Background
Apixaban, a non‐vitamin K oral anticoagulant (
NOAC
), was approved in Japan in 2012 for the prevention of thromboembolic events in patients with nonvalvular atrial fibrillation (
NVAF
). However, the safety and effectiveness of apixaban in clinical practice have not yet been elucidated thoroughly among Japanese
NVAF
patients.
Methods
A postmarketing surveillance study was conducted to determine the safety and effectiveness of apixaban. Patients were followed‐up for 104 weeks. Outcome events included adverse drug reactions (
ADR
s), hemorrhages, and thromboembolic events (ischemic stroke, systemic embolism [
SE
], and transient ischemic attack [
TIA
]).
Results
Among 6306
NVAF
patients in the safety analysis set (age, 74.5 ± 10.1 years; women, 41.1%; and
CHADS
2
score, 2.0 ± 1.4), 3600 patients (57.1%) received the standard dose (5 mg twice daily) and 2694 (42.7%) received a reduced dose (2.5 mg twice daily) of apixaban.
ADR
s occurred in 604 patients (9.58%), with the most common being epistaxis (0.86%), subcutaneous hemorrhage (0.67%), and hematuria (0.57%). Incidence rate of any hemorrhages and major hemorrhage was 5.52% per year and 2.36% per year, respectively. Incidence rate of ischemic stroke/
SE
/
TIA
was 1.00% per year among 6286 patients in the effectiveness analysis set. Among three subgroups (3106 apixaban initiators, 2038 patients switched from warfarin, and 1118 patients switched from other
NOAC
s), incidence rates of major hemorrhage (
P
= 0.221 for trend) and ischemic stroke/
SE
/
TIA
(
P
= 0.686 for trend) were comparable.
Conclusions
No new safety signals of apixaban were identified in Japanese
NVAF
patients. Safety and effectiveness of apixaban were consistent with those in the
ARISTOTLE
study.
Background: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.
The microwave spectrum of the PBr radical in the X (3)Sigma(-) ground electronic state has been observed by a source modulated spectrometer. The PBr radical was generated in a free space cell by an acdc glow discharge in a mixture of PBr(3) with He andor H(2). A spectrum with three spin components for each of the two isotopomers, P(79)Br and P(81)Br, was observed. The spectrum showed hyperfine splitting caused by interactions due to both bromine and phosphorus nuclei. The molecular constants including the magnetic hyperfine and nuclear quadrupole hyperfine interaction constants were determined by analyzing the observed spectrum. The spin density of the unpaired electrons was estimated from the observed hyperfine coupling constants to be 85.4% and 16.3% on the phosphorus and bromine atoms, respectively.
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