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: The coronavirus disease-2019 (COVID-19) pandemic has contributed to the change in the epidemiology of many infectious diseases. This study aimed to establish the pre-pandemic epidemiology of pediatric invasive bacterial infection (IBI). Methods: A retrospective multicenter-based surveillance for pediatric IBIs has been maintained from 1996 to 2020 in Korea. IBIs caused by eight bacteria (Streptococcus pneumoniae, Haemophilus influenzae, Neisseria meningitidis, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, Listeria monocytogenes, and Salmonella species) in immunocompetent children > 3 months of age were collected at 29 centers. The annual trend in the proportion of IBIs by each pathogen was analyzed. Results: A total of 2,195 episodes were identified during the 25-year period between 1996 and 2020. S. pneumoniae (42.4%), S. aureus (22.1%), and Salmonella species (21.0%) were common in children 3 to 59 months of age. In children ≥ 5 years of age, S. aureus (58.1%), followed by Salmonella species (14.8%) and S. pneumoniae (12.2%) were common. Excluding the year 2020, there was a trend toward a decrease in the relative proportions of S. pneumoniae (rs = −0.430, P = 0.036), H. influenzae (rs = −0.922, P < 0.001), while trend toward an increase in the relative proportion of S. aureus (rs = 0.850, P < 0.001), S. agalactiae (rs = 0.615, P = 0.001), and S. pyogenes (rs = 0.554, P = 0.005). Conclusion In the proportion of IBIs over a 24-year period between 1996 and 2019, we observed a decreasing trend for S. pneumoniae and H. influenzae and an increasing trend for S. aureus, S. agalactiae, and S. pyogenes in children > 3 months of age. These findings can be used as the baseline data to navigate the trend in the epidemiology of pediatric IBI in the post COVID-19 era.

Purpose: The KNOG-1101 study showed improved 2-year PFS with temozolomide during and after radiotherapy compared to radiotherapy alone for patients with anaplastic gliomas. This trial investigates the effect of concurrent and adjuvant temozolomide on health-related quality of life (HRQoL). Materials and Methods: In this randomized, open-label, phase II trial, 90 patients with World Health Organization grade III glioma were enrolled across multiple centers in South Korea between March 2012 to February 2015 and followed up through 2017. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) and 20-item EORTC QLQ-Brain Neoplasm (QLQ-BN20) were used to compare HRQoL between patients assigned to concurrent chemoradiotherapy with temozolomide followed by 6 cycles of adjuvant temozolomide (arm A) and radiotherapy (RT) alone (arm B). Results: Of the 90 patients in the study, 84 patients (93.3%) completed the baseline HRQoL questionnaire. Emotional functioning, fatigue, nausea and vomiting, dyspnea, constipation, appetite loss, diarrhea, seizures, itchy skin, drowsiness, hair loss, and bladder control were not affected by the addition of temozolomide. All other items did not differ significantly between arm A and arm B throughout treatment. Global health status particularly stayed consistent at the end of adjuvant temozolomide (p=0.47) and at the end of RT (p=0.33). Conclusion The addition of concurrent and adjuvant temozolomide did not show negative influence on HRQoL with improvement of progression-free survival for patients with anaplastic gliomas. The absence of systematic and clinically relevant changes in HRQoL suggests that an overall long-term net clinical benefit exists for concurrent and adjuvant temozolomide.

Background/Aims: The efficacy of propofol in gastrointestinal endoscopy for patients with midazolam-induced paradoxical reactions remains unclarified. This study aimed to compare the efficacy and safety of propofol-based sedation in patients who previously experienced paradoxical reactions. Methods: This was a prospective, single-blinded, randomized controlled pilot study. Participants with a history of paradoxical reactions to midazolam during a previous esophagogastroduodenoscopy were recruited and randomly assigned to group I (propofol monosedation) or group II (combination of propofol and midazolam). The primary endpoint was the occurrence of a paradoxical reaction. Results: A total of 30 participants (mean age, 54.7±12.6 years; male, 19/30) were randomly assigned to group I (n=16) or group II (n=14). There were no paradoxical reactions in group I, but there were two in group II, without a significant difference (p=0.209). The mean dose of propofol was higher in group I than in group II (p=0.002). Meanwhile, the procedure and recovery times did not differ between groups. Conclusions Propofol-based sedation was safe and effective for patients who experienced paradoxical reactions to midazolam. However, caution is needed because few cases of paradoxical reaction again can happen in group II in which midazolam was readministered.

The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.

The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.

Purpose: We investigated the efficacy of temozolomide during and after radiotherapy in Korean adultswith anaplastic gliomas without 1p/19q co-deletion. Materials and Methods: This was a randomized, open-label, phase 2 study and notably the first multicenter trial forKorean grade III glioma patients. Eligible patients were aged 18 years or older and hadnewly diagnosed non-co-deleted anaplastic glioma with an Eastern Cooperative OncologyGroup performance status of 0-2. Patients were randomized 1:1 to receive radiotherapyalone (60 Gy in 30 fractions of 2 Gy) (control group, n=44) or to receive radiotherapy withconcurrent temozolomide (75 mg/m2/day) followed by adjuvant temozolomide (150-200mg/m2/day for 5 days during six 28-day cycles) (treatment group, n=40). The primary endpointwas 2-year progression-free survival (PFS). Seventy patients (83.3%) were availablefor the analysis of the isocitrate dehydrogenase 1 gene (IDH1) mutation status. Results: The two-year PFS was 42.2% in the treatment group and 37.2% in the control group. Overallsurvival (OS) did not reach to significant difference between the groups. In multivariableanalysis, age was a significant risk factor for PFS (hazard ratio [HR], 2.08; 95% confidenceinterval [CI], 1.04 to 4.16). The IDH1mutation was the only significant prognostic factor forPFS (HR, 0.28; 95% CI, 0.13 to 0.59) and OS (HR, 0.19; 95% CI, 0.07 to 0.50). Adverseevents over grade 3 were seen in 16 patients (40.0%) in the treatment group and werereversible. Conclusion Concurrent and adjuvant temozolomide in Korean adults with newly diagnosed nonco-deleted anaplastic gliomas showed improved 2-year PFS. The survival benefit of this regimenneeds further analysis with long-term follow-up at least more than 10 years.

BACKGROUND AND OBJECTIVES: Intermediate coronary lesion that can be under- or over-estimated by visual estimation frequently results in stenting of functionally nonsignificant lesions or deferral of percutaneous coronary intervention (PCI) of significant lesions inappropriately. We evaluated current status of PCI for intermediate lesions from a standardized database in Korea. METHODS: We analyzed the Korean percutaneous coronary intervention (K-PCI) registry data which collected a standardized PCI database of the participating hospitals throughout the country from January 1, 2014, through December 31, 2014. Intermediate lesion was defined as a luminal narrowing between 50% and 70% by visual estimation and then compared whether the invasive physiologic or imaging study was performed or not. RESULTS: Physiology-guided PCI for intermediate lesions was performed in 16.8% for left anterior descending artery (LAD), 9.8% for left circumflex artery (LCX), 13.2% for right coronary artery (RCA). PCI was more frequently performed using intravascular ultrasound (IVUS) than using fractional flow reserve (FFR) for coronary artery segments (27.7% vs. 13.9% for LAD, 32.9% vs. 8.1% for LCX, and 33.8% vs. 10.8% for RCA). In accordance with or without FFR, PCI for intermediate lesions was more frequently performed in the hospitals with available FFR device than without FFR, especially in left main artery (LM), proximal LAD lesion (40.9% vs. 5.9% for LM, 24.6% vs 7.6% for proximal LAD). CONCLUSIONS: These data provide the current PCI practice pattern with the use of FFR and IVUS in intermediate lesion. More common use of FFR for intermediate lesion should be encouraged.
Arteries ; Coronary Artery Disease ; Coronary Stenosis ; Coronary Vessels ; Fractional Flow Reserve, Myocardial ; Korea ; Percutaneous Coronary Intervention ; Phenobarbital ; Stents ; Ultrasonography

BACKGROUND AND OBJECTIVES: Intermediate coronary lesion that can be under- or over-estimated by visual estimation frequently results in stenting of functionally nonsignificant lesions or deferral of percutaneous coronary intervention (PCI) of significant lesions inappropriately. We evaluated current status of PCI for intermediate lesions from a standardized database in Korea. METHODS: We analyzed the Korean percutaneous coronary intervention (K-PCI) registry data which collected a standardized PCI database of the participating hospitals throughout the country from January 1, 2014, through December 31, 2014. Intermediate lesion was defined as a luminal narrowing between 50% and 70% by visual estimation and then compared whether the invasive physiologic or imaging study was performed or not. RESULTS: Physiology-guided PCI for intermediate lesions was performed in 16.8% for left anterior descending artery (LAD), 9.8% for left circumflex artery (LCX), 13.2% for right coronary artery (RCA). PCI was more frequently performed using intravascular ultrasound (IVUS) than using fractional flow reserve (FFR) for coronary artery segments (27.7% vs. 13.9% for LAD, 32.9% vs. 8.1% for LCX, and 33.8% vs. 10.8% for RCA). In accordance with or without FFR, PCI for intermediate lesions was more frequently performed in the hospitals with available FFR device than without FFR, especially in left main artery (LM), proximal LAD lesion (40.9% vs. 5.9% for LM, 24.6% vs 7.6% for proximal LAD). CONCLUSIONS These data provide the current PCI practice pattern with the use of FFR and IVUS in intermediate lesion. More common use of FFR for intermediate lesion should be encouraged.

BACKGROUND: Oral glucose tolerance test (OGTT) is a traditional diagnostic tool for diabetes. Hemoglobin A1c (HbA1c) is an alternative method used in adults; however, its application in youths has been controversial. We evaluated the diagnostic performance of HbA1c and determined optimal cutoff points for detecting prediabetes and diabetes in youth. METHODS: This retrospective study included 389 obese children (217 boys, 55.8%) who had undergone simultaneous OGTT and HbA1c testing at six hospitals, Korea, between 2010 and 2016. Subjects were diagnosed with diabetes (fasting glucose ≥ 7.0 mmol/L; 2-hour glucose ≥ 11.1 mmol/L) or prediabetes (fasting glucose 5.6–6.9 mmol/L; 2-hour glucose 7.8–11.0 mmol/L). The diagnostic performance of HbA1c for prediabetes and diabetes was determined using the area under the receiver operating characteristic curve (AUC). RESULTS: At diagnosis, 197 (50.6%) subjects had normoglycemia, 121 (31.1%) had prediabetes, and 71 (18.3%) had diabetes. The kappa coefficient for agreement between OGTT and HbA1c was 0.464. The optimal HbA1c cutoff points were 5.8% (AUC, 0.795; a sensitivity of 64.1% and a specificity of 83.8%) for prediabetes and 6.2% (AUC, 0.972; a sensitivity of 91.5% and a specificity of 93.7%) for diabetes. When HbA1c (≥ 6.2%) and 2-hour glucose level were used to diagnose diabetes, 100% were detected. CONCLUSION: Pediatric criteria for HbA1c remain unclear, therefore, we recommend the combination of fasting and 2-hour glucose levels, in addition to HbA1c, in the diagnosis of childhood prediabetes and diabetes.
Adolescent* ; Adult ; Child* ; Diabetes Mellitus ; Diagnosis ; Fasting ; Glucose ; Glucose Tolerance Test* ; Humans ; Korea ; Methods ; Prediabetic State* ; Retrospective Studies ; ROC Curve ; Sensitivity and Specificity