae Woo JUNG ; Sae Hoon KIM ; Jae Woo KWON ; Tae Wan KIM ; Hye Ryun KANG ; Heung Woo PARK ; Sun Sin KIM ; Yoon Seok CHANG ; Sang Heon CHO ; Kyung Up MIN ; Cohort-For-Reality-And-Evolution-Of-Adult-Asthma (COREA)
Asia Pacific Allergy 2011;1(1):16-24
BACKGROUND: Bronchial asthma is usually associated with high sputum eosinophil levels. However, recent reports have suggested the importance of noneosinophilic asthma (NEA) as a distinct phenotype of asthma. OBJECTIVE: The aim of this study was to evaluate clinical significance of sputum eosinophilia and long-term treatment outcomes related to sputum eosinophilia in Korean asthmatics. METHODS: A total of 201 steroid-naive asthmatics who had undergone induced sputum analysis at baseline were selected from the Cohort for Reality and Evolution of Adult Asthma study population. Clinical evaluation, spirometry, a skin-prick test, a methacholine bronchial provocation test, and sputum eosinophil analysis were performed initially, and patients received the treatment recommended by the Global Initiative for Asthma. Lung function was evaluated every 6 months, and 53 patients completed 24 months of regular follow-up visits. Sputum eosinophilia was defined as a sputum eosinophil count of >3%.
Adult
;
Asthma
;
Bronchial Provocation Tests
;
Cohort Studies
;
Eosinophilia
;
Eosinophils
;
Follow-Up Studies
;
Forced Expiratory Volume
;
Humans
;
Lung
;
Methacholine Chloride
;
Phenotype
;
Spirometry
;
Sputum
10.Physicians' Preferences for Asthma Guidelines Implementation.
Min Koo KANG ; Byung Keun KIM ; Tae Wan KIM ; Sae Hoon KIM ; Hye Ryun KANG ; Heung Woo PARK ; Yoon Seok CHANG ; Sun Sin KIM ; Kyung Up MIN ; You Young KIM ; Sang Heon CHO
Allergy, Asthma & Immunology Research 2010;2(4):247-253
PURPOSE: Patient care based on asthma guidelines is cost-effective and leads to improved treatment outcomes. However, ineffective implementation strategies interfere with the use of these recommendations in clinical practice. This study investigated physicians' preferences for asthma guidelines, including content, supporting evidence, learning strategies, format, and placement in the clinical workplace. METHODS: We obtained information through a questionnaire survey. The questionnaire was distributed to physicians attending continuing medical education courses and sent to other physicians by airmail, e-mail, and facsimile. RESULTS: A total of 183 physicians responded (male to female ratio, 2.3:1; mean age, 40.4+/-9.9 years); 89.9% of respondents were internists or pediatricians, and 51.7% were primary care physicians. Physicians preferred information that described asthma medications, classified the disease according to severity and level of control, and provided methods of evaluation/treatment/monitoring and management of acute exacerbation. The most effective strategies for encouraging the use of the guidelines were through continuing medical education and discussions with colleagues. Physicians required supporting evidence in the form of randomized controlled trials and expert consensus. They preferred that the guidelines be presented as algorithms or flow charts/flow diagrams on plastic sheets, pocket cards, or in electronic medical records. CONCLUSIONS: This study identified the items of the asthma guidelines preferred by physicians in Korea. Asthma guidelines with physicians' preferences would encourage their implementation in clinical practice.
Asthma
;
Consensus
;
Surveys and Questionnaires
;
Education, Medical, Continuing
;
Electronic Health Records
;
Electronic Mail
;
Female
;
Humans
;
Korea
;
Learning
;
Patient Care
;
Physician's Practice Patterns
;
Physicians, Primary Care
;
Plastics
;
Surveys and Questionnaires

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