5.Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study
Jeonghee HAN ; Woo Je LEE ; Kyu Yeon HUR ; Jae Hyoung CHO ; Byung Wan LEE ; Cheol-Young PARK
Diabetes & Metabolism Journal 2024;48(3):418-428
Background:
To investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM).
Methods:
This was a real-world, prospective, non-interventional post-marketing safety study conducted from May 26, 2015 to May 25, 2021 at 85 Korean healthcare centers using electronic case data. Data on patients using dulaglutide 0.75 mg/0.5 mL or the dulaglutide 1.5 mg/0.5 mL single-use pens were collected and pooled. The primary objective was to report the frequency and proportion of adverse and serious adverse events that occurred. The secondary objective was to monitor the effectiveness of dulaglutide at 12 and 24 weeks by evaluating changes in glycosylated hemoglobin (HbA1c ), fasting plasma glucose, and body weight.
Results:
Data were collected from 3,067 subjects, and 3,022 subjects who received ≥1 dose (of any strength) of dulaglutide were included in the safety analysis set (53% female, mean age 56 years; diabetes duration 11.2 years, mean HbA1c 8.8%). The number of adverse events reported was 819; of these, 68 (8.3%) were serious adverse events. One death was reported. Adverse events were mostly mild in severity; 60.81% of adverse events were considered related to dulaglutide. This study was completed by 72.73% (2,198/3,022) of subjects. At 12/24 weeks there were significant (P<0.0001) reductions from baseline in least-squares mean HbA1c (0.96%/0.95%), fasting blood glucose (26.24/24.43 mg/dL), and body weight (0.75/1.21 kg).
Conclusion
Dulaglutide was generally well tolerated and effective in real-world Korean individuals with T2DM. The results from this study contribute to the body of evidence for dulaglutide use in this population.
6.Atrial fibrillation fact sheet in Korea 2024 (part 3): treatment for atrial fibrillation in Korea: medicines and ablation
Yun Gi KIM ; Kwang‑No LEE ; Yong‑Soo BAEK ; Bong‑Seong KIM ; Kyung‑Do HAN ; Hyoung‑Seob PARK ; Jinhee AHN ; Jin‑Kyu PARK ; Jaemin SHIM
International Journal of Arrhythmia 2024;25(3):15-
Background:
Atrial fibrillation (AF) is a prevalent cardiac arrhythmia associated with significant morbidity and mortality, posing a considerable burden on healthcare systems. In Republic of Korea, the prevalence and incidence of AF have increased in recent years. There have also been significant changes in the trends of antiarrhythmic drug (AAD) use and procedural treatments for AF.
Objectives:
This study aims to review the trends in AF treatment strategies in Republic of Korea, particularly focusing on the utilization of antiarrhythmic drugs and catheter ablation.
Methods:
The Korean National Health Insurance Service (K-NHIS) data were used to identify AF patients from 2013 to 2022. AAD usage and catheter ablation procedures were analyzed annually. AADs were classified into Class IC and III drugs. Trends in beta-blockers, calcium channel blockers, and digoxin prescriptions were also examined. The primary endpoint was the trend of AAD use and AF catheter ablation (AFCA) over 10 years.
Results:
In 2022, 940,063 patients had a prior diagnosis of AF. From 2013 to 2022, the use of AADs increased from 12.1 to 16.4% among prevalent AF patients. Beta-blockers were the most commonly prescribed rate control medication, while the use of calcium channel blockers and digoxin declined. The frequency of AFCA procedures also increased, from 0.5% of prevalent AF patients in 2013 to 0.7% in 2022. Younger patients, males, and those with lower CHA2DS2-VASc scores were more likely to receive AFCA. Regional variations in treatment patterns were observed, with Seoul exhibiting higher rates of procedural treatments and AAD prescriptions.
Conclusions
Over the past decade, there has been a significant increase in the use of AADs and AFCA procedures in Republic of Korea. These trends reflect recent advancements in AF management advocating a refined rhythm control strategy.
7.Changes in Disc Height as a Prognostic Factor in Patients Undergoing Microscopic Discectomy
Myeonggeon KWEON ; Koang-Hum BAK ; Hyeong-Joong YI ; Kyu-Sun CHOI ; Myung-Hoon HAN ; Min-Kyun NA ; Hyoung-Joon CHUN
Journal of Korean Neurosurgical Society 2024;67(2):209-216
Objective:
: Some patients with disc herniation who underwent discectomy complain of back pain after surgery and are unsatisfied with the surgical results. This study aimed to evaluate the relationship between preoperative disc height (DH), postoperative DH, and pain score 12 months after surgery in patients who underwent microdiscectomy for herniated lumbar disc.
Methods:
: This study enrolled patients who underwent microdiscectomy at a medical center between January 2012 and December 2020. Patients with X-ray or computed tomography and pain score assessment (visual analog scale score) prior to surgery, immediately post-op, and at 1, 6, and 12 months after surgery were included. The DH index was defined as DH/overlying vertebral width. The DH ratio was defined as the postoperative DH/preoperative DH. Simple linear regression and multivariate linear regression analyses were applied to assess the correlation between DHs and leg pain scores 12 months after surgery.
Results:
: A total of 118 patients who underwent microdiscectomy were included. DH decreased up to 12 months after surgery. The DH ratio at 1, 6, and 12 months after discectomy showed a significant positive correlation with the pain scores at 12 months after discectomy (1 month : p=0.045, B=0.52; 6 months : p=0.008, B=0.78; 12 months : p=0.005, B=0.69). Multivariate linear regression analysis revealed that the level of surgery, sex, age, and body mass index had no significant relationship with back pain scores after 12 months.
Conclusion
: In patients who underwent microdiscectomy, the DH ratios at 1, 6, and 12 months after surgery were prognostic factors for back pain scores at 12 months after surgery. Aggressive discectomy is recommended for lower postoperative DH ratios and Visual analog scale scores, leading to improved patient satisfaction.
8.Efficacy and Safety of Lurasidone vs. Quetiapine XR in Acutely Psychotic Patients With Schizophrenia in Korea: A Randomized, Double-Blind, Active-Controlled Trial
Se Hyun KIM ; Do-Un JUNG ; Do Hoon KIM ; Jung Sik LEE ; Kyoung-Uk LEE ; Seunghee WON ; Bong Ju LEE ; Sung-Gon KIM ; Sungwon ROH ; Jong-Ik PARK ; Minah KIM ; Sung Won JUNG ; Hong Seok OH ; Han-yong JUNG ; Sang Hoon KIM ; Hyun Seung CHEE ; Jong-Woo PAIK ; Kyu Young LEE ; Soo In KIM ; Seung-Hwan LEE ; Eun-Jin CHEON ; Hye-Geum KIM ; Heon-Jeong LEE ; In Won CHUNG ; Joonho CHOI ; Min-Hyuk KIM ; Seong-Jin CHO ; HyunChul YOUN ; Jhin-Goo CHANG ; Hoo Rim SONG ; Euitae KIM ; Won-Hyoung KIM ; Chul Eung KIM ; Doo-Heum PARK ; Byung-Ook LEE ; Jungsun LEE ; Seung-Yup LEE ; Nuree KANG ; Hee Yeon JUNG
Psychiatry Investigation 2024;21(7):762-771
Objective:
This study was performed to evaluate the efficacy and safety of lurasidone (160 mg/day) compared to quetiapine XR (QXR; 600 mg/day) in the treatment of acutely psychotic patients with schizophrenia.
Methods:
Patients were randomly assigned to 6 weeks of double-blind treatment with lurasidone 160 mg/day (n=105) or QXR 600 mg/day (n=105). Primary efficacy measure was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions severity (CGI-S) score. Adverse events, body measurements, and laboratory parameters were assessed.
Results:
Lurasidone demonstrated non-inferiority to QXR on the PANSS total score. Adjusted mean±standard error change at week 6 on the PANSS total score was -26.42±2.02 and -27.33±2.01 in the lurasidone and QXR group, respectively. The mean difference score was -0.91 (95% confidence interval -6.35–4.53). The lurasidone group showed a greater reduction in PANSS total and negative subscale on week 1 and a greater reduction in end-point CGI-S score compared to the QXR group. Body weight, body mass index, and waist circumference in the lurasidone group were reduced, with significantly lower mean change compared to QXR. Endpoint changes in glucose, cholesterol, triglycerides, and low-density lipoprotein levels were also significantly lower. The most common adverse drug reactions with lurasidone were akathisia and nausea.
Conclusion
Lurasidone 160 mg/day was found to be non-inferior to QXR 600 mg/day in the treatment of schizophrenia with comparable efficacy and tolerability. Adverse effects of lurasidone were generally tolerable, and beneficial effects on metabolic parameters can be expected.
9.Corrigendum to: Cardioprotection via mitochondrial transplantation supports fatty acid metabolism in ischemia-reperfusion injured rat heart
Jehee JANG ; Ki-Woon KANG ; Young-Won KIM ; Seohyun JEONG ; Jaeyoon PARK ; Jihoon PARK ; Jisung MOON ; Junghyun JANG ; Seohyeon KIM ; Sunghun KIM ; Sungjoo CHO ; Yurim LEE ; Hyoung Kyu KIM ; Jin HAN ; Eun-A KO ; Sung-Cherl JUNG ; Jung-Ha KIM ; Jae-Hong KO
The Korean Journal of Physiology and Pharmacology 2024;28(4):391-391
10.Cardioprotection via mitochondrial transplantation supports fatty acid metabolism in ischemia-reperfusion injured rat heart
Jehee JANG ; Ki-Woon KANG ; Young-Won KIM ; Seohyun JEONG ; Jaeyoon PARK ; Jihoon PARK ; Jisung MOON ; Junghyun JANG ; Seohyeon KIM ; Sunghun KIM ; Sungjoo CHO ; Yurim LEE ; Hyoung Kyu KIM ; Jin HAN ; Eun-A KO ; Sung-Cherl JUNG ; Jung-Ha KIM ; Jae-Hong KO
The Korean Journal of Physiology and Pharmacology 2024;28(3):209-217
In addition to cellular damage, ischemia-reperfusion (IR) injury induces substantial damage to the mitochondria and endoplasmic reticulum. In this study, we sought to determine whether impaired mitochondrial function owing to IR could be restored by transplanting mitochondria into the heart under ex vivo IR states. Additionally, we aimed to provide preliminary results to inform therapeutic options for ischemic heart disease (IHD). Healthy mitochondria isolated from autologous gluteus maximus muscle were transplanted into the hearts of Sprague–Dawley rats damaged by IR using the Langendorff system, and the heart rate and oxygen consumption capacity of the mitochondria were measured to confirm whether heart function was restored. In addition, relative expression levels were measured to identify the genes related to IR injury. Mitochondrial oxygen consumption capacity was found to be lower in the IR group than in the group that underwent mitochondrial transplantation after IR injury (p < 0.05), and the control group showed a tendency toward increased oxygen consumption capacity compared with the IR group. Among the genes related to fatty acid metabolism, Cpt1b (p < 0.05) and Fads1 (p < 0.01) showed significant expression in the following order: IR group, IR + transplantation group, and control group. These results suggest that mitochondrial transplantation protects the heart from IR damage and may be feasible as a therapeutic option for IHD.

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