Emulating Six Cardiovascular Outcome Trials of Antidiabetic Drugs in Individuals with Type 2 Diabetes: Analyses Based on Real-World Databases from Korea and Taiwan.

With the increasing volume of clinical evidence derived from large-scale Asian real-world data (RWD) and the growing interest in its use in regulatory decision-making, it is important to conduct benchmarking exercises that evaluate whether studies using Asian RWD can generate similar conclusions as randomized controlled trials (RCTs). We aimed to assess whether observational studies based on Korea and Taiwan RWD can yield comparable results with trials by emulating six cardiovascular outcome trials (CVOTs) of antidiabetic drugs in individuals with type 2 diabetes (T2D). We emulated six CVOTs using nationwide claims of Korea and Taiwan.

Association between sacubitril/valsartan and risk of dementia in patients with heart failure: a nationwide cohort study.

Aims: To evaluate the risk of incident dementia associated with sacubitril/valsartan in patients with heart failure (HF) in South Korea.

Methods And Results: We conducted a retrospective cohort study using the National Health Insurance Database in South Korea. Patients diagnosed with HF and prescribed either sacubitril/valsartan or angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs) within 90 days of their first HF diagnosis between October 2017 and December 2020 were included.

Risk of new-onset seizures following immunization against COVID-19: a self-controlled case-series study.

Objectives: Despite emerging reports of new-onset seizures (NOS) following coronavirus disease 2019 (COVID-19) vaccination, safety evidence regarding the risk of NOS after vaccination remains limited. We aimed to investigate the potential association between NOS and COVID-19 vaccination.

Methods: We conducted a self-controlled case series study utilizing a nationwide database linking the COVID-19 vaccination registry and the National Health Information Database (from February 2021 to October 2022).

Association between the body mass index and risk of cardiovascular events in sodium-glucose cotransporter 2 inhibitor users compared with dipeptidyl-peptidase 4 inhibitor users: A nationwide cohort study in Korea.

Aims: There is limited evidence regarding whether obesity modifies the association between the use of sodium-glucose cotransporter 2 inhibitors (SGLT2is) and the risk of cardiovascular events. We assessed whether baseline body mass index (BMI) modifies the association between SGLT2i use and the risk of major adverse cardiovascular events (MACE) and heart failure (HF) in patients with type 2 diabetes (T2D).

Materials And Methods: We used the nationwide claims data of Korea (September 2014-December 2022) to construct an active-comparator, new-user cohort of patients with T2D stratified by the Asian BMI categories: normal weight, 18.

Incretin-based drugs and the risk of gallbladder or biliary tract diseases among patients with type 2 diabetes across categories of body mass index: a nationwide cohort study.

Background: Despite emerging evidence of gallbladder or biliary tract diseases (GBD) risk regarding incretin-based drugs, population-specific safety profile considering obesity is lacking. We aimed to assess whether stratification by body mass index (BMI) modifies the measures of association between incretin-based drugs and the risk of GBD.

Methods: We conducted an active-comparator, new-user cohort study using a nationwide claims data (2013-2022) of Korea.

Risk of Kawasaki Disease/Multisystem Inflammatory Syndrome Following COVID-19 Vaccination in Korean Children: A Self-Controlled Case Series Study.

Background: Rare cases of Kawasaki disease (KD) and multisystem inflammatory syndrome in children (MIS-C) have been reported following the coronavirus disease 2019 (COVID-19) vaccination; however, the association between COVID-19 vaccination and the risk of developing KD/MIS-C has not yet been established.

Methods: We conducted a self-controlled case series analysis using a large-linked database that connects the COVID-19 immunization registry with nationwide claims data. We identified individuals aged < 18 years who received their initial COVID-19 vaccination and had a KD/MIS-C diagnosis with a prescription for intravenous immunoglobulin or corticosteroids between October 18, 2021, and April 15, 2023.

Risk of hepatic events associated with use of sodium-glucose cotransporter-2 inhibitors versus glucagon-like peptide-1 receptor agonists, and thiazolidinediones among patients with metabolic dysfunction-associated steatotic liver disease.

Objective: To examine the hepatic effectiveness of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) through a head-to-head comparison with glucagon-like peptide-1 receptor agonists (GLP-1RA) or thiazolidinediones (TZD) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD).

Design: This population-based cohort study was conducted using a nationwide healthcare claims database (2014-2022) of Korea. We included individuals with MASLD (aged ≥40 years) who initiated SGLT-2i or comparator drugs (GLP-1RA or TZD).

Treatment Patterns and Persistence Among Patients Newly Diagnosed With Migraine in South Korea: A Retrospective Analysis of Health Claims Data.

Background And Purpose: Migraine is one of the most common chronic neurological diseases worldwide. Although diverse treatment regimens have been recommended, there is insufficient evidence for which treatment patterns to apply in routine clinical settings.

Methods: We used nationwide claims data from South Korea for 2015-2021 to identify incident migraine patients with at least one prescription for migraine.

Sodium-Glucose Cotransporter-2 Inhibitors, Dulaglutide, and Risk for Dementia : A Population-Based Cohort Study.

Background: Both sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may have neuroprotective effects in patients with type 2 diabetes (T2D). However, their comparative effectiveness in preventing dementia remains uncertain.

Objective: To compare the risk for dementia between SGLT2 inhibitors and dulaglutide (a GLP-1 RA).

Risk of encephalitis and meningitis after COVID-19 vaccination in South Korea: a self-controlled case series analysis.

Background: Several neurological manifestations shortly after a receipt of coronavirus infectious disease 2019 (COVID-19) vaccine have been described in the recent case reports. Among those, we sought to evaluate the risk of encephalitis and meningitis after COVID-19 vaccination in the entire South Korean population.

Methods: We conducted self-controlled case series (SCCS) analysis using the COVID-19 immunization record data from the Korea Disease Control Agency between February 2021 and March 2022, linked with the National Health Insurance Database between January 2021 and October 2022.

Sodium-Glucose Cotransporter 2 Inhibitors vs Incretin-Based Drugs and Risk of Fractures for Type 2 Diabetes.

Importance: Postmenopausal individuals with type 2 diabetes are susceptible to fractures due to the interaction of elevated blood glucose levels and a deficiency of the hormone estrogen. Despite continued concerns of fracture risks associated with sodium-glucose cotransporter 2 inhibitors (SGLT2i), existing evidence in this high-risk population is lacking.

Objective: To assess the risk of fractures associated with SGLT2i vs incretin-based drugs of dipeptidyl-peptidase 4 inhibitors (DPP4i) and glucagon-like peptide 1 receptor agonists (GLP1RA), separately, in postmenopausal individuals with type 2 diabetes.

Barriers to COVID-19 vaccine surveillance: the issue of under-reporting adverse events.

Objectives: This study investigated the reporting rates of adverse events following immunization (AEFIs) to the spontaneous reporting system (SRS) and its predictors among individuals with AEFIs after coronavirus disease 2019 (COVID-19) vaccination.

Methods: A cross-sectional, web-based survey was conducted from December 2, 2021 to December 20, 2021, recruiting participants >14 days after completion of a primary COVID-19 vaccination series. Reporting rates were calculated by dividing the number of participants who reported AEFIs to the SRS by the total number of participants who experienced AEFIs.