澄清因果对比:一个应用普遍新用户研究设计的经验示例
Jessica C Young1,2,3, Michael Webster-Clark2,4,5, Shahar Shmuel2,4
1Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Pharmacoepidemiology and drug safety
|April 4, 2024
概括
类似葡萄糖-1受体激动剂 (GLP-1 RA) 在新用户中显示出对心力衰竭的保护作用. 然而,这种保护作用在从硫尿素 (SU) 转换为GLP-1RA的患者下降.
科学领域:
- 心血管疾病流行病学
- 药物监督 药物监督 药物监督
- 现实世界的证据研究研究.
背景情况:
- 药物流行病学中的新用户设计对于了解药物的安全性和有效性至关重要.
- 纳入改变治疗方法的患者增加了新用户设计的复杂性.
- 区分事件新用户和切换者对于准确的风险估计至关重要.
研究的目的:
- 评估将治疗切换器纳入新用户设计对住院心力衰竭估计危险比率 (HR) 的影响.
- 为了比较开始使用GLP-1受体激动剂 (GLP-1 RA) 和硫尿素 (SU) 的患者之间心力衰竭的风险.
- 分析三个不同的患者群体:事件新用户,切换者和组合组.
主要方法:
- 利用MarketScan分析2000年至2014年的索赔数据.
- 采用时间条件倾向分数 (TCPS) 和时间分层的标准化发病率 (SMR) 权重来控制混.
- 在不同患者队伍中,医院住院心力衰竭的计算危险比率.
主要成果:
- 确定了76,179名GLP-1RA新用户,其中12%的人在30天内从SU转换.
- GLP-1 RA在新用户中显示出对心力衰竭的保护作用 (adjHRSMR = 0.74 [0.69,0.80]).
- 在转换者中没有观察到显著的保护作用 (adjHRSMR = 0.99 [0.83,1.18]),结果在TCPS和SMR权重中一致.
结论:
- 对于新用户来说,GLP-1 RA具有保护作用,但对于从SU切换的人来说,它没有保护作用.
- 结合事件用户和切换者可以掩盖重要的治疗效果异质性.
- 仔细考虑患者的治疗史对于在药物流行病学研究中强有力的混控制至关重要.
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