现实世界的证据揭示:患者支持计划提供药物使用数据的潜力
Eszter Palffy1, David John Lewis2,3
1Novartis Ireland Limited, Dublin, Ireland.
PloS one
|February 8, 2024
概括
萨库比特里尔/瓦尔沙坦的患者支持计划 (PSP) 没有显示出新的安全信号. 然而,这些计划确定了现实世界的药物使用模式,例如平板电脑分片以降低成本.
科学领域:
- 药物监督 药物监督 药物监督
- 现实世界的证据生成.
- 患者支持计划 患者支持计划
背景情况:
- 制药行业越来越多地利用患者支持计划 (PSP) 来帮助患者遵守和治疗管理.
- 关于PSP对药物监督和安全信号识别的贡献的数据有限.
- 虽然PSP不是协议驱动的,但会生成不良事件 (AE) 报告.
研究的目的:
- 调查诺华公司发起的萨库比特里尔/瓦尔沙坦PSP及其对安全信号的贡献.
- 在公司的安全数据库中分析PSP的AE报告.
- 评估PSP数据是否影响了核心数据表 (CDS) 的更新或安全标签的更改.
主要方法:
- 标识所有诺华公司的SACUBITRIL/VALSARTAN的PSP.
- 挖掘公司安全数据库以获取与这些PSP相关的AE报告.
- 审查CDS以评估信号验证和监管影响.
主要成果:
- 通过PSP报告的不良事件并没有导致CDS的更新或sacubitril/valsartan的新安全信号.
- 对PSP的现实数据的分析揭示了分片和改变剂量方案的情况.
- 没有观察到PSP生成的数据对sacubitril/valsartan安全标签变化的影响.
结论:
- 萨库比特里尔/瓦尔沙坦的PSP没有为新的安全信号或CDS更新做出贡献.
- 医疗服务提供者可以为药物使用模式提供有价值的现实洞察力,例如基于成本的药片分割.
- 需要进一步的研究来探索PSP在收集药物利用和疗效数据方面的潜力.
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