托尔瓦普坦风险评估和缓解战略中的5年营销后肝脏安全数据
Emanuel Lohrmann1, Thomas Jaeger1, Kene Enekebe2
1Otsuka Pharmaceutical GmbH, Frankfurt, Germany.
Clinical kidney journal
|March 25, 2025
概括
托尔瓦普坦治疗自身主导多囊性病 (ADPKD) 在五年内显示出一致的肝安全性. 风险评估和缓解策略 (REMS) 有效监测药物诱导性肝损伤 (DILI),最近没有报告新的严重病例.
科学领域:
- 药物监督 药物监督 药物监督
- 腎臟病學 (nephrology) 是一種醫學專業.
- 肝病学 肝病学是一种肝病学.
背景情况:
- 托尔瓦普坦在美国被批准用于自身主导多囊性病 (ADPKD),需要风险评估和缓解策略 (REMS) 来监测药物诱导的肝损伤 (DILI).
- 从REMS计划 (2018年5月至2021年2月) 之前的肝脏安全数据已经公布.
- 此更新提供了基于扩展的REMS数据的托尔瓦普坦营销后肝脏安全性的进一步描述.
研究的目的:
- 更新和分析Tolvaptan治疗的ADPKD患者的潜在药监数据.
- 在REMS框架内进一步描述托尔瓦普坦的营销后肝脏安全概况.
- 评估药物诱导性肝损伤 (DILI) 在五年时间内的发生率和严重程度.
主要方法:
- 对从ADPKD患者获得的前性药监数据进行分析,这些患者在市场营销后开始使用托尔瓦.
- 数据采集期从2018年5月延长至2023年2月.
- 在REMS计划中评估肝脏安全事件,包括可能的严重DILI.
主要成果:
- 在接受托尔瓦普坦治疗的10879名患者中,45%的患者暴露时间超过12个月,35%的患者暴露时间超过18个月.
- 在五年内,可能严重的DILI的总频率保持在0.8% (82/10,879) 的水平,与三年后报告的0.9% (60/6,711) 类似.
- 可能严重的DILI的发生率为每100个患者年0.52事件; 4/82事件被确认为严重和可能致命的,自三年报告期以来没有新的病例. 没有报告与托尔瓦相关的DILI死亡或肝移植.
结论:
- 五年的REMS数据支持对托尔瓦普坦的肝功能监测计划的遵守,以便及时检测和管理肝毒性.
- 监测策略在管理潜在的肝脏相关不良事件方面显得有效.
- 研究结论受数据可用性限制,未来有可能确定更多的DILI病例.
关键词:
自体主导多囊性病 (ADPKD) 是一种自体主导多囊性病.药物引起的肝损伤 (DILI)肝脏安全 肝脏安全销售后的监测监测是指市场上销售后的监测.托尔瓦普坦 (托尔瓦普坦) 是一个多元的东西.更多相关视频
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