Expert Opinion on Drug Safety最新文献

Adverse events associated with aromatase inhibitors: an analysis of real-world datasets and drug-gene interaction network. 与芳香化酶抑制剂相关的不良事件：真实世界数据集和药物基因相互作用网络分析》。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-11 DOI: 10.1080/14740338.2024.2424443

Si-Qi Zhang, Shujing Jia, Xiang Li, Rui-Rui Hu, Zhanyang Luo, Junhai Wang, Hongyan Xi

{"title":"Adverse events associated with aromatase inhibitors: an analysis of real-world datasets and drug-gene interaction network.","authors":"Si-Qi Zhang, Shujing Jia, Xiang Li, Rui-Rui Hu, Zhanyang Luo, Junhai Wang, Hongyan Xi","doi":"10.1080/14740338.2024.2424443","DOIUrl":"10.1080/14740338.2024.2424443","url":null,"abstract":"Background: Aromatase inhibitors (AIs) are commonly used to treat postmenopausal hormone receptor positive breast cancer, but there is currently a lack of comprehensive safety reports on AIs in large-scale cohorts.Research design and methods: We conducted a retrospective pharmacovigilance survey based on the FDA Adverse Event Reporting System, retrieving relevant reports from the 2004 to the 2023, aiming to conduct a comprehensive comparative analysis of adverse reactions associated with AIs. In addition, we elucidated the potential toxicological mechanisms of AIs related adverse events through functional enrichment analysis.Results: A total of 7,933 adverse event reports related to AIs were collected, and there were 642 positive signals at the preferred term level. The top three signal intensities for anastrozole are: antiphospholipid syndrome, plantar fasciitis and autoimmune pancreatitis. The top three signal intensities for letrozole are: androgenetic alopecia and myosclerosis, pneumonic herpes virus. The top three signal intensities for exemestane are: infection reactivation, thyroxine free decreased and dilatation atrial. In terms of onset time, letrozole has the earliest onset time overall, followed by exemestane, and finally anastrozole.Conclusions: Our research corroborates the typical adverse events linked to AIs while highlighting potential safety concerns in their real-world clinical application.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Real-world analysis of levetiracetam-associated rhabdomyolysis: insights from the FDA adverse event reporting system. 左乙拉西坦相关横纹肌溶解症的真实世界分析：美国食品药品管理局不良事件报告系统的启示。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-08 DOI: 10.1080/14740338.2024.2421340

Guo Yinan, Gong Guangming, Guo Guangyu, Cheng Xianghai, Yin Jingwen, Qin Jie

{"title":"Real-world analysis of levetiracetam-associated rhabdomyolysis: insights from the FDA adverse event reporting system.","authors":"Guo Yinan, Gong Guangming, Guo Guangyu, Cheng Xianghai, Yin Jingwen, Qin Jie","doi":"10.1080/14740338.2024.2421340","DOIUrl":"10.1080/14740338.2024.2421340","url":null,"abstract":"Background: Levetiracetam, a widely prescribed antiseizure medication, is recognized for its broad-spectrum efficacy, good tolerability, and minimal drug interactions. This study examines the association between levetiracetam and rhabdomyolysis, utilizing real-world data from the FDA Adverse Event Reporting System (FAERS) database to further elucidate its safety profile.Methods: This study extracted adverse events related to levetiracetam from the FAERS database (Q1 2013 to Q1 2024). Four types of disproportionality analysis identified rhabdomyolysis as a significant adverse event. Logistic regression assessed risk factors, including gender, age, and severity. A Gaussian Mixture Model analyzed the time-to-onset distribution of rhabdomyolysis, while the impact of concomitant medications on its risk was evaluated using Reporting Odds Ratio (ROR).Results: Levetiracetam significantly increased rhabdomyolysis risk (ROR = 13.5). Males showed a higher incidence (OR = 2.60). Most adverse events occurred within the first 30 days, with a bimodal onset distribution. Co-administration of antibiotics, antipsychotics, and PPIs elevated the risk while other antiseizure medications did not.Conclusion: This study found a significant association between levetiracetam and the risk of rhabdomyolysis, highlighting the need for increased clinical vigilance in this patient population. Future research should focus on elucidating the underlying mechanisms and optimizing clinical guidelines.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Ocular adverse events associated with GLP-1 receptor agonists: a real-world study based on the FAERS database and network pharmacology. 与 GLP-1 受体激动剂相关的眼部不良事件：基于 FAERS 数据库和网络药理学的真实世界研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-07 DOI: 10.1080/14740338.2024.2419989

Zhan-Yang Luo, Xiang Li, Cui-Ting Chen, Hong-Hua Kang, Zhi-Jie Zhang, Dong Wang, Jing-Ru Gong

{"title":"Ocular adverse events associated with GLP-1 receptor agonists: a real-world study based on the FAERS database and network pharmacology.","authors":"Zhan-Yang Luo, Xiang Li, Cui-Ting Chen, Hong-Hua Kang, Zhi-Jie Zhang, Dong Wang, Jing-Ru Gong","doi":"10.1080/14740338.2024.2419989","DOIUrl":"10.1080/14740338.2024.2419989","url":null,"abstract":"Objective: This study evaluates the risk of ocular adverse events (AEs) associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) using data from the FDA Adverse Event Reporting System (FAERS) and network pharmacology methods.Methods: FAERS data from 2004 to 2024 were analyzed for ocular AEs linked to GLP-1 RA treatments. Disproportionality analysis (Reporting Odds Ratio, ROR) was used to identify signals, and a drug-gene interaction network explored potential mechanisms.Results: Among 17,785,793 FAERS reports, semaglutide and lixisenatide were significantly associated with ocular AEs, with RORs of 1.25 (95% CI, 1.20-1.31) and 1.96 (95% CI, 1.70-2.27), respectively. Commonly reported AEs included blurred vision, visual impairment, and diabetic retinopathy, with some AEs occurring as early as 10 days after treatment initiation. Gene enrichment analysis highlighted potential links between GLP-1-related genes and ocular AEs.Conclusion: The widespread use of GLP-1 RAs has raised concerns regarding their ophthalmic safety. This study contributes new evidence from real-world data, suggesting that semaglutide and lixisenatide are associated with significant risks of ocular AEs. Further experimental studies are warranted to elucidate the underlying mechanisms and confirm these associations.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Is metformin safe in pregnancy: a focus on offspring outcomes. 二甲双胍在孕期是否安全：关注后代的结果。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-04 DOI: 10.1080/14740338.2024.2424410

Rana Malek, Stephen N Davis

{"title":"Is metformin safe in pregnancy: a focus on offspring outcomes.","authors":"Rana Malek, Stephen N Davis","doi":"10.1080/14740338.2024.2424410","DOIUrl":"10.1080/14740338.2024.2424410","url":null,"abstract":"Introduction: Metformin has been part of treatment algorithms for type 2 diabetes mellitus (T2DM) for decades. While it has formal approval in the U.S.A. for treatment of T2DM, it is used off-label in gestational diabetes mellitus (GDM), polycystic ovarian syndrome (PCOS), and ovarian hyperstimulation prevention. Its role as an insulin sensitizer has made it an attractive therapeutic to address the insulin resistance seen in these syndromes. In 2022, the European Union approved metformin as the only oral antidiabetic medication for diabetes in pregnancy. While its safety and benefits for the mother are well documented, it does cross the placenta with plasma concentrations comparable between mother and child at delivery.Areas covered: This special report will focus on major randomized control trials investigating metformin use in pregnancies impacted by PCOS, GDM, T2DM, and obesity and their offspring follow-up trials.Expert opinion: For the mother, metformin can be beneficial, with reduction in insulin therapeutic burden, weight gain, hypoglycemia and in certain situations, pre-eclampsia. For the neonate, benefits may include reduction in hypoglycemia and no increased risk of congenital anomalies. It is the long-term data in the offspring that remains unknown with some areas of concerns (SGA, altered anthropometrics) requiring continued research.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Statin alternatives for the treatment of hypercholesterolemia - a safety evaluation. 治疗高胆固醇血症的他汀类药物替代品--安全性评估。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-03 DOI: 10.1080/14740338.2024.2424411

Weiwei Zeng, Brian Tomlinson

{"title":"Statin alternatives for the treatment of hypercholesterolemia - a safety evaluation.","authors":"Weiwei Zeng, Brian Tomlinson","doi":"10.1080/14740338.2024.2424411","DOIUrl":"10.1080/14740338.2024.2424411","url":null,"abstract":"Introduction: Statins are well established as the first-line treatment to reduce low-density-lipoprotein cholesterol (LDL-C) and cardiovascular (CV) events, but some patients are unable to tolerate effective doses or sometimes any dose of statins and alternative treatments may be required.Areas covered: In this review we summarize the relevant published literature obtained from a PubMed search on the safety of statin alternatives for the treatment of hypercholesterolemia.Expert opinion: The main alternatives to statins are ezetimibe, the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, evolocumab, alirocumab, and inclisiran, and the recently approved bempedoic acid. These have all shown an excellent safety profile and have not been associated with skeletal muscle symptoms or with increased risk of new onset diabetes and they have no major drug interactions. The injectable PCSK9 inhibitors are associated with a small increase in injection site reactions which are usually of mild or moderate intensity. Bempedoic acid is associated with a small increase in plasma uric acid and slightly increased frequency of episodes of gout in susceptible subjects. The cost and availability and the degree of lowering of LDL-C required are more likely to determine the choice of statin alternatives than the safety issues.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database. 药物诱发的非感染性心肌炎：FAERS 数据库的比例失调分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-03 DOI: 10.1080/14740338.2024.2423679

Liyuan Yan, Guanqun Zheng

{"title":"Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database.","authors":"Liyuan Yan, Guanqun Zheng","doi":"10.1080/14740338.2024.2423679","DOIUrl":"10.1080/14740338.2024.2423679","url":null,"abstract":"Background: This investigation aims to identify and evaluate the most common and critical drugs associated with the risk of noninfectious myocarditis utilizing the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods: Data pertaining to noninfectious myocarditis from 2004 Q1 to 2024 Q2 were extracted. Following data standardization, multiple signal quantification techniques, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio, were employed for analysis.Results: The study identified a total of 10,763 adverse event reports associated with noninfectious myocarditis. Disproportionality analysis revealed that the top 5 drugs by ROR were phendimetrazine tartrate (ROR 104.64), trimethoprim + sulfamethoxazole (ROR 67.65), aldesleukin (ROR 52.67), mesalazine (ROR 49.73), and balsalazide disodium (ROR 45.26). Notably, among the 30 drugs with the strongest ROR signals, 8 drugs lacked myocarditis risk information in their package inserts.Conclusion: Through comprehensive analysis of the FAERS database, our study identified drugs with a strong signal for myocarditis that are not currently indicated on their labels. The findings suggest that the potential risk of myocarditis associated with these medications is significant and warrants close monitoring in clinical practice.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Adverse events in patients with cardiovascular disease taking proton pump inhibitors. 服用前列腺素泵抑制剂的心血管疾病患者的不良反应。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-10-28 DOI: 10.1080/14740338.2024.2409702

Aitor Lanas-Gimeno, Ángel Lanas

{"title":"Adverse events in patients with cardiovascular disease taking proton pump inhibitors.","authors":"Aitor Lanas-Gimeno, Ángel Lanas","doi":"10.1080/14740338.2024.2409702","DOIUrl":"10.1080/14740338.2024.2409702","url":null,"abstract":"Introduction: Proton pump inhibitors (PPIs) rank among the most frequently prescribed medications to treat acid-related diseases. Mounting concerns surround the potential for serious adverse events, including cardiovascular events, associated with their prolonged use/misuse.Areas covered: This comprehensive review explores cardiovascular adverse events linked to PPI use among high-risk cardiovascular patients. A structured search was conducted on PubMed.Expert opinion: Many patients with cardiovascular disease who require antiplatelet treatment will require long-term PPI treatment. Interpreting the published data is not straightforward. First, because there is no plausible mechanistic explanation for PPIs to induce cardiovascular events apart from the potential interaction with the metabolism of thienopyridines. Although several observational studies have shown an increased cardiovascular risk and mortality in patients taking long-term PPIs, most available clinical trials and meta-analyses of available studies do not. However, the absence of firm evidence of this link does not necessarily imply that this association does not exist, and other hypothesis must be explored. Anemia is a common event in patients who take antiplatelet therapy and PPIs, and it is a factor associated with cardiovascular events and death. Anemia in these patients is often attributed to erosive lesions of the small intestine, where PPI may play a key role by modifying the microbiota.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Safety considerations for drugs newly approved for treating acute myeloid leukemia. 新批准用于治疗急性髓性白血病的药物的安全性考虑因素。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-10-08 DOI: 10.1080/14740338.2024.2412236

Aleksandra Gołos, Joanna Góra-Tybor, Tadeusz Robak

{"title":"Safety considerations for drugs newly approved for treating acute myeloid leukemia.","authors":"Aleksandra Gołos, Joanna Góra-Tybor, Tadeusz Robak","doi":"10.1080/14740338.2024.2412236","DOIUrl":"10.1080/14740338.2024.2412236","url":null,"abstract":"Introduction: Acute myeloid leukemia (AML) is typically characterized by a poor prognosis, mainly due to the median age at diagnosis. Until recently, treatment options were limited to intensive chemotherapy (IC) for young patients or hypomethylating agents for those ineligible for IC. Since 2017, nine molecules were registered for newly-diagnosed AML: midostaurin, gilteritinib, quizartinib, enasidenib, ivosidenib, gemtuzumab ozogamicin, CPX-351, glasdegib, and venetoclax.Areas covered: The review examines the safety profile of these drugs and their interactions with other agents used in supportive care. The PubMed and Google Scholar databases were searched for articles in English concerning new agents in AML from 2017 until 2023. Further relevant publications were obtained by reviewing the prescribing information and Food and Drug Administration (FDA) data.Expert opinion: The therapeutic spectrum in AML has broadened over several years and can also improve outcomes in older patients. However, in addition to their well-known cytotoxic activity, new molecules cause several unique, off-target toxicities. Also, potential drug-drug interactions (DDI) should be taken into consideration when choosing optimal first-line therapy; this remains a challenge in clinical practice.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of hemorrhagic drug-drug interactions between P-gp inhibitors and direct oral anticoagulants from the FDA Adverse Event Reporting System. 从 FDA 不良事件报告系统中分析 P-gp 抑制剂和直接口服抗凝剂之间的出血性药物相互作用。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-07-08 DOI: 10.1080/14740338.2024.2376693

Mengyao Li, Jian Xiao, Ting Yu, Ling Huang, Ruwen Cai, Huimin Yu, Jingyang Li, Shuqiao Cheng

{"title":"Analysis of hemorrhagic drug-drug interactions between P-gp inhibitors and direct oral anticoagulants from the FDA Adverse Event Reporting System.","authors":"Mengyao Li, Jian Xiao, Ting Yu, Ling Huang, Ruwen Cai, Huimin Yu, Jingyang Li, Shuqiao Cheng","doi":"10.1080/14740338.2024.2376693","DOIUrl":"10.1080/14740338.2024.2376693","url":null,"abstract":"Background: Limited understanding exists regarding the hemorrhagic risk resulting from potential interactions between P-glycoprotein (P-gp) inhibitors and direct oral anticoagulants (DOACs). Utilizing the Food and Drug Administration Adverse Event Reporting System (FAERS) data, we analyzed hemorrhagic adverse events (AEs) linked with the co-administration of P-gp inhibitors and DOACs, aiming to offer guidance for their safe and rational use.Methods: Hemorrhagic events associated with P-gp inhibitors in combination with DOACs were scrutinized from the FAERS database. Hemorrhagic signals mining was performed by estimating the reported odds ratios (RORs), corroborated by additive and multiplicative models and a combination risk ratio (PRR) model.Results: Our analysis covered 4,417,195 cases, revealing 11,967 bleeding events associated with P-gp inhibitors. We observed a significantly higher risk of bleeding with the combination of apixaban and felodipine (ROR 118.84, 95% CI 78.12-180.79, additive model 0.545, multiplicative model 1.253, PRR 22.896 (2450.141)). Moreover, consistent associations were found in the co-administration analyzes of rivaroxaban with dronedarone and diltiazem, and apixaban with losartan, telmisartan, and simvastatin.Conclusion: Our FAERS data analysis unveils varying degrees of bleeding risk associated with the co-administration of P-gp inhibitors and DOACs, underscoring the importance of vigilance about them in clinical practice.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141497544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

PARP inhibitor-related acute renal failure: a real-world study based on the FDA adverse event reporting system database. PARP 抑制剂相关急性肾衰竭：基于 FDA 不良事件报告系统数据库的真实世界研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-07-08 DOI: 10.1080/14740338.2024.2376690

Xiayang Ren, Ping Sun, Yanfeng Wang

{"title":"PARP inhibitor-related acute renal failure: a real-world study based on the FDA adverse event reporting system database.","authors":"Xiayang Ren, Ping Sun, Yanfeng Wang","doi":"10.1080/14740338.2024.2376690","DOIUrl":"10.1080/14740338.2024.2376690","url":null,"abstract":"Background: Current clinical trial data on PARP inhibitors (PARPis)-related acute renal failure (ARF) are not entirely representative of real-world situations. Therefore, in this study, the US Food and Drug Administration Adverse Event Reporting System (FAERS) was used to evaluate PARPis-related ARF.Research design and methods: Data were obtained from 1 January 2015, to 30 September 2023. ARF event reports were analyzed based on four algorithms. The time-to-onset (TTO) and clinical outcomes of PARPis-associated ARF were assessed.Results: The total included cases were 2726. Significant signals were observed for olaparib, niraparib, and rucaparib (reporting odds ratio (ROR): 1.62, 95% confidence interval (CI): 1.49-1.78, 1.25, 95% CI: 1.19-1.32 and 1.59, 95% CI: 1.47-1.72 respectively). The median TTO of ARF onset was 57, 36, and 85 days for olaparib, niraparib, and rucaparib, respectively. The proportion of deaths with olaparib (9.88%) was significantly higher than for niraparib (2.52%) and rucaparib (2.94%) (p < 0.005). The proportion of life-threatening adverse events associated with niraparib (4.89%) was significantly higher than for rucaparib (0.98%) (p < 0.005).Conclusions: ARF and PARPi were related, with the exception of talazoparib. More emphasis should be given to PARPis-related ARF due to the high proportion of serious AEs and delayed adverse reactions.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141533977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0