cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.28769163
title: Dementia-related adverse events associated with direct oral anticoagulants use: a real-world, pharmacovigilance study based on the FAERS database

description: Direct oral anticoagulants (DOACs) are commonly used to prevent and treat thromboembolic diseases. This study aimed to assess and compare dementia related adverse events (AEs) associated with DOACs. AEs related to DOACs from January 2014 to June 2023 were extracted from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis methods, including reporting odds ratio (ROR), proportional reporting ratio, Bayesian Confidence Propagation Neural Network, and Multi-Item Gamma Poisson Shrinker, were used to evaluate the association between DOACs and dementia-related AEs. There were 12,692,968 AEs reported in FAERS after deduplication. Among these, 165, 206, 1574, and 12 dementia-related AEs that were attributed to dabigatran, rivaroxaban, apixaban, and edoxaban, respectively. Apixaban showed the strongest association with dementia-related AEs (ROR 7.66, 95% confidence interval (CI) 7.27–8.06), while rivaroxaban had the lowest ROR (0.95, 95%CI 0.83–1.09). Women exhibited higher RORs for all DOACs, with apixaban showing the most significant correlation. Subgroup analysis indicated a significant link between apixaban and dementia, dementia Alzheimer’s type and senile dementia. Apixaban appears most associated with dementia-related AEs among DOACs, whereas rivaroxaban poses a lower risk. Further research is needed to validate these findings through large-scale prospective studies.
DOI: 10.6084/m9.figshare.28769163.v1
title: Dementia-related adverse events associated with direct oral anticoagulants use: a real-world, pharmacovigilance study based on the FAERS database

description: Direct oral anticoagulants (DOACs) are commonly used to prevent and treat thromboembolic diseases. This study aimed to assess and compare dementia related adverse events (AEs) associated with DOACs. AEs related to DOACs from January 2014 to June 2023 were extracted from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis methods, including reporting odds ratio (ROR), proportional reporting ratio, Bayesian Confidence Propagation Neural Network, and Multi-Item Gamma Poisson Shrinker, were used to evaluate the association between DOACs and dementia-related AEs. There were 12,692,968 AEs reported in FAERS after deduplication. Among these, 165, 206, 1574, and 12 dementia-related AEs that were attributed to dabigatran, rivaroxaban, apixaban, and edoxaban, respectively. Apixaban showed the strongest association with dementia-related AEs (ROR 7.66, 95% confidence interval (CI) 7.27–8.06), while rivaroxaban had the lowest ROR (0.95, 95%CI 0.83–1.09). Women exhibited higher RORs for all DOACs, with apixaban showing the most significant correlation. Subgroup analysis indicated a significant link between apixaban and dementia, dementia Alzheimer’s type and senile dementia. Apixaban appears most associated with dementia-related AEs among DOACs, whereas rivaroxaban poses a lower risk. Further research is needed to validate these findings through large-scale prospective studies.
DOI: 10.6084/m9.figshare.28397062
title: Postmarketing safety of [<sup>177</sup>Lu]Lu-PSMA-617 radioligand therapy for prostate cancer: a disproportionality analysis of the FDA adverse event reporting system

description: [<sup>177</sup>Lu]Lu-PSMA-617 (Pluvicto), a new radioligand therapy that targets prostate-specific membrane antigen (PSMA), has been approved to treat metastatic castration-resistant prostate cancer (mCRPC). However, the real-world safety profile of [<sup>177</sup>Lu]Lu-PSMA-617 has not been systemically evaluated. Adverse event reports for [<sup>177</sup>Lu]Lu-PSMA-617 were retrieved from April 2022 to June 2024 from The Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analysis was conducted by four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Multi-Item Gamma Poisson Shrinker (MGPS) and Bayesian Confidence Propagation Neural Network (BCPNN). Subgroup analysis, time-to-onset and sensitivity analysis were also employed. 384,2712 adverse event reports were retrieved, of which 870 were associated with [<sup>177</sup>Lu]Lu-PSMA-617 in prostate cancer patients. We identified known adverse events (fatigue/asthenia, anemia, thrombocytopenia and nausea) and discovered adverse events not specified on the label (loss of libido, hydronephrosis, supraventricular tachycardia, tumor lysis syndrome, and tumor flare). Subgroup analysis revealed high-risk signals included stomatitis, pneumonia, leukopenia, and sepsis for patients aged over 85. The median onset time was 55 days (interquartile range 24–124 days). The findings provide new insights into the adverse events of [<sup>177</sup>Lu]Lu-PSMA-617 and valuable references for clinical applications of radioligand therapy for mCRPC.
DOI: 10.6084/m9.figshare.28397062.v1
title: Postmarketing safety of [<sup>177</sup>Lu]Lu-PSMA-617 radioligand therapy for prostate cancer: a disproportionality analysis of the FDA adverse event reporting system

description: [<sup>177</sup>Lu]Lu-PSMA-617 (Pluvicto), a new radioligand therapy that targets prostate-specific membrane antigen (PSMA), has been approved to treat metastatic castration-resistant prostate cancer (mCRPC). However, the real-world safety profile of [<sup>177</sup>Lu]Lu-PSMA-617 has not been systemically evaluated. Adverse event reports for [<sup>177</sup>Lu]Lu-PSMA-617 were retrieved from April 2022 to June 2024 from The Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analysis was conducted by four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Multi-Item Gamma Poisson Shrinker (MGPS) and Bayesian Confidence Propagation Neural Network (BCPNN). Subgroup analysis, time-to-onset and sensitivity analysis were also employed. 384,2712 adverse event reports were retrieved, of which 870 were associated with [<sup>177</sup>Lu]Lu-PSMA-617 in prostate cancer patients. We identified known adverse events (fatigue/asthenia, anemia, thrombocytopenia and nausea) and discovered adverse events not specified on the label (loss of libido, hydronephrosis, supraventricular tachycardia, tumor lysis syndrome, and tumor flare). Subgroup analysis revealed high-risk signals included stomatitis, pneumonia, leukopenia, and sepsis for patients aged over 85. The median onset time was 55 days (interquartile range 24–124 days). The findings provide new insights into the adverse events of [<sup>177</sup>Lu]Lu-PSMA-617 and valuable references for clinical applications of radioligand therapy for mCRPC.
DOI: 10.6084/m9.figshare.28143293
title: Autoimmune hepatitis associated with statins: a retrospective study of pharmacovigilance databases and review of the literature

description: Statin-associated autoimmune hepatitis (AIH) is a rare but potentially life-threatening adverse event. Currently, no studies have investigated the association between AIH and different statins. This retrospective analysis of statin-associated AIH utilized the FDA Adverse Event Reporting System (FAERS) database (Q1 2004 to Q1 2024) and a systematic literature review. Disproportionality and Bayesian analyses were used to detect potential AIH signals associated with statin use. Among 3,581 AIH reports in the FAERS database, 337 (9.41%) were associated with statins. Among all statins, fluvastatin exhibited the strongest signal, with a relative odds ratio (ROR) of 54.85 (95% CI: 32.32–93.10). Stratified analysis revealed stronger signals in patients ≥ 65 years (ROR 16.83 vs 9.45) and females (ROR 13.88 vs 9.00) compared to patients &lt; 65 years and males, respectively. Statins showed a higher risk of AIH compared to evolocumab, and a similar or lower risk when compared to ezetimibe and fenofibrate. Additionally, 30 cases reported in 20 independent studies were summarized. This study demonstrates a significant association between AIH and the use of statins, particularly among older patients and females. Further research is needed to explore additional risk factors for statin-associated AIH.
DOI: 10.6084/m9.figshare.28143293.v1
title: Autoimmune hepatitis associated with statins: a retrospective study of pharmacovigilance databases and review of the literature

description: Statin-associated autoimmune hepatitis (AIH) is a rare but potentially life-threatening adverse event. Currently, no studies have investigated the association between AIH and different statins. This retrospective analysis of statin-associated AIH utilized the FDA Adverse Event Reporting System (FAERS) database (Q1 2004 to Q1 2024) and a systematic literature review. Disproportionality and Bayesian analyses were used to detect potential AIH signals associated with statin use. Among 3,581 AIH reports in the FAERS database, 337 (9.41%) were associated with statins. Among all statins, fluvastatin exhibited the strongest signal, with a relative odds ratio (ROR) of 54.85 (95% CI: 32.32–93.10). Stratified analysis revealed stronger signals in patients ≥ 65 years (ROR 16.83 vs 9.45) and females (ROR 13.88 vs 9.00) compared to patients &lt; 65 years and males, respectively. Statins showed a higher risk of AIH compared to evolocumab, and a similar or lower risk when compared to ezetimibe and fenofibrate. Additionally, 30 cases reported in 20 independent studies were summarized. This study demonstrates a significant association between AIH and the use of statins, particularly among older patients and females. Further research is needed to explore additional risk factors for statin-associated AIH.
DOI: 10.6084/m9.figshare.28058213
title: Pulmonary toxicity assessment of tumor necrosis factor α inhibitors in the treatment of IBD: a real world study based on US food and drug administration adverse events reporting system (FAERS)

description: Tumor necrosis factor α (TNF-α) inhibitors are widely used in the treatment of inflammatory bowel disease (IBD), but there is still a lack of systematic risk assessment for pulmonary toxicity. We calculated the pulmonary-related risk signals for four TNF-α inhibitors using the disproportionality analysis and also compared them with the pulmonary-related signals of seven other therapies. There were 8736 reports of pulmonary-related adverse events (AEs) to TNF-α inhibitors as the ‘primary suspect (PS)’ therapies. The median time to incident for pulmonary-related AEs was 148 (interquartile range [IQR] 21–721) days. TNF-α inhibitors exhibited the strongest signal of pulmonary toxicity compared to Interleukin 12/23 (IL-12/23) inhibitors, Integrin blockers, Jak inhibitors, and S1P receptor modulator. Golimumab exhibited the strongest signal compared to infliximab, certolizumab pegol, and adalimumab. The strongest signal corresponding to pneumonia, pulmonary tuberculosis, asthma, chronic obstructive pulmonary disease (COPD), pulmonary thrombosis, and pulmonary fibrosis is golimumab, infliximab, infliximab, natalizumab, upadacitinib, and adalimumab. TNF-α inhibitors had the strongest signal of pulmonary toxicity relative to other control therapies. Golimumab had the strongest signal of pulmonary toxicity relative to other TNF-α inhibitors. When TNF-α inhibitors are used in the treatment of IBD, pulmonary-related AEs should be vigilant.
DOI: 10.6084/m9.figshare.28058213.v1
title: Pulmonary toxicity assessment of tumor necrosis factor α inhibitors in the treatment of IBD: a real world study based on US food and drug administration adverse events reporting system (FAERS)

description: Tumor necrosis factor α (TNF-α) inhibitors are widely used in the treatment of inflammatory bowel disease (IBD), but there is still a lack of systematic risk assessment for pulmonary toxicity. We calculated the pulmonary-related risk signals for four TNF-α inhibitors using the disproportionality analysis and also compared them with the pulmonary-related signals of seven other therapies. There were 8736 reports of pulmonary-related adverse events (AEs) to TNF-α inhibitors as the ‘primary suspect (PS)’ therapies. The median time to incident for pulmonary-related AEs was 148 (interquartile range [IQR] 21–721) days. TNF-α inhibitors exhibited the strongest signal of pulmonary toxicity compared to Interleukin 12/23 (IL-12/23) inhibitors, Integrin blockers, Jak inhibitors, and S1P receptor modulator. Golimumab exhibited the strongest signal compared to infliximab, certolizumab pegol, and adalimumab. The strongest signal corresponding to pneumonia, pulmonary tuberculosis, asthma, chronic obstructive pulmonary disease (COPD), pulmonary thrombosis, and pulmonary fibrosis is golimumab, infliximab, infliximab, natalizumab, upadacitinib, and adalimumab. TNF-α inhibitors had the strongest signal of pulmonary toxicity relative to other control therapies. Golimumab had the strongest signal of pulmonary toxicity relative to other TNF-α inhibitors. When TNF-α inhibitors are used in the treatment of IBD, pulmonary-related AEs should be vigilant.
DOI: 10.6084/m9.figshare.28423515
title: Impact of baseline glucocorticoids (GCs) on cardiotoxic events and myocardial damage related to immune checkpoint inhibitors: a retrospective clinical research

description: Immune checkpoint inhibitors (ICIs)-associated cardiotoxic events (CEs) are of increasing concern. Existing research about glucocorticoids (GCs) on immunotherapy focused on ICIs’ efficacy and patients’ outcome. The influence of GCs on ICIs-associated CEs and myocardial damage (MD) remains unknown. This single-center retrospective study included patients treated with ICIs from 2018 to 2022, with follow-up period ending on 30 June 2023. The incidence, risk factors of ICIs-associated CEs, especially MD were described. Additionally, the impact of baseline GCs was assessed by propensity score matching (PSM) to mitigate intergroup differences and ensure comparability. Among 1018 patients, 204 (20.04%) experienced ICIs-associated CEs, including 71 (6.97%) with MD. The mean follow-up time was 40.39 (95% CI 38.47–42.31) weeks. The median time to onset of MD was the shortest at 12.57 weeks (IQR 5.29–25.14). Tumor type, co-medication with platinum and angiogenesis inhibitors may be influential factors of MD. After PSM, the relative risks of CEs (OR 0.4625,95%CI 0.2514–0.7235, <i>p</i> = 0.0020) and MD (OR 0.3254, 95% CI 0.1190–0.8898, <i>p</i> = 0.0378) in GCs1 ≥ 20 mg group were both significantly lower than those in GCs1 &lt; 20 mg. GCs ≥ 20 mg during the first ICIs treatment cycle is significantly associated with the reduced risks of both ICIs-associated CEs and MD.
DOI: 10.6084/m9.figshare.28423515.v1
title: Impact of baseline glucocorticoids (GCs) on cardiotoxic events and myocardial damage related to immune checkpoint inhibitors: a retrospective clinical research

description: Immune checkpoint inhibitors (ICIs)-associated cardiotoxic events (CEs) are of increasing concern. Existing research about glucocorticoids (GCs) on immunotherapy focused on ICIs’ efficacy and patients’ outcome. The influence of GCs on ICIs-associated CEs and myocardial damage (MD) remains unknown. This single-center retrospective study included patients treated with ICIs from 2018 to 2022, with follow-up period ending on 30 June 2023. The incidence, risk factors of ICIs-associated CEs, especially MD were described. Additionally, the impact of baseline GCs was assessed by propensity score matching (PSM) to mitigate intergroup differences and ensure comparability. Among 1018 patients, 204 (20.04%) experienced ICIs-associated CEs, including 71 (6.97%) with MD. The mean follow-up time was 40.39 (95% CI 38.47–42.31) weeks. The median time to onset of MD was the shortest at 12.57 weeks (IQR 5.29–25.14). Tumor type, co-medication with platinum and angiogenesis inhibitors may be influential factors of MD. After PSM, the relative risks of CEs (OR 0.4625,95%CI 0.2514–0.7235, <i>p</i> = 0.0020) and MD (OR 0.3254, 95% CI 0.1190–0.8898, <i>p</i> = 0.0378) in GCs1 ≥ 20 mg group were both significantly lower than those in GCs1 &lt; 20 mg. GCs ≥ 20 mg during the first ICIs treatment cycle is significantly associated with the reduced risks of both ICIs-associated CEs and MD.
DOI: 10.6084/m9.figshare.28483122
title: Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023

description: Levonorgestrel has been utilized in emergency contraception (EC) and for endometrial conditions. While abnormal uterine bleeding is a recognized adverse event (AE), other potential AEs remain undocumented. Safety data for levonorgestrel were acquired from the United States FDA Adverse Event Reporting System (FAERS) database, covering the period from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2023. A disproportionality analysis was conducted to assess the association between levonorgestrel and AEs. A total of 136,168 AEs associated with levonorgestrel were reported. 106 preferred terms (PTs) and 2 system organ class (SOCs) met the criteria established by four algorithms. The identified PTs were vaginal hemorrhage, irregular menstruation, genital hemorrhage and so on. The SOCs encompassed reproductive system and breast disorders, as well as pregnancy, puerperium, and perinatal conditions. Although most findings align with the existing drug inserts for levonorgestrel, several novel AEs were identified in our study. Therefore, ongoing monitoring of this drug is essential and its safety profile should be updated regularly to enhance clinical practice regulation.
DOI: 10.6084/m9.figshare.28483122.v1
title: Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023

description: Levonorgestrel has been utilized in emergency contraception (EC) and for endometrial conditions. While abnormal uterine bleeding is a recognized adverse event (AE), other potential AEs remain undocumented. Safety data for levonorgestrel were acquired from the United States FDA Adverse Event Reporting System (FAERS) database, covering the period from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2023. A disproportionality analysis was conducted to assess the association between levonorgestrel and AEs. A total of 136,168 AEs associated with levonorgestrel were reported. 106 preferred terms (PTs) and 2 system organ class (SOCs) met the criteria established by four algorithms. The identified PTs were vaginal hemorrhage, irregular menstruation, genital hemorrhage and so on. The SOCs encompassed reproductive system and breast disorders, as well as pregnancy, puerperium, and perinatal conditions. Although most findings align with the existing drug inserts for levonorgestrel, several novel AEs were identified in our study. Therefore, ongoing monitoring of this drug is essential and its safety profile should be updated regularly to enhance clinical practice regulation.
DOI: 10.6084/m9.figshare.28359504
title: Post-marketing safety concerns with luspatercept: a disproportionality analysis of the FDA adverse event reporting system

description: Luspatercept, approved for treating beta thalassemia, myelodysplastic syndromes (MDS) associated anemia, and MDS with ring sideroblasts or myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis associated anemia, has uncertain long-term safety in large populations. This study analyzed adverse events (AEs) linked to luspatercept using data from the FDA Adverse Event Reporting System (FAERS) with data mining techniques. We collected and analyzed luspatercept-related reports from the FAERS database from the first quarter of 2022 through the first quarter of 2024. Disproportionality analysis was used in data mining to quantify luspatercept-related AE signals. A total of 46 AE signals were detected in 13 SOCs (system organ classes). In addition to the AEs identified during the clinical trial stage, this study also identified some unexpected and important AEs, such as product preparation error, prescribed overdose, product preparation issue, prescribed underdose, and acute hepatitis. Our study provides a comprehensive description of the post-marketing safety of luspatercept and identifies new potential AEs. Healthcare workers must be vigilant in avoiding product preparation errors, an adverse event that highlights the need for enhanced training and the participation of pharmacists in assessing medication utilization scenarios.
DOI: 10.6084/m9.figshare.28359504.v1
title: Post-marketing safety concerns with luspatercept: a disproportionality analysis of the FDA adverse event reporting system

description: Luspatercept, approved for treating beta thalassemia, myelodysplastic syndromes (MDS) associated anemia, and MDS with ring sideroblasts or myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis associated anemia, has uncertain long-term safety in large populations. This study analyzed adverse events (AEs) linked to luspatercept using data from the FDA Adverse Event Reporting System (FAERS) with data mining techniques. We collected and analyzed luspatercept-related reports from the FAERS database from the first quarter of 2022 through the first quarter of 2024. Disproportionality analysis was used in data mining to quantify luspatercept-related AE signals. A total of 46 AE signals were detected in 13 SOCs (system organ classes). In addition to the AEs identified during the clinical trial stage, this study also identified some unexpected and important AEs, such as product preparation error, prescribed overdose, product preparation issue, prescribed underdose, and acute hepatitis. Our study provides a comprehensive description of the post-marketing safety of luspatercept and identifies new potential AEs. Healthcare workers must be vigilant in avoiding product preparation errors, an adverse event that highlights the need for enhanced training and the participation of pharmacists in assessing medication utilization scenarios.