| アブストラクト | BACKGROUND: ORENITRAM, an oral treprostinil formulation, was approved in 2013 for pulmonary arterial hypertension (PAH) treatment, necessitating ongoing safety monitoring. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2024/9/11 |
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| 投稿者 | Chai, Shengjun; Xu, Haiming; Xu, Guocai; Cai, Chunmei |
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| 組織名 | 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.;Key Laboratory of Applied Fundamentals of High Altitude Medicine, Qinghai-Utah;Joint Key Laboratory of Plateau Medicine, Qinghai University, Xining, Qinghai,;Laboratory for High Altitude Medicine of Qinghai Province, Qinghai University,;Medical School of Chinese People's Liberation Army (PLA), Beijing, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39259190/ |
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