共 61 条
Metformin and the Risk of Cancer Time-related biases in observational studies
被引:429
作者:

Suissa, Samy
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McGill Univ, Jewish Gen Hosp, Lady Davis Inst, Ctr Clin Epidemiol, Montreal, PQ H3T 1E2, Canada
McGill Univ, Dept Epidemiol & Biostat, Montreal, PQ, Canada
McGill Univ, Dept Med, Montreal, PQ, Canada McGill Univ, Jewish Gen Hosp, Lady Davis Inst, Ctr Clin Epidemiol, Montreal, PQ H3T 1E2, Canada

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机构:
[1] McGill Univ, Jewish Gen Hosp, Lady Davis Inst, Ctr Clin Epidemiol, Montreal, PQ H3T 1E2, Canada
[2] McGill Univ, Dept Epidemiol & Biostat, Montreal, PQ, Canada
[3] McGill Univ, Dept Med, Montreal, PQ, Canada
[4] McGill Univ, Dept Oncol, Montreal, PQ, Canada
关键词:
TYPE-2;
DIABETES-MELLITUS;
CHRONIC LIVER-DISEASE;
BREAST-CANCER;
HEPATOCELLULAR-CARCINOMA;
PANCREATIC-CANCER;
PROSTATE-CANCER;
COLORECTAL-CANCER;
DECREASED RISK;
EUROPEAN ASSOCIATION;
CONSENSUS STATEMENT;
D O I:
10.2337/dc12-0788
中图分类号:
R5 [内科学];
学科分类号:
1002 ;
100201 ;
摘要:
OBJECTIVE-Time-related biases in observational studies of drug effects have been described extensively in different therapeutic areas but less so in diabetes. Immortal time bias, time-window bias, and time-lag bias all tend to greatly exaggerate the benefits observed with a drug. RESEARCH DESIGN AND METHODS-These time-related biases are described and shown to be prominent in observational studies that have associated metformin with impressive reductions in the incidence of and mortality from cancer. As a consequence, metformin received much attention as a potential anticancer agent; these observational studies sparked the conduction of randomized, controlled trials of metformin as cancer treatment. However, the spectacular effects reported in these studies are compatible with time-related biases. RESULTS-We found that 13 observational studies suffered from immortal time bias; 9 studies had not considered time-window bias, whereas other studies did not consider inherent time-lagging issues when comparing the first-line treatment metformin with second-or third-line treatments. These studies, subject to time-related biases that are avoidable with proper study design and data analysis, led to illusory extraordinarily significant effects, with reductions in cancer risk with metformin ranging from 20 to 94%. Three studies that avoided these biases reported no effect of metformin use on cancer incidence. CONCLUSIONS-Although observational studies are important to better understand the effects of drugs, their proper design and analysis is essential to avoid major time-related biases. With respect to metformin, the scientific evidence of its potential beneficial effects on cancer would need to be reassessed critically before embarking on further long and expensive trials.
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页码:2665 / 2673
页数:9
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