Effects of Regional Differences in Asia on Efficacy and Safety of Edoxaban Compared With Warfarin--Insights From the ENGAGE AF-TIMI 48 Trial.
Circ J
; 79(12): 2560-7, 2015.
Article
em En
| MEDLINE
| ID: mdl-26460886
ABSTRACT
BACKGROUND:
In 21,105 patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial, edoxaban was non-inferior to warfarin in preventing thromboembolic events while reducing bleeding. We compared results in Japan with the rest of East Asia (EA), including China, Korea, and Taiwan. METHODSâANDâRESULTS:
We compared baseline characteristics, time-in-therapeutic range (TTR) for warfarin, and outcomes (efficacy stroke or systemic embolic events [SEE], safety major bleeding). Interaction P values were used to assess for effect modification of treatment (higher-dose edoxaban [HDE, 60 mg/30 mg] vs. warfarin; lower-dose edoxaban [LDE, 30 mg/15 mg] vs. warfarin) by region with adjustments for baseline characteristics. Fewer patients in Japan (n=1,010) were female, taking aspirin or amiodarone, naïve to warfarin (P<0.001 for each), had a history of stroke or transient ischemic attack (P=0.02), and more patients needed dose reduction (P<0.001) compared with EA (n=933). The mean TTR was higher in Japan (70% vs. 56%, P<0.001). Evidence for statistical interactions was observed for HDE vs. warfarin by region for stroke/SEE (adjusted P-int=0.052) and major bleeding (adjusted P-int=0.048) with greater relative efficacy and safety with HDE in EA compared with Japan. No interactions were observed for LDE vs. warfarin after adjustment.CONCLUSIONS:
HDE had a greater relative efficacy and safety in EA compared with Japan that was only partially explained by differences in baseline characteristics and TTR.
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Base de dados:
MEDLINE
Assunto principal:
Tromboembolia
/
Varfarina
/
Ciclofosfamida
/
Hemorragia
Tipo de estudo:
Clinical_trials
Limite:
Aged
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Female
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Humans
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Male
/
Middle aged
País como assunto:
Asia
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article