| アブストラクト | AIM: To investigate the effects of off-label non-vitamin K oral anticoagulant (NOAC) dose reduction compared with on-label standard dosing in atrial fibrillation (AF) patients in routine care. METHODS: Population-based cohort study using data from the United Kingdom Clinical Practice Research Datalink, comparing adults with non-valvular AF receiving an off-label reduced NOAC dose to patients receiving an on-label standard dose. Outcomes were ischaemic stroke, major/non-major bleeding and mortality. Inverse probability of treatment weighting and inverse probability of censoring weighting on the propensity score were applied to adjust for confounding and informative censoring. RESULTS: Off-label dose reduction occurred in 2466 patients (8.0%), compared with 18 108 (58.5%) on-label standard-dose users. Median age was 80 years (interquartile range [IQR] 73.0-86.0) versus 72 years (IQR 66-78), respectively. Incidence rates were higher in the off-label dose reduction group compared to the on-label standard dose group, for ischaemic stroke (0.94 vs 0.70 per 100 person years), major bleeding (1.48 vs 0.83), non-major bleeding (6.78 vs 6.16) and mortality (10.12 vs 3.72). Adjusted analyses resulted in a hazard ratio of 0.95 (95% confidence interval [CI] 0.57-1.60) for ischaemic stroke, 0.88 (95% CI 0.57-1.35) for major bleeding, 0.81 (95% CI 0.67-0.98) for non-major bleeding and 1.34 (95% CI 1.12-1.61) for mortality. CONCLUSION: In this large population-based study, the hazards for ischaemic stroke and major bleeding were low, and similar in AF patients receiving an off-label reduced NOAC dose compared with on-label standard dose users, while non-major bleeding risk appeared to be lower and mortality risk higher. Caution towards prescribing an off-label reduced NOAC dose is therefore required. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| Pubmed追加日 | 2022/9/15 |
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| 投稿者 | van den Dries, Carline J; Pajouheshnia, Romin; van den Ham, Hendrika A; Souverein, Patrick; Moons, Karel G M; Hoes, Arno W; Geersing, Geert-Jan; van Doorn, Sander |
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| 組織名 | Julius Center for Health Sciences and Primary Care, University Medical Center;Utrecht, Utrecht University, Utrecht, The Netherlands.;Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for;Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36102068/ |
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