1.Evaluation of the Regulatory Required Post-Authorization Safety Study for Propacetamol:Nested Case-Control and Case-Time-Control Studies
Sungho BEA ; Dongwon YOON ; Han Eol JEONG ; Juhong JUNG ; Seung-Mok PARK ; Juhee JEON ; Young-Min YE ; Jae-Hyun LEE ; Ju-Young SHIN
Yonsei Medical Journal 2024;65(2):120-128
Purpose:
Following the withdrawal of propacetamol in Europe owing to safety issues, the regulatory authority of South Korea requested a post-marketing surveillance study to investigate its safety profile.
Materials and Methods:
We conducted nested case-control and case-time-control (CTC) analyses of cases and controls identified for outcomes of interest, including anaphylaxis, thrombosis, and Stevens–Johnson syndrome (SJS), using the claims database of South Korea, 2010–2019. Risk-set sampling was used to match each case with up to 10 controls for age, sex, cohort entry date, and follow-up duration. Exposure to anaphylaxis, thrombosis, and SJS was assessed within 7, 90, and 30 days of the index date, respectively. We calculated odds ratios (OR) with 95% confidence intervals (CIs) using conditional logistic regression to assess the risk of outcomes associated with propacetamol.
Results:
We identified cases of anaphylaxis (n=61), thrombosis (n=95), and SJS (n=1) and matched them to controls (173, 268, and 4, respectively). In the nested case-control analysis, the ORs for anaphylaxis and SJS were inestimable given the small number of propacetamol users during the risk period; meanwhile, the OR for thrombosis was 1.60 (95% CI 0.71–3.62). In the CTC design, the effect estimate was only estimated for thrombosis (OR 0.56, 95% CI 0.09–3.47).
Conclusion
In both nested case-control and CTC analyses, propacetamol was not associated with an increased risk of anaphylaxis, thrombosis, or SJS. The findings from this study, which used routinely collected clinical data, provide reassuring real-world evidence regarding the safety of propacetamol in a nationwide population to support regulatory decision-making.
2.The Ratio of Estimated Glomerular Filtration Rate Based on Cystatin C and Creatinine Reflecting Cardiovascular Risk in Diabetic Patients
Ah Reum KHANG ; Min Jin LEE ; Dongwon YI ; Yang Ho KANG
Diabetes & Metabolism Journal 2023;47(3):415-425
Background:
The ratio of estimated glomerular filtration rate (eGFR) based on cystatin C and creatinine (eGFRcystatin C/eGFRcreatinine ratio) is related to accumulating atherosclerosis-promoting proteins and increased mortality in several cohorts.
Methods:
We assessed whether the eGFRcystatin C/eGFRcreatinine ratio is a predictor of arterial stiffness and sub-clinical atherosclerosis in type 2 diabetes mellitus (T2DM) patients, who were followed up during 2008 to 2016. GFR was estimated using an equation based on cystatin C and creatinine.
Results:
A total of 860 patients were stratified according to their eGFRcystatin C/eGFRcreatinine ratio (i.e., <0.9, 0.9–1.1 [a reference group], and >1.1). Intima-media thickness was comparable among the groups; however, presence of carotid plaque was frequent in the <0.9 group (<0.9 group, 38.3%; 0.9–1.1 group, 21.6% vs. >1.1 group, 17.2%, P<0.001). Brachial-ankle pulse wave velocity (baPWV) was faster in the <0.9 group (<0.9 group, 1,656.3±333.0 cm/sec; 0.9–1.1 group, 1,550.5±294.8 cm/sec vs. >1.1 group, 1,494.0±252.2 cm/sec, P<0.001). On comparing the <0.9 group with the 0.9–1.1 group, the multivariate-adjusted odds ratios of prevalence of high baPWV and carotid plaque were 2.54 (P=0.007) and 1.95 (P=0.042), respectively. Cox regression analysis demonstrated near or over 3-fold higher risks of the prevalence of high baPWV and carotid plaque in the <0.9 group without chronic kidney disease (CKD).
Conclusion
We concluded that eGFRcystatin C/eGFRcreatinine ratio <0.9 was related to an increased risk of high baPWV and carotid plaque in T2DM patients, especially, those without CKD. Careful monitoring of cardiovascular disease is needed for T2DM patients with low eGFRcystatin C/eGFRcreatinine ratio.
4.Association between serum uric acid and relative hand grip strength in comparison with metabolic syndrome components
Dongwon YI ; Min Jin LEE ; Ah Reum KHANG ; Yang Ho KANG
Osteoporosis and Sarcopenia 2022;8(4):158-164
Objectives:
To investigate the association between serum uric acid (UA) and relative hand grip strength (HGS) in comparison with metabolic syndrome components.
Methods:
We analyzed the data of 5247 Korean adults aged ≥ 20 years (2422 men and 2825 women) who participated in the KNHNES VII (2018).
Results:
Among women, relative HGS was significantly lower in participants with hyperuricemia (1.65 ± 0.04) than in those without (1.95 ± 0.01) and was significantly decreased in the highest quartile (4Q: 1.77 ± 0.02) of serum UA compared with that in the lowest quartile (1Q: 1.98 ± 0.02). Among men, relative HGS was lower in participants with hyperuricemia (3.09 ± 0.04 vs. 3.16 ± 0.02) and decreased in 4Q (3.08 ± 0.03) of serum UA compared with that in 1Q (3.15 ± 0.03); however, these results were not statistically significant. In age- and multivariate-adjusted analyses in men, relative HGS was significantly lower in 4Q compared with that in 1Q in model 1 (adjusted for age), but there were no significant differences in model 2 (adjusted for age, BMI, and waist circumference) and model 3 (adjusted for age, BMI, waist circumference, systolic and diastolic blood pressure, fasting blood glucose, triglycerides, and high-density lipoprotein cholesterol). Meanwhile, in women, relative HGS was significantly decreased in 4Q compared with that in 1Q in all models.
Conclusions
A significant inverse correlation was observed between serum UA levels and relative HGS in women, and their significance was maintained even after adjusting for age and metabolic syndrome components.
5.Synergistic Interaction between Hyperuricemia and Abdominal Obesity as a Risk Factor for Metabolic Syndrome Components in Korean Population
Min Jin LEE ; Ah Reum KHANG ; Yang Ho KANG ; Mi Sook YUN ; Dongwon YI
Diabetes & Metabolism Journal 2022;46(5):756-766
Background:
The present study investigated the role of synergistic interaction between hyperuricemia and abdominal obesity as a risk factor for the components of metabolic syndrome.
Methods:
We performed a cross-sectional study using the data of 16,094 individuals from the seventh Korean National Health and Nutrition Examination Survey (2016 to 2018). The adjusted odds ratios of metabolic syndrome and its components were analyzed by multivariate logistic regression analysis. The presence of synergistic interaction between hyperuricemia and abdominal obesity was evaluated by calculating the additive scales—the relative excess risk due to interaction, attributable proportion due to interaction, and synergy index (SI).
Results:
There was a synergistic interaction between hyperuricemia and abdominal obesity in hypertriglyceridemia (men: SI, 1.39; 95% confidence interval [CI], 1.01 to 1.98; women: SI, 1.61; 95% CI, 1.02 to 2.69), and low high-density lipoprotein cholesterol (HDL-C) (men: SI, 2.03; 95% CI, 1.41 to 2.91; women: SI, 1.70; 95% CI, 1.05 to 2.95). There was no significant synergistic interaction between hyperuricemia and abdominal obesity for the risk of high blood pressure (men: SI, 1.22; 95% CI, 0.85 to 1.77; women: SI, 1.53; 95% CI, 0.79 to 2.97), and hyperglycemia (men: SI, 1.03; 95% CI, 0.72 to 1.47; women: SI, 1.39; 95% CI, 0.75 to 2.57).
Conclusion
Hyperuricemia and abdominal obesity synergistically increased the risk of hypertriglyceridemia and low HDL-C in both sexes.
6.Arthralgia and Myalgia Associated with the Use of Bisphosphonate:An Active Monitoring Study
Jung-woo SONG ; So-Hee PARK ; Dongwon YOON ; Mo-Se LEE ; Jung-Min LEE ; Na-Young KIM ; Young-Wook KIM ; Ju-Yeun LEE ; Ju-Young SHIN
Korean Journal of Clinical Pharmacy 2021;31(3):180-187
Objective:
We investigated arthralgia and myalgia associated with the use of oral bisphosphonate (BP) by conducting a survey of patient.
Methods:
The pharmacists conducted a survey between 1 Oct 2019 and 30 Sep 2020 among patients who were dispensed BP in community pharmacies to assess their demographic and medical characteristics, and their experiences with, and process for pain. Logistic regression analyses were performed to find the risk factors associated with the pain, and the odds ratios (OR) and 95% confidence intervals (CI) were determined.
Results:
A total of 160 patients who used BP participated in the survey (74 [46.3%] used risedronate; 61 [38.1%] used alendronate; 23 [14.4%] used ibandronate), and 20 (12.5%) of them experienced pain. Significant statistical differences of the characteristics between patients who experienced pain or not were observed regarding menopause, and parity. Compared with women who had one or two parity, women who had more than three parity were associated with the decreased risk of pain (OR, 0.24; 95% CI, 0.04-0.98). Moreover, steady exercise was associated with the decreased risk of pain compared to less exercise (OR, 0.37; 95% CI, 0.14-0.98).
Conclusion
Our findings suggest that the risk of pain in BP-treated patients might be different regarding the different ingredients of BP, and dosing frequency. This survey highlights a need for a further safety research to understand the factors influencing the pain associated with the BP treatment.
7.Arthralgia and Myalgia Associated with the Use of Bisphosphonate:An Active Monitoring Study
Jung-woo SONG ; So-Hee PARK ; Dongwon YOON ; Mo-Se LEE ; Jung-Min LEE ; Na-Young KIM ; Young-Wook KIM ; Ju-Yeun LEE ; Ju-Young SHIN
Korean Journal of Clinical Pharmacy 2021;31(3):180-187
Objective:
We investigated arthralgia and myalgia associated with the use of oral bisphosphonate (BP) by conducting a survey of patient.
Methods:
The pharmacists conducted a survey between 1 Oct 2019 and 30 Sep 2020 among patients who were dispensed BP in community pharmacies to assess their demographic and medical characteristics, and their experiences with, and process for pain. Logistic regression analyses were performed to find the risk factors associated with the pain, and the odds ratios (OR) and 95% confidence intervals (CI) were determined.
Results:
A total of 160 patients who used BP participated in the survey (74 [46.3%] used risedronate; 61 [38.1%] used alendronate; 23 [14.4%] used ibandronate), and 20 (12.5%) of them experienced pain. Significant statistical differences of the characteristics between patients who experienced pain or not were observed regarding menopause, and parity. Compared with women who had one or two parity, women who had more than three parity were associated with the decreased risk of pain (OR, 0.24; 95% CI, 0.04-0.98). Moreover, steady exercise was associated with the decreased risk of pain compared to less exercise (OR, 0.37; 95% CI, 0.14-0.98).
Conclusion
Our findings suggest that the risk of pain in BP-treated patients might be different regarding the different ingredients of BP, and dosing frequency. This survey highlights a need for a further safety research to understand the factors influencing the pain associated with the BP treatment.
8.Purpura Associated with Onion Extract Consumption
Dongwon LEE ; Sung Jin PARK ; Min Seok HAM ; Ji Hyuck HONG ; Soo Hong SEO
Korean Journal of Dermatology 2020;58(3):217-219
9.Trends in Risk-Reducing Mastectomy and Risk-Reducing SalpingoOophorectomy in Korean Carriers of the BRCA1/2 Mutation
Sung Mi JUNG ; Jai Min RYU ; Hyung Seok PARK ; Ji Soo PARK ; Eunyoung KANG ; Seeyoun LEE ; Han-Byoel LEE ; Hyun Jo YOUN ; Tae-Kyung YOO ; Jisun KIM ; Jeong Eon LEE ; Sang Ah HAN ; Dongwon KIM ; Sung-Won KIM ;
Journal of Breast Cancer 2020;23(6):647-655
Purpose:
BRCA1/2 mutations are associated with risks of breast and ovarian cancer. In Korea, incidences of BRCA1/2 genetic testing and risk-reducing surgery (RRS) have increased with insurance coverage and the Angelina Jolie effect. The aim of this study was to identify trends in RRS performed in Korean women with the BRCA1/2 mutation.
Methods:
We retrospectively reviewed the medical records of BRCA1/2 mutation carriers with (affected carriers) and without (unaffected carriers) breast cancer until August 2018 from 25 Korean Hereditary Breast Cancer (KOHBRA)-affiliated hospitals.
Results:
The numbers of contralateral risk-reducing mastectomy (RRM) and risk-reducing bilateral salpingo-oophorectomy (RRBSO) in affected carriers have increased 5.8- and 3.6-fold, respectively, since 2013. The numbers of RRBSO in unaffected carriers has increased 8-fold since 2013. The number of institutions that perform RRS has increased gradually. The number of hospitals that perform contralateral RRM on affected carriers increased from 3 in 2012 to 11 in 2018, and that of those that perform RRBSO increased from 7 to 17. The number of hospitals that perform bilateral RRM on unaffected carriers increased from 1 in 2012 to 2 in 2018, and that of those that perform RRBSO increased from 1 to 8. However, the hospitals showed differences in the rates of RRM or RRBSO performed.
Conclusion
The incidence of RRS increased each year throughout the study period. However, in Korea, the rate of RRS procedures depended on the hospital.
10.The Revised Korean Practice Parameter for the Treatment of Attention-Deficit Hyperactivity Disorder (I): Clinical Presentation and Comorbidity.
Eun Jin KIM ; Yunsin KIM ; Wan Seok SEO ; So Hee LEE ; Eun Jin PARK ; Seung Min BAE ; Dongwon SHIN
Journal of the Korean Academy of Child and Adolescent Psychiatry 2017;28(2):46-57
Attention-deficit hyperactivity disorder (ADHD) is a common psychiatric disorder that can affect individuals across their lifespan. It is characterized by the core symptoms of inattention, impulsivity and hyperactivity. ADHD develops as a result of the complex interplay between genetic and environmental factors. Children and adults with ADHD usually suffer concomitantly from other psychiatric comorbidities, including both externalizing and internalizing disorders. It is associated with functional impairment and poor long-term outcomes. This review aims to summarize the key findings from recent research into ADHD and its prevalence, core symptoms, cause and comorbidities from childhood to adulthood.
Adult
;
Child
;
Comorbidity*
;
Humans
;
Impulsive Behavior
;
Prevalence

Result Analysis
Print
Save
E-mail