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Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 7/2017 (581-587)

Trends in the prescribing of atypical antipsychotics in elderly patients with dementia in Korea 

Namjoo Seo*, Inmyung Song*, Hyekyung Park, Dongmun Ha, Ju-Young Shin 

School of Pharmacy, Sungkyunkwan University, Suwon, Korea
Objective: In 2005, the Food and Drug Administration warned that atypical antipsychotics (AAPs) increased mortality in elderly patients with dementia. We investigated AAP prescribing in elderly patients with dementia in the ambulatory setting in Korea and the factors affecting AAP prescribing in elderly patients with dementia. Methods: Subjects ≥ 65 years of age with at least one diagnosis of dementia (ICD-10: F00-F03, G30, G31.8) from January 1 to December 31, 2013 were identified from a health insurance database. Using multiple logistic regression analysis to estimate adjusted odds ratios (ORs) with 95% confidence intervals (CIs) for AAP prescribing in elderly patients with dementia, AAP user prevalence was estimated and presented by dementia type, individual AAP, medical institution, and region. Results: A total of 61,550 elderly patients with dementia were identified: 6,504 (9.8%) received AAPs, 12.3% of them had Alzheimer’s disease; only 2 patients with vascular dementia were prescribed AAPs (0.04%). Female patients were less likely to be prescribed AAPs than male patients. The likelihood of AAP prescribing was higher for patients aged 70 years and older than for those < 70 years. AAP prescribing was higher for patients visiting secondary care institutions (OR, 1.12; 95% CI, 1.65 – 1.74) than for those visiting primary care institutions, and for patients in cities (OR, 1.57; 95% CI, 1.52 – 1.62) than for those in metropolitan regions. Conclusions: Although the prevalence of AAP prescribing has decreased, especially among patients with vascular dementia, it remains high. Efforts to reduce AAP use should focus on secondary care institutions in nonmetropolitan regions. 

*Co first authorsCorrespondence to:
Ju-Young Shin, PhD, School of Pharmacy, Sungkyunkwan University 2066 Seobu-ro, Jangan-gu, Suwon, Gyeong gi-do, South Korea 
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 6/2017 (472-479)

Real-world prescribing patterns of long-acting benzodiazepines for elderly Koreans in 2013 

So Yun Park¹, SeungJin Bae¹, Ju-Young Shin² 

¹College of Pharmacy, Ewha Womans University, Seoul, and ²School of Pharmacy, Sungkyunkwan University, Suwon, South Korea
Objective: We aimed to estimate the prevalence of prescriptions to long-acting benzodiazepines (BZDs) among elderly outpatients in Korea in 2013 and analyze the factors that led to inappropriate prescription practices. Methods: Using the Korea Health Insurance Review and Assessment Service-National Patients Sample database in 2013, we estimated the pattern of BZD prescription among elderly outpatients. BZDs were categorized as long-acting (half-life (T_1/2) ≥ 20 hours) or short-acting (T_1/2 < 20 hours). In addition, we investigated the pattern of BZD prescription for populations defined according to patient, healthcare provider, and geographic characteristics. Multivariate logistic regression analysis was performed to estimate odds ratios and 95% confidence intervals and identify predictors of long-acting BZD use. Results: Overall, 58,056 elderly patients (38,910 females, 67%) received at least 1 BZD prescription. The total number of BZD prescriptions was 78,843, of which long-acting BZD prescriptions accounted for 44.7%. Diazepam was the most frequently prescribed BZD (39.7%). Long-acting BZDs were most frequently prescribed in the primary-care setting and were relatively frequently prescribed in rural areas. Of the patients prescribed long-acting BZDs, 435 (3.5%) had chronic obstructive pulmonary disease. Long-acting BZD use varied across different medical institutions (p < 0.05). Conclusions: A decrease in long-acting BZD use was identified relative to data from previous studies. However, BZDs continued to be used, and their use should be further limited in the primary-care setting and in rural areas. The results of this study may provide fundamental data for further review of BZD utilization. Correspondence to:
SeungJin Bae
Associate Professor
College of Pharmacy, Ewha Womans University 
52 Ewhayeodae-gil, Seodaemun-gu, Seoul 03760, South Korea

or

Ju-Young Shin
Assistant Professor, School of Pharmacy,
Sungkyunkwan University
2066 Seobu-ro, Jangan-gu,
Suwon, Gyeong gi-do, South Korea
Email: [email protected] or [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 6/2017 (480-482)

Benzodiazepine prescribing in the elderly in Germany and Korea: A comparison of two observational studies 

Barry Woodcock¹, Karel Kostev², Ju-Young Shin³ 

¹Dustri Medical Science Publications, Rockledge, FL, USA,  ²IMS Health, Epidemiology, Frankfurt, Germany, and  ³School of Pharmacy, Sungkyunkwan University, Suwon, Korea
Objectives: To identify differences and similarities in benzodiazepine (BZD) prescribing patterns in elderly patients reported in two separate and independent investigations, one from Germany for the year 2014 and the other from Korea for the year 2013. Methods: Data on patients over 65 years, who were prescribed at least one BZD, were obtained from population databases. The design and characteristics of the two studies were similar. Results: The use of BZDs in the elderly in Korea was several-fold higher than in Germany depending on the age stratification. Sleep disorders and depression were less common indications for BZDs in Korea. The use of long-acting BZDs in both countries was higher in patients attending general practitioners compared to specialized hospital departments and clinics. In Korea, diazepam was the most commonly used BZD in general practice. In Germany, lorazepam was the most commonly used BZD both in general practice and neuropsychiatric clinics. Conclusions: The results of this comparison show that a reduction in the use of BZDs in the elderly in Korea may be possible and that in Germany, in some instances, these drugs may be under-used in this patient group. This cross-national comparison may help to reduce inappropriate use of BZD medication and improve prescribing in the elderly but this would have to be the subjects of a more detailed analysis. Correspondence to:
Prof. Barry G. Woodcock, PO 20 02 32, 63308 Rödermark, Germany
Email: woodcock@ clinpharmacol.com

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 10/2017 (781-788)

Comparison of first- and second-generation antihistamine prescribing in elderly outpatients: A health insurance database study in 2013

Young-Mi Lee*, Inmyung Song*, Eui-Kyung Lee, and Ju-Young Shin

School of Pharmacy, Sungkyunkwan University, Suwon, Korea
Background: This descriptive study analyzed the scale of first- and second-generation antihistamine prescription in elderly outpatients in Korea and the characteristics associated with this prescription. Materials and methods: We conducted a drug utilization study using the Korea Health Insurance Review and Assessment Service-Aged Patient Sample (HIRA-APS) database from January 1 to December 31, 2013. The study subjects were elderly outpatients aged 65 years and older who were prescribed antihistamines. The study drugs included 6 first-generation and 16 second-generation antihistamines. The prescription pattern of first-generation antihistamines was based on region, diagnosis, and clinical specialty. Multivariate logistic regression analysis was used to determine the factors associated with first-generation antihistamine prescription. Odds ratios (ORs) with 95% confidence interval (CI) were calculated. Results: A total of 1,152,556 elderly outpatients were identified as having visited various medical facilities in 2013, of which 23.4% received at least one prescription for first-generation antihistamine monotherapy. First-generation antihistamines were more likely to be prescribed in secondary care hospitals (OR = 1.74; 95% CI 1.69 – 1.78) than in tertiary care hospitals, and in urban areas (OR = 1.21; 95% CI 1.20 – 1.21) than in the Seoul metropolitan area. First-generation antihistamines were also more likely to be prescribed for treating the common cold (OR = 1.06; 95% CI 1.05 – 1.06) than any other disease. Conclusion: A large proportion (23.4%) of elderly outpatients in Korea received prescriptions for first-generation antihistamines. Efforts to reduce prescriptions of first-generation antihistamines are recommended, especially prescriptions associated with common cold diagnosis in secondary care hospitals and in urban areas. 

*Co-first authorCorrespondence to:
Ju-Young Shin, PhD,
School of Pharmacy, Sungkyunkwan University
2066 Seobu-ro, Jangan-gu, Suwon,
Gyeong gi-do, South Korea 
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 5/2018 (224-230)

Prevalence and predictors of tricyclic antidepressant use among elderly Koreans in primary-care and specialty clinics

Jung Eun Hwang*, Inmyung Song*, Eui-Kyung Lee, Dongmun Ha, and Ju-Young Shin

School of Pharmacy, Sungkyunkwan University, Jangan-gu, Suwon, Gyeonggi-do, South Korea
Objectives: Tricyclic antidepressants (TCAs) are prescribed with caution in the elderly due to diverse side effects. We analyzed the patterns of TCA use in elderly patients in primary-care and specialty clinics and investigated factors influencing TCA prescriptions. Materials and methods: Elderly patients (≥ 65 years old) prescribed antidepressants in primary-care clinics in 2013 were included from the Health Insurance Review and Assessment Service-Aged Patient Sample (HIRA-APS). Prevalence of TCA prescriptions was assessed by insurance coverage status, clinical specialty, and region. Multiple logistic regression analysis was performed to compute odds ratios (ORs) and 95% confidence intervals (CIs) for factors associated with TCA prescriptions. Results: TCAs and selective serotonin reuptake inhibitors (SSRIs) comprised 45.2% and 15.0% of all antidepressant prescriptions, respectively. TCAs comprised 61.5% and 20.7% of antidepressant prescriptions for pain and depression, respectively. Patients aged ≥ 85 years were less likely to be treated with TCAs (OR 0.81, 95% CI 0.79 – 0.84) than those aged 65 – 69 years. The odds for being prescribed TCAs were higher for patients residing in cities (OR 1.20, 95% CI 1.18 – 1.23), treated in nonpsychiatric clinics (OR 5.64, 95% CI 5.53 – 5.76), and those covered by Veteran’s Health (OR 1.62, 95% CI 1.37 – 1.90) when compared to patients residing in the Seoul metropolitan area, treated in psychiatric clinics, or covered by National Health Insurance, respectively. The prescriptions of TCAs with pain diagnoses were much higher than prescriptions for depression (OR 1.87, 95% CI 1.82 – 1.93). Conclusions: Compared with a 2005 report, the prevalence of TCA prescriptions in elderly patients in Korea has decreased substantially, but remains high. Various efforts should be considered to reduce TCA prescriptions in the elderly. 

*Co-first authorsCorrespondence to:
Ju-Young Shin, PhD
School of Pharmacy, Sungkyunkwan University
2066 Seobu-ro, Jangan-gu, Suwon,
Gyeonggi-do, South Korea 
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 57 – No. 2/2019 (73-81)

Association between use of antiemetics, antipsychotics, or antidepressants and the risk of Parkinson’s disease 

Ju-Young Shin¹, Ha-Lim Jeon¹, Han Eol Jeong¹, Hyeo-Il Ma², and Sunmee Jang³

¹School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, ²Department of Neurology, College of Medicine, Hallym University, Anyang, Gyeonggi-do, and ³College of Pharmacy and Gachon Institute of Pharmaceutical Sciences, Gachon University, Incheon, South Korea
Objective: Antipsychotics, antidepressants, and antiemetics are well-known causative agents of parkinsonism. However, it is not certain that the use of these medications increases the risk of Parkinson’s disease (PD). We aim to define the risk of PD associated with use of antipsychotic, antidepressant, or antiemetic therapy. Materials and methods: We conducted a population-based nested case-control study using data from the South Korean health insurance database. For each PD case, we randomly selected sex, age group, cohort entry date, duration of follow-up, and Charlson comorbidity score-matched controls (up to 3). Exposure was categorized into six groups based on treatments received 1 – 90 days before the index date (separate use of either: antiemetics; antipsychotics; or antidepressants; combined use of antiemetics with either: antipsychotics; or antidepressants; and combined use of all three). We used conditional logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for PD. Results: Final subjects included 31,428 cases and 94,284 matched controls. We observed an increased risk of PD with the separate use of antiemetics (adjusted OR, 1.08; 95% CI, 1.05 – 1.11) and that of antipsychotics (1.31; 1.12 – 1.52), and the combined use of antiemetics and antipsychotics (1.42; 1.15 – 1.75). Both antidepressants alone and with antipsychotics were not associated with higher risk of PD. Conclusions: Separate or concurrent use of antiemetics and antipsychotics showed increased risks of PD. Although statistical significance was observed, when taking into account that there still lie unmeasured, unconsidered confounders, there may be no clinical association present. Caution will be needed in prescribing these drugs in patients who have prognostic factors for PD.  Correspondence to:
Sunmee Jang, PhD
College of Pharmacy and Gachon Institute  of Pharmaceutical Sciences
Gachon University
191 Hambakmoero, Yeonsu-gu, Incheon, 13120, South Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 57 – No. 9/2019 (445-449)

The Zuellig Pharma Korea Consortium Database: An on-site drug wholesales database for pharmacoepidemiological studies using real-world data 

Han Eol Jeong¹*, In-Sun Oh¹*, Junqing Li¹, Erwan Vilfeu², Sang A Ryuu², and Ju-Young Shin¹

¹School of Pharmacy, Sungkyunkwan University, Gyeonggi-do, and ²Zuellig Pharma Korea LTD, Seoul, South Korea
Objective: To assess the value and representativeness of the Zuellig Pharma Korea Consortium (ZPK-C) database, which contains drug wholesales data collected in a weekly interval, for its prospective use as a data source for pharmacoepidemiology studies. Materials and methods: Wholesales and nationwide claims data of antidiabetic and antihypertensive products were compared in 17 administrative regions using the defined daily dose per 100,000 inhabitants per day (DID) and its proportion for standardized evaluation. Results: We found regional concordance in 12 and 13 regions (out of 17) for antidiabetic and antihypertensive products, respectively, of which concordance was higher in rural than metropolitan regions. Conclusion: The ZPK-C showed potential as a valuable data source for pharmacoepidemiology research.

*These authors contributed equally to this work.Correspondence to:
 Ju-Young Shin, PhD
School of Pharmacy, Sungkyunkwan University
2066, Seobu-ro, Jangan-gu, Suwon, Gyeonggi-do, 16419, South Korea 
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 57 – No. 10/2019 (489-499)

Comparison of signal detection between statin and statin/ezetimibe fixed-dose combination using the Korea Adverse Events Reporting System Database, 2005 – 2016 

Dongmun Ha*, Yeon-Ju Lee*, Yoonsoo Chun, and Ju-Young Shin

School of Pharmacy, Sungkyunkwan University, Gyeonggi-do, South Korea
Background and objectives: Statin/ezetimibe fixed-dose combination is often used as statin monotherapy; however, no study has analyzed its adverse effect (AE) signals. We comparatively analyzed the AE status of statin and statin/ezetimibe fixed-dose combination and compared the signal information using a 12-year AE reporting database.
Materials and methods: We used data from the Korea Adverse Events Reporting System database from 2005 to 2016. Drug-AE pairs corresponded to drugs and AEs for analysis of demographic characteristics, causality, number, and type of serious AEs. Metrics, including proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) were used to detect signals. Signals were compared with drug labels in the USA and Korea.
Results: Of the 4,569 AE cases identified, 4,130 and 442 were of statin and statin/ezetimibe fixed-dose combination, respectively. There were no statistically significant differences in AE report characterization for statin and the statin/ezetimibe fixed-dose combination. The number of AE signal detections for statin, statin/ezetimibe fixed-dose combination, and both, based on PRR and ROR, was 16, 4, and 2, respectively, and the number of cases not included on the label was 3, 2, and 0, respectively. The number of AE signals that only met IC indicators was greater in statin/ezetimibe fixed-dose combination (33) than in statin (4), and 12 of the 33 cases in statin/ezetimibe fixed-dose combination were not included on the drug label.
Conclusion: The combination of statin and ezetimibe exhibited greater AE signal detection than statin alone, and the inclusion of AEs on the drug label was insufficient.

*Co-first authors contributed equallyCorrespondence to:
 Ju-Young Shin, PhD
School of Pharmacy, Sungkyunkwan University
2066 Seobu-ro, Jangan-gu,
Suwon, Gyeonggi-do, South Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 59 – No. 3/2021 (224-230)

Disproportionality analysis of spontaneously reported hypoglycemia events due to insulin use: A comparison between insulin detemir and insulin degludec using the Korea Adverse Event Reporting System 

DaWo Jeong*, Won Kim*, and Ju-Young Shin

School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, Republic of Korea
Objective: This study aimed to compare the rate of hypoglycemic events from all spontaneously reported adverse events (AEs) between insulin detemir and insulin degludec using the Korea Adverse Event Reporting System (KAERS) database.
Materials and methods: We analyzed data on the reported hypoglycemia events retrieved from adverse drug reactions (ADR) on the use of different insulin types from 2016 to 2017 in the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD). After defining hypoglycemic events as the AE of interest, we performed a disproportionality analysis by calculating the reporting odds ratio (ROR) to identify the disproportionality of AEs following treatment with insulin degludec (IDeg) and insulin detemir (IDet). Because spontaneously reported hypoglycemic events were not distinguished between insulin glargine 100 U/mL (Gla-100) and insulin glargine 300 U/mL (Gla-300) due to same ATC code by KIDS-KD, direct comparisons of Gla-100 and Gla-300 or comparisons of each analog of insulin glargine vs. IDet or IDeg, respectively, could not be achieved.
Results: Of the 3,220 AEs caused by the use of long-acting basal insulin, 739 and 296 were caused by IDeg and IDet, respectively. Among these, 172 (23.3%) of the 739 and 83 (28.0%) of the 296 AEs were reported to be hypoglycemic events caused by IDeg and IDet, respectively. The rate of reported hypoglycemic events caused by IDeg was lower than that of IDet (ROR (95% CI): 0.78 (0.71 – 0.86)). Further, IDeg consistently caused lower hypoglycemia events than IDet in the sensitivity analysis (ROR (95% CI): 0.41 (0.37 – 0.46)).
Conclusion: When we compared the proportionality of hypoglycemic events among the total number of reported AEs for each of the two basal insulins through disproportionality analysis using the spontaneous ADR reporting system, IDeg showed a relatively lower rate of reported hypoglycemic events than IDet.

*DaWo Jeong and Won Kim contributed equally to the manuscript.Correspondence to:
Ju-Young Shin, PhD
 School of Pharmacy, Sungkyunkwan University
2066, Seobu-ro, Jangan-gu, Suwon,
Gyeonggi-do, 16419, South Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 59 – No. 5/2021 (386-397)

Signal detection of botulinum toxin type A (BoNT/A) using the Korea Adverse Event Reporting System Database, 1999 – 2016 

Sang-Eun Lee*, Seon Hee Lee*, and Ju-Young Shin

School of Pharmacy, Sungkyunkwan University, Suwon, South Korea
Objective: To detect signals of potential adverse events (AEs) after botulinum toxin (BTX) treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD).
Materials and methods: The individual case safety reports (ICSRs) submitted to KIDS-KD from 1999 to 2016 were analyzed. To detect safety signals, disproportionality analysis was introduced, and the three indices (proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC)) were calculated based on the reported preferred terms (WHO-ART, preferred term (PT)). The signals detected were compared with drug labels from Korea and the USA.
Results: A total of 5,896 AE reports were collected in January 1999 – December 2016 in the Korea Adverse Event Reporting System (KAERS) databases. Among the total of 103,785 drug-AE pairs, 1,413 were attributed to BTX. The disproportionality analysis produced 44 PTs as safety signals and detected 7 unlabeled PTs that were not listed on the labels. After matching for age and sex (1 : 2), the adjusted ROR of ineffective medicine and depression in BTX was 21.60 (95% confidence interval (CI), 19.12 – 24.41) and 6.02 (95% CI, 3.41 – 10.64) respectively.
Conclusion: The number of AE reports after BTX has increased, the majority of which were from females. Safety signals such as “medicine ineffective” and “concentration impaired” may be due to increasing off-label use, which warrants long-term surveillance, especially among females after BTX injection. 

*Both authors contributed equally as first authorsCorrespondence to:
Ju-Young Shin, PhD 
School of Pharmacy, Sungkyunkwan University
2066 Seobu-ro, Jangan-gu, Suwon,
Gyeonggi-do, South Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 59 – No. 10/2021 (639-644)

Utilization of targeted disease-modifying anti-rheumatic drugs (DMARDs) for managing rheumatoid arthritis in the last decade:  A two-country comparison 

So-Hee Park¹, Ha-Lim Jeon¹, Seoyoung C. Kim²#³, Jodie Hillen⁵, Svetla Gadzhanova⁵, Ju-Young Shin¹#⁴, and Nicole Pratt⁵

¹School of Pharmacy, Sungkyunkwan University, Suwon, Republic of Korea, ²Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, ³Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, ⁴Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Republic of Korea, and ⁵Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia
Objective: To compare trends in the use of targeted disease-modifying anti-rheumatic drugs (DMARDs) for rheumatoid arthritis (RA), between Korea and Australia.
Materials and methods: Using sampled claims databases in Korea and Australia (2010 – 2018), we analyzed the trends in the use of individual targeted DMARDs (biologic and targeted synthetic) for RA in both countries.
Results: The use of targeted DMARDs for the management of RA showed an increase of over 200 and 300% in Australia and Korea, respectively. The tumor necrosis factor inhibitors (TNFis) etanercept and adalimumab were the most commonly prescribed drugs in 2010 in both countries, with non-TNFi use increasing over the study period. The introduction of tofacitinib in 2015 led to 10 and 15% market share uptake in Korea and Australia, respectively.
Conclusion: Trends in the use of targeted DMARDs for RA were similar in Korea and Australia, and the use of non-TNFis, including tofacitinib, increased in both countries.Correspondence to:
 Ju-Young Shin, PhD, Associate Professor
 School of Pharmacy, Sungkyunkwan University
2066 Seobu-ro, Jangan-gu, Suwon,
Gyeonggi-do 16419, Republic of Korea  
or
 Nicole Pratt, PhD, Associate Professor 
Quality Use of Medicines and Pharmacy Research Centre
School of Pharmacy and Medical Sciences
University of South Australia
Adelaide, South Australia, Australia
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 62 – No. 11/2024 (534-537)

Comparison of uric acid elevation between aspirin-ticagrelor and aspirin-clopidogrel during dual antiplatelet therapy 

Sojin Park¹#², Sangah Chi³, Jeong Hoon Yang⁴, Myungsook Min², and Ju-Young Shin¹,⁵,⁶

¹School of Pharmacy, Sungkyunkwan University, Suwon, ²Department of Pharmaceutical Services, ³Biomedical Statistics Center, ⁴Division of Cardiology, Department of Critical Care Medicine and Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gangnam-gu, Seoul, ⁵Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, and ⁶Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul, South Korea
Objective: This study investigated whether serum uric acid levels are more elevated in the aspirin-ticagrelor group than in the aspirin-clopidogrel group. Materials and
Materials and methods: We conducted a retrospective cohort study with patients between 2013 and 2020. Baseline and maximum serum uric acid levels within a 6-month follow-up period were analyzed to determine the increase in both groups.
Results: A total of 41,877 patients were enrolled. A statistically significant elevation of serum uric acid levels was found in the aspirin-ticagrelor group compared to the aspirin-clopidogrel group (odds ratio (OR; 95% confidence interval (CI)) = 1.36 (1.15 – 1.60), p < 0.001). Kidney dysfunction and diuretic use were also identified as risk factors for uric acid elevation.
Conclusion: Monitoring serum uric acid levels is recommended during aspirin-ticagrelor therapy, especially in patients with kidney dysfunction or those using diuretics.Correspondence to:
Professor Ju-Young Shin, PhD
School of Pharmacy, Sungkyunkwan University
2066, Seobu-ro, Jangan-gu, Suwon,
Gyeonggi-do 16419, South Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 63 – No. 1/2025 (21-29)

The association between alphablockers in the treatment of benign prostatic hyperplasia and heart failure: A nationwide population-based cohort study in South Korea

Ji-Young Jeong¹, Mu Kyung Kim¹, and Ju-Young Shin¹#²#³

¹School of Pharmacy, ²Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, and ³Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences and Technology (SAIHST), Sungkyunkwan University, Seoul, South Korea
Background and objectives: This study aimed to determine whether there is an association between the use of α-blockers to treat benign prostatic hyperplasia (BPH) and the development of heart failure in elderly Asian patients.
Materials and methods: An Elderly Cohort Database of the National Health Insurance Service was used to select 22,540 patients with newly diagnosed BPH between January 1, 2008, and December 31, 2018. They were divided into two equal groups, one prescribed α-blockers and one not. They were followed up through December 31, 2019. Cox proportional hazards models were used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) for the occurrence of heart failure with α-blockers. In addition, α-blockers were categorized according to α1a receptor selectivity to estimate the hazard ratios for heart failure.
Results: Heart failure occurred in 283 patients in the non-user group and 74 patients in the α-blocker group, with an incidence rate of 553.4 in the non-user group and 516.8 in the α-blocker group per 100,000 person-years. Although α-blocker users had a higher hazard ratio for heart failure compared to the non-user group, this was not statistically significant (HR: α-blocker HR 1.14, 95% CI 0.87 – 1.491). Furthermore, when α-blockers were stratified by selectivity, the results were also not statistically significant (non-selective α-blocker HR 0.86, 95% CI 0.31 – 2.36).
Conclusion: In this nationwide, population-based cohort study, treatment with α-blockers was not associated with the incidence of heart failure in patients with BPH.Correspondence to:
Ju-Young Shin, PhD, Associate Professor
School of Pharmacy, Sungkyunkwan University
2066, Seobu-ro, Jangan-gu,
Suwon, Gyeonggi-do 16419 South Korea
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 63 – No. 4/2025 (160-163)

Cardiovascular safety profile of JAK inhibitors and ethnic factors in Asians: A signal detection study using the Global ICSR (WHO-UMC VigBase) database 

Woongshik Nam¹#², Ji-Hwan Bae¹, Jeongin Oh¹, Ju-Young Shin¹#³#⁴, and Hoon Kim¹#³#⁵

¹School of Pharmacy, Sungkyunkwan University, Suwon-si, ²Korea Institute of Drug Safety and Risk Management, Dongan-gu, Anyang-si, ³Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon-si, Gyeonggi-do, ⁴Department of Clinical Research Design & Evaluation, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Gangnam-gu, Seoul, and ⁵Department of Biopharmaceutical Convergence, Sungkyunkwan University, Suwon-si, Gyeonggi-do, Republic of Korea
Objective: This study aimed to detect cardiovascular disease-related signals using Global Individual Case Safety Report data on JAK inhibitors.
Materials and methods: A signal detection study was conducted using the WHO-UMC VigiBase.
Results: This study identified four cardiovascular adverse event signals associated with JAK inhibitors in Asian populations, including pulmonary embolism, deep vein thrombosis, thrombosis, and cerebrovascular accidents.
Conclusion: Analysis of Asian populations revealed a higher risk of thromboembolic events associated with JAK inhibitors than with TNF inhibitors. However, unlike in the Western populations, no myocardial infarction signal was detected in the Asian populations.Correspondence to:
Hoon Kim, PhD, Associate Professor
or
Ju-Young Shin, PhD, Associate Professor
School of Pharmacy
Sungkyunkwan University
2066, Seobu-ro, Jangan-gu, Suwon,
Gyeonggi-do 16419, South Korea
Email: [email protected]; [email protected]

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