评估PDE5阻断剂在勃起功能障碍中的营销后安全性:来自FDA不良事件报告系统的真实证据
Zi-Hao Zhao1, Yang Xiong, Wei Wang
1Department of Urology and Andrology Laboratory, West China Hospital, Sichuan University, Chengdu 610041, China.
Asian journal of andrology
|July 8, 2025
概括
这项研究分析了FDA对基化酶5型抑制剂 (PDE5I) 的不良事件报告,发现了预期和意想不到的副作用. 患者的年龄和体重等因素显著影响了PDE5I不良事件,需要个性化治疗方法.
科学领域:
- 药监和药物安全 药监和药物安全
- 泌尿病学和男性健康
- 临床药理学 临床药理学
背景情况:
- 勃起功能障碍 (ED) 在全球范围内普遍存在,代酶5型抑制剂 (PDE5Is) 是主要治疗方法.
- 与PDE5抑制剂相关的不良事件 (AE) 的现实数据有限.
- 了解PDE5I安全概况对于有效的ED管理至关重要.
研究的目的:
- 通过FDA不良事件报告系统 (FAERS) 数据全面评估PDE5抑制剂的现实安全性.
- 为了识别和比较不同PDE5抑制剂 (西尔德纳菲尔,塔达拉菲尔,瓦尔德纳菲尔,阿瓦纳菲尔) 的副作用.
- 调查影响PDE5I相关性AE的人口和临床因素.
主要方法:
- 从FAERS数据库 (2004年1月至2024年6月) 分析了53517份AE报告.
- 使用不相称性分析来评估PDE5Is的安全信号.
- 根据年龄,体重和发病时间进行了人口分层和子组分析.
主要成果:
- 确定了每个PDE5I的众多副作用,包括已批准的标签上列出的副作用和新发现.
- 检测到与神经,心血管和眼睛系统相关的显著副作用,此前未被标记.
- 根据患者的年龄,体重和症状发病时间,观察到与PDE5I相关的副作用的显著变化.
结论:
- PDE5抑制剂与一系列的副作用有关,其中一些在当前药物标签上没有详细说明.
- 不同的PDE5抑制剂和患者人口统计数据显示,AE的发生率有很大差异.
- 量身定制的患者管理策略对于优化PDE5I治疗和最大限度地降低风险至关重要.
相关概念视频
Pharmacovigilance
999
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...
999
Treatment for Pulmonary Arterial Hypertension: Phosphodiesterase Inhibitors
254
Phosphodiesterase 5 (PDE5) inhibitors are potent enzymes that function to hydrolyze cyclic nucleotides to their corresponding 5' monophosphates. Their unique biochemical properties have been applied in treating Pulmonary Arterial Hypertension (PAH).
Among the PDE5 inhibitors, sildenafil (Revatio) stands out as a competitive and selective inhibitor. It operates by elevating cellular levels of cGMP and augmenting signaling through the cGMP-PKG pathway, promoting vasodilation. Upon oral...
Among the PDE5 inhibitors, sildenafil (Revatio) stands out as a competitive and selective inhibitor. It operates by elevating cellular levels of cGMP and augmenting signaling through the cGMP-PKG pathway, promoting vasodilation. Upon oral...
254
Drug Regulation
1.9K
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...
1.9K
Antiplatelet Drugs: Prostaglandin Synthesis, P2Y12 and Glycoprotein IIb/IIIa Inhibitors
652
Antiplatelet drugs emerge as frontline defenders against the insidious threat of thromboembolic diseases, where abnormal clots obstruct vital blood vessels. These drugs stand as bulwarks, inhibiting platelet aggregation and clot formation, thereby mitigating the risk of life-threatening conditions like myocardial infarction, coronary artery disease, and thrombotic strokes.
Prostaglandin synthesis inhibitors, exemplified by the widely known aspirin, wield their power by irreversibly acetylating...
Prostaglandin synthesis inhibitors, exemplified by the widely known aspirin, wield their power by irreversibly acetylating...
652
Treatment for Pulmonary Arterial Hypertension: Prostacyclin Receptor Agonists
258
Prostacyclin receptor agonists are a class of therapeutic agents integral to managing pulmonary arterial hypertension (PAH). These drugs operate by mimicking the action of prostaglandin I2, or PGI2, a naturally occurring compound in the body.
These agonists bind to the IPR receptor situated on the plasma membrane of the pulmonary artery smooth muscle cells. This binding triggers a cascade of reactions known as the GS-AC-cAMP-PKA pathway. This pathway results in the relaxation of smooth muscle...
These agonists bind to the IPR receptor situated on the plasma membrane of the pulmonary artery smooth muscle cells. This binding triggers a cascade of reactions known as the GS-AC-cAMP-PKA pathway. This pathway results in the relaxation of smooth muscle...
258
Male Sexual Response: Erection & Ejaculation
5.1K
Sexual stimulation can take various forms, such as physical touch and visual or auditory cues. When this happens, the parasympathetic reflex in the sacral portion of the spinal cord is activated. This reflex stimulates the release of nitric oxide (NO), which then dilates the arterioles in the penis, increasing blood flow to the erectile tissues - the corpora cavernosa and corpus spongiosum.
The blood filling the erectile tissues compresses the veins, which helps to prevent blood from leaving...
The blood filling the erectile tissues compresses the veins, which helps to prevent blood from leaving...
5.1K


