In 2406 patients 80 years and older with or without dose-reduction criteria, patients receiving edoxaban, 30 mg, vs warfarin had lower rates of the primary net clinical outcome (HR, 0.78; 95% CI, 0.68-0.91; P =.001), major bleeding (HR, 0.59; 95% CI, 0.45-0.77; P <.001), and ...
(P<.001 for noninferiority,P=.02 for superiority) and 1.61% per year for the low-dose edoxaban group (P=.005 for noninferiority,P=.44 for superiority). In the trial design, if a dose met the prespecified criteria for noninferiority, it was then compared with warfarin in a test of ...
Randomization is performed with the use of a central, 24-hour, interactive Web response system and stratified according to geographic region (Asia, Eastern Europe, Western Europe), clinical presentation (ACS or stable coronary disease), and presence of edoxaban dose reduction criteria. The edoxaban-...
批准时间:2015-01-08 Savaysa (edoxaban) 药品使用说明书 用于预防心房颤动(房颤)患者发生 中风和全身性栓塞(SE) HAOEYOU ( 好医友 ) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SAVAYSA? safely and effectively. See full prescribing information for...
The recommended edoxaban dose is 60 mg for patients with NVAF or VTE not meeting the dose reduction criteria, and 30 mg for patients meeting the dose reduction criteria (i.e., creatinine clearance 15–50 mL/min for NVAF, or creatinine clearance 15–50 mL/min, body weight ≤60 kg, or ...
A total of 8292 patients with acute VTE were randomised, 733 and 719 patients in the edoxaban and warfarin groups met the criteria for dose reduction. These patients were older, more often female or Asian and had more extensive VTE. Edoxaban levels were lower in the 30 mg edoxaban group. ...
Treatment of pulmonary thromboembolism with edoxaban in a cancer patient with borderline fulfillment of the dose reduction criteria.doi:10.1177/2050313X19878047Takuro TakamaMitsunori FukueKoji KanayaMasato TaniuchiSAGE PublicationsSage UK: London, England...
Available label dose reduction criteria (N = 4232) revealed that 3278 (77.5%) patients received recommended doses and 954 (22.5%) non-recommended doses. Northeast (53.0%) and West (43.1%) regions had the highest prescriptions of 60 mg and 30 mg recommended doses, respectively. Non-...
Patients who met clinical criteria for dose reduction at randomisation (n=5356) had higher rates of stroke, bleeding, and death compared with those who did not have a dose reduction (n=15 749). Edoxaban dose ranged from 15 mg to 60 mg, resulting in a two-fold to three fold gradient...
We considered as the primary outcome of safety the occurrence of major bleedings (defined according to the criteria of the International Society on Thrombosis and Hemostasis [13]). Other safety outcomes were the occurrence of minor bleedings, the need for blood transfusions, and hospitalization for...