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结合致命和非致命终点在心力衰竭试验中的可变影响
Hicham Skali1, Marc A Pfeffer, Jacobus Lubsen
1Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA.
Circulation
|November 23, 2006
概括
在临床试验中,将心力衰竭 (HF) 住院治疗与全因死亡率相结合,显著增加了事件发生率. 然而,这种复合端点的
科学领域:
- 心脏病学 心脏病学
- 临床试验 临床试验
- 基于证据的医学基于证据的医学.
背景情况:
- 随机临床试验 (RCT) 对基于证据的医学至关重要.
- 综合终点,结合心力衰竭 (HF) 住院和全因死亡率,越来越多地用于HF试验的统计和经济可行性.
- 在RCT设计,实施和解释中的潜在缺陷需要仔细选择终点.
研究的目的:
- 在慢性HFRCT中分析使用HF住院病例加上所有原因死亡率的复合终点的增量值.
- 测试假设,这个复合终点产生的事件率与单独死亡率相比持续可预测的增加.
- 评估疾病严重程度和试验持续时间对复合终点事件率的影响.
主要方法:
- 分析了12个主要的高频率RCT,其中有>1000名安慰剂患者和>9个月的平均随访时间.
- 估计每100个患者年标准化安慰剂事件率的估计.
- 评估综合终点与单独死亡率相对增加的事件率.
- 评估事件发生率的增加,疾病严重程度 (年死亡率) 和试验持续时间之间的关系.
主要成果:
- 综合终点表明事件率相对大幅增加,从64%到134%不等.
- 这种增加与疾病严重程度无关,正如年度死亡率所表明的那样.
- 综合终点的相对贡献受到试验持续时间的显著影响.
- 较长时间的试验显示,与较短的试验相比,事件的增加更容易预测.
结论:
- 将HF住院治疗与全因死亡率相结合,有效地增加了HF临床试验中的整体事件率.
- 这种相对增加的幅度是可变的,并且独立于疾病的严重程度.
- 试验持续时间是影响HFRCT中使用复合终点时事件率可预测性的关键因素.
- 在使用复合终点的高频RCT的设计和解释阶段,考虑试验持续时间至关重要.
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