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.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.
3.In-flight Electrocardiography Monitoring in a Pilot During Cross Country Flight
William D. KIM ; Sang-Wook KIM ; Seong-Kyu CHO ; Ju Hyeon BYEON ; GunYoung LEE ; WooSeok HYUN ; JoungSoon JANG
Korean Journal of Aerospace and Environmental Medicine 2024;34(4):101-107
Purpose:
The diagnosis and management of cardiovascular diseases are important for pilots, as well as the assessment of workload. Heart rate variability (HRV) can be evaluated from electrocardiography (ECG) signals during flight phases to assess the activation of the autonomic nervous system.
Methods:
In this study, continuous ECG activity was recorded of one pilot who flied as a pilot flying during a 4-hour long round trip using wearable ECG machine and was analyzed with MATLAB (R2020b ver. 9.9, The Mathworks Inc.). Total flight was divided into five phases: preflight, take off, cruise, landing, and postflight.
Results:
Mean heart rate (HR) was lowest in the postflight phase (76 bpm), and highest in the landing phase (86 bpm). Landing phase showed the highest values in standard deviation of NN interval (59.3 ms), triangular index (11.7), and triangular interpolation of NN interval (195 ms), while the postflight phase had highest root mean square of successive difference (20.5 ms) and proportion of successive RR interval (3.4 ms). As for frequency-domain metrics, the landing phase had the highest lowfrequency/high-frequency ratio of 5.33. Among the non-linear HRV measures, the landing phase presented the lowest SD1/SD2 ratio (0.15).
Conclusion
We observed the relative increase of mean HR and change of HRV in the landing phase, indicating elevated sympathetic nervous tone. Further studies should be considered to evaluate specific changes of ECG signals in flight phases and confirm the clinical use of the MATLAB signal analysis tools.
4.Guideline for Minimizing Radiation Exposure of Interventionalists during Fluoroscopy-guided Interventional Procedures
Il Sang SHIN ; Yun Nah LEE ; Jun Kyu LEE ; Joo Seong KIM ; Sung Bum KIM ; Jiyoung KEUM ; Chang Hoon OH ; Kang Won LEE ; Joowon CHUNG ; Lyo Min KWON ; Nam Hee KIM ; Sang Soo LEE ; Byoung Kwan SON ; Miyoung CHOI
The Korean Journal of Gastroenterology 2024;84(6):251-264
As fluoroscopy-guided interventional procedures gain popularity, the associated health threats from radiation exposure to interventionalists during these procedures are increasing. Therefore, an understanding of the potential risks of radiation and careful consideration on minimizing exposure to radiation during the procedures are of paramount importance. The Korean Pancreatobiliary Association has developed a clinical practice guideline to minimize radiation exposure during fluoroscopy-guided interventional procedures. This guideline provides recommendations to deal with the risk of radiation exposure to interventionalists who perform fluoroscopy-guided procedures, and emphasizes the importance of proper and practical approaches to avoid unnecessary radiation exposure.
5.In-flight Electrocardiography Monitoring in a Pilot During Cross Country Flight
William D. KIM ; Sang-Wook KIM ; Seong-Kyu CHO ; Ju Hyeon BYEON ; GunYoung LEE ; WooSeok HYUN ; JoungSoon JANG
Korean Journal of Aerospace and Environmental Medicine 2024;34(4):101-107
Purpose:
The diagnosis and management of cardiovascular diseases are important for pilots, as well as the assessment of workload. Heart rate variability (HRV) can be evaluated from electrocardiography (ECG) signals during flight phases to assess the activation of the autonomic nervous system.
Methods:
In this study, continuous ECG activity was recorded of one pilot who flied as a pilot flying during a 4-hour long round trip using wearable ECG machine and was analyzed with MATLAB (R2020b ver. 9.9, The Mathworks Inc.). Total flight was divided into five phases: preflight, take off, cruise, landing, and postflight.
Results:
Mean heart rate (HR) was lowest in the postflight phase (76 bpm), and highest in the landing phase (86 bpm). Landing phase showed the highest values in standard deviation of NN interval (59.3 ms), triangular index (11.7), and triangular interpolation of NN interval (195 ms), while the postflight phase had highest root mean square of successive difference (20.5 ms) and proportion of successive RR interval (3.4 ms). As for frequency-domain metrics, the landing phase had the highest lowfrequency/high-frequency ratio of 5.33. Among the non-linear HRV measures, the landing phase presented the lowest SD1/SD2 ratio (0.15).
Conclusion
We observed the relative increase of mean HR and change of HRV in the landing phase, indicating elevated sympathetic nervous tone. Further studies should be considered to evaluate specific changes of ECG signals in flight phases and confirm the clinical use of the MATLAB signal analysis tools.
6.Guideline for Minimizing Radiation Exposure of Interventionalists during Fluoroscopy-guided Interventional Procedures
Il Sang SHIN ; Yun Nah LEE ; Jun Kyu LEE ; Joo Seong KIM ; Sung Bum KIM ; Jiyoung KEUM ; Chang Hoon OH ; Kang Won LEE ; Joowon CHUNG ; Lyo Min KWON ; Nam Hee KIM ; Sang Soo LEE ; Byoung Kwan SON ; Miyoung CHOI
The Korean Journal of Gastroenterology 2024;84(6):251-264
As fluoroscopy-guided interventional procedures gain popularity, the associated health threats from radiation exposure to interventionalists during these procedures are increasing. Therefore, an understanding of the potential risks of radiation and careful consideration on minimizing exposure to radiation during the procedures are of paramount importance. The Korean Pancreatobiliary Association has developed a clinical practice guideline to minimize radiation exposure during fluoroscopy-guided interventional procedures. This guideline provides recommendations to deal with the risk of radiation exposure to interventionalists who perform fluoroscopy-guided procedures, and emphasizes the importance of proper and practical approaches to avoid unnecessary radiation exposure.
7.In-flight Electrocardiography Monitoring in a Pilot During Cross Country Flight
William D. KIM ; Sang-Wook KIM ; Seong-Kyu CHO ; Ju Hyeon BYEON ; GunYoung LEE ; WooSeok HYUN ; JoungSoon JANG
Korean Journal of Aerospace and Environmental Medicine 2024;34(4):101-107
Purpose:
The diagnosis and management of cardiovascular diseases are important for pilots, as well as the assessment of workload. Heart rate variability (HRV) can be evaluated from electrocardiography (ECG) signals during flight phases to assess the activation of the autonomic nervous system.
Methods:
In this study, continuous ECG activity was recorded of one pilot who flied as a pilot flying during a 4-hour long round trip using wearable ECG machine and was analyzed with MATLAB (R2020b ver. 9.9, The Mathworks Inc.). Total flight was divided into five phases: preflight, take off, cruise, landing, and postflight.
Results:
Mean heart rate (HR) was lowest in the postflight phase (76 bpm), and highest in the landing phase (86 bpm). Landing phase showed the highest values in standard deviation of NN interval (59.3 ms), triangular index (11.7), and triangular interpolation of NN interval (195 ms), while the postflight phase had highest root mean square of successive difference (20.5 ms) and proportion of successive RR interval (3.4 ms). As for frequency-domain metrics, the landing phase had the highest lowfrequency/high-frequency ratio of 5.33. Among the non-linear HRV measures, the landing phase presented the lowest SD1/SD2 ratio (0.15).
Conclusion
We observed the relative increase of mean HR and change of HRV in the landing phase, indicating elevated sympathetic nervous tone. Further studies should be considered to evaluate specific changes of ECG signals in flight phases and confirm the clinical use of the MATLAB signal analysis tools.
8.Guideline for Minimizing Radiation Exposure of Interventionalists during Fluoroscopy-guided Interventional Procedures
Il Sang SHIN ; Yun Nah LEE ; Jun Kyu LEE ; Joo Seong KIM ; Sung Bum KIM ; Jiyoung KEUM ; Chang Hoon OH ; Kang Won LEE ; Joowon CHUNG ; Lyo Min KWON ; Nam Hee KIM ; Sang Soo LEE ; Byoung Kwan SON ; Miyoung CHOI
The Korean Journal of Gastroenterology 2024;84(6):251-264
As fluoroscopy-guided interventional procedures gain popularity, the associated health threats from radiation exposure to interventionalists during these procedures are increasing. Therefore, an understanding of the potential risks of radiation and careful consideration on minimizing exposure to radiation during the procedures are of paramount importance. The Korean Pancreatobiliary Association has developed a clinical practice guideline to minimize radiation exposure during fluoroscopy-guided interventional procedures. This guideline provides recommendations to deal with the risk of radiation exposure to interventionalists who perform fluoroscopy-guided procedures, and emphasizes the importance of proper and practical approaches to avoid unnecessary radiation exposure.
9.Endovascular Treatment Strategies for Vertebral Artery Dissection: A Single-Center Experience and Literature Review
Junhyung KIM ; Sang Kyu PARK ; Joonho CHUNG
Journal of Neurointensive Care 2024;7(1):1-11
Although some vertebral artery dissection (VADs) cases heal naturally, others progress to stroke, necessitating intervention. Endovascular treatment (EVT) has gained prominence as a viable approach for addressing VADs owing to its perceived low risk of procedure-related complications and high effectiveness. In this review, we share our practical experience of this technique by incorporating the indications and methods for VAD treatment via EVT. Our EVT strategies covered the management of both ruptured and selected cases of unruptured VADs. Unruptured cases that require treatment include those complicated by lesions with recurring or progressive ischemia, large dissecting aneurysms with mass effects, early changes in the VAD structure during follow-up, and involvement of the basilar or bilateral vertebral arteries (VAs). In cases of ruptured VADs, we aimed to occlude the site of rupture through either VA occlusion or stent-assisted coiling. For unruptured VADs, the goal is to restore the original blood flow dynamics using a range of stenting techniques. The choice of EVT technique should be made on a case-by-case basis, considering factors such as the patient's presenting symptoms, hemodynamic status, adequacy of collateral blood supply, and anatomical characteristics of the important arteries and perforators.
10.In-flight Electrocardiography Monitoring in a Pilot During Cross Country Flight
William D. KIM ; Sang-Wook KIM ; Seong-Kyu CHO ; Ju Hyeon BYEON ; GunYoung LEE ; WooSeok HYUN ; JoungSoon JANG
Korean Journal of Aerospace and Environmental Medicine 2024;34(4):101-107
Purpose:
The diagnosis and management of cardiovascular diseases are important for pilots, as well as the assessment of workload. Heart rate variability (HRV) can be evaluated from electrocardiography (ECG) signals during flight phases to assess the activation of the autonomic nervous system.
Methods:
In this study, continuous ECG activity was recorded of one pilot who flied as a pilot flying during a 4-hour long round trip using wearable ECG machine and was analyzed with MATLAB (R2020b ver. 9.9, The Mathworks Inc.). Total flight was divided into five phases: preflight, take off, cruise, landing, and postflight.
Results:
Mean heart rate (HR) was lowest in the postflight phase (76 bpm), and highest in the landing phase (86 bpm). Landing phase showed the highest values in standard deviation of NN interval (59.3 ms), triangular index (11.7), and triangular interpolation of NN interval (195 ms), while the postflight phase had highest root mean square of successive difference (20.5 ms) and proportion of successive RR interval (3.4 ms). As for frequency-domain metrics, the landing phase had the highest lowfrequency/high-frequency ratio of 5.33. Among the non-linear HRV measures, the landing phase presented the lowest SD1/SD2 ratio (0.15).
Conclusion
We observed the relative increase of mean HR and change of HRV in the landing phase, indicating elevated sympathetic nervous tone. Further studies should be considered to evaluate specific changes of ECG signals in flight phases and confirm the clinical use of the MATLAB signal analysis tools.

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