Gabapentinoids-Related Delirium Adverse Events: A Real-World Study from 2004 to 2022 Based on FAERS.

Purpose: This study comprehensively describes and evaluates the correlation between gabapentinoids and all types of delirium. Methods: We used AERSMine to select all adverse reaction data from 2004 Q1 to the 2022 Q4 in the FDA Adverse Event Reporting System (FAERS) database, and delirium events reported by gabapentinoids drugs were included in this study. Collected and analyzed the clinical details of these reports. We have developed four models. Among the four models, reporting odds ratio (ROR) and proportional reporting ratio (PRR) were used to evaluate the potential association between and delirium. We undertook a subgroup analysis for the age and sex cohorts. Results: A total of 2950 reports of gabapentinoids-related delirium was collected. Excluding cases with a history of delirium (Model 2), opioid drugs (Model 3), and other adverse events related to gabapentinoids drugs (Model 4), pain cases with gabapentin drugs as the main suspected drug were selected. In model 1, the reporting rates of delirium at the delirium and delirium tremens levels were higher in the gabapentinoids group than in the non-gabapentinoids group (ROR 1.09(1.05,1.13); ROR 1.54(1.16,2.04)). In model 2.3 the delira and the delirium level were higher in the gabapentinoids group (ROR 1.42(1.29,1.56), ROR 1.44(1.31,1.59); ROR 1.43(1.30,1.58), ROR 1.46(1.33,1.61)). There is no difference in delirium levels in Model 4. Delirium levels were higher in the gabapentinoids group than in the non-gabapentinoids group in ≥65 years old. The delirium and deliria levels were higher in the male group than in the female group. Conclusion: The delirium adverse reactions of the gabapentinoids group were significantly higher than those of non-gabapentinoids group in the first three models. However, with the removal of confounding factors, there was no significant difference in this type of adverse reaction in Model 4. In elderly and male patients, the incidence of delirium with gabapentinoids was significantly increased.

Association of thrombopoietin-related drugs with thromboembolic events: Mendelian randomization and a real-world study.

Background: Studies have shown conflicting results when using thrombopoietin-related drugs (TPORD) for thromboembolic events (TEEs). Our study aimed to explore the correlation between TPORDs and TEEs. Method: Drug-targeted Mendelian randomization (MR) and multivariate MR (MVMR) analysis were used to explore the causal relationship between TPORDs and TEEs such as venous thromboembolism (VTE), deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI) and ischemic stroke (STR). At the same time, a real-world study was conducted by extracting adverse events (AEs) from the FDA Adverse Event Reporting System database included in AERSMine to further validate our findings. Outcome: In drug-target MR, TPORDs were associated with VTE (OR = 1.193, 95% confidence interval (CI): 1.001-1.423, p = 0.049], DVT (OR = 1.321, 95% CI: 1.027-1.700, p = 0.030), MI (OR = 1.216, 95% CI: 1.010-1.464, p = 0.039), STR (OR = 1.224, 95% CI: 1.021-1.468, p = 0.029). VTE/DVT/STR remained stable in MVMR (VTE: OR = 1.3, 95% CI: 1.187-1.422, p < 0.001; DVT: OR = 1.465,95% CI:1.285-1.671, p < 0.001; STR: OR = 1.119, 95% CI: 1.018-1.229, p = 0.019) and real-world studies [lower bound of proportional reporting ratio (ROR) greater than 1]. The significance of myocardial infarction disappeared in MVMR (OR = 0.996, 95% CI: 0.894-1.109, p = 0.942) and in real-world studies (lower ROR lower than 1). There was no evidence of a causal relationship between TPORD and PE (OR = 1.244, 95% CI: 0.969-1.597, p = 0.087), but it generated a signal from a real-world study (lower bound of ROR greater than 1). Conclusion: This study suggests that TPORDs may be associated with an increased risk of TEEs, particularly AEs leading to VTE/DVT/STR. In addition, the relationship between TPORDs and PE/MI is debatable and requires more research.

Examining Blood Clot Risk for Drugs: A Fusion of Genetic Research and Real-World Insights Why did this study be conducted? To investigate whether drugs used to treat low platelet counts increase the risk of thrombosis-related events. Platelets are essential for blood clotting, and a low platelet count increases the risk of bleeding. Drugs that stimulate platelet production were prescribed, and this study aims to elucidate their safety. Blood clot-related events, such as deep vein thrombosis and pulmonary embolism, are serious health problems that can lead to morbidity and mortality. For the sake of patient safety, it is critical to understand the possible link between these drugs and thrombosis-related events. What did the researchers do? To explore this question, we used a robust analytical method called Mendelian randomization (MR). MR uses genetic information to assess this link, helping researchers conclude whether the exposure (in this case, the drug) directly contributed to the outcome (blood clot-related event). They also examined real-world patient data, combining two different methods for a comprehensive analysis. What did the researchers find? We found that some of these platelet drugs may be associated with an increased risk of thrombosis-related events. However, it is important to note that these findings need to be further confirmed by more research and clinical studies. The complexity of medical research often means that preliminary observations must be confirmed through rigorous investigations. What do these findings mean? This study highlights the need for healthcare providers to closely monitor patients receiving these medications for any signs of thrombosis-related events. It also highlights the importance of further research to better understand the potential risks and benefits of these treatments. Ultimately, the goal is to provide physicians with more accurate information to make informed decisions about prescribing these medications, improving patient care, and minimizing potential risks.

Risk factors for taxane-induced peripheral neuropathy in patients with breast cancer.

PURPOSE: This study investigated the clinical risk factors for peripheral neuropathy induced by docetaxel and albumin-bound paclitaxel (AP) in patients with breast cancer. METHODS: This prospective observational study recruited 268 patients between March 2019 and December 2020. Patient information was obtained through the query system for laboratory test results, patient consultations, and scale evaluations. Neuropathic symptoms were followed up throughout and until 3 months after taxane chemotherapy. Univariate and multivariate analyses were used to find the risk factors for overall and moderate-severe taxane-induced peripheral neuropathy (TIPN). RESULTS: Cumulative dose (odds ratio [OR] = 3.533, 95% confidence interval [CI]: 1.797-6.944, p < 0.001), body mass index (BMI) (OR = 2.926, 95% CI: 1.621-5.281, p < 0.001), body surface area (BSA) (OR = 1.724, 95% CI: 1.011-2.941, p = 0.045), and hypocalcemia (OR = 4.899, 95% CI: 1.518-15.811, p = 0.008) all increased the risk of TIPN. Only cumulative dose (OR = 2.577, 95% CI: 1.161-5.719, p = 0.020) and BSA (OR = 2.040, 95% CI: 1.073-3.877, p = 0.030) were independent risk factors for moderate-severe TIPN. CONCLUSION: Cumulative dose, BMI, BSA, and hypocalcemia are all risk factors for overall TIPN, whereas cumulative dose and BSA are risk factors for moderate-severe TIPN. Patients with breast cancer who have high BMI, large BSA, hypocalcemia, and large cumulative dose may be at risk of TIPN, and intervention measures must be actively carried out for them.