A post-marketing surveillance study (STANDARD-VTE) evaluated the real-world safety and effectiveness of
apixaban in Japanese patients prescribed for either the treatment of
venous thromboembolism (VTE) or prevention of recurrent VTE.Methods and Results:Patients newly initiated on
apixaban were followed up for 52 weeks or 28 days post-discontinuation. Subgroup analysis was performed on patients with and without active
cancer, and on patients with provoked VTE and with unprovoked VTE. A total of 1,119 patients were enrolled. Of these, 43.1% were aged ≥75 years, 46.4% had
body weight ≤60 kg, and 21.3% had active
cancer; mean serum
creatinine was 0.76 mg/dL. The incidence of
adverse drug reactions (ADRs) was 8.85%, and that of severe ADRs was 3.22%. Incidence of any
bleeding, major
bleeding, and recurrent VTE was 6.70%, 3.40%, and 0.80%, respectively. In patients starting
apixaban 10 mg twice daily, THE incidence of any
bleeding and major
bleeding was 7.72% and 3.86%, respectively. In patients with active
cancer, THE incidence of any
bleeding and major
bleeding was 16.81% and 9.24%, respectively.
CONCLUSIONS: No new safety signals of
apixaban were identified in Japanese patients with VTE. In this study, the safety and effectiveness of
apixaban in real-world practice was consistent with the results of the
apixaban phase III trial.