In the present study VTE recurrence occurred in a

In the present study, VTE recurrence occurred in a non-cancer patient during edoxaban administration, representing recurrence rates of 1.7% in non-cancer patients and 0.8% in all patients. In a sub-analysis of cancer patients [27] and the main analysis [19] in the HOKUSAI-VTE trial, recurrent VTE occurred in 4% and 3.2% of patients taking edoxaban, respectively. The patients in that trial were enrolled from 37 countries, including patients of various ethnicities. An analysis based on the 1996 California Patient Discharge Data set showed that the annual incidence of idiopathic DVT was highest in black Americans, followed by white Americans, Hispanics, and Pacific Islanders and Asians [31]. Asians/Pacific Islanders have a 3- to 5-fold lower incidence of symptomatic first-time idiopathic and secondary VTE [32]. The present study only included Japanese patients. Therefore, the lower frequency of VTE recurrence might be due to ethnic differences. The incidence of clinically relevant bleeding was also lower in the present patients with cancer (8.2%) than in cancer patients (12%) in the sub-analysis of the HOKUSAI-VTE trial [27]. In contrast, 34.4% vs. 28% of active cancer patients who took edoxaban died during analysis of edoxaban's effect in the present study as compared to in the HOKUSAI-VTE trial sub-analysis [27], although the definition of active cancer was different in the two studies. In addition, 27.9% of our patients succumbed to their cancer. These facts suggest that more terminal cancer patients were included in the present study than in the HOKUSAI trial sub-analysis. This could be the reason for the fewer bleeding events in the present study, because the patients died before the events occurred. Thus, although edoxaban can be used for VTE treatment in advanced cancer patients with similar efficacy and safety as in non-cancer patients, further evaluation in advanced cancer patients with a longer observation estrogen antagonist is required. Xa inhibitors are clinically attractive drugs for the treatment of VTE in cancer patients, especially for long-term treatment, due to their fixed-dose regimens and oral administration. However, some adverse effects could arise from their interactions with anticancer therapies [8]. Among the Xa inhibitors used for VTE treatment in Japan, rivaroxaban and apixaban are metabolized via the cytochrome P450 (CYP) system, including 3A4 and 2J2,and they are eliminated by the P-glycoprotein system, while edoxaban is a substrate of P-glycoprotein, but only minimally metabolized by CYP 3A4 [33], indicating that edoxaban has fewer interactions with anticancer drugs. Hence, in the current Japanese situation, edoxaban could be a useful agent for VTE treatment in cancer patients.
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Disclosures
Acknowledgments The results of the present study were presented at the 65th Annual Scientific Session of the Japanese College of Cardiology.
Venous thromboembolism (VTE) includes thrombus that forms in the legs and lungs, respectively known as deep venous thromboembolism (DVT) and pulmonary embolism (PE). VTE events can be life or limb threatening and represent a major health care burden for patients and health care systems alike. Deaths from PE are more common than deaths from breast cancer, motor vehicle accidents, and AIDS combined. In September 2008, the US Surgeon General issued a Call to Action highlighting public awareness for risk factors, triggering events such as trauma and major surgery, and symptoms. The Call to Action also places great emphasis on risk reduction and developing new or novel treatments to prevent VTE. Based on consensus guidelines searches, the National Quality Forum (NQF) recommends that all hospitalized patients be evaluated for VTE prophylaxis, and the American College of Chest Physicians provides recommendations on prophylaxis regimens., Hospitals are under scrutiny regarding compliance with VTE prophylaxis, and the Joint Commission has 2 measures that can be used in public reporting: surgery patients with recommended prophylaxis ordered and surgery patients who receive appropriate prophylaxis within 24 hours before and after surgery. One of the most common agents used for chemical prophylaxis is enoxaparin, which has been shown to prevent VTE events in the perioperative period. Relative risk reduction of 50% or greater is common among high-risk surgical populations., , , However, despite receiving standard prophylaxis, VTE still occurs at a rate of 2% to 10% in highest risk patients., , , , At present, we do not have a good explanation for why prophylaxis is ineffective for some patients, and why “breakthrough” events occur despite compliance with prophylaxis. This gap in knowledge has important ramifications for patient safety in the perioperative period.