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    • LMWHs are currently recommended for the

    2022-06-22

    LMWHs are currently recommended for the treatment of VTE in patients with cancer. Compared to vitamin K antagonists, LMWHs are more effective in reducing the risk of recurrent VTE without increasing the risk of bleeding [13]. However, a post hoc analysis of this IFN-alpha 1, human recombinant protein previous study showed no significant difference in mortality between the two treatment groups [26], indicating that LMWHs for VTE treatment are beneficial in relatively early-phase cancer patients. Regarding Xa inhibitors vs. warfarin in cancer patients with VTE, a sub-analysis of the HOKUSAI trial, which enrolled 771 cancer patients, demonstrated that edoxaban resulted in a trend of less VTE recurrence and significantly less clinically relevant bleeding compared to warfarin [27]. Other Xa inhibitors, rivaroxaban and apixaban, also showed similar effects in a sub-analysis of the EINSTEIN-DVT and PE [22] and AMPLIFY trials [28], respectively. These results suggest that Xa inhibitors may be as effective as and safer than warfarin in the treatment of VTE in patients with cancer. The results of clinical trials directly comparing LMWHs with oral direct Xa inhibitors in patients with cancer have not yet been released (ClinicalTrials.gov NCT 02073682 and NCT 02744092). A network meta-analysis showed comparable effects on VTE recurrence and major bleeding of LMWHs and direct-acting oral anticoagulants in cancer patients [29]. Given that LMWHs are not approved for the treatment of VTE in Japan, Xa inhibitors are considered to be clinically useful drugs for VTE treatment in patients both with and without cancer. Therefore, the differences in Xa inhibitor effects on VTE treatment were examined in cancer and non-cancer patients in this study. The HOKUSAI VTE trial protocol showed that edoxaban therapy should be preceded by pretreatment with parenteral anticoagulants [19]. However, no pretreatment with parenteral drugs was given in 37.5% of non-cancer and 55.7% of cancer patients in the present study. Most of these patients had uncomplicated DVT. Edoxaban was also approved for the prophylaxis of VTE in patients who have undergone orthopedic surgery of the lower limb before being approved for VTE treatment; therefore, surgeons might be used to giving this drug without parenteral pretreatment. Otherwise, non-administration of parenteral anticoagulant pretreatment might have been due to a misunderstanding of the administration protocol, since the other Xa inhibitors do not require pretreatment. We also found no significant differences in clinically relevant bleeding and the changes in thrombus amount between cancer patients with and without parenteral anticoagulant pretreatment; however, these effects were still uncertain because of a small number of patients and the difference of the type of VTE in the two groups (data not shown). Regarding quantitative assessment of the thrombus, 89.6% and 94.1%, respectively, of DVT and PE patients showed changes in thrombus status to “improved” or “normalized” on day 22 and at the end of the intended treatment period after taking rivaroxaban in the J-EINSTEIN DVT and PE programs [23]. In the present study as well, approximately 90% of VTE patients were categorized as “improved” or “normalized” after 2–3 months of edoxaban therapy. In contrast, most patients who underwent two imaging tests within 1 month of treatment showed “unchanged” thrombus status. This suggests that the effect of rivaroxaban on thrombus amount appears earlier than that of edoxaban. This may be caused by the difference in administration protocol, since twice the maintenance dose of rivaroxaban is given in the initial 3 weeks. In addition, 37.5%–55.7% of the present patients did not receive pretreatment with parenteral anticoagulants, which could be another reason for the different results in the present study versus previous studies. However, it is recommended that anticoagulant treatment should be continued for at least 3 months even in patients with VTE provoked by transient risk factors [30]. Hence, the favorable changes in thrombus amount at a median duration of 2–3 months in the present study are considered clinically acceptable. There were no differences in the changes in thrombus amount between cancer and non-cancer patients.