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.Contemporary Statistics of Acute Ischemic Stroke and Transient Ischemic Attack in 2021: Insights From the CRCS-K-NIH Registry
Do Yeon KIM ; Tai Hwan PARK ; Yong-Jin CHO ; Jong-Moo PARK ; Kyungbok LEE ; Minwoo LEE ; Juneyoung LEE ; Sang Yoon BAE ; Da Young HONG ; Hannah JUNG ; Eunvin KO ; Hyung Seok GUK ; Beom Joon KIM ; Jun Yup KIM ; Jihoon KANG ; Moon-Ku HAN ; Sang-Soon PARK ; Keun-Sik HONG ; Hong-Kyun PARK ; Jeong-Yoon LEE ; Byung-Chul LEE ; Kyung-Ho YU ; Mi Sun OH ; Dong-Eog KIM ; Dong-Seok GWAK ; Soo Joo LEE ; Jae Guk KIM ; Jun LEE ; Doo Hyuk KWON ; Jae-Kwan CHA ; Dae-Hyun KIM ; Joon-Tae KIM ; Kang-Ho CHOI ; Hyunsoo KIM ; Jay Chol CHOI ; Joong-Goo KIM ; Chul-Hoo KANG ; Sung-il SOHN ; Jeong-Ho HONG ; Hyungjong PARK ; Sang-Hwa LEE ; Chulho KIM ; Dong-Ick SHIN ; Kyu Sun YUM ; Kyusik KANG ; Kwang-Yeol PARK ; Hae-Bong JEONG ; Chan-Young PARK ; Keon-Joo LEE ; Jee Hyun KWON ; Wook-Joo KIM ; Ji Sung LEE ; Hee-Joon BAE ;
Journal of Korean Medical Science 2024;39(34):e278-
This report presents the latest statistics on the stroke population in South Korea, sourced from the Clinical Research Collaborations for Stroke in Korea-National Institute for Health (CRCS-K-NIH), a comprehensive, nationwide, multicenter stroke registry. The Korean cohort, unlike western populations, shows a male-to-female ratio of 1.5, attributed to lower risk factors in Korean women. The average ages for men and women are 67 and 73 years, respectively.Hypertension is the most common risk factor (67%), consistent with global trends, but there is a higher prevalence of diabetes (35%) and smoking (21%). The prevalence of atrial fibrillation (19%) is lower than in western populations, suggesting effective prevention strategies in the general population. A high incidence of large artery atherosclerosis (38%) is observed, likely due to prevalent intracranial arterial disease in East Asians and advanced imaging techniques.There has been a decrease in intravenous thrombolysis rates, from 12% in 2017–2019 to 10% in 2021, with no improvements in door-to-needle and door-to-puncture times, worsened by the coronavirus disease 2019 pandemic. While the use of aspirin plus clopidogrel for noncardioembolic stroke and direct oral anticoagulants for atrial fibrillation is well-established, the application of direct oral anticoagulants for non-atrial fibrillation cardioembolic strokes in the acute phase requires further research. The incidence of early neurological deterioration (13%) and the cumulative incidence of recurrent stroke at 3 months (3%) align with global figures. Favorable outcomes at 3 months (63%) are comparable internationally, yet the lack of improvement in dependency at 3 months highlights the need for advancements in acute stroke care.
3.Avoiding unnecessary intraoperative sentinel lymph node frozen section biopsy of patients with early breast cancer
Jongwon KANG ; Tae-Kyung YOO ; Ahwon LEE ; Jun KANG ; Chang Ik YOON ; Bong Joo KANG ; Sung Hun KIM ; Woo Chan PARK
Annals of Surgical Treatment and Research 2022;102(5):241-247
Purpose:
After the publication of the ACOSOG (American College of Surgeons Oncology Group) Z0011 trial, the rate of axillary lymph node dissection has reduced. Thus, the need for intraoperative frozen section biopsy of sentinel lymph nodes (SLNs) has become controversial. We identified patients for whom intraoperative SLN frozen section biopsy could be omitted and found that frozen section biopsy rate can be reduced.
Methods:
We reviewed the records of patients with tumors ≤5 cm in diameter who underwent breast-conserving surgery between January 2013 and December 2019 at Seoul St. Mary’s Hospital. Clinicopathological and imaging characteristics were compared according to number of positive SLNs (0–2 SLNs positive vs. ≥3 SLNs positive).
Results:
A total of 1,983 patients were included in this study. Thirty-two patients (1.6%) had at least 3 positive SLNs. Patients with ≥3 positive SLNs had significantly larger tumors and were more frequently high-grade tumors (P < 0.001 and P = 0.002, respectively). Identification of suspicious lymph nodes on imaging studies was also associated with the presence of ≥3 positive SLNs (hazard ratio, 11.54; 95% confidence interval, 4.42–30.10). All patients with none or only 1 suspicious lymph node on any imaging modality (n = 647, 32.6%) had 0–2 positive SLNs. Also, among patients with clinical T1-stage tumors and at least 2 suspicious lymph nodes on only 1 imaging modality (n = 514, 25.9%), only 2 cases had ≥3 positive SLNs.
Conclusion
We found that intraoperative SLN frozen biopsy could be omitted in patients using tumor size and axillary lymph node status on imaging modality.
4.The relationship between lymphedema severity and awareness of lymphedema surgery
Hyun Seung LEE ; Yong Chan BAE ; Su Bong NAM ; Chang Ryul YI ; Jin A YOON ; Joo Hyoung KIM
Archives of Plastic Surgery 2021;48(5):534-542
Background:
During the early stages of lymphedema, active physiologic surgical treatment can be applied. However, lymphedema patients often have limited knowledge and misconceptions regarding lymphedema and surgical treatment. We analyzed the correlations between lymphedema severity and surgical technique according to patients’ awareness of surgical treatment for secondary upper extremity lymphedema (UEL).
Methods:
Patients with UEL diagnosed between December 2017 and December 2019 were retrospectively evaluated. At the time of their presentation to our hospital for the treatment of lymphedema, they were administered a questionnaire about lymphedema and lymphedema surgery. Based on the results, patients were classified as being aware or unaware of surgical treatment. Lymphedema severity was classified according to the arm dermal backflow (ADB) stage and the MD Anderson Cancer Center (MDACC) stage based on indocyanine green lymphography conducted at presentation. Surgical techniques were compared between the two groups.
Results:
Patients who were aware of surgical treatment had significantly lower initial ADB and MDACC stages (P<0.05) and more frequently underwent physiologic procedures than excisional procedures (P=0.003).
Conclusions
If patients are actively educated regarding surgical treatment of lymphedema, physiologic procedures may be performed during the early stages of UEL.
5.The relationship between lymphedema severity and awareness of lymphedema surgery
Hyun Seung LEE ; Yong Chan BAE ; Su Bong NAM ; Chang Ryul YI ; Jin A YOON ; Joo Hyoung KIM
Archives of Plastic Surgery 2021;48(5):534-542
Background:
During the early stages of lymphedema, active physiologic surgical treatment can be applied. However, lymphedema patients often have limited knowledge and misconceptions regarding lymphedema and surgical treatment. We analyzed the correlations between lymphedema severity and surgical technique according to patients’ awareness of surgical treatment for secondary upper extremity lymphedema (UEL).
Methods:
Patients with UEL diagnosed between December 2017 and December 2019 were retrospectively evaluated. At the time of their presentation to our hospital for the treatment of lymphedema, they were administered a questionnaire about lymphedema and lymphedema surgery. Based on the results, patients were classified as being aware or unaware of surgical treatment. Lymphedema severity was classified according to the arm dermal backflow (ADB) stage and the MD Anderson Cancer Center (MDACC) stage based on indocyanine green lymphography conducted at presentation. Surgical techniques were compared between the two groups.
Results:
Patients who were aware of surgical treatment had significantly lower initial ADB and MDACC stages (P<0.05) and more frequently underwent physiologic procedures than excisional procedures (P=0.003).
Conclusions
If patients are actively educated regarding surgical treatment of lymphedema, physiologic procedures may be performed during the early stages of UEL.
6.Short-term Outcomes of Elective 2-Stage Restorative Proctocolectomy for Ulcerative Colitis in Korea: Does Laparoscopy Have Benefits?
Jun Woo BONG ; Yong Sik YOON ; Jong Lyul LEE ; Chan Wook KIM ; In Ja PARK ; Seok-Byung LIM ; Chang Sik YU ; Jin Cheon KIM
Annals of Coloproctology 2020;36(1):41-47
Purpose:
This study aimed to compare the short-term outcomes of the open and laparoscopic approaches to 2-stage restorative proctocolectomy (RPC) for Korean patients with ulcerative colitis (UC).
Methods:
We retrospectively analyzed the medical records of 73 patients with UC who underwent elective RPC between 2009 and 2016. Patient characteristics, operative details, and postoperative complications within 30 days were compared between the open and laparoscopic groups.
Results:
There were 26 cases (36%) in the laparoscopic group, which had a lower mean body mass index (P = 0.025), faster mean time to recovery of bowel function (P = 0.004), less intraoperative blood loss (P = 0.004), and less pain on the first and seventh postoperative days (P = 0.029 and P = 0.027, respectively) compared to open group. There were no deaths, and the overall complication rate was 43.8%. There was no between-group difference in the overall complication rate; however, postoperative ileus was more frequent in the open group (27.7% vs. 7.7%, P = 0.043). Current smoking (odds ratio [OR], 44.4; P = 0.003) and open surgery (OR, 5.4; P = 0.014) were the independent risk factors for postoperative complications after RPC.
Conclusion
Laparoscopic RPC was associated with acceptable morbidity and faster recovery than the open approach. The laparoscopic approach is a feasible and safe option for surgical treatment for UC in selective cases.
7.Dynamic Contrast-Enhanced MR Imaging of Tietze’s Syndrome: a Case Report
Dong Chan KIM ; Sang Yoon KIM ; Bong Man KIM
Investigative Magnetic Resonance Imaging 2020;24(1):55-60
Tietze's syndrome is an inflammatory condition associated with painful swelling of the costochondral, costosternal, and sternoclavicular joints. Tietze's syndrome has been mostly attributed to microtrauma until now; however, this etiology is currently disputed. The diagnosis is based on clinical findings, although a few studies suggest the advantages of imaging. We report a case of Tietze's syndrome with a review of radiological findings, especially magnetic resonance imaging (MRI) with dynamic contrast enhancement.
8.Long-term Transanal Excision Outcomes in Patients With T1 Rectal Cancer: Comparative Analysis of Radical Resection
Yunghuyn HWANG ; Yong Sik YOON ; Jun Woo BONG ; Hye Yun CHOI ; In Ho SONG ; Jong Lyul LEE ; Chan Wook KIM ; In Ja PARK ; Seok Byung LIM ; Chang Sik YU ; Jin Cheon KIM
Annals of Coloproctology 2019;35(4):194-201
PURPOSE: Transanal excision (TAE) is an alternative surgical procedure for early rectal cancer. This study compared long-term TAE outcomes, in terms of survival and local recurrence (LR), with total mesorectal excision (TME) in patients with pathologically confirmed T1 rectal cancer. METHODS: T1 rectal adenocarcinoma patients who underwent surgery from 1990 to 2011 were retrospectively reviewed. Patients that were suspected to have preoperative lymph node metastasis were excluded. Demographics, recurrence, and survival were analyzed based on TAE and TME surgery. RESULTS: Of 268 individuals, 61 patients (26%) underwent TAE, which was characterized by proximity to the anus, submucosal invasion depth, and lesion infiltration, compared with TME patients (P < 0.001–0.033). During a median follow-up of 10.4 years, 12 patients had systemic and/or LR. Ten-year cancer-specific survival in the TAE and TME groups was not significantly different (98% vs. 100%). However, the 10-year LR rate in the TAE group was greater than that of TME group (10% vs. 0%, P < 0.001). Although 5 of the 6 TAE patients with LR underwent salvage surgery, one of the patients eventually died. The TAE surgical procedure (hazard ratio, 19.066; P = 0.007) was the only independent risk factor for LR. CONCLUSION: Although long-term survival after TAE was comparable to that after TME, TAE had a greater recurrence risk than TME. Thus, TAE should only be considered as an alternative surgical option for early rectal cancer in selected patients.
Adenocarcinoma
;
Anal Canal
;
Colorectal Surgery
;
Demography
;
Follow-Up Studies
;
Humans
;
Lymph Nodes
;
Neoplasm Metastasis
;
Rectal Neoplasms
;
Recurrence
;
Retrospective Studies
;
Risk Factors
9.Clinical Characteristics and Prognosis Associated with Multiple Primary Cancers in Breast Cancer Patients.
Bong Kyun KIM ; Se Jeong OH ; Jeong Yoon SONG ; Han Byoel LEE ; Min Ho PARK ; Yongsik JUNG ; Woo Chan PARK ; Jina LEE ; Woo Young SUN
Journal of Breast Cancer 2018;21(1):62-69
PURPOSE: Breast cancer is one of the most common malignancies worldwide and the second most common cancer among Korean women. The prognosis of breast cancer is poor in patients with other primary cancers. However, there have been few clinical studies regarding this issue. Therefore, we analyzed the characteristics and prognosis of patients with breast cancer with multiple primary cancers (MPCs). METHODS: Data from the Korean Breast Cancer Society Registry were analyzed. Data from enrolled patients who underwent surgery for breast cancer were analyzed for differences in prognosis dependent on the presence of MPCs, and which MPC characteristics affected their prognosis. RESULTS: Among the 41,841 patients analyzed, 913 patients were found to have MPCs, accounting for 950 total MPCs. There was a significant difference in survival rates between the breast cancer only group and the MPC group. The 5-year survival rates were 93.6% and 86.7% and the 10-year survival rates were 87.5% and 70.4%, respectively. Among the 913 patients with MPCs, patients with two or more MPCs had significantly worse prognoses than patients with a single MPC. With respect to the time interval between breast cancer and MPC occurrence, patients with a 5-year or greater interval had significantly better prognoses than patients with less than 1 year between occurrences. Among MPCs, thyroid cancer was the most common primary cancer. However, this type was not related to the prognosis of breast cancer. Gynecologic cancer, colorectal cancer, upper gastrointestinal cancer, and lung cancer were related to breast cancer prognosis. CONCLUSION: MPCs were a poor prognostic factor for patients with breast cancer. Two or more MPCs and a shorter time interval between occurrences were worse prognostic factors. Although MPCs were a poor prognostic factor, thyroid cancer did not affect the prognosis of patients with breast cancer.
Breast Neoplasms*
;
Breast*
;
Colorectal Neoplasms
;
Female
;
Gastrointestinal Neoplasms
;
Humans
;
Lung Neoplasms
;
Neoplasms, Multiple Primary
;
Prognosis*
;
Survival Rate
;
Thyroid Neoplasms
10.Comparative Study between Sentinel Lymph Node Biopsy and Axillary Dissection in Patients with One or Two Lymph Node Metastases.
Jina LEE ; Jung Eun CHOI ; Sei Joong KIM ; Sae Byul LEE ; Min Ki SEONG ; Joon JEONG ; Chan Seok YOON ; Bong Kyun KIM ; Woo Young SUN
Journal of Breast Cancer 2018;21(3):306-314
PURPOSE: Sentinel lymph node biopsy (SLNB) is a standard axillary surgery in early breast cancer. If the SLNB result is positive, subsequent axillary lymph node dissection (ALND) is a routine procedure. In 2011, the American College of Surgeons Oncology Group Z0011 trial revealed that ALND may not be necessary in early breast cancer with one or two positive sentinel lymph nodes. The purpose of this study was to compare outcomes among Korean patients with one or two positive axillary lymph nodes in the final pathology who did and did not undergo ALND. METHODS: A total of 131,717 patients from the Korea Breast Cancer Society registry database received breast cancer surgery from January 1995 to December 2014. Inclusion criteria were T stage 1 or 2, one or two positive lymph nodes, and having received breast-conserving surgery (BCS), whole breast radiation therapy, and no neoadjuvant therapy. We analyzed the differences in disease-specific survival (DSS) and overall survival (OS) between patients who received SLNB only and those who underwent SLNB+ALND. RESULTS: A total 4,442 patients met the inclusion criteria, with 1,268 (28.6%) in the SLNB group and 3,174 (71.4%) in the SLNB+ALND group. There were no differences in DSS and OS between the two groups (p=0.378 and p=0.925, respectively). The number of patients who underwent SLNB alone for one or two positive lymph nodes increased continuously from 2004 to 2014. CONCLUSION: Korean patients with early breast cancer and 1 or 2 positive axillary lymph nodes who received BCS plus SLNB showed no significant difference in DSS and OS regardless of whether they received ALND. The findings of this retrospective study demonstrate that omitting ALND can be considered when treating selected patients with early breast cancer who have one or two positive lymph nodes.
Breast
;
Breast Neoplasms
;
Humans
;
Korea
;
Lymph Node Excision
;
Lymph Nodes*
;
Lymphatic Metastasis
;
Mastectomy, Segmental
;
Neoadjuvant Therapy
;
Neoplasm Metastasis*
;
Pathology
;
Retrospective Studies
;
Sentinel Lymph Node Biopsy*
;
Surgeons

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