| アブストラクト | Real-world data provide the potential for generating evidence on drug treatment effects in groups excluded from trials, but rigorous, validated methodology for doing so is lacking. We investigated whether non-interventional methods applied to real-world data could reproduce results from the landmark TORCH COPD trial.We performed a historical cohort study (2000-2017) of COPD drug treatment effects in the UK Clinical Practice Research Datalink (CPRD). Two control groups were selected from CPRD by applying TORCH inclusion/exclusion criteria and 1:1 matching to TORCH participants, as follows. Control group 1: people with COPD not prescribed fluticasone propionate (FP)-salmeterol (SAL); control group 2: people with COPD prescribed SAL only. FP-SAL exposed groups were then selected from CPRD by propensity score matching to each control group. Outcomes studied were COPD exacerbations, death from any cause and pneumonia.2652 FP-SAL exposed people were propensity score matched to 2652 FP-SAL unexposed people while 991 FP-SAL exposed people were propensity score matched to 991 SAL exposed people. Exacerbation rate ratio was comparable to TORCH for FP-SAL versus SAL (0.85, 95% CI 0.74-0.97 versus 0.88, 0.81-0.95) but not for FP-SAL versus no FP-SAL (1.30, 1.19-1.42 versus 0.75, 0.69-0.81). In addition, active comparator results were consistent with TORCH for mortality (hazard ratio 0.93, 0.65-1.32 versus 0.93, 0.77-1.13) and pneumonia (risk ratio 1.39, 1.04-1.87 versus 1.47, 1.25-1.73).We obtained very similar results to the TORCH trial for active comparator analyses, but were unable to reproduce placebo-controlled results. Application of these validated methods for active comparator analyses to groups excluded from randomised controlled trials provides a practical way for contributing to the evidence base and supporting COPD treatment decisions. |
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| ジャーナル名 | The European respiratory journal |
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| 投稿日 | 2020/10/24 |
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| 投稿者 | Wing, Kevin; Williamson, Elizabeth; Carpenter, James R; Wise, Lesley; Schneeweiss, Sebastian; Smeeth, Liam; Quint, Jennifer K; Douglas, Ian |
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| 組織名 | Dept of Non-communicable Disease Epidemiology, Faculty of Epidemiology and;Population Health, London School of Hygiene and Tropical Medicine, London, UK.;Dept of Medical Statistics, Faculty of Epidemiology and Population Health, London;School of Hygiene and Tropical Medicine, London, UK.;Dept of Epidemiology, Harvard Medical School, Boston, MA, USA.;Division of Pharmacoepidemiology and Pharmacoeconomics, Dept of Medicine, Brigham;and Women's Hospital, Boston, MA, USA.;National Heart and Lung Institute, Imperial College London, London, UK. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33093119/ |
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