使用不同国家药监数据库对托尔瓦普坦相关肝脏疾病的评估
Takaya Uno1, Kouichi Hosomi2, Satoshi Yokoyama2
1Division of Drug Informatics, School of Pharmacy, Kindai University, 3-4-1 Kowakae, Higashi-Osaka, Osaka, 577-8502, Japan. uno@phar.kindai.ac.jp.
Scientific reports
|October 30, 2024
概括
托尔瓦普坦可以导致肝损伤,这是一个罕见但严重的副作用. 与年轻人相比,老年患者 (≥60) 经历了与托尔瓦普坦相关的肝脏疾病的更快发病,需要对肝功能进行警监测.
科学领域:
- 药物监督 药物监督 药物监督
- 肝病学 肝病学是一种肝病学.
- 药品安全 药品安全
背景情况:
- 托尔瓦普坦相关的肝脏疾病是一种罕见的,可能致命的不良事件.
- 这种疾病的确切风险和发病时间尚不清楚.
- 了解这些因素对于患者安全至关重要.
研究的目的:
- 为了描述tolvaptan相关肝脏疾病的严重程度,发病时间和结果.
- 研究患者年龄和性别对这些特征的影响.
- 为改善临床监测和风险管理提供数据.
主要方法:
- 从日本药物不良事件报告数据库 (JADER) 和JAPIC AERS数据库 (来源于FDA FAERS) 的患者数据分析.
- 肝脏疾病分为严重和不严重的类别.
- 统计分析包括报告几率比率 (ROR) 和信息组件 (IC) 来评估关联,以及按年龄分层的时间到发病分析.
主要成果:
- 在两个数据库中,托尔瓦普坦使用与严重和不严重的肝脏疾病有显著的关联 (RORs从4.21到6.78).
- 在60岁以上的患者中,与60岁以下的患者相比,在数据库和严重程度水平 (p < 0.0001) 中,发病的中位时间显著缩短 (p < 0.0001).
- 无论肝脏疾病的初始严重程度如何,都观察到严重的结局.
结论:
- 托尔瓦普坦与肝脏疾病的显著风险有关.
- 年龄是影响托尔瓦普坦相关肝脏疾病发病时间的关键因素,老年患者发病速度更快.
- 持续监测肝功能,特别是在老年患者中,对于预防与托尔瓦普坦使用相关的严重结果至关重要.
更多相关视频
06:14Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients
Published on: October 15, 2017
8.3K
09:18Intraventricular Drug Delivery and Sampling for Pharmacokinetics and Pharmacodynamics Study
Published on: March 31, 2022
2.6K
相关概念视频
01:19Pharmacovigilance
778
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...
778
01:11Clinical Trials: Overview
2.8K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.8K
01:20Antiepileptic Drugs: Modulators of Neurotransmitter Release Mediated by SV2A Protein
258
Antiepileptic drugs, such as levetiracetam (Keppra) and brivaracetam (Briviact), have emerged as crucial tools in managing epilepsy. These medications exert their therapeutic effects by targeting the synaptic vesicle protein SV2A, a transmembrane glycoprotein primarily found in the brain.
SV2A is a transmembrane glycoprotein located predominantly in the brain, modulating the release of neurotransmitters for neuronal communication. Both levetiracetam and brivaracetam exhibit a high affinity for...
SV2A is a transmembrane glycoprotein located predominantly in the brain, modulating the release of neurotransmitters for neuronal communication. Both levetiracetam and brivaracetam exhibit a high affinity for...
258
01:09Hepatic Drug Clearance: Effect of Protein Binding
161
Hepatic clearance is influenced by protein binding based on the drug's extraction ratio. Drugs with high extraction ratios are considered flow-limited and remain unaffected by protein binding during hepatic clearance. On the other hand, drugs with low extraction ratios may be impacted by plasma protein binding, although the extent of this influence depends on the fraction of the drug bound.
For low-extraction-ratio drugs that are less than 80% protein-bound, minor changes in protein binding...
For low-extraction-ratio drugs that are less than 80% protein-bound, minor changes in protein binding...
161
01:31Factors Affecting Renal Clearance: Drug's Physicochemical Properties and Plasma Levels
182
Renal clearance of a drug is influenced by various factors, including its physicochemical properties and plasma levels. These factors play a significant role in determining how efficiently the kidneys eliminate a drug.
One important factor is the drug's molecular size. The kidneys readily excrete smaller molecules below 300 Daltons (Da). On the other hand, molecules weighing between 300 and 500 Da are excreted through both urine and bile. Larger molecules above 500 Da tend to be excreted...
One important factor is the drug's molecular size. The kidneys readily excrete smaller molecules below 300 Daltons (Da). On the other hand, molecules weighing between 300 and 500 Da are excreted through both urine and bile. Larger molecules above 500 Da tend to be excreted...
182
01:25Drug Regulation
1.3K
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...
1.3K