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.Replacing Mercury Sphygmomanometers With Mercury-Free Sphygmomanometers for the National Health Survey in Children: Direct Comparisons Applying Two Types of Mercury-Free Sphygmomanometer
Sung Hye KIM ; Yu-Mi KIM ; Seong Heon KIM ; Jinho SHIN ; Eun Mi LEE
Korean Circulation Journal 2024;54(5):270-287
Background and Objectives:
Blood pressure (BP) measurement using an auscultatory sphygmomanometer is recommended for diagnosing hypertension in children. As mercury sphygmomanometers (MSs) are banned owing to environmental concerns, it is crucial to determine the accuracy of mercury-free sphygmomanometers to replace them. We analyzed the accuracy of these devices to guide the National Survey selection.
Methods:
BP was measured thrice each with MS, auscultatory device (AD), and oscillometric device (OD) in 104 participants aged 10–18 using the National Survey data. The difference in BP was defined as the difference between MS and other devices. The BP differences, correlations, and influencing factors were analyzed. The frequencies of hypertension were also compared.
Results:
Systolic BP (SBP) and diastolic BP (DBP) differences between MS and AD were 0.88±3.36 mmHg and 0.63±3.95 mmHg, and those between MS and OD were 0.43±5.83 mmHg and 4.57±6.89 mmHg, respectively. The absolute error of <10 mmHg for DBP between MS and OD was 76%. The concordance correlation coefficient between MS and AD was 0.94 for SBP and 0.90 for DBP, and 0.81 and 0.67, respectively for MS and OD. Arm circumference negatively correlated with BP differences except for SBP between the MS and OD. The frequency of hypertension was not different between MS and AD but was underestimated by OD.
Conclusions
AD correlated well with MS, while OD did not, especially for DBP. The superiority of AD over OD suggests AD as a possible alternative for MS in the National Survey.
3.Patient Perspectives and Preferences Regarding Gout and Gout Management:Impact on Adherence
Min Kyung CHUNG ; Sung Soo KIM ; Yun-Hong CHEON ; Seung-Jae HONG ; Hyo Jin CHOI ; Mi Ryoung SEO ; Jiwon HWANG ; Joong Kyong AHN ; Sang-Heon LEE ; Hong Ki MIN ; Hoon-Suk CHA ; Shin-Seok LEE ; Jennifer LEE ; Ki Won MOON ; Chang-Keun LEE ; Hyun-Ok KIM ; Young Sun SUH ; Seung-Cheol SHIM ; Seong Wook KANG ; Jinhyun KIM ; Sang Tae CHOI ; Jung Soo SONG ; Jisoo LEE ;
Journal of Korean Medical Science 2021;36(32):e208-
Background:
Patient-centered management is becoming increasingly important in gout, but there are limited studies exploring patients' perspectives and preferences. We aimed to investigate patients' perspectives and preferences regarding gout and gout management, and their impacts on adherence to urate lowering therapy (ULT).
Methods:
A paper-based survey was performed in patients with gout seen at the rheumatology outpatient clinics of 16 tertiary hospitals. The survey included questions regarding demographics, comorbidities, gout attacks, current treatment and adherence, and patients' perspectives and preferences regarding gout and gout management. Multivariate regression analysis was performed to determine the factors associated with ULT adherence.
Results:
Of 809 surveyed patients with gout, 755 (94.5%) were using ULT. Among those using ULT, 89.1% had ≥ 80% adherence to ULT. Majority of the patients knew management strategies to some extent (94.8%), perceived gout as a life-long disease (91.2%), and were making efforts toward practicing at least one lifestyle modification (89.2%). Most patients (71.9%) obtained information about gout management during their clinic visits.Approximately half of the patients (53.6%) preferred managing their disease with both ULT and lifestyle modification, 28.4% preferred ULT only, and 17.4% preferred lifestyle modification only. Adherence was better in patients with older age (odds ratio [OR], 1.03), those with better knowledge of gout management strategies (OR, 3.56), and those who had preference for ULT (OR, 2.07).
Conclusion
Patients' perspectives and management preferences had high impacts on adherence to ULT in gout. Consideration of patients' perspectives and preferences is important for achieving the desired clinical outcome in gout.
4.Patient Perspectives and Preferences Regarding Gout and Gout Management:Impact on Adherence
Min Kyung CHUNG ; Sung Soo KIM ; Yun-Hong CHEON ; Seung-Jae HONG ; Hyo Jin CHOI ; Mi Ryoung SEO ; Jiwon HWANG ; Joong Kyong AHN ; Sang-Heon LEE ; Hong Ki MIN ; Hoon-Suk CHA ; Shin-Seok LEE ; Jennifer LEE ; Ki Won MOON ; Chang-Keun LEE ; Hyun-Ok KIM ; Young Sun SUH ; Seung-Cheol SHIM ; Seong Wook KANG ; Jinhyun KIM ; Sang Tae CHOI ; Jung Soo SONG ; Jisoo LEE ;
Journal of Korean Medical Science 2021;36(32):e208-
Background:
Patient-centered management is becoming increasingly important in gout, but there are limited studies exploring patients' perspectives and preferences. We aimed to investigate patients' perspectives and preferences regarding gout and gout management, and their impacts on adherence to urate lowering therapy (ULT).
Methods:
A paper-based survey was performed in patients with gout seen at the rheumatology outpatient clinics of 16 tertiary hospitals. The survey included questions regarding demographics, comorbidities, gout attacks, current treatment and adherence, and patients' perspectives and preferences regarding gout and gout management. Multivariate regression analysis was performed to determine the factors associated with ULT adherence.
Results:
Of 809 surveyed patients with gout, 755 (94.5%) were using ULT. Among those using ULT, 89.1% had ≥ 80% adherence to ULT. Majority of the patients knew management strategies to some extent (94.8%), perceived gout as a life-long disease (91.2%), and were making efforts toward practicing at least one lifestyle modification (89.2%). Most patients (71.9%) obtained information about gout management during their clinic visits.Approximately half of the patients (53.6%) preferred managing their disease with both ULT and lifestyle modification, 28.4% preferred ULT only, and 17.4% preferred lifestyle modification only. Adherence was better in patients with older age (odds ratio [OR], 1.03), those with better knowledge of gout management strategies (OR, 3.56), and those who had preference for ULT (OR, 2.07).
Conclusion
Patients' perspectives and management preferences had high impacts on adherence to ULT in gout. Consideration of patients' perspectives and preferences is important for achieving the desired clinical outcome in gout.
5.Simplified disease activity changes in real-world practice: a nationwide observational study of seropositive rheumatoid arthritis patients with moderate-to-high disease activity
Kichul SHIN ; Sung Soo KIM ; Sang-Heon LEE ; Seung-Jae HONG ; Sung Jae CHOI ; Jung-Yoon CHOE ; Seung-Geun LEE ; Hoon-Suk CHA ; Eun Young LEE ; Sung-Hwan PARK ; Jin-Wuk HUR ; Sung Soo NA ; Chang-Hee SUH ; Min Wook SO ; Seung Won CHOI ; Dong-Hyuk SHEEN ; Won PARK ; Shin-Seok LEE ; Wan Hee RYU ; Jin Seok KIM ; Jung Soo SONG ; Hye Soon LEE ; Seong Ho KIM ; Dae-Hyun YOO
The Korean Journal of Internal Medicine 2020;35(1):231-239
The objective of this study was to compare changes in the simplified disease activity index (SDAI) between biologic (b) and conventional (c) disease-modifying antirheumatic drugs (DMARD) users with seropositive rheumatoid arthritis (RA) in daily clinical practice. Methods: This was a nationwide multicenter observational study. Patients who had three or more active joint counts and abnormal inf lammatory marker in blood test were enrolled. The selection of DMARDs was determined by the attending rheumatologist. Clinical parameters, laboratory findings, and Health Assessment Questionnaire (HAQ) scores were obtained at baseline and at 6 and 12 months. Serial SDAI changes and clinical remission rate at 6 and 12 months were assessed. Results: A total of 850 patients participated in this study. The mean baseline SDAI score in bDMARD group was higher than that in cDMARD group (32.08 ± 12.98 vs 25.69 ± 10.97, p < 0.0001). Mean change of SDAI at 12 months was –19.0 in the bDMARD group and –12.6 in the cDMARD group (p < 0.0001). Clinical remission rates at 12 months in bDMARD and cDMARD groups were 15.4% and 14.6%, respectively. Patient global assessment and HAQ at 12 months were also significantly improved in both groups. Multivariate logistic regression showed that baseline HAQ score was the most notable factor associated with remission. Conclusions: There was a significant reduction in SDAI within 12 months after receiving DMARDs in Korean seropositive RA patients irrespective of bDMARD or cDMARD use in real-world practice. Clinical remission was achieved in those with lower baseline HAQ scores.
6.Productivity Loss of Rheumatoid Arthritis Patients according to the Their Stages of the Disease Activity Score.
Sang Cheol BAE ; Jin Hye CHA ; Jung Yoon CHOE ; Sung Jae CHOI ; Soo Kyung CHO ; Won Tae CHUNG ; Chung Il JOUNG ; Young Ok JUNG ; Young Mo KANG ; Dong Wook KIM ; Jinseok KIM ; Young Joo KIM ; Choong Ki LEE ; Hye Soon LEE ; Jisoo LEE ; Sang Heon LEE ; Sang Hoon LEE ; Shin Seok LEE ; Yeon Ah LEE ; Seong Su NAH ; Seung Cheol SHIM ; Gwan Gyu SONG ; Chang Hee SUH ; Soyoung WON ; Wan Hee YOO ; Bo Young YOON
Journal of Rheumatic Diseases 2018;25(2):122-130
OBJECTIVE: Productivity loss was compared by 3-stage of disease activity and associations between higher disease activity and high productivity loss were identified. METHODS: Data were extracted from Rheumatoid Arthritis (RA) Patient-reported Outcomes Research, which enrolled 2,000 RA patients (>20-year) on disease-modifying-antirheumatic-drugs (DMARDs) (≥6-month) from December 2012 to June 2013. This included 1,457 RA patients with the disease activity score (DAS-28-ESR) in their medical charts. Productivity loss in time and indirect cost was estimated using The World Health Organization Health and Work Performance Questionnaire (HPQ). Baseline characteristics and productivity loss outcomes were compared according to DAS-28-ESR groups. RESULTS: 84.4% were females, 54.2% had low DAS-28-ESR ( < 3.2), and 38.2% and 7.6% had moderate (3.2∼5.1) and high DAS-28-ESR (>5.1). Patients with moderate to high DAS-28-ESR had higher lost productivity time (LPT) and monthly costs of LPT than those with low DAS-28-ESR (time in hours: 110.0±58.4 vs. 132.4±57.2 vs. 71.5±52.0, p < 0.0001; monthly costs of LPT in 1,000 Korean won: 1,097±607 vs. 1,302±554 vs. 741±531, p < 0.0001). Multiple regression analyses revealed significant associations with high LPT in high (adjusted odds ratio [OR]=3.87, 95% confidence interval [CI]: 2.18∼6.87) and moderate DAS-28-ESR (adjusted OR=1.88, 95% CI: 1.41∼2.52) compared to low DAS-28-ESR. In addition, positive associations with high monthly costs of LPT were observed in high (adjusted OR=3.45, 95% CI: 1.98∼5.99) and moderate DAS-28-ESR (adjusted OR=1.93, 95% CI: 1.43∼2.54) compared to low DAS-28-ESR. CONCLUSION: Timely therapeutic strategies should be taken into consideration given that the RA patients with moderate to high DAS-28-ESR showed strong associations with high productivity loss for effective management of RA.
Arthritis, Rheumatoid*
;
Efficiency*
;
Female
;
Humans
;
Odds Ratio
;
Outcome Assessment (Health Care)
;
Work Performance
;
World Health Organization
7.Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatitis B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study).
Dae Won JUN ; Sang Bong AHN ; Tae Yeob KIM ; Joo Hyun SOHN ; Sang Gyune KIM ; Se Whan LEE ; Byung Ho KIM ; Dong Joon KIM ; Ja Kyung KIM ; Hyoung Su KIM ; Seong Gyu HWANG ; Won Choong CHOI ; Won Young TAK ; Heon Ju LEE ; Ki Tae YOON ; Byung Cheol YUN ; Sung Wook LEE ; Soon Koo BAIK ; Seung Ha PARK ; Ji Won PARK ; Sol Ji PARK ; Ji Sung LEE
Chinese Medical Journal 2018;131(14):1645-1651
BackgroundUntil now, various types of combined therapy with nucleotide analogs and pegylated interferon (Peg-INF) in patients with hepatitis B patients have been tried. However, studies regarding the benefits of de novo combination, late-add on, and sequential treatment are very limited. The objective of the current study was to identify the efficacy of sequential treatment of Peg-INF after short-term antiviral treatment.
MethodsBetween June 2010 and June 2015, hepatitis B e antigen (HBeAg)-positive patients (n = 162) received Peg-IFN for 48 weeks (mono-treatment group, n = 81) and entecavir (ETV) for 12 weeks with a 48-week course of Peg-IFN starting at week 5 of ETV therapy (sequential treatment group, n = 81). The primary endpoint was HBeAg seroconversion at the end of follow-up period after the 24-week treatment. The primary endpoint was analyzed using Chi-square test, Fisher's exact test, and regression analysis.
ResultsHBeAg seroconversion rate (18.2% vs. 18.2%, t = 0.03, P = 1.000) and seroclearance rate (19.7% vs. 19.7%, t = 0.03, P = 1.000) were same in both mono-treatment and sequential treatment groups. The rate of alanine aminotransferase (ALT) normalization (45.5% vs. 54.5%, t = 1.12, P = 0.296) and serum hepatitis B virus (HBV)-DNA <2000 U/L (28.8% vs. 28.8%, t = 0.10, P = 1.000) was not different in sequential and mono-treatment groups at 24 weeks of Peg-INF. Viral response rate (HBeAg seroconversion and serum HBV-DNA <2000 U/L) was not different in the two groups (12.1% vs. 16.7%, t = 1.83, P = 0.457). Baseline HBV-DNA level (7 logU/ml vs. 7.5 logU/ml, t = 1.70, P = 0.019) and hepatitis B surface antigen titer (3.6 logU/ml vs. 4.0 logU/ml, t = 2.19, P = 0.020) were lower and predictors of responder in mono-treatment and sequential treatment groups, respectively.
ConclusionsThe current study shows no differences in HBeAg seroconversion rate, ALT normalization, and HBV-DNA levels between mono-therapy and sequential therapy regimens.
Trial RegistrationClinicalTrials.gov, NCT01220596; https://clinicaltrials.gov/ct2/show/NCT01220596?term=NCT01220596&rank=1.
8.Impact of early diagnosis on functional disability in rheumatoid arthritis.
Dam KIM ; Chan Bum CHOI ; Jiyoung LEE ; Soo Kyung CHO ; Soyoung WON ; So Young BANG ; Hoon Suk CHA ; Jung Yoon CHOE ; Won Tae CHUNG ; Seung Jae HONG ; Jae Bum JUN ; Young Ok JUNG ; Jinseok KIM ; Seong Kyu KIM ; Tae Hwan KIM ; Tae Jong KIM ; Eunmi KOH ; Hye Soon LEE ; Jaejoon LEE ; Jisoo LEE ; Sang Heon LEE ; Shin Seok LEE ; Sung Won LEE ; Seung Cheol SHIM ; Dae Hyun YOO ; Bo Young YOON ; Yoon Kyoung SUNG ; Sang Cheol BAE
The Korean Journal of Internal Medicine 2017;32(4):738-746
BACKGROUND/AIMS: To determine whether early diagnosis is beneficial for functional status of various disease durations in rheumatoid arthritis (RA) patients. METHODS: A total of 4,540 RA patients were enrolled as part of the Korean Observational Study Network for Arthritis (KORONA). We defined early diagnosis as a lag time between symptom onset and RA diagnosis of ≤ 12 months, whereas patients with a longer lag time comprised the delayed diagnosis group. Demographic characteristics and outcomes were compared between early and delayed diagnosis groups. Logistic regression analyses were performed to identify the impact of early diagnosis on the development of functional disability in RA patients. RESULTS: A total of 2,597 patients (57.2%) were included in the early diagnosis group. The average Health Assessment Questionnaire-Disability Index (HAQ-DI) score was higher in the delayed diagnosis group (0.64 ± 0.63 vs. 0.70 ± 0.66, p < 0.01), and the proportion of patients with no functional disability (HAQ = 0) was higher in the early diagnosis group (22.9% vs. 20.0%, p = 0.02). In multivariable analyses, early diagnosis was independently associated with no functional disability (odds ratio [OR], 1.19; 95% confidence interval [CI], 1.01 to 1.40). In a subgroup analysis according to disease duration, early diagnosis was associated with no functional disability in patients with disease duration < 5 years (OR, 1.37; 95% CI, 1.09 to 1.72) but not in patients with longer disease duration (for 5 to 10 years: OR, 1.07; 95% CI, 0.75 to 1.52; for ≥ 10 years: OR, 0.92; 95% CI, 0.65 to 1.28). CONCLUSIONS: Early diagnosis is associated with no functional disability, especially in patients with shorter disease duration.
Arthritis
;
Arthritis, Rheumatoid*
;
Delayed Diagnosis
;
Diagnosis
;
Early Diagnosis*
;
Humans
;
Logistic Models
;
Observational Study
9.Invasive Primary Colonic Aspergillosis in the Immunocompetent Host without Classical Risk Factors.
Seon Ah CHA ; Mi Hee KIM ; Tae Seok LIM ; Hyun Ho KIM ; Kyung Yoon CHANG ; Hoon Suk PARK ; Hyung Wook KIM ; Seong Heon WIE ; Dong Chan JIN
Yonsei Medical Journal 2015;56(5):1453-1456
Invasive aspergillosis (IA), generally considered an opportunistic infection in immunocompromised hosts, is associated with high morbidity and mortality. IA commonly occurs in the respiratory tract with isolated reports of aspergillosis infection in the nasal sinuses, central nervous system, skin, liver, and urinary tract. Extra-pulmonary aspergillosis is usually observed in disseminated disease. To date, there are a few studies regarding primary and disseminated gastrointestinal (GI) aspergillosis in immunocompromised hosts. Only a few cases of primary GI aspergillosis in non-immunocompromised hosts have been reported; of these, almost all of them involved the upper GI tract. We describe a very rare case of IA involving the lower GI tract in the patient without classical risk factors that presented as multiple colon perforations and was successfully treated by surgery and antifungal treatment. We also review related literature and discuss the characteristics and risk factors of IA in the immunocompetent hosts without classical risk factors. This case that shows IA should be considered in critically ill patients, and that primary lower GI aspergillosis may also occur in the immunocompetent hosts without classical risk factors.
Amphotericin B/administration & dosage/therapeutic use
;
Antifungal Agents/administration & dosage/*therapeutic use
;
Aspergillosis/*diagnosis/drug therapy/microbiology/surgery
;
Aspergillus/*isolation & purification
;
Colon/microbiology/radiography/*surgery
;
Colonic Diseases/diagnosis/therapy
;
Combined Modality Therapy
;
Humans
;
*Immunocompetence
;
Laparotomy
;
Male
;
Middle Aged
;
Treatment Outcome
;
Voriconazole/administration & dosage/therapeutic use
10.Solitary Cavernous Sinus Neurosarcoidosis Mimicking Neurosyphilis.
Dong Ha KIM ; Won Ho CHO ; Kyu Sup CHO ; Seong Heon CHA
Journal of Korean Neurosurgical Society 2014;55(1):61-63
A differential diagnosis between neurosarcoidosis and neurosyphilis is particularly problematic in patients with a positive serologic result for syphilis. We report here a patient with a solitary cavernous sinus sarcoidosis who had a history of syphilis and showed rapidly progressing cavernous sinus syndrome. A transsphenoidal biopsy was performed and a histopathologic examination revealed a non-caseating granuloma with an asteroid body. His facial pain disappeared after steroid therapy. He received oral prednisolone for one year. A follow-up magnetic resonance imaging of the brain revealed resolution of the mass over the cavernous sinus. Particularly in patients with a history of syphilis, neurosyphilis should be included in a differential diagnosis of neurosarcoidosis.
Biopsy
;
Brain
;
Cavernous Sinus*
;
Diagnosis, Differential
;
Facial Pain
;
Follow-Up Studies
;
Granuloma
;
Humans
;
Magnetic Resonance Imaging
;
Neurosyphilis*
;
Prednisolone
;
Sarcoidosis
;
Syphilis

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