索托拉西布的营销后安全问题:基于FDA不良事件报告系统的不成比例分析
Yiling Ding1, Hongyan Su2, Yamin Shu1
1Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Heliyon
|May 10, 2024
概括
这项研究分析了FDA不良事件报告系统数据,以识别索托拉西布的安全信号,索托拉西布是非小细胞肺癌的KRAS G12C抑制剂. 肝胆道疾病成为一个关键的安全问题,需要监测.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
背景情况:
- 索托拉西布已批准用于治疗KRAS G12C突变非小细胞肺癌 (NSCLC).
- 临床试验在检测罕见或长期不良事件方面存在局限性.
- 营销后监测对于全面的药物安全性评估至关重要.
研究的目的:
- 用FDA不良事件报告系统 (FAERS) 数据库来评估与索托拉西布相关的副作用.
- 识别和描述索托拉西布的潜在安全信号.
- 评估索托拉西布相关不良事件的发病时间.
主要方法:
- 利用FAERS数据库对索托拉西布的营销后AE报告进行分析.
- 进行了不成比例分析 (ROR,PRR,IC,EBGM) 来检测AE信号.
- 使用中位数持续时间,四分位数和韦布尔形状参数 (WSP) 测试评估AE发病时间.
主要成果:
- 在5个器官分类系统 (SOC) 中识别了27个AE信号,来自1538例索托拉西布首要疑似病例.
- 肝胆道疾病成为一个重要的安全信号 (ROR 4.48,PRR 4.07,IC 2.02,EBGM 4.07).
- 索托拉西布相关副作用的中位发病时间为42天,随着时间的推移,不同SOC的风险概况变化.
结论:
- 该研究成功地确定了市场营销后索托拉西布的潜在不良事件信号.
- 肝胆道疾病是监测索托拉西布安全性的关键领域.
- 描述AE信号和发病时间有助于管理索托拉西布治疗风险.
相关概念视频
Pharmacovigilance
826
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
826
Drug Regulation
1.4K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.4K
Structure-Activity Relationships and Drug Design
701
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
701
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
125
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
125
Nonlinear Pharmacokinetics: Dependence of Elimination Half-Life and Dose Clearance
126
The elimination half-life and drug clearance of drugs following nonlinear kinetics can vary with dosage. The Michaelis-Menten parameters and drug concentration influence these factors. As the dose increases, the elimination half-life tends to lengthen, resulting in a reduction in clearance and a disproportionately larger area under the curve. The total clearance can be derived from the Michaelis-Menten equation for drugs following a one-compartment model.
A study on guinea pigs examined the...
A study on guinea pigs examined the...
126
Hazard Ratio
115
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
For example, in a clinical trial...
115


