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Post-marketing safety concern of PI3K inhibitors in the cancer therapies: an 8-year disproportionality analysis from the FDA Adverse Event Reporting System. 癌症疗法中 PI3K 抑制剂上市后的安全性问题:美国食品及药物管理局不良事件报告系统的 8 年比例失调分析。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-18 DOI: 10.1080/14740338.2024.2387317
Xiaorong Lin, Yimin Zhang, Hongyan Huang, Wei Zhuang, Lisha Wu

Background: The Phosphoinositide 3-kinases (PI3Ks) family plays a crucial role in tumorigenesis. Alpelisib (inhibiting PI3Kα), copanlisib (inhibiting PI3Kα andPI3Kδ), duvelisib (inhibiting PI3Kδ and PI3Kγ), and idelalisib (inhibiting PI3Kδ) were developed to target the PI3K pathway. However, the toxicity limits their application to some extent. It's necessary to investigate the adverse effects (AEs) of these inhibitors.

Research design and methods: We conducted a comparative analysis of the safety signals of AEs in PI3K inhibitors using disproportionality analysis in the FDA Adverse Event Reporting System database(FAERS).

Results: Our study identified significant safety signals for metabolic disorders with all PI3K inhibitors. Notable safety signals for gastrointestinal disorders were observed with most PI3K inhibitors, with the exception of copanlisib. Common AEs shared among all PI3K inhibitors included colitis and dehydration. Alpelisib displayed unique AEs associated with metabolic disorders, whereas copanlisib exhibited idiosyncratic AEs linked to cardiac and vascular disorders. Stevens-Johnson syndrome emerged as a common severe adverse event (SAE) among alpelisib, copanlisib, and idelalisib, while febrile neutropenia was prevalent among copanlisib, duvelisib, and idelalisib. Intestinal perforation was solely associated with alpelisib.

Conclusions: The safety profiles of the five PI3K inhibitors vary concerning adverse events. These findings could guide drug selection and inform future prospective research.

背景:磷脂酰肌醇3-激酶(PI3Ks)家族在肿瘤发生中起着至关重要的作用。针对 PI3K 通路开发了 Alpelisib(抑制 PI3Kα)、copanlisib(抑制 PI3Kα 和 PI3Kδ)、duvelisib(抑制 PI3Kδ 和 PI3Kγ)和 idelalisib(抑制 PI3Kδ)。然而,毒性在一定程度上限制了它们的应用。有必要对这些抑制剂的不良反应(AEs)进行研究:我们利用 FDA 不良事件报告系统数据库(FAERS)中的比例失调分析法对 PI3K 抑制剂的 AEs 安全信号进行了比较分析:结果:我们的研究发现,所有 PI3K 抑制剂都存在代谢紊乱的重大安全性信号。除 copanlisib 外,大多数 PI3K 抑制剂都出现了明显的胃肠道紊乱安全性信号。所有 PI3K 抑制剂共有的 AE 包括结肠炎和脱水。Alpelisib 表现出与代谢紊乱有关的独特不良反应,而 copanlisib 则表现出与心脏和血管紊乱有关的独特不良反应。Stevens-Johnsonsyndrome是alpelisib、copanlisib和idelalisib中常见的严重不良事件(SAE),而发热性中性粒细胞减少症则在copanlisib、duvelisib和idelalisib中普遍存在。肠穿孔仅与阿帕尼单抗有关:五种 PI3K 抑制剂在不良事件方面的安全性各不相同。这些发现可以指导药物选择并为未来的前瞻性研究提供信息。
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引用次数: 0
A real-world disproportionality analysis of baloxavir marboxil: post-marketing pharmacovigilance data. 巴洛沙韦 Marboxil 真实世界比例失调分析:上市后药物警戒数据。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-16 DOI: 10.1080/14740338.2024.2393269
Jie Zhou, Junchang Ye, Maohua Chen, Xinlei Zheng

Objective: Baloxavir marboxil (hereafter referred to as baloxavir) is the only cap-dependent endonuclease inhiabitor approved for the treatment and prevention of influenza. However, as a new drug marketed in 2018, the long-term safety of baloxavir in large sample population was unclear. This study aims to evaluate baloxavir-associated adverse events (AEs) through data mining of the international pharmacovigilance database of US FDA Adverse Event Reporting System (FAERS).

Methods: Disproportionality analysis was conducted to assess the association between baloxavir and its AEs. Data were collected from FAERS from March 2018 to June 2023. After standardizing the data, signal quantification techniques including ROR, PRR, BCPNN and MGPS were used for analysis.

Results: A total of 49 significant baloxavir-related preferred terms (PTs) in 20 system organ classes (SOCs) were identified in our data analysis. Compared to baloxavir's FDA label, some new PTs emerged, with the top 10 being pneumonia, loss of consciousness, rhabdomyolysis, seizure, altered state of consciousness, hepatic function abnormal, delirium, depressed level of consciousness, encephalopathy and cardio-respiratory arrest.

Conclusion: In clinical application of baloxavir, attention should be paid to the new AE signals in addition to the those recorded in the labels, so as to ensure the safety of the patients.

目的:巴洛沙韦 marboxil(以下简称 "巴洛沙韦")是唯一获批用于治疗和预防流感的瓶盖依赖性内切酶抑制剂。然而,作为 2018 年上市的新药,巴洛沙韦在大样本人群中的长期安全性尚不明确。本研究旨在通过对美国FDA不良事件报告系统(FAERS)国际药物警戒数据库的数据挖掘,评估与巴洛沙韦相关的不良事件(AEs):方法:采用比例失调分析法评估巴洛沙韦与不良事件之间的关联。数据收集自2018年3月至2023年6月的FAERS。对数据进行标准化处理后,采用包括 ROR、PRR、BCPNN 和 MGPS 在内的信号量化技术进行分析:我们的数据分析在 20 个系统器官分类(SOC)中共发现了 49 个与巴洛沙韦相关的重要优先术语(PTs)。与巴洛沙韦的 FDA 标签相比,出现了一些新的首选术语,排名前 10 位的分别是肺炎、意识丧失、横纹肌溶解症、癫痫发作、意识状态改变、肝功能异常、谵妄、意识水平低下、脑病和心肺骤停:结论:在巴洛沙韦的临床应用中,除了标签中记录的AE信号外,还应注意新的AE信号,以确保患者的安全。
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引用次数: 0
Investigating drug-induced urinary retention: a pharmacovigilance analysis of FDA adverse event reports from 2004 to 2024 调查药物引起的尿潴留:对 2004 年至 2024 年美国食品药物管理局不良事件报告的药物警戒分析
IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-13 DOI: 10.1080/14740338.2024.2405126
Fuchun Zheng, Fei Wang, Yuyang Yuan, Zhipeng Wang, Sheng Li, Bin Fu, Wei Liu
Drug-induced urinary retention (DIUR) can severely impact patient quality of life and complicate treatment. This study investigates the incidence and characteristics of DIUR using data from the FDA...
药物引起的尿潴留 (DIUR) 会严重影响患者的生活质量并使治疗复杂化。本研究利用美国食品药品管理局(FDA)的数据,调查了药物性尿潴留的发生率和特征。
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引用次数: 0
Adverse events associated with Atogepant: a FAERS-based pharmacovigilance analysis. 与阿托格潘相关的不良事件:基于法尔斯的药物警戒分析。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-12 DOI: 10.1080/14740338.2024.2393268
Ying Zhang, Shengzhu Sun, Yuming Wang

Background: Migraine, a prevalent neurovascular disorder, can significantly disrupt an individual's daily life. Atogepant (AGN-241689), an orally administered small-molecule drug classified as a calcitonin gene-related peptide receptor antagonist, is utilized for prophylactic migraine treatment. The objective of this study was to investigate adverse events (AEs) associated with atogepant through data mining in the FDA Adverse Event Reporting System (FAERS) to enhance clinical safety.

Methods: Data for atogepant were obtained from the FAERS database covering Q3 2021 through Q4 2023. Disproportionality analysis was employed to quantify relevant AEs associated with atogepant. Reported Ratio of Ratios (ROR) was utilized for identifying risk signals within the FAERS data. This methodology relies on the System Organ Class (SOC) and Preferred Terminology (PT) of the Medical Dictionary for Regulatory Activities (MedDRA).

Results: From the FAERS database, a collection of 7,991,243 reports was obtained. Among these reports, a subset of 3015 was identified as 'primary suspected (PS)' AEs specifically related to atogepant. AEs induced by atogepant were observed across 27 organ systems. A total of 48 significantly disproportionate Preferred Terminologies (PTs) meeting all four algorithms were identified.

Conclusion: Our study has identified adverse events (AEs) associated with atogepant, potentially providing crucial support for the clinical monitoring and risk identification of atogepant.

背景:阿托格潘(AGN-241689)是一种口服小分子药物,被归类为降钙素基因相关肽受体拮抗剂,用于偏头痛的预防性治疗。本研究旨在通过FDA不良事件报告系统(FAERS)中的数据挖掘,调查与阿托格潘相关的不良事件(AEs),以提高临床安全性:方法:从FAERS数据库中获取阿托格潘的数据,涵盖2021年第3季度至2023年第4季度。采用比例失调分析法量化与阿托格潘相关的不良事件。结果:从 FAERS 数据库中收集到 7,991,243 份报告,其中有 3015 份报告被确定为与阿托格潘特别相关的 "主要疑似 (PS) "不良事件,阿托格潘诱发的不良事件涉及 27 个器官系统:我们的研究发现了与阿托格潘相关的不良事件(AEs),为阿托格潘的临床监测和风险识别提供了重要支持。
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引用次数: 0
Antibody-drug conjugates-related interstitial lung diseases: data mining of the FAERS database. 抗体药物共轭物相关间质性肺病:FAERS 数据库的数据挖掘。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-12 DOI: 10.1080/14740338.2024.2401025
Zicheng Yu, Haibin Zhu, Xiaolan Liao

Background: Interstitial lung diseases (ILD) is a serious adverse event (AE) associated with antibody-drug conjugates (ADCs). This study aims to delve deeply into the signals of AE associated with ILD linked to ADCs.

Research design and methods: The AE reports were extracted from the first quarter of 2004 to the fourth quarter of 2023 based on the FDA Adverse Event Reporting System (FAERS) database. Signal mining was performed using the reporting odds ratio (ROR) method and the multi-item gamma Poisson shrinker (MGPS) method. Data management, analysis, and visualization were carried out using Python, R software, and MySQL.

Results: A total of 1389 AE reports related to ILD with 11 types of ADCs as the primary suspected drugs were obtained. The age groups most represented were 61-80 age group. ILD-related AE signals were detected for 11 ADCs in the study. Trastuzumab deruxtecan showed the strongest signals in both for ROR and MGPS methods. The median onset time vary from 8 days to 207 days.

Conclusions: The signals of ILD AE associated with ADCs are notably strong. ILD should be closely monitored and assessed in the clinical use of ADCs taking full account of the efficacy and risks of these drugs.

背景:间质性肺病(ILD)是与使用抗体药物共轭物(ADCs)相关的严重不良事件(AE)。本研究旨在利用数据挖掘方法深入研究与ADCs相关的间质性肺病的AE信号:根据FDA不良事件报告系统(FAERS)数据库,对2004年第一季度至2023年第四季度与ADC和ILD相关的AE报告进行了回顾性分析。采用报告几率比(ROR)法和多项目伽马泊松收缩器(MGPS)法进行信号挖掘。数据管理、分析和可视化使用 Python(3.8 版)、R 软件(4.2.1 版)和 MySQL(8.0.34 版)进行:结果:共获得 1389 份与 ILD 相关的 AE 报告,其中 11 种 ADC 为主要可疑药物。这些报告中出现最多的年龄组是 61-80 岁年龄组和 41-60 岁年龄组。曲妥珠单抗德鲁替康的报告最多。数据挖掘结果表明,研究中的 11 种 ADC 均检测到与 ILD 相关的 AE 信号。在 ROR 和 MGPS 两种方法中,曲妥珠单抗地昔康的信号最强。与 ILD 相关的 ADC 的中位发病时间从 8 天到 207 天不等:结论:与 ADC 相关的 ILD AE 信号并不强烈。在临床使用 ADCs 时,应充分考虑药物的疗效和风险以及患者的具体情况,密切监测和评估 ILD。
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引用次数: 0
ORENITRAM's decadal journey: unveiling safety profiles and adverse event through a real-world pharmacovigilance study of FAERS events. ORENITRAM 的十年历程:通过对 FAERS 事件的真实世界药物警戒研究揭示安全性概况和不良事件。
IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-11 DOI: 10.1080/14740338.2024.2396410
Shengjun Chai,Haiming Xu,Guocai Xu,Chunmei Cai
BACKGROUNDORENITRAM, an oral treprostinil formulation, was approved in 2013 for pulmonary arterial hypertension (PAH) treatment, necessitating ongoing safety monitoring.RESEARCH DESIGN AND METHODSThis retrospective analysis used FDA Adverse Event Reporting System data from Q4 2013 to Q4 2023, employing disproportionality analysis and the reporting odds ratio (ROR) to identify adverse events (AEs) linked with ORENITRAM.RESULTSOut of 15,660,695 reports, ORENITRAM was the primary suspect in 10,125 cases. We identified 174 significant adverse events across 27 organ systems, with notable issues like pulmonary edema, ascites, and ventricular fibrillation. Females reported more AEs (75.6%) than males (24.0%), suggesting potential metabolic differences. AEs were most common within 30 days of starting treatment or after one year.CONCLUSIONSThe study indicates significant safety issues with ORENITRAM, including serious unexpected events such as pulmonary edema, ascites, and ventricular fibrillation. These findings highlight the necessity for careful clinical monitoring and effective risk management, particularly with observed gender differences in AE profiles. The study's retrospective nature and reliance on spontaneous reports may affect result generalizability.
背景ORENITRAM是一种口服曲普瑞替尼制剂,于2013年获批用于肺动脉高压(PAH)治疗,因此有必要对其进行持续的安全性监测。研究设计和方法这项回顾性分析使用了2013年第4季度至2023年第4季度的FDA不良事件报告系统数据,采用了不相称性分析和报告几率比(ROR)来确定与奥伦尼特仑相关的不良事件(AEs)。结果在15,660,695份报告中,奥伦尼特仑是10125个病例的主要嫌疑对象。我们在 27 个器官系统中发现了 174 起重大不良事件,其中包括肺水肿、腹水和心室颤动等显著问题。女性报告的不良反应(75.6%)多于男性(24.0%),这表明潜在的代谢差异。结论该研究表明,奥伦尼特罗姆存在严重的安全性问题,包括肺水肿、腹水和心室颤动等严重意外事件。这些发现凸显了仔细临床监测和有效风险管理的必要性,尤其是在观察到AE概况的性别差异时。该研究的回顾性和对自发报告的依赖可能会影响结果的普遍性。
{"title":"ORENITRAM's decadal journey: unveiling safety profiles and adverse event through a real-world pharmacovigilance study of FAERS events.","authors":"Shengjun Chai,Haiming Xu,Guocai Xu,Chunmei Cai","doi":"10.1080/14740338.2024.2396410","DOIUrl":"https://doi.org/10.1080/14740338.2024.2396410","url":null,"abstract":"BACKGROUNDORENITRAM, an oral treprostinil formulation, was approved in 2013 for pulmonary arterial hypertension (PAH) treatment, necessitating ongoing safety monitoring.RESEARCH DESIGN AND METHODSThis retrospective analysis used FDA Adverse Event Reporting System data from Q4 2013 to Q4 2023, employing disproportionality analysis and the reporting odds ratio (ROR) to identify adverse events (AEs) linked with ORENITRAM.RESULTSOut of 15,660,695 reports, ORENITRAM was the primary suspect in 10,125 cases. We identified 174 significant adverse events across 27 organ systems, with notable issues like pulmonary edema, ascites, and ventricular fibrillation. Females reported more AEs (75.6%) than males (24.0%), suggesting potential metabolic differences. AEs were most common within 30 days of starting treatment or after one year.CONCLUSIONSThe study indicates significant safety issues with ORENITRAM, including serious unexpected events such as pulmonary edema, ascites, and ventricular fibrillation. These findings highlight the necessity for careful clinical monitoring and effective risk management, particularly with observed gender differences in AE profiles. The study's retrospective nature and reliance on spontaneous reports may affect result generalizability.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142191198","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
Toxicity profiles associated with EGFR-TKIs combined with angiogenesis inhibitors in non-small cell lung cancer: an epidemiological surveillance analysis of the FDA adverse event reporting system. 与表皮生长因子受体-TKIs 联合血管生成抑制剂治疗非小细胞肺癌相关的毒性概况:对 FDA 不良事件报告系统的流行病学监测分析。
IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-11 DOI: 10.1080/14740338.2024.2399082
Wenjie Li,Ruxue Lv,Wei Wang
BACKGROUNDOngoing studies are evaluating the efficacy and toxicity profiles of combining epidermal growth factor receptor inhibitors (EGFR-TKIs) with antiangiogenic agents in non-small cell lung cancer (NSCLC). However, the complete toxicity profiles remain elusive.RESEARCH DESIGN AND METHODSThis study conducted an extensive pharmacovigilance analysis utilizing the FDA Adverse Event Reporting System database. The analysis focused on identifying and characterizing adverse events (AEs) associated with the concurrent use of EGFR-TKIs and antiangiogenic inhibitors in patients with NSCLC.RESULTSThe study identified significant occurrences of AEs linked to the combination therapy, particularly impacting general disorders, skin and subcutaneous tissue conditions, and vascular disorders. Frequently reported AEs included rash, diarrhea, fatigue, nausea, decreased appetite, and anemia. Notably, the combination of EGFR-TKIs with antiangiogenic inhibitors resulted in an increased incidence of AEs across multiple organ systems compared to EGFR-TKIs alone, with some adverse effects, such as anemia, arrhythmia, and ulcerative keratitis, persisting beyond one year in a subset of patients.CONCLUSIONSThe combination of EGFR-TKIs and antiangiogenic inhibitors in NSCLC treatment presents a distinct and substantial AE profile, often with delayed onset. This finding underscores the necessity for rigorous and ongoing monitoring protocols to mitigate potential long-term adverse effects.
背景正在进行的研究评估了表皮生长因子受体抑制剂(EGFR-TKIs)与抗血管生成药物联合治疗非小细胞肺癌(NSCLC)的疗效和毒性概况。本研究利用 FDA 不良事件报告系统数据库进行了广泛的药物警戒分析。结果本研究发现了与联合治疗相关的大量不良事件,尤其是影响全身疾病、皮肤和皮下组织状况以及血管疾病的不良事件。经常报告的不良反应包括皮疹、腹泻、疲劳、恶心、食欲下降和贫血。值得注意的是,与单用 EGFR-TKIs 相比,EGFR-TKIs 与抗血管生成抑制剂联用会导致多个器官系统的 AEs 发生率增加,部分患者的某些不良反应(如贫血、心律失常和溃疡性角膜炎)会持续一年以上。这一发现突出表明,有必要制定严格、持续的监测方案,以减轻潜在的长期不良反应。
{"title":"Toxicity profiles associated with EGFR-TKIs combined with angiogenesis inhibitors in non-small cell lung cancer: an epidemiological surveillance analysis of the FDA adverse event reporting system.","authors":"Wenjie Li,Ruxue Lv,Wei Wang","doi":"10.1080/14740338.2024.2399082","DOIUrl":"https://doi.org/10.1080/14740338.2024.2399082","url":null,"abstract":"BACKGROUNDOngoing studies are evaluating the efficacy and toxicity profiles of combining epidermal growth factor receptor inhibitors (EGFR-TKIs) with antiangiogenic agents in non-small cell lung cancer (NSCLC). However, the complete toxicity profiles remain elusive.RESEARCH DESIGN AND METHODSThis study conducted an extensive pharmacovigilance analysis utilizing the FDA Adverse Event Reporting System database. The analysis focused on identifying and characterizing adverse events (AEs) associated with the concurrent use of EGFR-TKIs and antiangiogenic inhibitors in patients with NSCLC.RESULTSThe study identified significant occurrences of AEs linked to the combination therapy, particularly impacting general disorders, skin and subcutaneous tissue conditions, and vascular disorders. Frequently reported AEs included rash, diarrhea, fatigue, nausea, decreased appetite, and anemia. Notably, the combination of EGFR-TKIs with antiangiogenic inhibitors resulted in an increased incidence of AEs across multiple organ systems compared to EGFR-TKIs alone, with some adverse effects, such as anemia, arrhythmia, and ulcerative keratitis, persisting beyond one year in a subset of patients.CONCLUSIONSThe combination of EGFR-TKIs and antiangiogenic inhibitors in NSCLC treatment presents a distinct and substantial AE profile, often with delayed onset. This finding underscores the necessity for rigorous and ongoing monitoring protocols to mitigate potential long-term adverse effects.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142191200","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
Clozapine may consistently protect from suicidal behaviors while other antipsychotics may lack a specific protective effect: a comprehensive VigiBase study interpreted in the context of the prior literature. 氯氮平可持续防止自杀行为,而其他抗精神病药物可能缺乏特定的保护作用:根据以往文献解读的 VigiBase 综合研究。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-11 DOI: 10.1080/14740338.2024.2399094
Carlos De Las Cuevas, Victoria C de Leon, Hilario Blasco-Fontecilla, Enrique Baca-García, Marina Sagud, Emilio J Sanz, Jose de Leon

Background: In the United States, clozapine was first approved for treatment-resistant schizophrenia and then for suicidality in schizophrenia psychoses. Systematic reviews support clozapine's anti-suicidal effect, but the forensic literature stresses its lethality during overdoses.

Research design and methods: Clozapine reports to the international pharmacovigilance database (VigiBase) were analyzed for suicidal ideation, suicide attempts, intentional overdose, and completed suicides from introduction to 1 January 2024. VigiBase uses the information component (IC) as a disproportionality analysis.

Results: The clozapine ICs (range: other antipsychotics) were: 1) suicidal ideation IC = 0.570 with IC025 = 0.454 to IC975 = 0.680 (IC = 3.568 for aripiprazole and 1.729 for risperidone), 2) suicide attempt IC = 1.428 with IC025 = 1.323 to IC975 = 1.529 (IC = 4.150 for quetiapine and 2.968 for risperidone), 3) intentional overdose: IC = 0.995 with IC025 = 0.864 to IC975 = 1.120 (IC = 4.080 for quetiapine and 1.957 for aripiprazole), and 4) completed suicide IC = 1.133 with IC025 = 1.026 to IC975 = 1.235 (IC = 4.648 for quetiapine and 2.160 for risperidone). In summary, all clozapine ICs were significantly lower. We found 2391 clozapine-treated patients on the suicidality spectrum (627 cases with suicidal ideation, 752 with suicide attempt, 488 with intentional overdose, and 731 with completed suicide) but many were taking other antipsychotics. The most frequent reporting countries were the United States, the United Kingdom, and Croatia.

Conclusion: This pharmacovigilance study, with all its inherent limitations, provides independent proof, not overlapping with prior literature, that clozapine may have specific strong anti-suicidal effects that do not appear to be present in other antipsychotics. Further VigiBase studies are needed to compare the lethality of an intentional overdose of clozapine (14.3%) with other antipsychotics.

背景:在美国,氯氮平首先被批准用于治疗耐药性精神分裂症,然后被批准用于治疗精神分裂症精神病患者的自杀倾向。系统综述支持氯氮平的抗自杀作用,但法医文献强调其在过量用药时的致命性:对国际药物警戒数据库(VigiBase)中的氯氮平报告进行分析,以了解从引入到 2024 年 1 月 1 日期间的自杀意念、自杀未遂、故意用药过量和自杀完成情况。VigiBase 使用信息成分(IC)进行比例失调分析:结果:氯氮平的 IC(范围:其他抗精神病药物)为1)自杀意念 IC = 0.570,IC025 = 0.454 至 IC975 = 0.680(阿立哌唑的 IC = 3.568,利培酮的 IC = 1.729);2)自杀未遂 IC = 1.428,IC025 = 1.323 至 IC975 = 1.529(喹硫平的 IC = 4.150,利培酮的 IC = 2.968);3)自杀倾向 IC = 0.570,IC025 = 0.454 至 IC975 = 0.680(阿立哌唑的 IC = 3.568,利培酮的 IC = 1.729)。3) 故意用药过量:IC = 0.995,IC025 = 0.864 至 IC975 = 1.120(喹硫平的 IC = 4.080,阿立哌唑的 IC = 1.957),以及 4) 完成自杀:IC = 1.133,IC025 = 1.026 至 IC975 = 1.235(喹硫平的 IC = 4.648,利培酮的 IC = 2.160)。总之,所有氯氮平的 IC 均显著降低。我们发现有 2391 例接受氯氮平治疗的患者有自杀倾向(627 例有自杀意念,752 例自杀未遂,488 例故意用药过量,731 例自杀完成),但其中许多人正在服用其他抗精神病药物。报告最多的国家是美国、英国和克罗地亚:这项药物警戒研究虽然有其固有的局限性,但它提供了独立的证据,证明氯氮平可能具有其他抗精神病药物所不具有的特殊的强烈抗自杀作用。还需要进一步开展 VigiBase 研究,以比较故意过量服用氯氮平(14.3%)与其他抗精神病药物的致死率。
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引用次数: 0
The use of denosumab in osteoporosis - an update on efficacy and drug safety. 在骨质疏松症中使用地诺单抗--疗效和药物安全性的最新进展。
IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-11 DOI: 10.1080/14740338.2024.2386365
Dima L Diab,Nelson B Watts
INTRODUCTIONDenosumab (Prolia) is a fully human monoclonal antibody against the receptor activator of the nuclear factor kappaB ligand. It is a potent antiresorptive agent that reduces osteoclastogenesis.AREAS COVEREDDenosumab has been shown to improve bone mineral density and reduce the incidence of new fractures in postmenopausal women and men. It is also used in the treatment of glucocorticoid-induced osteoporosis, as well as for the prevention of bone loss and reduction of fracture risk in men receiving androgen deprivation therapy for non-metastatic prostate cancer and women receiving adjuvant aromatase inhibitor therapy for breast cancer. Initial safety concerns included infections, cancer, skin reactions, cardiovascular disease, hypocalcemia, osteonecrosis of the jaw, and atypical femur fractures; however, further study and experience provide reassurance on these issues. Anecdotal reports have raised concerns about an increased risk of multiple vertebral fractures following discontinuation of denosumab.EXPERT OPINIONAlthough bisphosphonates are often selected as initial therapy for osteoporosis, denosumab may be an appropriate initial therapy in patients at high risk for fracture, including older patients who have difficulty with the dosing requirements of oral bisphosphonates, as well as patients who are intolerant of, unresponsive to, or have contraindications to other therapies. Additional data is needed to address questions regarding treatment duration and discontinuation.
简介地诺单抗(Prolia)是一种针对核因子卡巴配体受体激活剂的全人源单克隆抗体。它是一种强效抗骨吸收剂,可减少破骨细胞的生成。研究表明,地诺单抗可改善绝经后女性和男性的骨矿物质密度,降低新骨折的发生率。它还用于治疗糖皮质激素诱发的骨质疏松症,以及预防骨质流失和降低接受雄激素剥夺疗法治疗非转移性前列腺癌的男性和接受芳香化酶抑制剂辅助疗法治疗乳腺癌的女性的骨折风险。最初的安全问题包括感染、癌症、皮肤反应、心血管疾病、低钙血症、颌骨坏死和非典型股骨骨折;然而,进一步的研究和经验使这些问题得到了解决。专家观点虽然双膦酸盐通常被选为骨质疏松症的初始疗法,但对于骨折高风险患者,包括难以满足口服双膦酸盐剂量要求的老年患者,以及对其他疗法不耐受、无反应或有禁忌症的患者,地诺单抗可能是一种合适的初始疗法。还需要更多数据来解决有关治疗持续时间和停药的问题。
{"title":"The use of denosumab in osteoporosis - an update on efficacy and drug safety.","authors":"Dima L Diab,Nelson B Watts","doi":"10.1080/14740338.2024.2386365","DOIUrl":"https://doi.org/10.1080/14740338.2024.2386365","url":null,"abstract":"INTRODUCTIONDenosumab (Prolia) is a fully human monoclonal antibody against the receptor activator of the nuclear factor kappaB ligand. It is a potent antiresorptive agent that reduces osteoclastogenesis.AREAS COVEREDDenosumab has been shown to improve bone mineral density and reduce the incidence of new fractures in postmenopausal women and men. It is also used in the treatment of glucocorticoid-induced osteoporosis, as well as for the prevention of bone loss and reduction of fracture risk in men receiving androgen deprivation therapy for non-metastatic prostate cancer and women receiving adjuvant aromatase inhibitor therapy for breast cancer. Initial safety concerns included infections, cancer, skin reactions, cardiovascular disease, hypocalcemia, osteonecrosis of the jaw, and atypical femur fractures; however, further study and experience provide reassurance on these issues. Anecdotal reports have raised concerns about an increased risk of multiple vertebral fractures following discontinuation of denosumab.EXPERT OPINIONAlthough bisphosphonates are often selected as initial therapy for osteoporosis, denosumab may be an appropriate initial therapy in patients at high risk for fracture, including older patients who have difficulty with the dosing requirements of oral bisphosphonates, as well as patients who are intolerant of, unresponsive to, or have contraindications to other therapies. Additional data is needed to address questions regarding treatment duration and discontinuation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142191199","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
Comparative risk of infection of medications used for type 2 diabetes. 治疗 2 型糖尿病的药物感染风险比较。
IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-11 DOI: 10.1080/14740338.2024.2401024
Estefania Zapata-Bravo,Antonios Douros,Oriana Hoi Yun Yu,Kristian B Filion
INTRODUCTIONGlucose-lowering drugs pose a potential infection risk among individuals with type 2 diabetes. The U.S. Food and Drug Administration has issued safety warnings regarding increased risks of urinary tract infections (UTIs) and genital infections with sodium-glucose cotransporter 2 (SGLT2) inhibitors. However, the infection risk associated with other glucose-lowering drugs remains unclear. We conducted a PubMed database search to review the infection risk of glucose-lowering drugs, focusing on meta-analysis of randomized controlled trials.AREAS COVEREDWe described the infection risks associated with SGLT2 inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucose-like peptide-1 receptor agonists, metformin, and thiazolidinediones, covering infections of the genitourinary, respiratory, and gastrointestinal systems, including skin and soft tissue infections (SSTIs).EXPERT OPINIONSGLT2 inhibitors are associated with a higher genital infection risk, while their UTI risk remains inconclusive. DPP-4 inhibitors could be a treatment option for those intolerant to SGLT2 inhibitors, given their lower genital infection risk compared to placebo. Uncertainty persists regarding the risks of respiratory infections, gastroenteritis, and SSTIs with SGLT2 inhibitors. Limited evidence is available regarding the impact of DPP-4 inhibitors on respiratory infections. Additional research is needed to determine the comparative infection risk of other glucose-lowering drugs.
简介:降糖药物对 2 型糖尿病患者构成潜在的感染风险。美国食品和药物管理局已就钠-葡萄糖共转运体 2 (SGLT2) 抑制剂增加尿路感染 (UTI) 和生殖器感染风险发布了安全警告。然而,与其他降糖药物相关的感染风险仍不清楚。我们在 PubMed 数据库中检索了降糖药物的感染风险,重点是随机对照试验的荟萃分析。我们描述了与 SGLT2 抑制剂、二肽基肽酶-4 (DPP-4) 抑制剂、类葡萄糖肽-1 受体激动剂、二甲双胍和噻唑烷二酮类药物相关的感染风险,涉及泌尿生殖系统、呼吸系统和胃肠道系统的感染,包括皮肤和软组织感染 (SSTI)。与安慰剂相比,DPP-4 抑制剂的生殖器感染风险较低,因此可以作为不耐受 SGLT2 抑制剂者的治疗选择。关于 SGLT2 抑制剂的呼吸道感染、肠胃炎和 SSTI 风险仍存在不确定性。有关 DPP-4 抑制剂对呼吸道感染影响的证据有限。还需要开展更多研究,以确定其他降糖药物的比较感染风险。
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Expert Opinion on Drug Safety
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