Background: It is well known that a large number of patients with diabetes also have dyslipidemia, which significantly increases the risk of cardiovascular disease (CVD). This study aimed to evaluate the efficacy and safety of combination drugs consisting of metformin and atorvastatin, widely used as therapeutic agents for diabetes and dyslipidemia. Methods: This randomized, double-blind, placebo-controlled, parallel-group and phase III multicenter study included adults with glycosylated hemoglobin (HbA1c) levels >7.0% and <10.0%, low-density lipoprotein cholesterol (LDL-C) >100 and <250 mg/dL. One hundred eighty-five eligible subjects were randomized to the combination group (metformin+atorvastatin), metformin group (metformin+atorvastatin placebo), and atorvastatin group (atorvastatin+metformin placebo). The primary efficacy endpoints were the percent changes in HbA1c and LDL-C levels from baseline at the end of the treatment. Results: After 16 weeks of treatment compared to baseline, HbA1c showed a significant difference of 0.94% compared to the atorvastatin group in the combination group (0.35% vs. −0.58%, respectively; P<0.0001), whereas the proportion of patients with increased HbA1c was also 62% and 15%, respectively, showing a significant difference (P<0.001). The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (−55.20% vs. −7.69%, P<0.001) without previously unknown adverse drug events. Conclusion The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or atorvastatin alone in diabetes and dyslipidemia patients. This study also suggested metformin’s preventive effect on the glucose-elevating potential of atorvastatin in patients with type 2 diabetes mellitus and dyslipidemia, insufficiently controlled with exercise and diet. Metformin and atorvastatin combination might be an effective treatment in reducing the CVD risk in patients with both diabetes and dyslipidemia because of its lowering effect on LDL-C and glucose.

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.

PURPOSE: Although mild to moderate asthma is much more common, the morbidity and mortality of severe asthma are much higher. This study was performed to identify and analyze the clinical characteristics of severe asthma in Korea. METHODS: We registered patients with severe refractory asthma into the Severe Asthma Registry supported by the Severe Asthma Work Group of the Korean Academy of Asthma, Allergy and Clinical Immunology. Patients were enrolled since 2010 from the 15 university hospitals nationwide in Korea. Severe asthma was defined according to modified European Respiratory Society/American Thoracic Society criteria. Information on demographics, medical history, pulmonary function tests and skin prick tests was collected; the clinical characteristics of severe asthmatics were analyzed from the collected data. RESULTS: A total of 489 patients were enrolled with a mean age of 62.3; 45% are male. Sixty percent of patients received Global Initiative for Asthma step 4 treatment, and 30% received step 5 treatment. The most common comorbidities were allergic rhinitis (58.7%). Aspirin hypersensitivity was observed in 14.0%. Approximately half (53.9%) are non-smokers. Atopy was proven in 38.5% of the patients. Regarding asthma medications, inhaled corticosteroids and long-acting β-agonist combination inhalers were most commonly prescribed (96.5%), followed by leukotriene antagonists (71.0%). A recombinant anti-immunoglobulin E monoclonal antibody (omalizumab) has been used in 1.8% of the patients. The mean forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and FEV1/FVC were 78.7%, 67.5% and 67.9% of predicted values, respectively. The mean Asthma Control Test and quality of life questionnaire scores were 16.5 out of 25 and 59.5 out of 85, respectively. CONCLUSIONS: The baseline characteristics of severe asthma patients in the Korea Severe Asthma Registry were analyzed and reported for the first time. With this cohort, further prospective studies should be performed to search for ways to improve management of severe refractory asthma.
Adrenal Cortex Hormones ; Adult* ; Allergy and Immunology ; Aspirin ; Asthma* ; Cohort Studies ; Comorbidity ; Demography ; Forced Expiratory Volume ; Hospitals, University ; Humans ; Hypersensitivity ; Korea* ; Leukotriene Antagonists ; Male ; Mortality ; Nebulizers and Vaporizers ; Prospective Studies ; Quality of Life ; Respiratory Function Tests ; Rhinitis, Allergic ; Skin ; Vital Capacity

BACKGROUND/AIMS: To compare the effect of levofloxacin and moxifloxacin on treatment outcomes among patients with multidrug-resistant tuberculosis (MDR-TB). METHODS: A retrospective analysis of 171 patients with MDR-TB receiving either levofloxacin or moxifloxacin was performed. Treatment responses were categorized into treatment success (cured and treatment completed) or adverse treatment outcome (death, failure, and relapsed). RESULTS: The median age of the patients was 42.0 years. Approximately 56% of the patients were male. Seventeen patients had extensively drug-resistant tuberculosis, and 20 had a surgical resection. A total of 123 patients (71.9%) received levofloxacin for a median 594 days, and 48 patients (28.1%) received moxifloxacin for a median 673 days. Other baseline demographic, clinical, and radiographic characteristics were similar between the two groups. The moxifloxacin group had a significantly higher number of resistant drugs (p < 0.001) and a higher incidence of resistance to ofloxacin (p = 0.005) in the drug sensitivity test. The treatment success rate was 78.9% in the levofloxacin group and 83.3% in the moxifloxacin group (p = 0.42). Adverse reactions occurred at similar rates in the groups (p = 0.44). Patients in the moxifloxacin group were not more likely to have treatment success than those in the levofloxacin group (adjusted odds ratio, 0.76; 95% confidence interval, 0.24 to 2.43; p = 0.65). CONCLUSIONS: Both levofloxacin and moxifloxacin showed equivalent efficacy for treating MDR-TB.
Adult ; Antitubercular Agents/adverse effects/*therapeutic use ; Aza Compounds/adverse effects/*therapeutic use ; Case-Control Studies ; Chi-Square Distribution ; *Drug Resistance, Multiple, Bacterial ; Drug Therapy, Combination ; Extensively Drug-Resistant Tuberculosis/*drug therapy/microbiology/mortality ; Female ; Humans ; Logistic Models ; Male ; Middle Aged ; Mycobacterium tuberculosis/*drug effects/pathogenicity ; Odds Ratio ; Ofloxacin/adverse effects/*therapeutic use ; Quinolines/adverse effects/*therapeutic use ; Recurrence ; Remission Induction ; Republic of Korea ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome ; Tuberculosis, Multidrug-Resistant/*drug therapy/microbiology/mortality

BACKGROUND/AIMS: Stomach cancer can be easily diagnosed via endoscopy, but also possible to be missed. The aim of this study was to investigate the clinical and endoscopic characteristics of advanced gastric cancers that were not diagnosed based on endoscopic examination. METHODS: We evaluated patients who had newly diagnosed advanced gastric cancer that was undetected via endoscopy within the last six months. RESULTS: Sixteen patients were included in this study. The locations of the cancers were the cardia in six cases, the greater curvature side of the body in eight cases and the antrum in two cases. The histological findings were tubular type adenocarcinoma in 11 cases, with ten cases of moderately to poorly differentiated adenocarcinoma and five cases of signet ring cell type adenocarcinoma. CONCLUSIONS: Even advanced gastric cancer lesions may not be detected during endoscopy. If a patient continues to complain of upper gastrointestinal symptoms, even though endoscopy does not find abnormal findings, repeated endoscopy and/or additional diagnostic studies should be considered.
Adenocarcinoma/*diagnosis/pathology ; Adult ; Aged ; Cardia/pathology ; Diagnostic Errors ; Female ; Gastroscopy ; Humans ; Male ; Middle Aged ; Prognosis ; Pyloric Antrum/pathology ; Stomach Neoplasms/*diagnosis/pathology

BACKGROUND/AIMS: Ascites is a fairly common condition, but the clinical features of pseudomembranous colitis with ascites are not well-known. The aim of this study was to determine how the existence of ascites is related to the clinical factors. METHODS: Between March 2002 and June 2006, 67 pseudomembranous colits patients were diagnosed by performing lower endoscopy and biopsy. The patients' ascites was identified by abdominal plain radiography, ultrasonography or computerized tomography. The extension of colitis was evaluated by ultrasonography or computerized tomography. RESULTS: 16 patients (23.9%) had ascites. The serum WBC (p=0.01), hypoalbuminemia (p<0.01), CRP (p<0.01), recurrence (p<0.01), and extension of colitis (p<0.01) were associated with the existence of ascites. The four patients who had undergone paracentesis had a low SAAG level and PMN dominant ascites. CONCLUSIONS: There were correlations of ascities with leukocytosis, hypoalbuminemia, CRP, extension of colitis and recurrence of PMC.
Ascites* ; Biopsy ; Colitis ; Endoscopy ; Enterocolitis, Pseudomembranous* ; Humans ; Hypoalbuminemia ; Leukocytosis ; Paracentesis ; Radiography ; Recurrence ; Ultrasonography

BACKGROUND: Osteoprotegerin (OPG) is a soluble glycoprotein which inhibits osteoclastogenesis through binding to receptor activator of nuclear factor-kappaB ligand (RANKL). OPG-knockout mice develop early-onset osteoporosis and arterial calcification. Recent studies report that serum OPG levels are elevated in diabetic patients with cardiovascular disease and are associated with the presence and severity of coronary artery disease. We examined the relationships between serum OPG levels and insulin resistance, bone metabolism and cardiovascular risk factors in diabetic patients. METHODS: In 84 diabetic patients (33 men, 51 women, mean age 56.7 years old) were studied. Blood pressure, body mass index (BMI), fasting blood glucose, postprandial 2-hour blood glucose, fasting insulin and lipid profiles were measured. Serum OPG levels were measured with sandwich ELISA method. Bone mineral density (BMD)s were checked and serum osteocalcin and urine deoxypyridinoline levels were checked as bone turnover markers. 24-hour urine microalbumin were checked and left ventricular mass index (LVMI) were evaluated with echocardiography. From simple chest X-ray, the presence of aortic calcification were confirmed by a trained radiologist. Homeostatic model assessment (HOMA)-insulin resistance (IR), quantitative insulin sensitivity check index (QUICKI) were calculated as insulin resistance indices. RESULTS: Serum OPG levels were positively correlated with age, LVMI, HOMA and negatively correlated with lumbar spine BMD and QUICKI. After adjustment for age, only LVMI showed persistent correlation with serum OPG levels and when multiple regression analysis was performed with LVMI as the dependent variable, BMI and OPG were the significant predictors of LVMI (R2=0.054, p=0.012). Dividing the subjects into 3 groups according to 24-hour urine microalbumin levels, mean values for serum OPG levels increased as 24-hours urine microalbumin levels increased, but without statistical significance. Mean serum OPG levels were higher in patients with aortic calcification, without statistical significance. CONCLUSION: Serum OPG levels were positively correlated with insulin resistance indices and negatively correlated with lumbar spine BMD in diabetic patients, suggesting a compensatory mechanism to counteract bone loss progression. Serum OPG levels were independent predictor for LVMI in diabetic patients, warranting further research on OPG as the marker for future cardiovascular mortality in diabetic patients.
Animals ; Blood Glucose ; Blood Pressure ; Body Mass Index ; Bone Density ; Cardiovascular Diseases ; Coronary Artery Disease ; Diabetes Mellitus ; Echocardiography ; Enzyme-Linked Immunosorbent Assay ; Fasting ; Female ; Glycoproteins ; Humans ; Hypertrophy, Left Ventricular ; Insulin Resistance* ; Insulin* ; Male ; Metabolism* ; Mice ; Mortality ; Osteocalcin ; Osteoporosis ; Osteoprotegerin* ; RANK Ligand ; Risk Factors* ; Spine ; Thorax

BACKGROUND: When a non small cell lung caner patient at the cT1-2N0M0 stage is diagnosed with intrapulmonary nodule(s), the treatment plan and prognosis of the patient largely depend on whether the nodule is benign or malignant. In most cases, however, it is hard to conduct a biopsy on such a nodule, due to its small size. Furthermore, the predictive factors that may imply benignancy or malignancy of the nodules remain unknown. As such, the purpose of our study was to validate the incidence of malignant nodules in such cases, and find if there are any predictive factors. METHODS: Chest computed tomography(CT) scans and the medical records of 444 patients, who had undergone non small cell lung cancer surgery, between July, 2001 and September, 2003, at Seoul National University Hospital, were retrospectively reviewed. Among cT1-2N0M0 non small cell lung cancer patients, with intrapulmonary nodule(s), only those cases where a CT scan or a biopsy of the nodules had been conducted, and had been followed up at intervals of more than 6 months were included. However, patients who had received chemotherapy or radiation therapy, pre- or post-operatively, or with calcified nodules, were excluded. RESULTS: Our study group consisted of 39 patients, divided into two groups. The first group, 33 patients, had benign nodules, and the second group, 6 patients, had malignant nodules. The two groups were compared with regard to gender, age, cell type, pathologic stage, shape, size, location and number of nodules and presence of calcification around the nodules. There was no statistically significant difference between the two groups. CONCLUSION: The intrapulmonary nodules in non small cell lung cancer patients at the cT1-2N0M0 stage were mostly benign. Therefore, surgical treatment for such patients can be considered. Moreover, without predictive factors, pathological confirmation of the diagnosed nodules should be sought in all patients.
Biopsy ; Drug Therapy ; Humans ; Incidence* ; Lung ; Medical Records ; Prognosis ; Retrospective Studies ; Seoul ; Small Cell Lung Carcinoma* ; Thorax ; Tomography, X-Ray Computed

Primary iliopsoas abscess is a rare but potentially serious condition. The diagnosis is frequently delayed due to its variable and nonspecific features and occult clinical course. The delayed diagnosis and treatment of iliopsoas abscess is the major poor prognostic factor. We report a rare case of primary iliopsoas abscess that presented as a femoral neuropathy in a patient on hemodialysis. A 49-year-old man with end stage renal disease was admitted due to pain in the left inguinal area, and weakness and hypoesthesia of left lower leg. Left iliopsoas abscess was confirmed by CT and MRI. Left femoral neuropathy was diagnosed with electrodiagnostic study. Iliopsoas abscess with femoral neuropathy was completely treated with CT-guided aspiration, antibiotics and prolonged physical therapy of hip and knee joints. To our knowledge, this is the first case report of primary iliopsoas abscess presented as a femoral neuropathy in a patient on hemodialysis in Korea.
Anti-Bacterial Agents ; Delayed Diagnosis ; Diagnosis ; Femoral Neuropathy* ; Hip ; Humans ; Hypesthesia ; Kidney Failure, Chronic ; Knee Joint ; Korea ; Leg ; Magnetic Resonance Imaging ; Middle Aged ; Psoas Abscess* ; Renal Dialysis*

BACKGROUND: Synthetic glucocorticoids are widely used in many chronic inflammatory diseases because of their excellent anti-inflammatory activity. Enhancing the transcription of IkappaB and preventing activated NF-kappaB from binding to kappaB sites are thought to be the underlying mechanisms. But these data are largely derived from in vitro studies using cell lines. In this study, after administrating a steroid to volunteers, we evaluated the effect on the NF-kappaB system. METHODS: Prednisolone(0.5mg/kg/d) was orally administered to 5 healthy volunteers for 7 days. Before and after the administration, we sampled their peripheral blood monocytes, and performed western blot analysis both with stimulation, using IL-1beta, LPS, TNF, and without stimulation(baseline). We also performed EMSA after stimulation with LPS. RESULTS: After ingestion of the steroid, baseline expressions of I(kappa)B(alpha) were increased in two of the subjects, while suppressed degradations of I(kappa)B(alpha) to stimulations were observed in all five. In addition, the binding capacity of NF-kappaB after the administration was decreased. CONCLUSION: Steroid plays such roles as enhancing the transcription of I(kappa)B(alpha), suppressing the DNA binding capacity of NF-kappaB, and suppressing the degradation of I(kappa)B(alpha).
Blotting, Western ; Cell Line ; DNA ; Eating ; Glucocorticoids ; Healthy Volunteers ; Humans* ; Monocytes* ; NF-kappa B ; Volunteers