Unpacking adverse events and associations post COVID-19 vaccination: a deep dive into vaccine adverse event reporting system data.

INTRODUCTION: The rapid development of COVID-19 vaccines has provided crucial tools for pandemic control, but the occurrence of vaccine-related adverse events (AEs) underscores the need for comprehensive monitoring. METHODS: This study analyzed the Vaccine Adverse Event Reporting System (VAERS) data from 2020-2022 using statistical methods such as zero-truncated Poisson regression and logistic regression to assess associations with age, gender groups, and vaccine manufacturers. RESULTS: Logistic regression identified 26 System Organ Classes (SOCs) significantly associated with age and gender. Females displayed especially higher odds in SOC 19 (Pregnancy, puerperium and perinatal conditions), while males had higher odds in SOC 25 (Surgical and medical procedures). Older adults (>65) were more prone to symptoms like Cardiac disorders, whereas those aged 18-65 showed susceptibility to AEs like Skin and subcutaneous tissue disorders. Moderna and Pfizer vaccines induced fewer SOC symptoms compared to Janssen and Novavax. The zero-truncated Poisson regression model estimated an average of 4.243 symptoms per individual. CONCLUSION: These findings offer vital insights into vaccine safety, guiding evidence-based vaccination strategies and monitoring programs for precise and effective outcomes.

Associations of Antihypertensive Medication Consumption and Drug-Drug Interaction with Statin and Metformin with Reduced Alzheimer's Disease and Related Dementias Risk among Hypertensive Patients with Mild Cognitive Impairment using High Volume Claims Data.

Background: While hypertension is a modifiable risk factor of Alzheimer's disease and related dementias (ADRD), limited studies have been conducted on the effectiveness of antihypertensive medications (AHMs) in altering the progression from mild cognitive impairment (MCI) to ADRD; similarly, few studies have assessed drug-drug interactions of AHMs with drugs targeted to modify other risk factors of ADRD such as type II diabetes and hypercholesterolemia. Method: 128,683 unique hypertensive patients with MCI on US-based Optum claims data were identified. Diuretics, beta blockers (BBs), calcium channel blockers (CCBs), angiotensin-converting enzyme inhibitors (ACE inhibitors), and angiotensin II receptor antagonists (ARBs) were identified as five major AHM classes. Baseline characteristics were compared. Cox proportional hazards (PH) models were used to study the association between specific AHM exposure and the progression from MCI to ADRD while controlling for demographic variables, comorbidities, and the use of Statins and Metformin. To examine the association of AHM-Statin or AHM-Metformin interaction with ADRD progression, we also investigated models controlling for the aforementioned confounders, as well as drug-drug interactions. Result: The study included 100,678 patients who were taking at least one class of AHM and 28,005 who were not taking any AHMs during the study period. AHM users had a higher incidence of comorbidities (all P≤0.039) and consumption of Metformin and Statins (both P<0.001) compared to non-users. Users of each major AHM class showed significantly lower risk of developing ADRD compared to non-users of that specific drug class (adjusted hazard ratio (aHR): 0.96-0.98; all P≤0.048). Within patients on monotherapy (using only one AHM drug), no specific AHM class had significantly lower risk of ADRD diagnosis compared to other AHM drug classes (aHR: 0.97-1.11; all P≥0.053). Use of Diuretics or CCBs in combination with Metformin consumption (aHR: 0.89, 0.91, respectively) showed lower risk of MCI to ADRD progression than use without Metformin consumption (aHR: 0.97, 0.98, respectively), whereas use of any of the five major AHMs with Statin consumption (aHR: 0.91-0.94) all showed lower risk than without Statin consumption (aHR: 0.98-1.04). Conclusion: All five major AHM classes showed a protective effect against ADRD progression among hypertensive patients with MCI. Also, certain combinations of AHMs with Metformin or Statins showed a stronger protective effect compared to AHMs alone, and some drug-drug interactions of AHM-Metformin or AHM-Statin also showed protective effects against progression from MCI to ADRD.

Higher mortality among lean patients with non-alcoholic fatty liver disease despite fewer metabolic comorbidities.

BACKGROUND & AIMS: Non-alcoholic fatty liver disease (NAFLD) can develop in individuals who are not overweight. Whether lean persons with NAFLD have lower mortality and lower incidence of cirrhosis, cardiovascular diseases (CVD), diabetes mellitus (DM) and cancer than overweight/obese persons with NAFLD remains inconclusive. We compared mortality and incidence of cirrhosis, CVD, DM and cancer between lean versus non-lean persons with NAFLD. METHODS: This is a retrospective study of adults with NAFLD in a single centre from 2012 to 2021. Primary outcomes were mortality and new diagnosis of cirrhosis, CVD, DM and cancer. Outcomes were modelled using competing risk analysis and Cox proportional hazards regression analysis. RESULTS: A total of 18,594 and 13,420 patients were identified for cross-sectional and longitudinal analysis respectively: approximately 11% lean, 25% overweight, 28% class 1 obesity and 35% class 2-3 obesity. The median age was 51.0 years, 54.6% were women. The median follow-up was 49.3 months. Lean patients had lower prevalence of metabolic diseases at baseline and lower incidence of cirrhosis and DM than non-lean patients and no difference in CVD, any cancer or obesity-related cancer during follow-up. However, lean patients had significantly higher mortality with incidence per 1000 person-years of 16.67, 10.11, 7.37 and 8.99, respectively, in lean, overweight, obesity class 1 and obesity class 2-3 groups respectively. CONCLUSIONS: Lean patients with NAFLD had higher mortality despite lower incidence of cirrhosis and DM, and similar incidence of CVD and cancer and merit similar if not more attention as non-lean patients with NAFLD.