Variations in time to benefit among clinical trials of cholesterol-lowering drugs

被引：19

作者：

Barter, Philip J. ^{[1
,2
]}

Waters, David D. ^{[1
,2
]}

机构：

[1] Univ New South Wales, Sch Med Sci, Sydney, NSW, Australia

[2] Zuckerberg San Francisco Gen Hosp, Div Cardiol, San Francisco, CA USA

来源：

JOURNAL OF CLINICAL LIPIDOLOGY | 2018年 / 12卷 / 04期

关键词：

Cholesterol lowering; Clinical trials; Statins; Time to benefit; RANDOMIZED CONTROLLED-TRIAL; ACUTE CORONARY SYNDROMES; PLACEBO-CONTROLLED TRIAL; DENSITY-LIPOPROTEIN CHOLESTEROL; HIGH-DOSE ATORVASTATIN; PRIMARY-PREVENTION; CARDIOVASCULAR-DISEASE; ACTIVE METABOLITE; MYOCARDIAL-INFARCTION; SECONDARY PREVENTION;

D O I：

10.1016/j.jacl.2018.04.006

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

BACKGROUND: Time to benefit (FIB) 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 FIB among clinical trials of cholesterol-lowering drugs. METHODS: We examined FIB 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. (C) 2018 National Lipid Association. All rights reserved.

引用

页码：857 / 862

页数：6

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