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  • 1
    Online Resource
    Online Resource
    Relationship between body mass index and outcomes in patients with atrial fibrillation treated with edoxaban or warfarin in the ENGAGE AF-TIMI 48 trial
    Oxford University Press (OUP) ; 2019
    In:  European Heart Journal Vol. 40, No. 19 ( 2019-05-14), p. 1541-1550
    Details
    In: European Heart Journal, Oxford University Press (OUP), Vol. 40, No. 19 ( 2019-05-14), p. 1541-1550
    Abstract: To investigate the relationship between body mass index (BMI) and outcomes in patients with atrial fibrillation (AF). Methods and results In the ENGAGE AF-TIMI 48 trial, patients with AF were randomized to warfarin (international normalized ratio 2.0–3.0) or edoxaban. The cohort (N = 21 028) included patients across BMI categories (kg/m2): underweight ( & lt;18.5) in 0.8%, normal (18.5 to & lt;25) in 21.4%, overweight (25 to & lt;30) in 37.6%, moderately obese (30 to & lt;35) in 24.8%, severely obese (35 to & lt;40) in 10.0%, and very severely obese (≥40) in 5.5%. In an adjusted analysis, higher BMI (continuous, per 5 kg/m2 increase) was significantly and independently associated with lower risks of stroke/systemic embolic event (SEE) [hazard ratio (HR) 0.88, P = 0.0001], ischaemic stroke/SEE (HR 0.87, P  & lt; 0.0001), and death (HR 0.91, P  & lt; 0.0001), but with increased risks of major (HR 1.06, P = 0.025) and major or clinically relevant non-major bleeding (HR 1.05, P = 0.0007). There was a significant interaction between sex and increasing BMI category, with lower risk of ischaemic stroke/SEE in males and increased risk of bleeding in women. Trough edoxaban concentration and anti-Factor Xa activity were similar across BMI groups & gt;18.5 kg/m2, while time in therapeutic range for warfarin improved significantly as BMI increased (P  & lt; 0.0001). The effects of edoxaban vs. warfarin on stroke/SEE, major bleeding, and net clinical outcome were similar across BMI groups. Conclusion An increased BMI was independently associated with a lower risk of stroke/SEE, better survival, but increased risk of bleeding. The efficacy and safety profiles of edoxaban were similar across BMI categories ranging from 18.5 to & gt;40.
    Type of Medium: Online Resource
    ISSN: 0195-668X , 1522-9645
    URL: Article
    DOI: 10.1093/eurheartj/ehy861
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
    detail.hit.zdb_id: 2001908-7
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  • 2
    Online Resource
    Online Resource
    Abstract 12680: Efficacy and Safety of Edoxaban Compared With Warfarin in Patients With Atrial Fibrillation and Heart Failure: Insights From Engage-AF TIMI 48
    Ovid Technologies (Wolters Kluwer Health) ; 2014
    In:  Circulation Vol. 130, No. suppl_2 ( 2014-11-25)
    Details
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 130, No. suppl_2 ( 2014-11-25)
    Abstract: BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) have emerged as the two epidemics of cardiovascular (CV) disease. The prevalence of AF increases with the severity of HF and contributes to HF disability. Among patients treated with vitamin K antagonists (VKAs), symptomatic HF is an independent risk factor for lower time in therapeutic range (TTR), which reduces the efficacy and safety of VKAs. METHODS: In the ENGAGE AF-TIMI 48 trial, both once-daily regimens of the direct oral factor Xa inhibitor edoxaban [high (HDE) and low dose (LDE)], were non inferior to warfarin (W) for prevention of stroke and systemic embolic events (SEE) in patients with AF and were associated with lower rates of bleeding. We evaluated the safety and the efficacy of edoxaban compared with W in patients with HF presenting with different severity of functional limitation (NYHA class). RESULTS: Among 21,105 patients enrolled 8,981(43%) had no history of HF, 9,489 (45%) had history of HF and a NYHA class I-II, whereas 2,635 (13%) had symptomatic HF with NYHA class III-IV. Patients with more severe HF symptoms had higher rates of stroke SEE, CV death and CV hospitalization (p 〈 0.0005 for all) and among those treated with W we observed a lower mean TTR (62.6% vs. 70.0%, p 〈 0.001). Compared with W, the efficacy of both edoxaban doses in reducing stroke or SEE was similar between patients with and without HF (HDE vs. W, p int=0.96; LDE vs. W, p int=0.63, Fig.) and there were no differences between NYHA classes. CV hospitalization was significantly reduced with HDE relative to W, without heterogeneity by different NYHA classes (p int=0.5, Fig.). Both edoxaban regimens reduced consistently major bleeding and intracranial hemorrhage, regardless of HF severity (Fig.). CONCLUSION: The relative efficacy and safety of both edoxaban regimens, compared to well-managed W in AF patients with HF, was consistent irrespective of the severity of functional class.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    URL: Article
    DOI: 10.1161/circ.130.suppl_2.12680
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 1466401-X
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  • 3
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    Online Resource
    Abstract 17211: Edoxaban versus Warfarin in Patients With Atrial Fibrillation in the US FDA Approval Population: An Analysis From the ENGAGE AF-TIMI 48 Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2015
    In:  Circulation Vol. 132, No. suppl_3 ( 2015-11-10)
    Details
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 132, No. suppl_3 ( 2015-11-10)
    Abstract: Background: Edoxaban (edo), a QD oral direct factor Xa inhibitor, is non-inferior to warfarin for preventing stroke or systemic embolism (SE) in mod-high risk pts with AF. Due to reduced protection from ischemic stroke in pts with CrCl 〉 95 ml/min, the US FDA approved the higher dose edo regimen in pts with AF and a CrCl 15-95 ml/min (60mg QD if CrCl 50-95 ml/min; 30mg QD if CrCl 15-50 ml/min) without dose reduction for weight 〈 60 kg or use of P-glycoprotein (P-gp) inhibitors. We report here for the first time the clinical characteristics, efficacy and safety of the FDA-approved population. Methods: From the ENGAGE AF-TIMI 48 trial population, we excluded pts who received the lower-dose edo regimen (30/15 mg), had CrCl 〉 95 ml/min, or were dose-reduced for weight≤ 60 kg or potent P-gp use. The 1° efficacy endpoint was stroke/SE and principal safety endpoint was major bleeding. Efficacy data are from the ITT cohort in the overall study period, unless otherwise specified. Results: There were 9387 pts with CrCl 15-95 ml/min randomized to either warfarin or edo 60/30 mg per the FDA label followed for 2.8 yrs (median). These pts were older (74 vs 64 yrs), more likely women (40 vs 33%), and had higher CHADS 2 and HAS-BLED scores compared to pts not included in the FDA label, but were balanced by randomization group. The annualized rate of stroke/SE on-treatment was 1.11% with edo vs. 1.72% with warfarin (HR vs. warfarin 0.64 [0.51-0.81], p 〈 0.001). Rates in the ITT cohort were 1.63% and 2.02% with edo and warfarin, respectively (HR 0.81 [0.67-0.97], p=0.023). Ischemic stroke rates were similar (1.31 vs 1.39%, HR 0.94, p=0.97). Edo significantly reduced hemorrhagic stroke, CV death, major and intracranial bleeding events (Fig). Conclusion: Among high risk pts in the ENGAGE AF-TIMI 48 trial who represent the FDA approval population and dosing regimen of edo, treatment with edo 60/30 mg is superior to warfarin in the prevention of stroke/SE and reduces major bleeding, intracranial hemorrhage, and CV death.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    URL: Article
    DOI: 10.1161/circ.132.suppl_3.17211
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
    detail.hit.zdb_id: 1466401-X
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