| アブストラクト | Statins are indicated in patients with elevated levels of high-sensitivity C-reactive protein and normal low-density lipoprotein cholesterol based on results of the multicountry trial, Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) (2003-2008), but the benefit in real-world populations remains unknown. We sought to generalize JUPITER results to trial-eligible population using data from the UK Clinical Practice Research Datalink (CPRD), 2001-2014. We multiply imputed missing baseline characteristics for the CPRD population and selected the trial-eligible participants as the target population based on observed and imputed values. Trial participants were weighted to be representative of the CPRD population (n = 383,418) based on individual predicted probability of selection into the trial. Trial participants were also standardized to the CPRD population without missing values (n = 2,677). In JUPITER, rosuvastatin reduced cardiovascular risk with a 3-year risk difference of -2.0% (95% confidence interval (CI): -2.9, -1.1). The rosuvastatin effect was muted in the first 2 years but remained strong at 3 years after standardizing to the imputed CPRD population (3-year risk difference = -2.7%; 95% CI: -5.8, 0.4) and the CPRD population without missing data (3-year risk difference = -1.7%; 95% CI: -3.5, 0.1). The study serves as an illustration of possible approaches to understanding generalizability of trials using real-world databases given limitations due to missing data on inclusion/exclusion criteria. |
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| ジャーナル名 | American journal of epidemiology |
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| 投稿日 | 2017/10/12 |
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| 投稿者 | Hong, Jin-Liern; Jonsson Funk, Michele; LoCasale, Robert; Dempster, Sara E; Cole, Stephen R; Webster-Clark, Michael; Edwards, Jessie K; Sturmer, Til |
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| 組織名 | Department of Epidemiology, Gillings School of Global Public Health, University;of North Carolina at Chapel Hill, Chapel Hill, North Carolina.;Medical Evidence and Observational Research, AstraZeneca Pharmaceuticals,;Gaithersburg, Maryland.;R&D Information, AstraZeneca Pharmaceuticals, Waltham, Massachusetts. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/29020193/ |
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