在SGLT-2抑制剂试验中缺少谁? 对药物安全性和一般化的影响:系统性审查和元分析
Mohammad Ali Omrani1, Bala Swetha Baskaran1, Hasti Sadeghi2
1Department of Physiology and Pharmacology, Western University, London, Ontario , Canada.
Expert opinion on drug safety
|March 5, 2026
概括
在针对2型糖尿病和心力衰竭的SGLT-2抑制剂试验中,黑人参与者,老年人和女性的代表性有限. 这种代表性不足可能会影响安全数据的概括性,强调需要更具包容性的临床试验招聘.
科学领域:
- 临床药理学 临床药理学
- 心血管医学 心血管医学
- 内分泌学 在内分泌学.
背景情况:
- -葡萄糖共运输体-2 (SGLT-2) 抑制剂对于管理2型糖尿病和心力衰竭至关重要.
- 然而,在关键临床试验中,不同的人口和临床子组的代表性仍然不充分理解.
研究的目的:
- 量化SGLT-2抑制剂临床试验的第3期和第4期临床试验中关键的人口统计和临床子组的代表性.
- 通过比较试验参与率与现实疾病患病率来评估潜在的不足.
主要方法:
- 在CENTRAL,MEDLINE和Embase数据库中进行了系统搜索,直到2025年5月5日.
- 包括随机对照试验 (RCT) 与至少300名参与者,报告了子组入学数据.
- 使用随机效应元分析估计了聚合流行率,并根据美国疾病负担数据计算了参与率与流行率 (PPRs).
主要成果:
- 对91个RCT的分析揭示了2型糖尿病的患病率:女性43.8%,EGFR<60 32.5%,老年人31.8%,黑人参与者4.9%.
- 对于心力衰竭试验,患病率为:老年人68.7%,女性34.1%,黑人参与者7.6%.
- 探索性PPR表明黑人参与者的代表性不足 (糖尿病:0.3;心力衰竭:0.5),糖尿病试验中的老年人 (0.7),心力衰竭试验中的女性 (0.7). 肝病和儿科患者群体的数据不足.
结论:
- 在糖尿病和心力衰竭试验中的黑人参与者,糖尿病试验中的老年人和心力衰竭试验中的女性中,观察到明显的代表性不足.
- 排除儿童和青少年,加上这些人口差异,可能会限制安全性和疗效数据的概括性.
- 临床试验中需要更具包容性的招聘策略,以确保研究结果适用于更广泛的患者群体.
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