cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.28089245.v2
title: Metoprolol adverse events and literature analyses: case/non-case analyses using the FDA Adverse Event Reporting System (FAERS)

description: In recent years, β-blockers such as metoprolol have been upgraded to first-line antihypertensive drugs. However, metoprolol demonstrates poor prognosis effects on diseases such as stroke. Further clinical application may expand the possibility of its related adverse reactions. Currently, there is a lack of comprehensive research on the overall safety of metoprolol. Statistical analysis and signal mining were conducted on adverse event reports related to metoprolol obtained from the FAERS database. Signal mining was conducted using the proportional reporting ratio, the report margin method, the bayesian confidence propagation neural network, and empirical Bayesian geometric mean in the measures of disproportionality to detect potential adverse reaction signals. The results showed 16,853 reports related to metoprolol use, identifying 506 preferred terms (PTs) covering 23 system organ classes (SOCs). In addition, some new potential adverse reactions appeared among the top 30 PTs ranked by signal strength, such as ‘orthostatic intolerance’ (IC025 = 3.00), ‘trigemino-cardiac reflex’ (IC025 = 4.30), ‘decorticate posture’ (IC025 = 3.34), etc. Notably, there was a strong association between ‘suspected suicide’ (IC025 = 5.59) and the drug signal. This study identified unexpected signals of serious adverse reactions, suggesting the importance of continuous post-marketing surveillance of metoprolol to understand its potential risks.
DOI: 10.6084/m9.figshare.29039889
title: Adverse events of concomitant use of immune checkpoint inhibitors and metformin or statin: an observational, retrospective disproportionality analysis

description: Preclinical investigations have indicated that the concurrent administration of ICIs with statins or metformin may enhance the anticancer properties. Nevertheless, the patterns of potential toxicity associated with this combination have yet to be elucidated. We utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) to provide an overview of the adverse event landscape tied to the concomitant utilization of ICI and statins or metformin. Our study reveals significant side effects associated with combining ICIs with metformin or statins, including gastrointestinal, respiratory, hepatobiliary, and renal disorders. Amalgamated treatment of ICIs plus metformin may heighten the likelihood of bone marrow aplasia, inflammatory bowel disease, intestinal perforation, hepatic impairments, insomnia, autoimmune nephritis, and eczematous manifestations. For ICIs plus statins, colitis, pneumonitis, interstitial lung disease, hypothyroidism, adrenal insufficiency, myocarditis, myositis, hypophysitis, myasthenia gravis, and hepatitis. Importantly, a significant number of adverse events occur within the first two months of starting ICIs alongside metformin or statins, with some appearing after a year of treatment, emphasizing the need for ongoing monitoring. The observations delineated offer pivotal insights into the refinement of the co-administration strategy for ICIs with metformin or statins, attenuating the incidence of adverse side effects.
DOI: 10.6084/m9.figshare.28089245
title: Metoprolol adverse events and literature analyses: case/non-case analyses using the FDA Adverse Event Reporting System (FAERS)

description: In recent years, β-blockers such as metoprolol have been upgraded to first-line antihypertensive drugs. However, metoprolol demonstrates poor prognosis effects on diseases such as stroke. Further clinical application may expand the possibility of its related adverse reactions. Currently, there is a lack of comprehensive research on the overall safety of metoprolol. Statistical analysis and signal mining were conducted on adverse event reports related to metoprolol obtained from the FAERS database. Signal mining was conducted using the proportional reporting ratio, the report margin method, the bayesian confidence propagation neural network, and empirical Bayesian geometric mean in the measures of disproportionality to detect potential adverse reaction signals. The results showed 16,853 reports related to metoprolol use, identifying 506 preferred terms (PTs) covering 23 system organ classes (SOCs). In addition, some new potential adverse reactions appeared among the top 30 PTs ranked by signal strength, such as ‘orthostatic intolerance’ (IC025 = 3.00), ‘trigemino-cardiac reflex’ (IC025 = 4.30), ‘decorticate posture’ (IC025 = 3.34), etc. Notably, there was a strong association between ‘suspected suicide’ (IC025 = 5.59) and the drug signal. This study identified unexpected signals of serious adverse reactions, suggesting the importance of continuous post-marketing surveillance of metoprolol to understand its potential risks.
DOI: 10.6084/m9.figshare.28089245.v1
title: Metoprolol adverse events and literature analyses: case/non-case analyses using the FDA adverse event reporting system (FAERS)

description: In recent years, β-blockers such as metoprolol have been upgraded to first-line antihypertensive drugs. However, metoprolol demonstrates poor prognosis effects on diseases such as stroke. Further clinical application may expand the possibility of its related adverse reactions. Currently, there is a lack of comprehensive research on the overall safety of metoprolol. Statistical analysis and signal mining were conducted on adverse event reports related to metoprolol obtained from the FAERS database. Signal mining was conducted using the proportional reporting ratio, the report margin method, the bayesian confidence propagation neural network, and empirical Bayesian geometric mean in the measures of disproportionality to detect potential adverse reaction signals. The results showed 16,853 reports related to metoprolol use, identifying 506 preferred terms (PTs) covering 23 system organ classes (SOCs). In addition, some new potential adverse reactions appeared among the top 30 PTs ranked by signal strength, such as ‘orthostatic intolerance’ (IC025 = 3.00), ‘trigemino-cardiac reflex’ (IC025 = 4.30), ‘decorticate posture’ (IC025 = 3.34), etc. Notably, there was a strong association between ‘suspected suicide’ (IC025 = 5.59) and the drug signal. This study identified unexpected signals of serious adverse reactions, suggesting the importance of continuous post-marketing surveillance of metoprolol to understand its potential risks.
DOI: 10.6084/m9.figshare.28436108
title: Drug-induced skin ulcer: real-world pharmacovigilance analysis based on the FDA adverse event reporting system

description: Skin ulcer (SU) may increase the risk of systemic infections and have evolved into an important public health problem. However, there is a lack of research specifically on drug-induced SU. We extracted data on adverse drug events (ADEs) associated with SU from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis was performed to calculate the risk signals for drugs that may induce SU. Logistic regression analysis was carried out to investigate the factors influencing the occurrence of SU. 21372 cases of SU were reported in FAERS database between 2005 and 2024. Based on the frequency of ADE reports, we compiled a list of the top 50 drugs associated with SU. Only 15 drugs had explicit mentions of SU in their instructions, while 32 drugs were recognized as positive signals for SU by reporting odds ratio model. Logistic regression revealed the duration of medication was the risk factor for tocilizumab, alendronate sodium, and erlotinib usage. Females were also identified as risk factor for erlotinib. Our study identified 32 drugs potentially inducing SU, which provides valuable insights for targeted prevention and treatment strategies aimed at mitigating the risk of drug-induced SU.
DOI: 10.6084/m9.figshare.27204728.v1
title: Clinical adverse events to letairis: a real-world drug safety study based on FDA adverse event reporting system (FAERS)

description: Letairis (ambrisentan), an endothelin receptor antagonist (ERA), is a critical medication for pulmonary arterial hypertension (PAH). Despite its efficacy, its safety profile is under scrutiny, warranting a detailed analysis. This study leveraged the FDA Adverse Event Reporting System (FAERS) from Q1 2007 to Q4 2023, focusing on Letairis as the primary suspect in adverse events. Employing advanced data mining techniques such as Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), the study aimed to uncover safety signals. A total of 43,774 cases were identified, with Letairis implicated in 16,038,963 adverse event reports. There was a notable predominance of female patients (75.30%), with a median age around 64 years. Severe outcomes, including hospitalization (51.63%) and fatalities (20.44%), were prevalent. Signal strength analysis highlighted concerns in infections and infestations, as well as cardiac disorders. The analysis underscores the need for vigilant pharmacovigilance and highlights Letairis’s potential to induce serious AEs, particularly in female and elderly populations. These findings are instrumental in guiding clinical practice and future drug safety assessments.
DOI: 10.6084/m9.figshare.28397065
title: Assessment of Riociguat-related adverse events: a disproportionality analysis utilizing the FDA adverse event reporting system database

description: Riociguat is a novel soluble guanylate cyclase stimulator approved for the treatment of pulmonary arterial hypertension (PAH). Despite its widespread use, there has been a lack of large-scale studies assessing the adverse events (AEs) associated with this medication. This study aimed to evaluate the AEs related to Riociguat by analyzing data from the FDA Adverse Event Reporting System (FAERS) from Q4 2013 to Q1 2024. A total of 12,149 AE reports were analyzed using four different disproportionality signal detection methodologies to identify significant AEs associated with Riociguat. The analysis revealed 117 preferred terms (PTs) with significant disproportionality signals across all four methods. Among these, common AEs included ‘headache,’ ‘dizziness,’ ‘hypotension,’ ‘nausea,’ ‘fall,’ and ‘loss of consciousness.’ Notably, several unexpected AEs, such as ‘fatigue,’ ‘malaise,’ ‘asthenia,’ ‘feeling abnormal,’ and ‘pain in extremity,’ were identified, which were not highlighted in the product’s package insert. Additionally, gender-specific differences were observed in certain adverse events. This study offers insights into Riociguat’s side effects. Clinicians should monitor patients closely for unexpected symptoms like limb pain and fatigue, paying particular attention to male patients, as some AEs occur more frequently in this group. Riociguat is used to treat PAH and chronic thromboembolic pulmonary hypertension (CTEPH), with its indications expanding. This study analyzed 12,149 reports from the FAERS between 2013 and 2024. Common side effects like headache, dizziness, and syncope were identified, along with unexpected ones such as fatigue, malaise, and limb pain. Notably, some side effects were observed differently in males and females. These findings suggest that doctors should closely monitor patients using Riociguat to minimize risks and ensure the safe use of the drug.
DOI: 10.6084/m9.figshare.28397065.v1
title: Assessment of Riociguat-related adverse events: a disproportionality analysis utilizing the FDA adverse event reporting system database

description: Riociguat is a novel soluble guanylate cyclase stimulator approved for the treatment of pulmonary arterial hypertension (PAH). Despite its widespread use, there has been a lack of large-scale studies assessing the adverse events (AEs) associated with this medication. This study aimed to evaluate the AEs related to Riociguat by analyzing data from the FDA Adverse Event Reporting System (FAERS) from Q4 2013 to Q1 2024. A total of 12,149 AE reports were analyzed using four different disproportionality signal detection methodologies to identify significant AEs associated with Riociguat. The analysis revealed 117 preferred terms (PTs) with significant disproportionality signals across all four methods. Among these, common AEs included ‘headache,’ ‘dizziness,’ ‘hypotension,’ ‘nausea,’ ‘fall,’ and ‘loss of consciousness.’ Notably, several unexpected AEs, such as ‘fatigue,’ ‘malaise,’ ‘asthenia,’ ‘feeling abnormal,’ and ‘pain in extremity,’ were identified, which were not highlighted in the product’s package insert. Additionally, gender-specific differences were observed in certain adverse events. This study offers insights into Riociguat’s side effects. Clinicians should monitor patients closely for unexpected symptoms like limb pain and fatigue, paying particular attention to male patients, as some AEs occur more frequently in this group. Riociguat is used to treat PAH and chronic thromboembolic pulmonary hypertension (CTEPH), with its indications expanding. This study analyzed 12,149 reports from the FAERS between 2013 and 2024. Common side effects like headache, dizziness, and syncope were identified, along with unexpected ones such as fatigue, malaise, and limb pain. Notably, some side effects were observed differently in males and females. These findings suggest that doctors should closely monitor patients using Riociguat to minimize risks and ensure the safe use of the drug.
DOI: 10.6084/m9.figshare.28415136
title: The efficacy and safety of omadacycline in treating acute bacterial infections: a meta-analysis of randomized controlled trials

description: This study aimed to reevaluate the clinical efficacy and safety of omadacycline in treating acute bacterial infections. We searched PubMed, Embase, Cochrane Library, Web of Science, and Clinical Trials up to 1 January 2024, including only randomized controlled trials comparing OMC with other antibiotics in adults. Primary outcomes were clinical and microbiological responses; secondary outcomes included adverse events. Seven RCTs with 2957 patients met the inclusion criteria. OMC showed a slightly better clinical response at the post-therapy evaluation phase in the clinically evaluable population (RR = 1.03, 95% CI = 1.01–1.05, I<sup>2</sup> = 0%). Microbial eradication rates for Gram-positive and Gram-negative infections showed no significant differences between OMC and comparators. Safety analysis revealed no significant differences in overall AEs, treatment-related AEs, serious AEs, or drug discontinuation due to AEs. However, OMC had a lower risk of diarrhea (RR: 0.48, 95% CI = 0.23–1.00, I<sup>2</sup> = 65%). All-cause mortality did not differ significantly between OMC and comparators. OMC is a safe and effective treatment for acute bacterial infections, comparable to other antibiotics. This study has been registered in the online systematic review database (Prospective Register of Systematic Reviews [PROSPERO]), and the registration number is CRD42024575416.
DOI: 10.6084/m9.figshare.28415136.v1
title: The efficacy and safety of omadacycline in treating acute bacterial infections: a meta-analysis of randomized controlled trials

description: This study aimed to reevaluate the clinical efficacy and safety of omadacycline in treating acute bacterial infections. We searched PubMed, Embase, Cochrane Library, Web of Science, and Clinical Trials up to 1 January 2024, including only randomized controlled trials comparing OMC with other antibiotics in adults. Primary outcomes were clinical and microbiological responses; secondary outcomes included adverse events. Seven RCTs with 2957 patients met the inclusion criteria. OMC showed a slightly better clinical response at the post-therapy evaluation phase in the clinically evaluable population (RR = 1.03, 95% CI = 1.01–1.05, I<sup>2</sup> = 0%). Microbial eradication rates for Gram-positive and Gram-negative infections showed no significant differences between OMC and comparators. Safety analysis revealed no significant differences in overall AEs, treatment-related AEs, serious AEs, or drug discontinuation due to AEs. However, OMC had a lower risk of diarrhea (RR: 0.48, 95% CI = 0.23–1.00, I<sup>2</sup> = 65%). All-cause mortality did not differ significantly between OMC and comparators. OMC is a safe and effective treatment for acute bacterial infections, comparable to other antibiotics. This study has been registered in the online systematic review database (Prospective Register of Systematic Reviews [PROSPERO]), and the registration number is CRD42024575416.
DOI: 10.6084/m9.figshare.28379229
title: Adverse event profile of setmelanotide in obesity: an integrated assessment and systematic review using disproportionality analysis, case reports and meta-analysis

description: Setmelanotide is approved for genetically determined obesity. While clinical trials and clinical evidence and practice provide some insights, a comprehensive assessment of its adverse event profile is needed that led to carrying out an assessment of reported adverse events in the USFDA Adverse Event Reporting System database, case reports and clinical trials. Multi-faceted analyses were carried out as follows: disproportionality measures employing frequentist and Bayesian methods; systematic review and meta-analysis (Medline, Cochrane CENTRAL and Google Scholar) generated-pooled estimates [proportion with 95% confidence intervals (CI)]; and published reports with adverse events to setmelanotide. The disproportionality analysis (<i>n</i> = 228) identified skin hyperpigmentation, injection-site reactions, nausea, melanocytic nevus and ephelides as key safety signals. Meta-analysis (seven trials; <i>n</i> = 185) confirmed high rates of injection-site reactions (96%; 95% CI: 89, 100), skin hyperpigmentation (62%; 95% CI: 43, 78), nausea (36%; 95% CI: 24, 49), vomiting (26%; 95% CI: 18, 34), and diarrhea (21%; 95% CI: 14, 29). Individual case reports corroborated these findings. This study provides a detailed overview of setmelanotide’s adverse event profile, highlighting the need for careful patient monitoring, emphasizing the importance of ongoing safety surveillance for at least 1.5 years, and further research to refine patient management strategies.
DOI: 10.6084/m9.figshare.28379229.v1
title: Adverse event profile of setmelanotide in obesity: an integrated assessment and systematic review using disproportionality analysis, case reports and meta-analysis

description: Setmelanotide is approved for genetically determined obesity. While clinical trials and clinical evidence and practice provide some insights, a comprehensive assessment of its adverse event profile is needed that led to carrying out an assessment of reported adverse events in the USFDA Adverse Event Reporting System database, case reports and clinical trials. Multi-faceted analyses were carried out as follows: disproportionality measures employing frequentist and Bayesian methods; systematic review and meta-analysis (Medline, Cochrane CENTRAL and Google Scholar) generated-pooled estimates [proportion with 95% confidence intervals (CI)]; and published reports with adverse events to setmelanotide. The disproportionality analysis (<i>n</i> = 228) identified skin hyperpigmentation, injection-site reactions, nausea, melanocytic nevus and ephelides as key safety signals. Meta-analysis (seven trials; <i>n</i> = 185) confirmed high rates of injection-site reactions (96%; 95% CI: 89, 100), skin hyperpigmentation (62%; 95% CI: 43, 78), nausea (36%; 95% CI: 24, 49), vomiting (26%; 95% CI: 18, 34), and diarrhea (21%; 95% CI: 14, 29). Individual case reports corroborated these findings. This study provides a detailed overview of setmelanotide’s adverse event profile, highlighting the need for careful patient monitoring, emphasizing the importance of ongoing safety surveillance for at least 1.5 years, and further research to refine patient management strategies.
DOI: 10.6084/m9.figshare.27981667
title: Thromboembolic events associated with combined oral contraceptives: a real-world study based on the FDA adverse event reporting system (FAERS) database

description: The clinical characteristics and time-to-onset of thromboembolic events (TEEs) associated with combined oral contraceptives (COCs) remain unclear, our current study was committed to providing more data for risk evaluation and management of COCs treatment. This pharmacovigilance study was conducted in the FAERS database. We evaluated significant pharmacovigilance signals by using disproportionality analysis. The Weibull shape parameter test was used to analyze the time-to-onset of TEEs. A total of 25,080 adverse events were involved in this study. Overall COCs were significantly related to venous thromboembolism (VTE) events. Levonorgestrel, desogestrel, and drospirenone containing COCs were significantly associated with arterial thromboembolism (ATE) besides norethisterone containing COCs. Drospirenone containing COCs associated with TEEs had the highest reporting frequencies (<i>n</i> = 22868, 91.18%). The most-mentioned PT was pulmonary embolism (<i>n</i> = 9244, 36.86%). The median time-to-onset of all TEEs was 264 days, the median time-to-onset of VTE was 258.0 days, shorter than ATE (344.0 days). The Weibull shape parameter test results showed that all of the disproportionality signals had early failure-type features. This study found an increased risk of TEEs treated with COCs, particularly with drospirenone. We should pay close attention to risk monitor on the treatment of early stages.
DOI: 10.6084/m9.figshare.27981667.v1
title: Thromboembolic events associated with combined oral contraceptives: a real-world study based on the FDA adverse event reporting system (FAERS) database

description: The clinical characteristics and time-to-onset of thromboembolic events (TEEs) associated with combined oral contraceptives (COCs) remain unclear, our current study was committed to providing more data for risk evaluation and management of COCs treatment. This pharmacovigilance study was conducted in the FAERS database. We evaluated significant pharmacovigilance signals by using disproportionality analysis. The Weibull shape parameter test was used to analyze the time-to-onset of TEEs. A total of 25,080 adverse events were involved in this study. Overall COCs were significantly related to venous thromboembolism (VTE) events. Levonorgestrel, desogestrel, and drospirenone containing COCs were significantly associated with arterial thromboembolism (ATE) besides norethisterone containing COCs. Drospirenone containing COCs associated with TEEs had the highest reporting frequencies (<i>n</i> = 22868, 91.18%). The most-mentioned PT was pulmonary embolism (<i>n</i> = 9244, 36.86%). The median time-to-onset of all TEEs was 264 days, the median time-to-onset of VTE was 258.0 days, shorter than ATE (344.0 days). The Weibull shape parameter test results showed that all of the disproportionality signals had early failure-type features. This study found an increased risk of TEEs treated with COCs, particularly with drospirenone. We should pay close attention to risk monitor on the treatment of early stages.