ABSTRACT
Background@#Little is known about the adverse events (AEs) associated with coronavirus disease 2019 (COVID-19) vaccination in patients with type 2 diabetes mellitus (T2DM). @*Methods@#This study used vaccine AE reporting system data to investigate severe AEs among vaccinated patients with T2DM. A natural language processing algorithm was applied to identify people with and without diabetes. After 1:3 matching, we collected data for 6,829 patients with T2DM and 20,487 healthy controls. Multiple logistic regression analysis was used to calculate the odds ratio for severe AEs. @*Results@#After COVID-19 vaccination, patients with T2DM were more likely to experience eight severe AEs than controls: cerebral venous sinus thrombosis, encephalitis myelitis encephalomyelitis, Bell’s palsy, lymphadenopathy, ischemic stroke, deep vein thrombosis (DVT), thrombocytopenia (TP), and pulmonary embolism (PE). Moreover, patients with T2DM vaccinated with BNT162b2 and mRNA-1273 were more vulnerable to DVT and TP than those vaccinated with JNJ-78436735. Among patients with T2DM administered mRNA vaccines, mRNA-1273 was safer than BNT162b2 in terms of the risk of DVT and PE. @*Conclusion@#Careful monitoring of severe AEs in patients with T2DM may be necessary, especially for those related to thrombotic events and neurological dysfunctions after COVID-19 vaccination.
ABSTRACT
Background and objectives@#A prolonged QTc interval is associated with an increased risk of a stroke or atrial fibrillation (AF). However, its direct causal relationship with AF associated a stroke has not been proven yet. To examine whether QTc interval is causally linked with risk of stroke in AF patients, we used the Mendelian randomization analysis. @*Subjects and methods@#Among 2742 patients (73.6% male; 58.2 ± 11.0 years old; 69.5% with paroxysmal AF) who underwent AF catheter ablation, we analyzed 1766 patients who had preablation sinus rhythm electrocardiograms off antiarrhythmic drugs after excluding amiodarone users. Among them, 1213 subjects had genome-wide association study dataset analyzable for the Mendelian randomization. We explored the mechanistic relationships between QTc interval (ms) and the risk of a stroke by analyzing the Mendelian randomization (1213 subjects) after reviewing 35 genetic polymorphisms associated with the QTc in 31 European descent studies. @*Results@#Among the patients in the higher quartile with a higher QTc, CHA2DS2-VASc score (p < 0.001), and age (p < 0.001), the proportions of a prior stroke (p < 0.001), females, heart failure, and persistent AF were significantly higher than in those in the lower quartile. The QTc was independently associated with the CHA2DS2-VASc score (β, 4.63E−5; 95% confidence interval, 3.57E−6–8.90E−5; p = 0.034) and ischemic strokes (odds ratio, 1.01; 95% confidence interval, 1.00–1.01; p = 0.027). However, there was no direct causal relationship between the QTc and CHA2DS2-VASc score or a prior stroke in either the one-sample or two-sample Mendelian randomizations. @*Conclusion@#The QTc was independently associated with the CHA2DS2-VASc score and strokes among the patients with AF who underwent catheter ablation, despite no genetically direct causal relationship.