Background: To examine how closely reporting rates in the FDA Adverse Event Reporting System (FAERS) reflect expected rates of known adverse drug events (ADEs). Methods: We selected three groups of drugs to reflect hypothesized variation in sensitivity to reporting, including statins, biologics, and narrow therapeutics index drugs (NTI). The numbers of ADEs in FAERS were divided by utilization estimates from ambulatory health care data (NAMCS/NHAMCS) to calculate a reported proportion. One sample z-test for proportions compared the proportion of ADEs reported to an expected ADE proportion derived from drug labels, reference databases, and peer-reviewed papers. Results: The majority of drug-ADE pairs showed significant under-reporting. For example, roughly 0.01% to 44% of statin events were reported (z-test p < 0.0001). Biological (0.002% to >100%) and NTI (20% to >100%) drugs had relatively higher reporting rates. Roughly 20% to 33% of the minimum number of expected serious events were reported with biologics and NTI drugs. Conclusions: This study supports previous evidence of under-reporting of ADEs in spontaneous reporting data. But, under-reporting varies considerably by the type of drug and the type of ADEs, and this variability in under-reporting should be considered when interpreting safety signals.

Type 2 Diabetes mellitus is a major public health concern with an alarming global growth rate. According to the World Health Organization (WHO), Saudi Arabia ranks seventh in the world and second in the Middle East for the largest estimated burden of diabetic cases. Evidence shows that pharmacist-led care programs can be beneficial for the effective treatment of diabetes mellitus. Current study was aimed to evaluate the impact of Pharmacist-Based Diabetic Intervention (PDIM) for Type 2 Diabetes patients on knowledge of the disease, adherence to medications and self-care practices during the first wave of COVID-19. A multi-arm pre-post study was conducted among type 2 diabetic patients from April to October 2021 in Sakaka, Saudi Arabia. Patients were randomly divided into an intervention and a control group. The intervention group received the PDIM, whereas the control group only received the usual care. The pharmacist-based diabetes intervention model consisted of a diabetic educational module and medication improvement strategies. Furthermore, the intervention group also received specific telepharmacy services (calls, messages or emails) to address their medication-related problems, inquire about medication adherence and follow-up. At the end of six months, disease knowledge, self-care practices, and medication adherence score were analyzed. Furthermore, HbA1c and lipid profile were also compared. A total of 109 patients were included in the study. A significant difference was observed in the knowledge score between the intervention and control group (16.89 ± 2.01 versus 15.24 ± 2.03, p-value < 0.001). Similarly, self-care practices also improved in the intervention group as compared to the control group (4.39 ± 1.10 versus 3.16 ± 0.97, p-value < 0.001). Furthermore, the medication adherence and HbA1c significantly improved during between the group analysis (p < 0.05). Our study demonstrates that pharmacist-based diabetes intervention model is effective in improving patients’ knowledge of diabetes, self-care practices, medication adherence and glycemic control.

Glucose-Potassium Ratio (GPR) has emerged as a biomarker in several pathophysiological conditions. However, the association between GPR and long-term outcomes in stroke patients has not been investigated. Our study evaluated the applicability of baseline GPR as a predictive prognostic tool for clinical outcomes in ischemic stroke patients. The multicenter retrospective cohort study included acute-subacute adult ischemic stroke patients who had their baseline serum GPR levels measured. Eligible patients were categorized into two sub-cohorts based on the baseline GPR levels (<1.67 vs. ≥ 1.67). The primary outcome was the incidence of 30-day hemorrhagic transformation, while stroke recurrence, and all-cause mortality within twelve months, were considered secondary. Among 4083 patients screened, 1047 were included in the current study. In comparison with GPR < 1.67 group, patients with ≥ 1.67 GPR had a significantly higher ratio of all-cause mortality within twelve months (aHR 2.07 [95 % CI 1.21–3.75] p = 0.01), and higher ratio of 30-day hemorrhagic transformation but failed to reach the statistical significance (aHR 1.60 [95 % CI 0.95–2.79], p = 0.08). Overall, baseline GPR serum is an independent predictor of all-cause mortality within twelve months in patients with acute and subacute ischemic stroke. Further clinical studies are necessary to validate these findings.

Post-stroke seizures present a global challenge, yet its frequency and factors associated with its incidence are poorly documented, particularly in the Middle East. Thus, this study aims to investigate post-stroke seizure frequency and stroke-associated factors among ischemic stroke patients in Saudi Arabia, addressing demographic, clinical, and comorbid aspects to improve prognosis, diagnosis, prevention, and management. A multicenter, cohort observational study included eligible ischemic stroke patients who were categorized into those who developed seizures after injury and those who did not. Additionally, the study assessed the association between post-stroke seizure and 12-month mortality, 12-month stroke recurrence, and the occurrence of hemorrhagic transformation (HT) within 30 days. The study involved 1235 ischemic stroke patients, in which 13.5% developed post-stroke seizures. Patients with post-stroke seizures had more extended hospital stays, higher intensive care unit (ICU) admission rates, and a higher prevalence of comorbidities. Factors independently associated with post-stroke seizures included previous stroke history (OR = 1.93; 1.35–2.75), ICU admission (OR = 1.7; 1.15–2.5), and depression (OR = 2.1; 1.38–3.30). Logistic regression revealed associations between post-stroke seizures and HT (OR = 2.61; 1.70-4.00), stroke recurrence (OR = 2.30; 1.58–3.36), and mortality (OR = 1.89; 1.33–2.68). However, after adjusting for covariates, post-stroke seizures were significantly associated with stroke recurrence only (aOR = 1.7; 1.11–2.63). Our study identifies notable associations and risk factors for post-stroke seizures in ischemic stroke patients. This underscores the importance of adopting a comprehensive approach to stroke care to enhance the prediction, prevention, and management of post-stroke seizures. Further research is warranted to validate these findings, enhance the understanding of post-stroke seizure mechanisms, and guide management strategies.