从2型糖尿病的随机对照试验中排除老年人:一个横截面研究
Jan Borysowski1, Danuta Kłosowska1, Leszek Pączek1
1Department of Clinical Immunology, Medical University of Warsaw, Warsaw, Poland.
大多数针对2型糖尿病的随机对照试验 (RCT) 排除了老年人,因为年龄和并发症标准很严格. 消除年龄限制和在RCT中使用脆弱性评估对于在老年人群中更好地评估糖尿病药物至关重要.
科学领域:
- 老年学是一门学科.
- 临床药理学 临床药理学
- 糖尿病研究 糖尿病研究
背景情况:
- 2型糖尿病的患病率随着年龄的增长而增加.
- 监管机构 (FDA,EMA) 鼓励将老年人纳入糖尿病临床试验.
- 对于2型糖尿病的随机对照试验 (RCT) 的资格标准往往限制了老年人的参与.
研究的目的:
- 评估限制老年人纳入2型糖尿病RCT的资格标准.
- 在糖尿病临床试验中确定特定的与年龄和并发症相关的排除.
- 评估当前RCT实践与对老年患者纳入的监管建议的一致性.
主要方法:
- 临床试验.gov数据的横截面分析.
- 包括药物和生物制品的第二,第三和第四阶段RCT.
- 专注于从2014年到2023年注册的≥100名参与者的试验.
主要成果:
- 46.8%的试验的年龄限制为90岁或以下.
- 在非商业资助的试验和第二阶段试验中,年龄限制更常见.
- 91.2%的试验具有老年患者常见的并发病的排除标准;没有一个基于虚弱而被排除.
结论:
- 大多数2型糖尿病RCT都规定了资格标准,限制了老年患者的入学.
- 应该取消年龄限制;排除应该基于科学合理的标准,包括并发症和脆弱性.
- 需要进行第四期试验,以评估多病症和虚弱的老年患者的药物益处和危害.
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