降脂药物临床试验中获益时间的差异。
Variations in time to benefit among clinical trials of cholesterol-lowering drugs.
机构信息
From the School of Medical Sciences, University of New South Wales, Sydney, Australia; Division of Cardiology, Zuckerberg San Francisco General Hospital, San Francisco, CA, USA.
From the School of Medical Sciences, University of New South Wales, Sydney, Australia; Division of Cardiology, Zuckerberg San Francisco General Hospital, San Francisco, CA, USA.
出版信息
J Clin Lipidol. 2018 Jul-Aug;12(4):857-862. doi: 10.1016/j.jacl.2018.04.006. Epub 2018 Apr 21.
BACKGROUND
Time to benefit (TTB) in clinical trials of cholesterol-lowering drugs is important because it may provide a clue as to the potential mechanism of action of the drug, it is helpful in determining when to stop a trial for futility, and it may inform treatment decisions in subjects with reduced life expectancy.
OBJECTIVE
To compare TTB among clinical trials of cholesterol-lowering drugs.
METHODS
We examined TTB in 24 trials of cholesterol-lowering drugs with positive outcomes. Benefit curves were constructed by subtracting the curve for a placebo or comparator drug from the curve for active treatment.
RESULTS
TTB ranged from 1 to 30 (mean 13.1) months, being shorter in trials of statins (n = 17) compared to nonstatins (n = 7), 10.3 vs 20.0 months. Among statin trials, TTB was shorter with atorvastatin (n = 6) than in trials with other statins (n = 11), 4.75 compared to 11.4 months.
CONCLUSIONS
TTB is variable among trials of cholesterol-lowering drugs, being shorter with statin compared to nonstatin drugs. TTB is shorter with atorvastatin than with other statins. For trials of new cholesterol-lowering drugs, outcome curves that do not separate for up to 30 months do not preclude eventual benefit.
背景
在降脂药物临床试验中，获益时间（TTB）很重要，因为它可能提供药物潜在作用机制的线索，有助于确定何时因无效而停止试验，并且可能为预期寿命缩短的患者的治疗决策提供信息。
目的
比较降脂药物临床试验中的 TTB。
方法
我们研究了 24 项降脂药物阳性结果临床试验中的 TTB。通过从活性治疗曲线中减去安慰剂或对照药物的曲线来构建获益曲线。
结果
TTB 范围为 1 至 30 个月（平均 13.1 个月），他汀类药物（n=17）试验的 TTB 短于非他汀类药物（n=7），为 10.3 个月与 20.0 个月。在他汀类药物试验中，阿托伐他汀（n=6）的 TTB 短于其他他汀类药物（n=11），为 4.75 个月与 11.4 个月。
结论
降脂药物临床试验中的 TTB 各不相同，与非他汀类药物相比，他汀类药物的 TTB 更短。与其他他汀类药物相比，阿托伐他汀的 TTB 更短。对于新的降脂药物试验，在长达 30 个月内没有分离的结果曲线并不排除最终获益。
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