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.Outcomes of Salvage Therapy for Oropharyngeal Cancer Recurrence Following Upfront Radiation Therapy and Prognostic Factors
Nayeon CHOI ; Hack Jung KIM ; Heejun YI ; Heejung KIM ; Tae Hwan KIM ; Han-Sin JEONG ; Young-Ik SON ; Chung-Hwan BAEK ; Dongryul OH ; Yong Chan AHN ; Man Ki CHUNG
Cancer Research and Treatment 2023;55(4):1123-1133
Purpose:
This study aimed to investigate the oncologic outcomes and prognostic factors of salvage treatments in patients with recurrent oropharyngeal squamous cell carcinoma (OPSCC) after radiotherapy (RT)-based treatment.
Materials and Methods:
A cancer registry was used to retrieve the records of 337 patients treated with definitive RT or concurrent chemoradiotherapy (CRT) from 2008 to 2018 at a single institution. The poor-responder group (PRG) was defined as patients with residual or recurrent disease after primary treatment, and the oncologic outcomes for each salvage treatment method were analyzed. In addition, prognostic indicators of recurrence-free survival (RFS) and overall survival (OS) were identified in patients who underwent salvage treatment.
Results:
After initial (C)RT, the PRG comprised 71 of the 337 patients (21.1%): 18 patients had residual disease, and 53 had recurrence after primary treatment (mean time to recurrence 19.5 months). Of these, 63 patients received salvage treatment (surgery 57.2%, re-(C)RT 23.8%, and chemotherapy 19.0%), and the salvage success rate was 47.6% at the last follow-up. The overall 2-year OS for salvage treatments was 56.4% (60.8% for the salvage surgery group and 46.2% for the salvage re-(C)RT). Salvage surgery patients with negative resection margins had better oncologic outcomes than those with close/positive resection margins. Using multivariate analyses, locoregional recurrence and residual disease after primary surgery were associated with poor outcome after salvage treatment. In Kaplan-Meier analyses, p16 status was significantly associated with OS in the initial treatment setting but not in the salvage setting.
Conclusion
In recurrent OPSCC after RT-based treatment, successful salvage was achieved in 56.4% patients who had undergone salvage surgery and radiation treatment. Salvage treatment methods should be selected carefully, given recurrence site as a prognostic factor for RFS.
3.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
4.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
5.Efficacy of a Once-Monthly Pill Containing Ibandronate and Cholecalciferol on the Levels of 25-Hydroxyvitamin D and Bone Markers in Postmenopausal Women with Osteoporosis.
In Jin CHO ; Ho Yeon CHUNG ; Sung Woon KIM ; Jae Won LEE ; Tae Won LEE ; Hye Soon KIM ; Sin Gon KIM ; Han Seok CHOI ; Sung Hee CHOI ; Chan Soo SHIN ; Ki Won OH ; Yong Ki MIN ; Jung Min KOH ; Yumie RHEE ; Dong Won BYUN ; Yoon Sok CHUNG ; Jeong Hyun PARK ; Dong Jin CHUNG ; Minho SHONG ; Eun Gyoung HONG ; Chang Beom LEE ; Ki Hyun BAEK ; Moo Il KANG
Endocrinology and Metabolism 2015;30(3):272-279
BACKGROUND: The present study evaluated the efficacy of a combination of ibandronate and cholecalciferol on the restoration of the levels of 25-hydroxyvitamin D (25[OH]D) and various bone markers in postmenopausal women with osteoporosis. METHODS: This was a randomized, double-blind, active-controlled, prospective 16-week clinical trial conducted in 20 different hospitals. A total of 201 postmenopausal women with osteoporosis were assigned randomly to one of two groups: the IBN group, which received a once-monthly pill containing 150 mg ibandronate (n=99), or the IBN+ group, which received a once-monthly pill containing 150 mg ibandronate and 24,000 IU cholecalciferol (n=102). Serum levels of 25(OH)D, parathyroid hormone (PTH), and various bone markers were assessed at baseline and at the end of a 16-week treatment period. RESULTS: After 16 weeks of treatment, the mean serum levels of 25(OH)D significantly increased from 21.0 to 25.3 ng/mL in the IBN+ group but significantly decreased from 20.6 to 17.4 ng/mL in the IBN group. Additionally, both groups exhibited significant increases in mean serum levels of PTH but significant decreases in serum levels of bone-specific alkaline phosphatase and C-telopeptide of type 1 collagen (CTX) at 16 weeks; no significant differences were observed between the groups. However, in subjects with a vitamin D deficiency, IBN+ treatment resulted in a significant decrease in serum CTX levels compared with IBN treatment. CONCLUSION: The present findings demonstrate that a once-monthly pill containing ibandronate and cholecalciferol may be useful for the amelioration of vitamin D deficiency in patients with postmenopausal osteoporosis. Moreover, this treatment combination effectively decreased serum levels of resorption markers, especially in subjects with a vitamin D deficiency, over the 16-week treatment period.
Alkaline Phosphatase
;
Cholecalciferol*
;
Collagen Type I
;
Female
;
Humans
;
Osteoporosis*
;
Osteoporosis, Postmenopausal
;
Parathyroid Hormone
;
Prospective Studies
;
Vitamin D Deficiency
6.Definitive Radiation Therapy for Early Glottic Cancer: Experience of Two Fractionation Schedules.
Tae Gyu KIM ; Yong Chan AHN ; Hee Rim NAM ; Man Ki CHUNG ; Han Sin JEONG ; Young Ik SON ; Chung Hwan BAEK
Clinical and Experimental Otorhinolaryngology 2012;5(2):94-100
OBJECTIVES: The authors would report the results of definitive radiation therapy (RT) for early glottic cancer by two different radiation dose schedules. METHODS: From February of 1995 till June of 2008, 157 patients with T1-2N0 glottic cancer were treated with curative RT at Samsung Medical Center. All patients had squamous cell carcinoma, and there were 89 patients (56.7%) with T1a, 36 (22.9%) with T1b, and 32 (20.4%) with T2. Two different radiation dose schedules were used: 70 Gy in 35 fractions to 64 patients (40.8%, group A); and 67.5 Gy in 30 fractions to 93 patients (59.2%, group B). The median treatment durations were 50 days (range, 44 to 59 days) and 44 days (range, 40 to 67 days) in the groups A and B, respectively. RESULTS: The median follow-up durations were 85 and 45 months for the groups A and B. No severe late complication of RTOG grade 3 or higher was observed, and there was no difference in acute or chronic complication between the groups. Twenty-four patients experienced treatment failure: local recurrence only in 19 patients; regional recurrence only in one; combined local and regional recurrence in four; and systemic metastasis in none. The overall 5-year disease-free survival and disease-specific survival rates were 84.7% and 94.8%. The disease-free survival rate in the group B was better (78.3% vs. 90.8%, P=0.031). This difference was significant only in T1 stage (83.4% vs. 94.6%, P=0.025), but not in T2 (62.7% vs. 60.6%, P=0.965). Univariate analysis showed that the tumor extent, cord mobility, T-stage, and the dose schedule had significant influence on the disease-free survival, and multivariate analysis showed that only the tumor extent and the dose schedule were associated with the disease-free survival. CONCLUSION: Superior disease-free survival could be achieved by 2.25 Gy per fraction without increased toxicity over shorter RT duration, when compared with 2.0 Gy per fraction.
Appointments and Schedules
;
Carcinoma, Squamous Cell
;
Disease-Free Survival
;
Dose Fractionation
;
Follow-Up Studies
;
Humans
;
Laryngeal Neoplasms
;
Multivariate Analysis
;
Neoplasm Metastasis
;
Recurrence
;
Survival Rate
7.Sexual Behavior of the Elderly in Urban Areas.
Hyun Cheol JEONG ; Sin Uk KIM ; Wan Chul LEE ; Ma Tae KIM ; Won Ki LEE ; Ha Young KIM ; Sung Yong KIM ; Dae Yul YANG
The World Journal of Men's Health 2012;30(3):166-171
PURPOSE: This study aimed at investigating sexual behavior patterns of elderly residents of urban areas in South Korea and their correlation with lower urinary tract symptoms. MATERIALS AND METHODS: From May, 2009 to October, 2009, 154 males and 299 females over 60 years old who visited senior welfare centers of Seoul were administered a questionnaire on sex life patterns and voiding symptoms. RESULTS: Among the 154 males, 59 (38.3%) had sexual intercourse at least one time per month. The remaining 95 males (61.7%) did not have sexual intercourse, because of impotence for 52 males (52.6%), no sexual desire for 28 males (29.4%), and sex partner's problems for 15 males (15.7%). The higher International Prostate Symptom Score was, the lower International Index of Erectile Dysfunction-5 was (p=0.035). Among 299 females, 37 (12.4%) had sexual intercourse at least one time per month. The remaining 262 females (87.6%) did not have sexual intercourse, because of no spouse for 163 females (63.2%), no sexual desire for 48 females (18.6%), the spouse's impotence for 34 females (13.2%), and the spouse's bad health for 10 females (3.9%). It was found that self-diagnosis of overactive bladder affects sex life negatively. CONCLUSIONS: The sexual behaviors of the elderly included varying activity. Sexual intercourse were significantly associated with lower urinary tract symptoms. Our results suggest that the counseling with the elderly about sexual health is as important as it is with non-elderly individuals.
Aged
;
Coitus
;
Counseling
;
Erectile Dysfunction
;
Female
;
Humans
;
Lower Urinary Tract Symptoms
;
Male
;
Prostate
;
Surveys and Questionnaires
;
Reproductive Health
;
Republic of Korea
;
Sexual Behavior
;
Spouses
;
Urinary Bladder, Overactive
;
Urinary Tract
8.Comparison of Heart Rate Variability in Kidney Transplantation and End-Stage Renal Disease Patients on Dialysis.
Hee Ryong LEE ; Joon Seok OH ; Seung Ho CHOI ; Peel JUNG ; Tae Hyun RYU ; Sung Min KIM ; Yong Hun SIN ; Joong Kyung KIM ; Woo Hyung BAE ; Taek Jong HONG
Korean Journal of Medicine 2012;83(5):606-612
BACKGROUND/AIMS: Heart rate variability (HRV) is a method for evaluation of autonomic nervous system activity by expressing the balance of sympathetic and parasympathetic tones. Some studies of HRV in patients with end-stage renal disease (ESRD) have been performed in Korea. However, few have examined kidney transplantation (KT) patients. Therefore, we investigated autonomic nervous system activity by means of HRV in patients with KT due to ESRD. METHODS: We compared the pattern of cardiac sympathetic and parasympathetic activity by time- and frequency-domain analysis of HRV with 24-h Holter monitoring of 23 KT and 56 dialysis patients. Patients underwent KT between January, 2008 and June, 2011. RESULTS: The mean ages of KT and dialysis patients were 54.2 +/- 12.3 and 53.7 +/- 12.6 years, respectively. The KT group showed increased time- and frequency-domain HRV (including HRV index), very low frequency (VLF), means and standard deviations of all normal R-R intervals for all 5-min segments of the entire recording (SDNNi), low frequency (LF), LF in normalized units (LF norm), and LF to high-frequency power ratio, compared with the dialysis group. CONCLUSIONS: Autonomic tone in patients with KT is higher than that in patients with ESRD on dialysis.
Autonomic Nervous System
;
Dialysis
;
Electrocardiography
;
Electrocardiography, Ambulatory
;
Heart
;
Heart Rate
;
Humans
;
Kidney
;
Kidney Failure, Chronic
;
Kidney Transplantation
;
Korea
9.A Case of Dermatomyositis Presenting with Rhabdomyolysis.
Hyang Sun LEE ; Yong Gwan JEE ; Sin Han SONG ; Se Yong SUNG ; Ji Ho LEE ; Jae Won YANG ; Byoung Geun HAN ; Soon Hee JUNG ; Jeong Ha PARK ; Tae Young KANG
Journal of Rheumatic Diseases 2011;18(3):203-207
Rhabdomyolysis is caused by injury to skeletal muscle and it involves leakage of intracellular contents into the plasma. Rhabdomyolysis is an extremely rare manifestation of dermatomyositis. Dermatomyositis is a rare idiopathic inflammatory myopathy that is characterized by chronic inflammation of skeletal muscles and skin, resulting in muscle weakness. A 20 year old Korean male soldier presented with acute muscle pain, weakness and skin rashes over the face, neck and anterior chest. He received military training with carrying a radio set one week previouslyago. The patient was treated for rhabdomyolysis. However, the patient's symptoms did not improve. Muscle biopsy results suggested the diagnosis of rhabdomyolysis. Nevertheless, the features of skin and muscle inflammation raised the possibility of dermatomyositis. High dose steroid treatment was started, and then the symptoms and signs of muscle inflammation were improved. Rhabdomyolysis as the presenting sign of dermatomyositis has not been reported in Korea. Thus, we report on this case with a literature review.
Biopsy
;
Dermatomyositis
;
Exanthema
;
Humans
;
Inflammation
;
Korea
;
Lifting
;
Male
;
Military Personnel
;
Muscle Weakness
;
Muscle, Skeletal
;
Muscles
;
Myositis
;
Neck
;
Plasma
;
Rhabdomyolysis
;
Skin
;
Thorax
10.Isolated Left Main Coronary Artery Spasm Detected by Multidetector Computed Tomography.
Min Kyung KANG ; Young Hoon JEONG ; Seong Eun YOON ; Jin Sin KOH ; Kwon Tae JUNG ; Yongwhi PARK ; Seok Jae HWANG ; Choong Hwan KWAK ; Kyung Nyeo JEON ; Jin Yong HWANG
Korean Circulation Journal 2011;41(1):43-45
Although atherosclerotic obstruction is the main cause of left main coronary artery (LMCA) disease, it can also be associated with vasospasm. We report a case of a 61-year-old male who presented with ostial stenosis of the LMCA, detected by 64-slice multi-detector computed tomographic coronary angiography (MDCT-CA). Careful review of MDCT and intravascular ultrasound findings showed suspicion of an isolated spasm of the LMCA without a significant atherosclerotic lesion. The patient was successfully treated with nitrates and a calcium channel blocker.
Calcium Channels
;
Constriction, Pathologic
;
Coronary Angiography
;
Coronary Vasospasm
;
Coronary Vessels
;
Humans
;
Male
;
Middle Aged
;
Multidetector Computed Tomography
;
Nitrates
;
Spasm
;
Tomography, Spiral Computed
;
Ultrasonography, Interventional

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