ETNA-VTE-Japan is an ongoing prospective observational study conducted as part of a postmarketing observational study to investigate the safety and effectiveness of edoxaban in Japanese patients for whom the drug has been newly prescribed to treat venous thromboembolism (VTE) and prevent VTE recurrence. The results of an interim analysis of data collected at 3 months are presented.Methods and Results:A total of 1,732 patients were enrolled. The safety and effectiveness analyses included data from 1,703 and 1,699 patients, respectively. In the safety analysis set, 39.4% of patients were aged ≥75 years, 58.2% had body weight ≤60 kg, and 22.2% had creatinine clearance <50 mL/min. Approximately 90% of patients received a dose in accordance with the package insert. Approximately 80% of patients continued treatment; the mean treatment period was 74.5 days. The incidence of bleeding adverse events and major bleeding was 6.3% and 1.4%, respectively. The incidence of VTE recurrence and symptomatic VTE recurrence in the on-treatment population was 0.8% and 0.4%, respectively. Safety and effectiveness profiles of edoxaban in patients receiving the low dose (30 mg/day), generally administered to patients with high bleeding risk, were similar to those of the standard dose (60 mg/day).The results confirm no major concerns about the safety and effectiveness of edoxaban in Japanese patients with VTE in the first 3 months of treatment. (Trial registration No.: UMIN000016387.).
Purpose: We identified the best predictors of clinical response to simple add-on tolvaptan (TLV) therapy in patients with heart failure (HF). Methods: We retrospectively enrolled 60 HF patients with excess fluid retention despite receiving adequate medical therapy including oral diuretics. All patients received simple add-on TLV (median of 7.5mg/day). They underwent right heart catheterization at baseline and after 7-day treatment. Results: Although the majority of patients were successfully treated with simple add-on TLV therapy (Group 1), but 22% (Group 2) were defined as being unsuccessfully treated because 1) HF symptom score worsened or 2) HF symptom score >6, and mean pulmonary capillary wedge pressure (PCWP) >18 mmHg and mean right atrial pressure (RAP) >10 mmHg after TLV therapy. Although the degrees of body weight reduction and increment of urine volume were similar between the two groups, HF symptom score and mean PCWP and RAP improved, and plasma BNP level decreased only in the group 1 after TLV therapy. The group 2 had lower urine sodium/creatinine ratio (UNa/UCr) and higher plasma BNP level than responders at baseline, and they were identified as the independent predictors of unsuccessful TLV therapy by multivariate logistic regression analysis. Receiver operating characteristic curve analysis showed that UNa/UCr was the strongest predictor of unsuccessful TLV therapy with cut-off point of 46.5 mEq/gCr (AUC 0.847, 95% CI; 0.718-0.976, sensitivity 77%, specificity 81%, P<0.001). Furthermore, combination with UNa/UCr 778 pg/ml best predicted unsuccessful TLV therapy with sensitivity of 54%, specificity of 100%, positive predictive value of 100%, negative predictive value of 89%, and accuracy of 90%. Conclusion: Simple add-on tolvaptan therapy ameliorated HF symptoms and provided hemodynamic improvement in majority of patients with HF, and the measurements of UNa/UCr and BNP level can help clinicians tailor HF treatment.
Objectives We assessed the effectiveness and safety of rivaroxaban in patients with isolated distal deep vein thrombosis (IDDVT). Methods Symptomatic venous thromboembolism (VTE) and major bleeding were assessed. Results Of 1016 patients with acute symptomatic/asymptomatic DVT and/or pulmonary embolism treated with rivaroxaban, 288 had IDDVT and 294 had proximal DVT (pDVT). The IDDVT group had fewer patients on the higher rivaroxaban dose (30 mg/day) (42.7% vs. 66.0%) and a shorter treatment duration (135.5 vs 369.5 days) than the pDVT group. VTE recurrence occurred in 14 and 11 patients with IDDVT and pDVT, respectively (2.89% vs. 2.29% per patient-year; p = 0.534). Major bleeding was less frequent in the IDDVT group (1.55% vs. 4.53% per patient-year; p = 0.044). Comparable effectiveness and safety were observed with 15 and 30 mg/day rivaroxaban in the IDDVT group. Conclusions Short-term, low-dose rivaroxaban seems safe and effective for IDDVT treatment.
We evaluated several molecular markers of hemostasis in 92 patients with hypercoagulable states treated with anticoagulant therapy. In all patients, the average values of the international normalized ratio (INR) were 1.70 +/- 0.50; this increase in INR was not, however, significant in patients under thrombotest (TT) monitoring. There were no thrombotic or severe bleeding complications in these patients during a period of 27 months. Plasma levels of thrombin-antithrombin complex (TAT), plasmin-plasmin inhibitor complex (PPIC), D-dimer, and soluble fibrin monomer (sFM) were slightly increased, suggesting that anticoagulant therapy was not completely effective in our Japanese patients based on the values of the TT. The INR was negatively correlated with TT, protein C, and protein S and particularly with TT between 10 and 80%. The range of TT was not correlated with the plasma level of TAT, PPIC, D-dimer, or sFM, but the range of INR was correlated with the plasma level of TAT, D-dimer, and sFM. The percentage of TAT, D-dimer, and sFM within normal range was significantly lower in patients with high INR. These findings show that INR is better than TT for the monitoring of warfarin therapy and that the therapeutic values of INR during the anticoagulant therapy should be > 1.7 in Japanese patients.
Introduction: Impacts of postdischarge physical activity (PA) and its change in a short period of time on rehospitalization remain unclear in older heart failure (HF). Methods: Forty-one patients (...
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