Chai Shengjun, Xu Haiming, Xu Guocai, Cai Chunmei
Research Center for High Altitude Medicine, Qinghai University, Xining, Qinghai, China.
Key Laboratory of the Ministry of High Altitude Medicine, Qinghai University, Xining, Qinghai, China.
Expert Opin Drug Saf. 2024 Sep 11:1-16. doi: 10.1080/14740338.2024.2396410.
ORENITRAM, an oral treprostinil formulation, was approved in 2013 for pulmonary arterial hypertension (PAH) treatment, necessitating ongoing safety monitoring.
This 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.
Out 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.
The 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.
口服曲前列尼尔制剂ORENITRAM于2013年获批用于治疗肺动脉高压（PAH），因此需要持续进行安全性监测。
这项回顾性分析使用了美国食品药品监督管理局（FDA）不良事件报告系统中2013年第四季度至2023年第四季度的数据，采用不成比例分析和报告比值比（ROR）来识别与ORENITRAM相关的不良事件（AE）。
在15,660,695份报告中，ORENITRAM是10,125例病例的主要怀疑药物。我们在27个器官系统中识别出174种严重不良事件，其中包括肺水肿、腹水和心室颤动等显著问题。女性报告的不良事件（75.6%）多于男性（24.0%），这表明可能存在代谢差异。不良事件在开始治疗后30天内或一年后最为常见。
该研究表明ORENITRAM存在重大安全问题，包括肺水肿、腹水和心室颤动等严重意外事件。这些发现凸显了进行仔细临床监测和有效风险管理的必要性，特别是考虑到观察到的不良事件谱中的性别差异。该研究的回顾性性质以及对自发报告的依赖可能会影响结果的普遍性。
