1.Efficacy and Safety of Metformin and Atorvastatin Combination Therapy vs. Monotherapy with Either Drug in Type 2 Diabetes Mellitus and Dyslipidemia Patients (ATOMIC): Double-Blinded Randomized Controlled Trial
Jie-Eun LEE ; Seung Hee YU ; Sung Rae KIM ; Kyu Jeung AHN ; Kee-Ho SONG ; In-Kyu LEE ; Ho-Sang SHON ; In Joo KIM ; Soo LIM ; Doo-Man KIM ; Choon Hee CHUNG ; Won-Young LEE ; Soon Hee LEE ; Dong Joon KIM ; Sung-Rae CHO ; Chang Hee JUNG ; Hyun Jeong JEON ; Seung-Hwan LEE ; Keun-Young PARK ; Sang Youl RHEE ; Sin Gon KIM ; Seok O PARK ; Dae Jung KIM ; Byung Joon KIM ; Sang Ah LEE ; Yong-Hyun KIM ; Kyung-Soo KIM ; Ji A SEO ; Il Seong NAM-GOONG ; Chang Won LEE ; Duk Kyu KIM ; Sang Wook KIM ; Chung Gu CHO ; Jung Han KIM ; Yeo-Joo KIM ; Jae-Myung YOO ; Kyung Wan MIN ; Moon-Kyu LEE
Diabetes & Metabolism Journal 2024;48(4):730-739
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.
2.Efficacy and Safety of Alogliptin-Pioglitazone Combination for Type 2 Diabetes Mellitus Poorly Controlled with Metformin: A Multicenter, Double-Blind Randomized Trial
Ji-Yeon PARK ; Joonyub LEE ; Yoon-Hee CHOI ; Kyung Wan MIN ; Kyung Ah HAN ; Kyu Jeung AHN ; Soo LIM ; Young-Hyun KIM ; Chul Woo AHN ; Kyung Mook CHOI ; Kun-Ho YOON ;
Diabetes & Metabolism Journal 2024;48(5):915-928
Background:
Guidelines for switching to triple combination therapy directly after monotherapy failure are limited. This study investigated the efficacy, long-term sustainability, and safety of either mono or dual add-on therapy using alogliptin and pioglitazone for patients with type 2 diabetes mellitus (T2DM) who did not achieve their target glycemic range with metformin monotherapy.
Methods:
The Practical Evidence of Antidiabetic Combination Therapy in Korea (PEAK) was a multicenter, placebo-controlled, double-blind, randomized trial. A total of 214 participants were randomized to receive alogliptin+pioglitazone (Alo+Pio group, n=70), alogliptin (Alo group, n=75), or pioglitazone (Pio group, n=69). The primary outcome was the difference in glycosylated hemoglobin (HbA1c) levels between the three groups at baseline to 24 weeks. For durability, the achievement of HbA1c levels <7% and <6.5% was compared in each group. The number of adverse events was investigated for safety.
Results:
After 24 weeks of treatment, the change of HbA1c in the Alo+Pio, Alo, and Pio groups were –1.38%±0.08%, –1.03%±0.08%, and –0.84%±0.08%, respectively. The Alo+Pio group had significantly lower HbA1c levels than the other groups (P=0.0063, P<0.0001) and had a higher proportion of patients with target HbA1c achievement. In addition, insulin sensitivity and β-cell function, lipid profiles, and other metabolic indicators were also improved. There were no significant safety issues in patients treated with triple combination therapy.
Conclusion
Early combination triple therapy showed better efficacy and durability than the single add-on (dual) therapy. Therefore, combination therapy with metformin, alogliptin, and pioglitazone is a valuable early treatment option for T2DM poorly controlled with metformin monotherapy.
3.Treatment and Prognosis for Tumors of the Foot and Ankle
Seung Soo HAN ; Jeung Il KIM ; Tae Sik GOH ; Seung Hun WOO ; Ji Youn KIM
Journal of Korean Foot and Ankle Society 2024;28(2):55-59
Purpose:
Tumors of the foot and ankle account for approximately 3%~5% of all musculoskeletal tumors, and accurate diagnosis is often delayed due to their rare prevalence. Therefore, the authors aimed to analyze the incidence, treatment methods, and prognostic factors of foot and ankle tumors treated at the authors’ hospital.
Materials and Methods:
A retrospective single-center study examined 342 patients treated for foot and ankle tumors at the authors’ hospital from January 2011 to February 2022. Data were collected from the electronic medical records (EMR) and picture archiving and communication systems (PACS). The information analyzed included gender, age, follow-up period, diagnosis, tumor occurrence and recurrence, treatment, and clinical outcomes.
Results:
Most cases (93.3%) were benign, but 6.7% were malignant. The main treatment for malignant tumors was surgical resection (91.3%). Approximately 53.1% of benign tumors and 91.3% of malignant tumors were treated with surgery, and two of the malignant tumors that did not undergo surgery had metastatic cancer. After surgery, 8.2% of benign lesions and 19.0% of malignant lesions recurred, and 9.5% of the patients with malignant tumors died after surgery.
Conclusion
Most foot and ankle tumors are benign tumors, and the prognosis is not poor if treated properly, but most malignant tumors often require amputation. In some cases, however, amputation can be avoided with a combination of chemotherapy and radiation therapy.
4.Evaluating Linkage Quality of Population-Based Administrative Data for Health Service Research
Ji-Woo KIM ; Hyojung CHOI ; Hyun jeung LIM ; Miae OH ; Jae Joon AHN
Journal of Korean Medical Science 2024;39(14):e127-
Background:
To overcome the limitations of relying on data from a single institution, many researchers have studied data linkage methodologies. Data linkage includes errors owing to legal issues surrounding personal information and technical issues related to data processing. Linkage errors affect selection bias, and external and internal validity. Therefore, quality verification for each connection method with adherence to personal information protection is an important issue. This study evaluated the linkage quality of linked data and analyzed the potential bias resulting from linkage errors.
Methods:
This study analyzed claims data submitted to the Health Insurance Review and Assessment Service (HIRA DATA). The linkage errors of the two deterministic linkage methods were evaluated based on the use of the match key. The first deterministic linkage uses a unique identification number, and the second deterministic linkage uses the name, gender, and date of birth as a set of partial identifiers. The linkage error included in this deterministic linkage method was compared with the absolute standardized difference (ASD) of Cohen’s according to the baseline characteristics, and the linkage quality was evaluated through the following indicators: linked rate, false match rate, missed match rate, positive predictive value, sensitivity, specificity, and F1-score.
Results:
For the deterministic linkage method that used the name, gender, and date of birth as a set of partial identifiers, the true match rate was 83.5 and the missed match rate was 16.5.Although there was bias in some characteristics of the data, most of the ASD values were less than 0.1, with no case greater than 0.5. Therefore, it is difficult to determine whether linked data constructed with deterministic linkages have substantial differences.
Conclusion
This study confirms the possibility of building health and medical data at the national level as the first data linkage quality verification study using big data from the HIRA. Analyzing the quality of linkages is crucial for comprehending linkage errors and generating reliable analytical outcomes. Linkers should increase the reliability of linked data by providing linkage error-related information to researchers. The results of this study will serve as reference data to increase the reliability of multicenter data linkage studies.
5.The efficacy and safety of Dendropanax morbifera leaf extract on the metabolic syndrome: a 12-week, placebo controlled, double blind, and randomized controlled trial
Ji Eun JUN ; You-Cheol HWANG ; Kyu Jeung AHN ; Ho Yeon CHUNG ; Se Young CHOUNG ; In-Kyung JEONG
Nutrition Research and Practice 2022;16(1):60-73
BACKGROUND/OBJECTIVES:
The extract from Dendropanax morbifera exhibited diverse therapeutic potentials. We aimed to evaluate the efficacy and safety of D. morbifera leaf extract for improving metabolic parameters in human.
SUBJECTS/METHODS:
A 12-week, double blind, placebo-controlled and randomized trial included a total of 74 adults, and they were assigned to the placebo group (n = 38) or 700 mg/day of D. morbifera group (n = 36). The efficacy endpoints were changes in glycemic, lipid, obesity, and blood pressure (BP) parameters, in addition to the prevalence of metabolic syndrome (MetS) and the numbers of MetS components. Safety was assessed by monitoring adverse events (AEs).
RESULTS:
After 12 weeks of treatment, the hemoglobin A1c (HbA1c) level significantly decreased in the D. morbifera group compared to that of the placebo group (difference: −0.13 ± 0.20% vs. 0.00 ± 0.28%, P = 0.031; % of change: −2.27 ± 3.63% vs. 0.10 ± 5.10%, P = 0.025). The homeostatic model assessment for insulin resistance level also decreased significantly from its baseline in the D. morbifera group. The systolic BP of D. morbifera group decreased significantly than that of placebo group (difference: −3.9 ± 9.8 mmHg vs. 3.3 ± 11.7 mmHg, P = 0.005; % of change: −2.8 ± 7.7% vs. 3.3 ± 10.2%, P = 0.005). However, the lipid parameters and body composition including body weight did not differ between the groups. The prevalence of MetS (36.8% vs. 13.9%, P = 0.022) and the incidence of MetS (10.5% vs. 13.9%, P = 0.027) at 12 weeks was significantly lower in the D. morbifera group than it was in the placebo group. No serious AEs occurred in either group.
CONCLUSIONS
Supplementation with D. morbifera extracts over a 12-week period improved metabolic parameters such as HbA1c and BP and reduced the prevalence of MetS.
6.Trends in the Prevalence of Obesity and Its Phenotypes Based on the Korea National Health and Nutrition Examination Survey from 2007 to 2017 in Korea
Sang Ouk CHIN ; You-Cheol HWANG ; Hong-Yup AHN ; Ji Eun JUN ; In-Kyung JEONG ; Kyu Jeung AHN ; Ho Yeon CHUNG
Diabetes & Metabolism Journal 2022;46(5):808-812
This study used data from the Korea National Health and Nutrition Examination Survey IV–VII from 2007 to identify the prevalence of obesity and its phenotypes (metabolically unhealthy obesity [MUO] and metabolically healthy obesity [MHO]) and their secular changes. The prevalence of obesity in Korea increased with significant secular changes observed (β=0.326, P trend <0.01) between 2007 and 2017, and especially in men (β=0.682, P trend <0.001) but not in women. The changes in the prevalence of obesity during the study period were different between men and women (P=0.001). The prevalence of MUO significantly increased only in men (β=0.565, P trend <0.01), while that of MHO increased only in women (β=0.179, P<0.05), especially in the younger age group (β=0.308, P<0.01).
7.Increased Visit-to-Visit Liver Enzyme Variability Is Associated with Incident Diabetes: A Community-Based 12-Year Prospective Cohort Study
Kyuhoon BANG ; Ji Eun JUN ; In-Kyung JEONG ; Kyu Jeung AHN ; Ho Yeon CHUNG ; You-Cheol HWANG
Diabetes & Metabolism Journal 2021;45(6):890-898
Background:
Fatty liver and/or increased liver enzyme values have been reported to be associated with incident diabetes. We sought to determine whether increased visit-to-visit liver enzyme variability is associated with incident diabetes.
Methods:
Study participants were recruited from the Korean Genome and Epidemiologic Study (KoGES). A total of 4,151 people aged 40 to 69 years was recruited and tested every 2 years for up to 12 years. Visit-to-visit aspartate aminotransferase (AST) and alanine aminotransferase (ALT) variability was evaluated in first the 6-year period through the use of various variability measurements: standard deviation (SD), average successive variability, coefficient of variation (CV), and variation independent of mean (VIM). Oral glucose tolerance test was performed at every visit.
Results:
During the 6-year follow‐up appointments, 13.0% (538/4,151) of people developed incident diabetes. Visit-to-visit AST variability was associated with an increased risk of diabetes independent of conventional risk factors for diabetes (hazard ratio per 1-SD increment [95% confidence interval]: 1.06 [1.00 to 1.11], 1.12 [1.04 to 1.21], and 1.13 [1.04 to 1.22] for SD, CV, and VIM, respectively; all P<0.05); however, no such associations were observed in the visit-to-visit ALT variability. According to alcohol consumption status, both AST and ALT variability were independent predictors for incident diabetes in subjects with heavy alcohol consumption; however, neither AST nor ALT variability was associated with diabetes risk in subjects who did not drink alcohol heavily.
Conclusion
Visit-to-visit liver enzyme variability is an independent predictor of incident diabetes. Such association was more evident in those who consumed significant amounts of alcohol.
8.Association between dairy product intake and hypertriglyceridemia in Korean adults
Seon Joo PARK ; Junghyun PARK ; Hong Ji SONG ; Chang Ho LEE ; Hae Jeung LEE
Nutrition Research and Practice 2020;14(2):152-159
BACKGROUND/OBJECTIVES: Hypertriglyceridemia may be a more important predictor of cardiovascular disease in Asian population consuming carbohydrate-rich foods than in Western populations. Dairy products are known to play a beneficial role in obesity, dyslipidemia, and metabolic syndrome, but the results vary depending on gender and obesity. In this study, we investigated the associations between dairy product intake and hypertriglyceridemia in Korean adults.SUBJECTS/METHODS: The participants were selected from the Korea National Health and Nutrition Examination Survey 2007–2012 (KNHANES IV and V). A total of 22,836 participants aged 19–64 years were included in the analysis. A food frequency questionnaire used to determine the frequency of consumption of products (milk and yogurt). Multivariable logistic regression was used to assess the associations between dairy product intake and hypertriglyceridemia.RESULTS: A significantly decreased risk of hypertriglyceridemia was detected in the highest dairy product intake frequency group (≥ 1 time/day) (odd ratio [OR] = 0.79; 95% confidence interval [CI] 0.64–0.97, P for trend = 0.022) compared to that for the lowest dairy product intake frequency group. Among obese participants, the group with the highest intakes of milk (in men, OR = 0.64; 95% CI: 0.46–0.91, P for trend = 0.036) and yogurt (in women; OR = 0.53; 95% CI: 0.29–0.94, P for trend = 0.019) showed inverse associations with hypertriglyceridemia. No associations were detected in normal weight participants.CONCLUSION: The association between dairy product intake and hypertriglyceridemia differed by gender and obesity status. Further prospective studies are needed to confirm these associations.
9.Performance of four different tools for predicting mortality in elderly patients with severe trauma
Ji Ho LEE ; Yong Il MIN ; Dong Hun LEE ; Yong Hun JUNG ; Kyung Woon JEUNG ; Byung Kook LEE ; Hyoung Youn LEE ; Yong Soo CHO ; Tag HEO
Journal of the Korean Society of Emergency Medicine 2020;31(1):111-119
Objective:
The present study aimed to analyze and compare the prognostic performances of Revised Trauma Score (RTS), Injury Severity Score (ISS), shock index (SI), and modified Early Warning Score (MEWS) for in-hospital mortality in severe trauma.
Methods:
This retrospective observational study included elderly (≥65 years) patients admitted for severe trauma between January 2018 and December 2018. Receiver operating characteristics analysis was performed to examine the prognostic performance of the four different tools. The primary outcome was in-hospital mortality following an injury.
Results:
Of the 279 patients included in the study, in-hospital mortality was 20.1% (n=56). In multivariate analysis, age (odds ratio [OR], 1.055; 95% confidence interval [CI], 1.004-1.109), ISS (OR, 1.080; 95% CI, 1.008-1.157), Glasgow Coma Scale (OR, 0.842; 95% CI, 0.785-0.904), and respiratory rate (OR, 1.261; 95% CI, 1.071-1.486) were independently associated with in-hospital mortality. The area under the curves (AUCs) of MEWS, RTS, ISS, and SI were 0.851 (95% CI, 0.763-0.857), 0.733 (0.677-0.784), 0.664 (0.606-0.720), and 0.567 (0.506-0.626), respectively. The AUC of MEWS was significantly different from those of RTS (P=0.034), ISS (P=0.001), and SI (P<0.001).
Conclusion
MEWS has the highest prognostic performance for in-hospital mortality among four different tools in elderly patients with severe trauma.
10.Clinical Course and Outcomes of 3,060 Patients with Coronavirus Disease 2019 in Korea, January–May 2020
Ho Kyung SUNG ; Jin Yong KIM ; Jeonghun HEO ; Haesook SEO ; Young soo JANG ; Hyewon KIM ; Bo Ram KOH ; Neungsun JO ; Hong Sang OH ; Young Mi BAEK ; Kyung-Hwa PARK ; Jeung A SHON ; Min-Chul KIM ; Joon Ho KIM ; Hyun-Ha CHANG ; Yukyung PARK ; Yu Min KANG ; Dong Hyun LEE ; Dong Hyun OH ; Hyun Jung PARK ; Kyoung-Ho SONG ; Eun Kyoung LEE ; Hyeongseok JEONG ; Ji Yeon LEE ; Ja-Young KO ; Jihee CHOI ; Eun Hwa RYU ; Ki-hyun CHUNG ; Myoung-don OH ;
Journal of Korean Medical Science 2020;35(30):e280-
Background:
The fatality rate of patients with coronavirus disease 2019 (COVID-19) varies among countries owing to demographics, patient comorbidities, surge capacity of healthcare systems, and the quality of medical care. We assessed the clinical outcomes of patients with COVID-19 during the first wave of the epidemic in Korea.
Methods:
Using a modified World Health Organization clinical record form, we obtained clinical data for 3,060 patients with COVID-19 treated at 55 hospitals in Korea. Disease severity scores were defined as: 1) no limitation of daily activities; 2) limitation of daily activities but no need for supplemental oxygen; 3) supplemental oxygen via nasal cannula; 4) supplemental oxygen via facial mask; 5) non-invasive mechanical ventilation; 6) invasive mechanical ventilation; 7) multi-organ failure or extracorporeal membrane oxygenation therapy; and 8) death. Recovery was defined as a severity score of 1 or 2, or discharge and release from isolation.
Results:
The median age of the patients was 43 years of age; 43.6% were male. The median time from illness onset to admission was 5 days. Of the patients with a disease severity score of 3–4 on admission, 65 (71.5%) of the 91 patients recovered, and 7 (7.7%) died due to illness by day 28. Of the patients with disease severity scores of 5–7, 7 (19.5%) of the 36 patients recovered, and 8 (22.2%) died due to illness by day 28. None of the 1,324 patients who were < 50 years of age died; in contrast, the fatality rate due to illness by day 28 was 0.5% (2/375), 0.9% (2/215), 5.8% (6/104), and 14.0% (7/50) for the patients aged 50–59, 60–69, 70–79, and ≥ 80 years of age, respectively.
Conclusion
In Korea, almost all patients of < 50 years of age with COVID-19 recovered without supplemental oxygen. In patients of ≥ 50 years of age, the fatality rate increased with age, reaching 14% in patients of ≥ 80 years of age.

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