Comparative safety analysis of mRNA and adenoviral vector COVID-19 vaccines: a nationwide cohort study using an emulated target trial approach.

OBJECTIVE: This nationwide cohort study compared the incidence of adverse events of special interest (AESIs) between adenoviral vector-based (ChAdOx1) and mRNA-based (BNT162b2 or mRNA-1273) coronavirus disease 2019 (COVID-19) vaccines. METHODS: A targeted trial emulation study was conducted using data from the National Health Insurance Service database. Vaccinees aged 18-85 years who had received at least one dose of ChAdOx1 or an mRNA-based vaccine were identified. The 42-day risks of AESIs were calculated. RESULTS: A total of 1 767 539 ChAdOx1 vaccinees were matched exactly with mRNA vaccinees according to their risk factors. The 42-day risks of adverse events were low (∼0 to 176 events per 100 000 persons in both vaccine groups), and the incidence rates of AESIs were comparable between the two platforms, except for a higher occurrence of acute cardiac injury (incidence rate ratio [IRR], 1.22; 95% CI, 1.10-1.35), myocarditis or pericarditis (IRR, 2.14; 95% CI, 1.14-4.04), and arrhythmia (IRR, 1.46; 95% CI, 1.24-1.71) in mRNA vaccinees. The incidence of Guillain-Barré syndrome (IRR, 0.20; 95% CI, 0.06-0.69), vasovagal syncope (IRR, 0.77; 95% CI, 0.62-0.97), radiculopathy (IRR = 0.59, 95% CI, 0.41-0.84), and aseptic arthritis (IRR, 0.81; 95% CI, 0.70-0.93) was significantly lower in mRNA-based vaccinees compared with ChAdOx1 vaccinees. DISCUSSION: A remarkable platform-dependent difference was observed in the safety profiles of COVID-19 vaccines, particularly for myocarditis or pericarditis and Guillain-Barré syndrome. However, the overall risk of AESIs was low for both vaccine platforms.

Association Between DPP4 Inhibitor Use and the Incidence of Cirrhosis, ESRD, and Some Cancers in Patients With Diabetes.

CONTEXT: There are relatively few data on noncardiovascular (non-CV) long-term clinical outcomes of dipeptidyl peptidase 4 inhibitor (DPP4i) treatment. OBJECTIVE: We aimed to evaluate some non-CV effects of DPP4is in patients with diabetes. METHODS: Based on data from the National Health Insurance Service database in Korea (2007-2018), we conducted 3 pairwise comparisons of metformin-combined antidiabetic therapies in adult patients with diabetes: DPP4is vs (1) all other oral antidiabetic agents, (2) sulfonylureas/glinides, and (3) thiazolidinediones (TZDs). Major outcomes were liver cirrhosis, end-stage renal disease (ESRD), and cancers in the liver, kidney, and pancreas. Adjusted hazard ratios (HRs) and 95% CIs for the outcomes were estimated using an adjusted Cox model. RESULTS: Of the 747 124 patients included, 628 217 had received DPP4i therapy for a mean duration of 33.8 ± 25.0 months. Compared with TZD therapy, DPP4i therapy was associated with higher adjusted HRs [95% CIs] for liver cirrhosis (1.267 [1.108-1.449]), ESRD (1.596 [1.139-2.236]), liver cancer (1.117 [1.011-1.235]), and pancreatic cancer (1.158 [1.040-1.290]). Furthermore, apart from liver cirrhosis, a higher risk of each of these outcomes was associated with DPP4i use than with non-DPP4i use. The higher adjusted HRs associated with DPP4i use further increased when patients with long-term exposure to DPP4is were analyzed. CONCLUSION: DPP4i therapy in patients with diabetes was associated with a higher risk of liver cirrhosis and cancer, ESRD, and pancreatic cancer than TZD therapy and, except for liver cirrhosis, the risk of these outcomes was greater with DPP4i treatment than with non-DPP4i treatment.

Association between height loss and cardiovascular disease in the Korean elderly.

Shorter people are at risk for cardiovascular disease (CVD), but data remain limited. This study sought to determine whether height loss is associated with an increased incidence of CVD. From the Korean National Health Insurance Service-Senior database (2002-2015), data of 134,952 individuals with available information on height loss was obtained. Height loss as percentages was measured 3-5 years from the baseline height. To assess hazard ratios for CVD incidence, multivariable Cox proportional hazard regression models were used before and after applying propensity score matching. The unmatched cohort consisted of 109,546 participants without height loss (< 1%): 20,208 participants with 1-2% height loss, and 5126 participants with ≥ 2% height loss. During a median follow-up period of 6.5 years (interquartile range, 3.7-8.5 years), 21,921 were newly diagnosed with CVD. Adults with height loss of > 2% had a greater risk of incident CVD than those with no height loss. This finding was statistically significant both in the original- and propensity score-matched cohorts. The increased risk for ischemic stroke was significant in the male subgroups, in line with degree of height loss. Overall, height loss is associated with an increased risk of subsequent ischemic stroke in Korean men.

Analysis of the Occurrence of Diseases Following Gastrectomy for Early Gastric Cancer: a Nationwide Claims Study.

PURPOSE: Various changes in nutrition, metabolism, immunity, and psychological status occur through multiple mechanisms after gastrectomy. The purpose of this study was to predict disease status after gastrectomy by analyzing diseases pattern that occur or change after gastrectomy. MATERIALS AND METHODS: A retrospective cohort study was conducted using nationwide claims data. Patients with gastric cancer who underwent gastrectomy or endoscopic resection were included in the study. Eighteen target diseases were selected and categorized based on their underlying mechanism. The incidence of each target disease was compared by dividing the study sample into those who underwent gastrectomy (cases) and those who underwent endoscopic resection for early gastric cancer (controls). The cases were matched with controls using propensity score matching. Thereafter, Cox proportional hazard models were used to evaluate intergroup differences in disease incidence after gastrectomy. RESULTS: A total of 97,634 patients who underwent gastrectomy (84,830) or endoscopic resection (12,804) were included. The incidence of cholecystitis (P<0.0001), pancreatitis (P=0.034), acute kidney injury (P=0.0083), anemia (P<0.0001), and inguinal hernia (P=0.0007) were higher after gastrectomy, while incidence of dyslipidemia (P<0.0001), vascular diseases (ischemic heart disease, stroke, and atherosclerosis; P<0.0001, P<0.0001, and P=0.0005), and Parkinson's disease (P=0.0093) were lower after gastrectomy. CONCLUSIONS: This study identifies diseases that may occur after gastrectomy in patients with gastric cancer.

Predicted and Observed Incidence of Thromboembolic Events among Koreans Vaccinated with ChAdOx1 nCoV-19 Vaccine.

We used the nationwide claims database to calculate the incidence of thrombotic events and predict their overall 2-week incidence. From 2006 to 2020, the incidence of deep vein thrombosis (DVT), pulmonary embolism (PE), and disseminated intravascular coagulation (DIC) tended to increase. Unlike intracranial venous thrombosis (ICVT) and intracranial thrombophlebitis (ICTP), which showed no age difference, other venous embolism, and thrombosis (OVET), DIC, DVT, and PE were significantly more common in over 65 years. The overall 2-week incidence of ICVT was 0.21/1,000,000 (95% confidence interval [CI], 0.11-0.32). ICTP, OVET, DIC, DVT and PE were expected to occur in 0.08 (95% CI, 0.02-0.14), 7.66 (95% CI, 6.08-9.23), 5.95 (95% CI, 4.88-7.03), 13.28 (95% CI, 11.92-14.64), 14.09 (95% CI, 12.80-15.37) per 1,000,000, respectively. To date, of 8,548,231 patients vaccinated with ChAdOx1 nCoV-19 in Korea, two had confirmed thrombosis with thrombocytopenia syndrome within 2 weeks. The observed incidence of ICVT after vaccination was 0.23/1,000,000.

Association of prescribed medications with the risk of COVID-19 infection and severity among adults in South Korea.

OBJECTIVES: Concerns have been expressed that some drugs may increase susceptibility to SARS-CoV-2 infection. In contrast, other drugs have generated interest as potential therapeutic agents. METHODS: All adults aged ≥18 years who were tested for COVID-19 were included. Exposure was defined as a prescription of study drugs which would have been continued until 7 days prior to test for COVID-19 or later. The outcome measures were the diagnosis of COVID-19 and severe COVID-19. Disease risk score matching and multiple logistic regression was used. RESULTS: Matched claims and testing results were available for 219,961 subjects, of whom 7,341 (3.34%) were diagnosed with COVID-19. Patients were matched to 36,705 controls, and the subset of 878 patients of severe COVID-19 also matched with 1,927 mild-to-moderate patients. Angiotensin receptor blockers were not associated with either the diagnosis of COVID-19 (adjusted OR [aOR], 1.02; 95% confidence interval [CI], 0.90-1.15) or severe disease (aOR, 1.11; 95% CI, 0.87-1.42). The use of hydroxychloroquine was not associated with a lower risk for COVID-19 (aOR, 0.94; 95% CI, 0.53-1.66) or severe disease (aOR, 3.51; 95% CI, 0.76-16.22). CONCLUSIONS: In this national claims data-based case-control study, no commonly prescribed medications were associated with risk of COVID-19 infection or COVID-19 severity.

Effect of Underlying Comorbidities on the Infection and Severity of COVID-19 in Korea: a Nationwide Case-Control Study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic is an emerging threat worldwide. It remains unclear how comorbidities affect the risk of infection and severity of COVID-19. METHODS: This is a nationwide retrospective case-control study of 219,961 individuals, aged 18 years or older, whose medical costs for COVID-19 testing were claimed until May 15, 2020. COVID-19 diagnosis and infection severity were identified from reimbursement data using diagnosis codes and on the basis of respiratory support use, respectively. Odds ratios (ORs) were estimated using multiple logistic regression, after adjusting for age, sex, region, healthcare utilization, and insurance status. RESULTS: The COVID-19 group (7,341 of 219,961) was young and had a high proportion of female. Overall, 13.0% (954 of 7,341) of the cases were severe. The severe COVID-19 group had older patients and a proportion of male ratio than did the non-severe group. Diabetes (odds ratio range [ORR], 1.206-1.254), osteoporosis (ORR, 1.128-1.157), rheumatoid arthritis (ORR, 1.207-1.244), substance use (ORR, 1.321-1.381), and schizophrenia (ORR, 1.614-1.721) showed significant association with COVID-19. In terms of severity, diabetes (OR, 1.247; 95% confidential interval, 1.009-1.543), hypertension (ORR, 1.245-1.317), chronic lower respiratory disease (ORR, 1.216-1.233), chronic renal failure, and end-stage renal disease (ORR, 2.052-2.178) were associated with severe COVID-19. CONCLUSION: We identified several comorbidities associated with COVID-19. Health care workers should be more careful while diagnosing and treating COVID-19 when patients have the abovementioned comorbidities.