| アブストラクト | PURPOSE: To compare the effectiveness and safety of a drug in daily practice with the outcomes of a target non-inferiority trial by rigorously mimickingin an observational study the trial's design features. METHODS: This cohort study was conducted using the British Clinical Practice Research Datalink (CPRD) to emulate the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial. Patients with atrial fibrillation who were newly prescribed (>=12 months of no use) either rivaroxaban or warfarinfrom October 2008 to December 2017 were included. Non-inferiority of rivaroxaban to warfarin in the prevention of stroke or systemic embolism was assessed in different analysis populations (intention-to-treat [ITT], per-protocol [PP], and as-treated populations) using a hazardratio (HR) of 1.46 as the non-inferiority margin. Major bleeding (safety outcome) was also assessed and compared to that of the target trial. All outcomes were analyzed using Cox-proportional hazard analyses. RESULTS: We included 25,473 incident users of rivaroxaban (n=4,008) or warfarin(n=21,465). Similar to the trial, non-inferiority in the primary out come was demonstrated in all three analysis populations: HR=1.04 (95%CI 0.84 to 1.30) (ITT), HR=0.98 (95%CI 0.70 to 1.38) (PP), and HR=1.11 (95%CI 0.86 to 1.42) (as-treated). Risk of major bleeding was also similar to the target trial. CONCLUSION: The results of this study provide supportive evidence to the effectiveness of rivaroxaban and adds knowledge on the usefulness of emulating a non-inferiority trial to assess drug effectiveness. |
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| ジャーナル名 | Pharmacoepidemiology and drug safety |
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| Pubmed追加日 | 2020/6/17 |
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| 投稿者 | Althunian, Turki A; de Boer, Anthonius; Groenwold, Rolf H H; Rengerink, Katrien O; Souverein, Patrick C; Klungel, Olaf H |
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| 組織名 | Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for;Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.;Chairman of the Dutch Medicines Evaluation Board, Dutch Medicines Evaluation;Board, Utrecht, The Netherlands.;Julius Center for Health Sciences and Primary Care, University Medical Center;Utrecht, Utrecht, The Netherlands. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/32537897/ |
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