Korea Institute of Drug Safety and Risk Management

Seoul, South Korea

Korea Institute of Drug Safety and Risk Management

Seoul, South Korea

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Choi N.-K.,Seoul National University | Lee J.,Seoul National University | Chang Y.,Sungkyunkwan University | Kim Y.-J.,Seoul National University | And 8 more authors.
Endoscopy | Year: 2014

Background and study aims: Oral sodium phosphate (OSP) is a cleansing agent for colonoscopy. Recent reports have cited an increased risk of acute renal failure (ARF) in OSP bowel purgative users, but this risk remains under debate. This study was performed to evaluate the association between OSP and ARF in patients who underwent colonoscopy. Patients and methods: A population-based case-crossover study was conducted using the Korean Health Insurance Review and Assessment Service (HIRA) claims data from 1 January 2005 to 31 December 2009. The study population consisted of patients aged ≥ 50 years who underwent colonoscopies after an OSP prescription prior to their first hospitalization for ARF. For each patient, one hazard and four control periods were matched at specified time windows. Conditional logistic regression analysis was used to estimate the odds ratio (OR) and 95 % confidence interval (CI), adjusting for concomitant medications that could induce ARF. Results: A total of 1105 patients were included (54 % male). The adjusted ORs for ARF related to the use of OSP when applying the 1-, 2-, 4-, 8-, or 12-week time windows were 3.7 (95 %CI 2.37 - 5.67), 3.5 (95 %CI 2.45 - 4.89), 3.0 (95 %CI 2.30 - 3.95), 2.4 (95 %CI 1.93 - 2.96), and 2.0 (95 %CI 1.69 - 2.46), respectively. When adopting an 8-week time window, the adjusted OR was 2.5 (95 %CI 1.98 - 3.16) for the subgroup without chronic renal failure. Conclusions: The use of OSP was significantly associated with ARF both in patients with and without co-morbidities. © Georg Thieme Verlag KG Stuttgart · New York.

Shin J.-Y.,Korea Institute of Drug Safety and Risk Management | Park M.-J.,Korea Institute of Drug Safety and Risk Management | Lee S.H.,Korea Institute of Drug Safety and Risk Management | Choi S.-H.,Korea Institute of Drug Safety and Risk Management | And 4 more authors.
BMJ (Online) | Year: 2015

OBJECTIVE: To define the risk of intracranial haemorrhage among patients treated with antidepressants and non-steroid anti-inflammatory drugs (NSAIDs), compared with the risk among those treated with antidepressants without NSAIDs. DESIGN: Retrospective nationwide propensity score matched cohort study. SETTING: Korean nationwide health insurance database between 1 January 2009 and 31 December 2013. PARTICIPANTS: Patients who began receiving antidepressants for the first time (index date) without a history of having received a prescription for antidepressants during the preceding year. Patients who had been diagnosed as having cerebrovascular diseases within a year before the index date were excluded. MAIN OUTCOME MEASURE: Time to first hospital admission with intracranial haemorrhage within 30 days after drug use. Matched Cox regression models were used to compare the risk of intracranial haemorrhage among patients who were treated with antidepressants with and without NSAIDs, after propensity score matching with a 1:1 ratio. RESULTS: After propensity score estimation and matching in a 1:1 ratio, the cohort used in the analysis included 4 145 226 people. The 30 day risk of intracranial haemorrhage during the entire study period was higher for combined use of antidepressants and NSAIDs than for use of antidepressants without NSAIDs (hazard ratio 1.6, 95% confidence interval 1.32 to 1.85). No statistically meaningful differences were found in risk of intracranial haemorrhage between the antidepressant drug classes. CONCLUSIONS: Combined use of antidepressants and NSAIDs was associated with an increased risk of intracranial haemorrhage within 30 days of initial combination.

Kim J.,Seoul National University | Lee J.,Seoul National University | Shin J.-Y.,Korea Institute of Drug Safety and Risk Management | Park B.-J.,Seoul National University
Journal of Preventive Medicine and Public Health | Year: 2015

Objectives: The present study was conducted in order to examine the association between socioeconomic status (SES) and osteoporosis prevalence in Korea and to assess whether different associations are found in single-person households. Methods: A cross-sectional population-based study was conducted using the Korea National Health and Nutrition Examination Survey, from 2008 to 2011. The study subjects were people aged ≥ 50 years with osteoporosis as defined by bone mineral density. Multivariate logistic models were used to estimate prevalence odds ratios (pORs) and 95% confidence intervals (CIs). Gender differences in the likelihood of osteoporosis were analyzed based on household income, education level, and residential area. Results: There were 8221 osteoporosis patients aged ≥ 50 years, of whom 927 lived in single-person households. There was a gender-specific association between osteoporosis prevalence and all three SES factors that we analyzed: income, education, and residential area. After adjusting for age, SES, and health behaviors, including body mass index (BMI), low household income was only significantly associated with osteoporosis in men, whereas education level had an inverse relationship with osteoporosis only in women (p= 0.01, p<0.001, respectively). However, after controlling for age and BMI, rural residency was only associated with osteoporosis in women living in single-person households (pOR, 1.59; 95% CI, 1.05 to 2.43). Conclusions: The Korean adult population showed a gender-specific relationship between SES and osteoporosis prevalence, with a different pattern found in single-person households. Copyright © 2015 The Korean Society for Preventive Medicine.

Song H.J.,Hallym University | Lee J.,Seoul National University | Kim Y.-J.,Seoul National University | Jung S.-Y.,Korea Institute of Drug Safety and Risk Management | And 4 more authors.
Bone | Year: 2012

Introduction: Hypertension and osteoporosis are prevalent in the elderly population. Treatments beneficial to both conditions would be helpful. We examined the protective effect of β-blockers (BBs) and their receptor selectivity against fractures compared to other antihypertensives. Materials and methods: A retrospective cohort was assembled using the Korean Health Insurance Review and Assessment Service database from January 2005 to June 2006. The cohort consisted of 501,924 patients (ages 65 and older) on single-drug therapy for hypertension. Participants were followed to either the date of the first fracture, date of death or end of the study period (30 June 2006), whichever came first. Cox's proportional hazard model was used to calculate the adjusted hazard ratio (aHR) and 95% confidence interval (CI) by sex, adjusting for confounders. Risk of fractures by BBs according to β1 selectivity was compared to non BBs measured in aHR. Results: Among 501,924 (65% female), the incidence density of fractures in non BB users was 29.3 and 48.2 per 1000 person-years for men and women, respectively, which was higher than in BB users (17.2 for men and 30.5 for women). Compared to BB users, non BB users showed an increased risk of all fracture [aHR 1.56 (95% CI, 1.42-1.72) in men and 1.44 (95% CI, 1.36-1.51) in women] and hip fracture [aHR 2.17 (95% CI 1.45-3.24) in men and 1.61 (95% CI 1.31-1.98) in women] after adjusting for confounding variables. Compared to BBs, the risks of all fractures in α-blockers, calcium channel blockers, diuretics, and renin-angiotensin-aldosterone system blockers were significantly higher (1.72, 1.77, 1.58, 1.29 in men; 2.11, 1.50, 1.46, 1.22 in women, respectively). Compared to non BBs, β1 selective BBs showed a lower risk of fracture (39% for men and 33% for women) after adjusting for confounding factors. On the contrary, non-selective BBs were not protective against fracture. Conclusion: Our results suggested that β1 selective BBs reduce the risk of fractures compared to other classes of antihypertensives in an elderly population, which could have practical applications for strategies to control and prevent adverse outcomes from both hypertension and osteoporosis in this population. © 2012 Elsevier Inc.

Park S.J.,Seoul National University | Choi N.-K.,Seoul National University | Yang B.R.,Seoul National University | Park K.H.,Seoul National University | And 3 more authors.
Ophthalmology | Year: 2015

PURPOSE: To investigate the risk of stroke and acute myocardial infarction (AMI) in patients with incident central retinal artery occlusion (CRAO).DESIGN: A self-controlled case series (SCCS) study.PARTICIPANTS: Patients with incident CRAO from the entire Korean population of 48 million individuals.METHODS: We used the Korean national claim database (2007-2011) for analyses. After identifying patients with incident CRAO, the relative incidence rate ratios (IRRs) for stroke and AMI in risk periods were measured in these patients using a SCCS method.MAIN OUTCOME MEASURES: The IRRs of stroke and AMI by risk periods.RESULTS: Of 1655 patients with incident CRAO in 2009-2010, 165 had stroke/AMI (ischemic stroke in 139, hemorrhagic stroke in 13, and AMI in 15) in the observation period spanning 365 days before and after the occurrence of CRAO. The IRR of stroke/AMI 1 to 30 days after CRAO occurrence significantly increased (14.0; 95% confidence interval [CI], 8.90-22.00); the IRR peaked during the 1 to 7 days after CRAO occurrence (44.51; 95% CI, 27.07-73.20), and the increased risk was present for the first 30 days. The IRR of stroke/AMI also significantly increased 1 to 30 days (6.82; 95% CI, 4.01-11.60) and 31 to 90 days (2.86; 95% CI, 1.66-4.93) before CRAO occurrence. Subanalysis for only ischemic stroke showed similar, magnified IRRs in the risk periods compared with all events. The IRRs were not significantly different between sexes or age groups (<65 vs. ≥65 years).CONCLUSIONS: Patients with incident CRAO are at increased risk of ischemic stroke just after CRAO occurrence, and the risk is particularly increased during the first week immediately after the CRAO occurrence. The results suggest that patients with incident CRAO require immediate neurologic evaluation and preventive treatment to reduce mortality and morbidity. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Shin J.-Y.,Korea Institute of Drug Safety and Risk Management | Choi N.-K.,Seoul National University | Lee J.,Seoul National University | Park M.-J.,Korea Institute of Drug Safety and Risk Management | And 3 more authors.
Journal of Psychopharmacology | Year: 2015

Objective: With an increase in antipsychotic use in the elderly, the safety profile of antipsychotics has been emphasized. Strong concerns have been raised about whether the risk of ischemic stroke differs between risperidone and haloperidol. This study compared the risk of ischemic stroke between elderly patients taking risperidone and haloperidol. Method: We conducted a retrospective cohort study using the Korea Health Insurance Review and Assessment Service database, applying a propensitymatched analysis. The cohort consisted of elderly patients who were newly prescribed haloperidol or risperidone between January 1, 2006 and December 31, 2009. Patients with prior cerebrovascular diseases (ICD-10, I60-I69), transient ischemic attack (ICD-10, G45), or cerebral tumors (ICD- 10, C31) during 365 days prior to the initiation date were excluded. The study subjects were selected by propensity score matching. The outcome was defined as the first hospitalization for ischemic stroke (ICD-10, I63). Cox regression models were used to estimate the hazard ratio (HR) and 95% confidence intervals (95% CI) for ischemic stroke with haloperidol compared with risperidone use. Results: A total of 14,103 patients were included in the propensity-matched cohort for each drug. Overall, the incidence rate was higher for haloperidol users compared to the risperidone users (6.43 per 1000 person-years vs. 2.88 per 1000 person-years). A substantially increased risk was observed in haloperidol users (adjusted HR = 2.02, 95% CI, 1.12-3.62). Conclusions: The evidence showed that haloperidol should be prescribed in the elderly with caution. © British Association for Psychopharmacology.

Kang Y.A.,Yonsei University | Choi N.-K.,Seoul National University | Seong J.-M.,Korea Institute of Drug Safety and Risk Management | Heo E.Y.,Seoul National University | And 5 more authors.
International Journal of Tuberculosis and Lung Disease | Year: 2014

OBJECTIVE: To evaluate whether statin use affects the development of tuberculosis (TB) among patients with diabetes mellitus (DM). METHODS: This is a retrospective cohort study of patients with newly diagnosed type 2 DM based on the South Korean nationwide claims database. The participants were type 2 DM patients aged 20-99 years who were newly treated with anti-diabetic drugs between 1 January 2007 and 31 December 2010. Patients who had statin prescriptions before a diagnosis of diabetes or were diagnosed with TB before diabetes were excluded. RESULTS: Of 840 899 newly diagnosed type 2 DM patients, 281 842 (33.5%) patients were statin users and 559 057 (66.5%) were non-users. During the study period, 4052 individuals were diagnosed with TB; the estimated incidence of TB in our cohort was 251/100 000 patient-years (95%CI 243-258). In comparison to non-TB patients, statin users were less frequent among TB patients (19.2% vs. 33.6%). After adjustment for potential baseline confounders, statin use was not associated with the development of TB in DM patients (aHR 0.98; 95%CI 0.89-1.07). CONCLUSIONS: TB development among newly diagnosed type 2 DM was considerable, and statin use among these diabetics was not associated with a protective effect on TB incidence. © 2014 The Union.

Kim J.-Y.,Seoul National University | Kim H.-J.,University of Ulsan | Jung S.-Y.,Korea Institute of Drug Safety and Risk Management | Kim K.-I.,Seoul National University | And 4 more authors.
BMC Cardiovascular Disorders | Year: 2012

Background: Chronic heart failure accounts for a great deal of the morbidity and mortality in the aging population. Evidence-based treatments include angiotensin-2 receptor blockers (ARBs), angiotensin-converting enzyme inhibitors (ACE-I), beta-blockers, and aldosterone antagonists. Underutilization of these treatments in heart failure patients were frequently reported, which could lead to increase morbidity and mortality. The aim of this study was to evaluate the utilization of evidence-based treatments and their related factors for elderly patients with chronic heart failure.Methods: This is retrospective observational study using the Korean National Health Insurance claims database. We identified prescription of evidence based treatment to elderly patients who had been hospitalized for chronic heart failure between January 1, 2005, and June 30, 2006.Results: Among the 28,922 elderly patients with chronic heart failure, beta-blockers were prescribed to 31.5%, and ACE-I or ARBs were prescribed to 54.7% of the total population. Multivariable logistic regression analyses revealed that the prescription from outpatient clinic (prevalent ratio, 4.02, 95% CI 3.31-4.72), specialty of the healthcare providers (prevalent ratio, 1.26, 95% CI, 1.12-1.54), residence in urban (prevalent ratio, 1.37, 95% CI, 1.23-1.52) and admission to tertiary hospital (prevalent ratio, 2.07, 95% CI, 1.85-2.31) were important factors associated with treatment underutilization. Patients not given evidence-based treatment were more likely to experience dementia, reside in rural areas, and have less-specialized healthcare providers and were less likely to have coexisting cardiovascular diseases or concomitant medications than patients in the evidence-based treatment group.Conclusions: Healthcare system factors, such as hospital type, healthcare provider factors, such as specialty, and patient factors, such as comorbid cardiovascular disease, systemic disease with concomitant medications, together influence the underutilization of evidence-based pharmacologic treatment for patients with heart failure. © 2012 Kim et al.; licensee BioMed Central Ltd.

Shin J.-Y.,Korea Institute of Drug Safety and Risk Management | Choi N.-K.,Seoul National University | Jung S.-Y.,Korea Institute of Drug Safety and Risk Management | Lee J.,Seoul National University | And 3 more authors.
Journal of Psychopharmacology | Year: 2013

We conducted a case-crossover study to evaluate the comparative risk of ischemic stroke associated with the use of risperidone, quetiapine and olanzapine in geriatric patients using the Korean Health Insurance Review and Assessment Service database. Cases included elderly patients >64 years old who had experienced their first ischemic stroke (International Classification of Disease, Tenth Revision (ICD-10), I63) hospitalization from July 2005 to June 2006 and who had been without prior cerebrovascular diseases (ICD-10, I60-I69), or transient ischemic attack (ICD-10, G45). Exposures to risperidone, quetiapine and olanzapine were assessed during the 30 days prior to the stroke episode. We set two control periods with lengths which were the same as the hazard periods. Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were estimated by conditional logistic regression. A total of 1601 cases of ischemic stroke with a mean age of 75.6 (±6.7) years were identified, among which 933 (58.3%) were female. An increased risk of ischemic stroke was associated with the use of risperidone (aOR=3.5, 95% CI 3.3-4.6) and quetiapine (aOR=2.7, 95% CI 2.0-3.6) during the 30 days prior to stroke: however, no significant risk was observed with olanzapine (aOR=1.2, 95% CI 0.7-2.0). The increased stroke risk in demented patients, assessed within 30 days after exposure, was also observed with olanzapine. However, the sample of olanzapine users was small and underpowered. © 2013 The Author(s).

PubMed | Health Services Research Unit, Tel Aviv University, Korea Institute of Drug Safety and Risk Management, Seoul National University and 8 more.
Type: | Journal: The Journal of pediatrics | Year: 2016

To describe the rates of pediatric antibiotic use across 6 countries on 3 continents.Cross-national analysis of 7 pediatric cohorts in 6 countries (Germany, Italy, South Korea, Norway, Spain, and the US) was performed for 2008-2012. Antibiotic dispensings were identified and grouped into subclasses. We calculated the rates of antimicrobial prescriptions per person-year specific to each age group, comparing the rates across different countries.A total of 74744302 person-years from all participating centers were included in this analysis. Infants in South Korea had the highest rate of antimicrobial consumption, with 3.41 prescribed courses per child-year during the first 2 years of life. This compares with 1.6 in Lazio, Italy; 1.4 in Pedianet, Italy; 1.5 in Spain; 1.1 in the US; 1.0 in Germany; and 0.5 courses per child-year in Norway. Of antimicrobial prescriptions written in Norway, 64.8% were for first-line penicillins, compared with 38.2% in Germany, 31.8% in the US, 27.7% in Spain, 25.1% in the Italian Pedianet population, 9.8% in South Korea, and 8% in the Italian Lazio population.We found substantial differences of up to 7.5-fold in pediatric antimicrobial use across several industrialized countries from Europe, Asia, and North America. These data reinforce the need to develop strategies to decrease the unnecessary use of antimicrobial agents.

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