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.

Background and Objectives: We investigated whether extra-pulmonary vein (PV) ablation targeting a high maximal slope of the action potential duration restitution curve (Smax) improves the rhythm outcome of persistent atrial fibrillation (PeAF) ablation. Methods: In this open-label, multi-center, randomized, and controlled trial, 178 PeAF patients were randomized with 1:1 ratio to computational modeling-guided virtual Smax ablation (V-Smax) or empirical ablation (E-ABL) groups. Smax maps were generated by computational modeling based on atrial substrate maps acquired during clinical procedures in sinus rhythm. Smax maps were generated during the clinical PV isolation (PVI). The V-Smax group underwent an additional extra-PV ablation after PVI targeting the virtual high Smax sites. Results: After a mean follow-up period of 12.3±5.2 months, the clinical recurrence rates (25.6% vs. 23.9% in the V-Smax and the E-ABL group, p=0.880) or recurrence appearing as atrial tachycardia (11.1% vs. 5.7%, p=0.169) did not differ between the 2 groups. The postablation cardioversion rate was higher in the V-Smax group than E-ABL group (14.4% vs. 5.7%, p=0.027). Among antiarrhythmic drug-free patients (n=129), the AF freedom rate was 78.7% in the V-Smax group and 80.9% in the E-ABL group (p=0.776). The total procedure time was longer in the V-Smax group (p=0.008), but no significant difference was found in the major complication rates (p=0.497) between the groups. Conclusions Unlike a dominant frequency ablation, the computational modeling-guided V-Smax ablation did not improve the rhythm outcome of the PeAF ablation and had a longer procedure time.

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

PURPOSE: Although chemotherapy is recommended by various guidelines for advanced biliary tract cancer (BTC), the evidence supporting its use over best supportive care (BSC) is limited. The aim of this study was to investigate the survival benefit of chemotherapy over that of BSC in advanced BTC patients. MATERIALS AND METHODS: Advanced BTC patientswith a good performance status (Eastern CooperativeOncologyGroup [ECOG] 0-2) were eligible for the study. Data were retrospectively collected from four tertiary cancer centers and analyzed using propensity score matching (PSM). Of the 604 patients enrolled, 206 received BSC and 398 received chemotherapy. PSM analysis was performed using the following variables: age, ECOG status, carcinoembryonic antigen (CEA) level, white blood cell level, albumin level, total bilirubin level, and aspartate aminotransferase level. The sample size of each group was 164 patients after PSM. Median survival was compared between the two groups by using the Kaplan-Meier method, and prognostic factors were investigated using Cox proportional regression analysis. RESULTS: In post-PSM analysis, the respective median survival for the chemotherapy and BSC groups was dependent on the following prognostic factors: total population, 12.0 months vs. 7.5 months (p=0.001); locally advanced disease, 16.7 months vs. 13.4 months (p=0.490); cancer antigen 19-9 ≤ 100 IU/mL, 12.7 months vs. 10.6 months (p=0.330); and CEA ≤ 3.4 ng/mL, 17.1 months vs. 10.6 months (p=0.052). CONCLUSION: Chemotherapy improved overall survival of patients with advanced BTC who had a good performance status. However, this survival benefit was not observed in BTC patients with locally advanced disease or with lower tumor marker. Individualized approach is needed for initiation of palliative chemotherapy in advanced BTC.
Aspartate Aminotransferases ; Biliary Tract Neoplasms ; Biliary Tract* ; Bilirubin ; Carcinoembryonic Antigen ; Drug Therapy* ; Humans ; Leukocytes ; Methods ; Propensity Score* ; Retrospective Studies ; Sample Size ; Survival Analysis

BACKGROUND/AIMS: The well-organized study to support that increased cholelithiasis and bile duct dilatation can occur after gastrectomy has not been reported. The aim of this study was to determine the incidence of cholelithiasis and the degree of common bile duct (CBD) dilatation in patients undergoing subtotal gastrectomy, compared to those undergoing endoscopic treatment for gastric cancer. METHODS: Patients who diagnosed with gastric cancer and received treatment at six academic referral centers were investigated for the incidence and time of cholelithiasis and the degree of CBD dilatation after treatment by analysis of 5-year follow-up CTs. The operation group underwent subtotal gastrectomy without vagotomy, while in the control group endoscopic treatment was administered for gastric cancer. RESULTS: A total of 802 patients were enrolled in 5-year analysis (735 patients in the operation group and 67 patients in the control group). Cholelithiasis occurred in 47 patients (6.39%) in the operation group and 3 patients (4.48%) in the control group (p=0.7909). The incidences of cholelithiasis were 4.28% in Billoth-I and 7.89% in Billoth-II (p=0.0487). The diameter of proximal CBD and distal CBD increased by 1.11 mm and 1.41 mm, respectively, in the operation group, compared to 0.4 mm and 0.38 mm, respectively, in the control group (p<0.05). Patients with increased CBD dilatation more than 5 mm showed statistically significant increases in alkaline phosphatase and gamma-glutamyltransferase. CONCLUSIONS: The incidence of cholelithiasis was not increased due to subtotal gastrectomy without vagotomy, but the incidence was higher after Billoth-II compared to Billoth-I. In addition, significant change in the CBD diameter was observed after subtotal gastrectomy.
Aged ; Alanine Transaminase/analysis ; Aspartate Aminotransferases/analysis ; Bilirubin/analysis ; Case-Control Studies ; Cholelithiasis/*diagnosis/epidemiology ; Common Bile Duct/diagnostic imaging/*physiopathology ; Endoscopy, Gastrointestinal ; Female ; Follow-Up Studies ; Gastrectomy ; Humans ; Incidence ; Male ; Middle Aged ; Odds Ratio ; Stomach Neoplasms/*surgery ; Tertiary Care Centers ; Tomography, X-Ray Computed

BACKGROUND/AIMS: Endoscopic papillary balloon dilation (EPBD) has been advocated as an alternative therapy to endoscopic sphincterotomy for the treatment of common bile duct (CBD) stones. However, there is no established consensus on the optimal balloon dilation duration (BDD). We prospectively evaluated the efficacy and post-endoscopic retrograde cholangiopancreatography (ERCP) complications between the 20- and 60-second EPBD groups. METHODS: A total of 228 patients with small CBD stones (< or =12 mm) were randomly assigned to undergo EPBD with a 20- or 60-second duration at six institutions. We evaluated baseline patient characteristics, endoscopic data, clinical outcomes, and procedure-related complications. In addition, we analyzed risk factors for postprocedural pancreatitis. RESULTS: CBD stones were removed successfully in 107 of 109 patients (98.1%) in the 20-second group and in 112 of 119 patients (94.1%) in the 60-second group (p=0.146). Post-ERCP pancreatitis developed in seven patients (6.4%) in the 20-second group and nine patients (7.5%) in the 60-second group (p=0.408). In multivariate analysis, contrast dye injection into the pancreatic duct is a significant risk factor for post-EPBD pancreatitis. CONCLUSIONS: Based on the data showing that there were no significant differences in safety and efficacy between the two BDD groups, 20 seconds of BDD may be adequate for treatment of small CBD stones with EPBD.
Choledocholithiasis ; Common Bile Duct* ; Consensus ; Humans ; Multivariate Analysis ; Pancreatic Ducts ; Pancreatitis ; Prospective Studies* ; Risk Factors ; Sphincterotomy, Endoscopic

PURPOSE: In the pediatric population, Rathke's cleft cysts (RCCs) are known to be an infrequent cause of headaches, visual disturbances, and pituitary dysfunction. We investigated the clinical characteristics of children in whom RCCs were incidentally discovered and evaluated whether RCCs influence the treatment response of patients with proven endocrinopathy. METHODS: A retrospective analysis was conducted in 34 patients with RCCs who were diagnosed between 2006 and 2013 at Hallym University Medical Center. Their clinical, hormonal, and imaging findings were reviewed. We evaluated the clinical outcomes of the patients with concomitant RCCs and endocrinopathy compared to matched controls. RESULTS: Twenty-six of 34 patients with radiologically proven RCCs had endocrine disorders. They were 9 boys and 17 girls, with ages ranging from 4.8 to 17.4 years at the time of the diagnosis. Of these, 7 (27%) had idiopathic short stature, 7 (27%) had growth hormone deficiency (GHD), and 12 (46%) had central precocious puberty (CPP). Nineteen of 26 patients (73.1%) showed low signal intensities on T1-weighted images (T1WI) and high signal intensities on T2-weighted images. The incidence of hypointensity on T1WI was higher in the patients with RCCs accompanied by endocrinopathy than in those without endocrinopathy (P=0.033). The treatment outcomes of the patients with CPP and GHD with and without RCCs were similar. CONCLUSION: CPP and GHD patients with a small RCC (less than 20 mm) expressing cystic magnetic resonance intensity can be managed with medical treatment, although the RCCs need to be closely monitored in radiological studies to observe their growth.
Academic Medical Centers ; Adolescent* ; Central Nervous System Cysts* ; Child* ; Diagnosis ; Dwarfism, Pituitary ; Female ; Growth Hormone ; Headache ; Humans ; Incidence ; Puberty, Precocious ; Retrospective Studies

BACKGROUND: The overexpression of transforming growth factor-beta 1 receptor II (TGF-beta1RII) and transforming growth factor-beta 1 (TGF-beta1) ligand may be involved in the formation of a bulla. In this study, we tested if serum TGF-beta1 ligand levels correlated with the expression level of TGF-beta1RII and TGF-beta1 in bullous tissues from patients with spontaneous pneumothorax. MATERIAL AND METHOD: Bullous lung tissues and blood samples were obtained from 19 patients with spontaneous pneumothorax, 18 males and 1 female, aged 17 to 35 years old. The bullous tissues were obtained by video-assisted thoracic surgery (VATS), fixed in formalin, embedded in paraffin, and cut into 5~6micrometer thick slices. Sections were immunohistochemically stained with primary antibodies against TGF-beta1 or TGF-beta1RII, and serum levels of TGF-beta1 in patients and normal controls was measured by enzyme-linked immunosorbent assay (ELISA). RESULT: Of the 19 patients, 16 were TGF-beta1 positive and 10 were TGF-beta1RII positive. Among the 16 TGF-beta1 positives, 9 were also TGF-beta1RII positive. As seen previously, strong immunohistochemical staining of TGF-beta1RII and TGF-beta was detected in the boundary region between the bullous and normal lung tissues. Average TGF-beta1 blood levels of both TGF-beta1 and TGF-beta1RII positive patients was 38.36+/-16.2 ng/mL, and that of five controls was 54.06+/-15 ng/mL. CONCLUSION: These results suggest that overexpression of TGF-beta1 and TGF-beta1RII expression may be involved in the formation of bullae. TGF-beta1 blood levels in patients with primary spontaneous pneumothorax is lower than normal people, suggesting that the high level of local TGF-beta1 expression in the bullous tissue region, but not in the whole blood, may contribute more in the formation of bullae.
Aged ; Antibodies ; Blister ; Enzyme-Linked Immunosorbent Assay ; Female ; Formaldehyde ; Humans ; Lung ; Male ; Paraffin ; Pneumothorax ; Thoracic Surgery, Video-Assisted ; Transforming Growth Factor beta ; Transforming Growth Factor beta1

BACKGROUND/AIMS: Colorectal cancer (CRC) is one of the major causes of death and poses a major public health concern. The National CRC Screening Programme (NCSP) provides annual CRC screening using a fecal occult blood test for individuals >50 years of age since 2004. The purpose of the current study was to determine the outcomes and efficacy of a fecal immunochemical test (FIT) based on the NCSP in a quality-controlled university hospital setting. METHODS: We retrospectively reviewed the medical records and a standardized questionnaire from the NCSP of 3,852 individuals who underwent a FIT between March and December 2009. All of the subjects submitted a stool specimen for a FIT, while a double-contrast barium enema or colonoscopy was performed as a confirmatory examination for FIT-positive individuals. The CRC screening rate and rate of detection colorectal adenomas, advanced adenomas, and colorectal cancers by FIT were evaluated. RESULTS: The CRC screening rate with FIT was very high (72.3%), but the positive rate of detection by FIT was only 1.3%. The rate of detection for colorectal cancers, adenomas, and advanced adenomas by FIT was 0.08%, 0.39%, and 0.13%, respectively. The quantitative values of FIT in individuals with colorectal adenomas and cancers were significantly higher than other colorectal diseases. Men (P=0.001) and elderly individuals (P=0.039) were significantly more common in the FIT-positive group than the FIT-negative group. Approximately 28% of the subjects with FIT-positive tests did not receive a confirmatory examination. CONCLUSIONS: Although the FIT had a low rate of detection, the FIT was a useful screening tool for detection of CRC in the NCSP. It will be important to increase CRC screening rates and confirmatory examination rates.
Adenoma ; Aged ; Barium ; Cause of Death ; Colonoscopy ; Colorectal Neoplasms ; Early Detection of Cancer ; Enema ; Humans ; Male ; Mass Screening ; Medical Records ; Occult Blood ; Public Health ; Retrospective Studies ; Surveys and Questionnaires

OBJECTIVE: The objective of this study was to examine the clinicopathologic characteristics and prognostic factors of primary peritoneal carcinoma (PPC). METHODS: Clinicopathologic variables were obtained by examining the medical records of patients with PPC who were diagnosed and treated at our institute, between January 1996 and December 2005. To find prognostic factors, the association of clinicopathologic variables with survival was evaluated by univariate and multivariate analysis. RESULTS: All patients had advanced-stage tumors. Residual tumor was smaller than 1 cm in 12 patients and was equal or larger than 1 cm in nine patients. The response rate to adjuvant chemotherapy was 47.6%. The median progression-free survival was eight months (range 1~95) and the median overall survival was 14 months (range 1~99). In univariate analysis, stage, the response to adjuvant chemotherapy, and neoadjuvant chemotherapy were associated with survival. However, in multivariate analysis, no variables were associated with survival. CONCLUSION: In spite of aggressive treatments, patients with PPC had poor prognosis. No prognostic factors were identified in this study.
Chemotherapy, Adjuvant ; Disease-Free Survival ; Humans ; Medical Records ; Multivariate Analysis ; Neoplasm, Residual ; Prognosis