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July 15, 2020

Data Presented From Global and European Analyses of Daiichi Sankyo’s ETNA-VTE Study of Edoxaban

July 15, 2020—Daiichi Sankyo Europe GmbH announced results from five analyses of 12-month data from ETNA-VTE, a noninterventional safety study evaluating edoxaban (Lixiana, Daiichi Sankyo) treatment in routine clinical practice in patients with venous thromboembolism (VTE). Edoxaban is a non–vitamin K antagonist oral anticoagulant. The findings were presented during the International Society on Thrombosis and Haemostasis (ISTH) 2020 Virtual Congress, held online July 12-14.

The primary objective of ETNA-VTE is overall symptomatic VTE recurrence rate during an overall observational period of 18 months in unselected patients with acute VTE. The coprimary objective is to collect rates of real-world safety data on bleeding events, drug-related adverse events, and mortality in VTE patients treated with edoxaban.

According to Daiichi Sankyo, the study showed low rates of bleeding and VTE recurrence in a range of VTE subpopulations in routine clinical practice in 4,595 patients (mean age, 64 years) with VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), who were enrolled at sites in Europe, Japan, East Asia, and Southeast Asia.

“These real-world findings provide clinicians with additional evidence of edoxaban’s safety and efficacy in specific VTE patient populations that are considered high-risk or have comorbidities,” commented Alexander T. Cohen, MBBS, MD, a vascular physician and epidemiologist at Guy’s and St. Thomas’ Hospital, King’s College in London, United Kingdom. Dr. Cohen continued, “This is of particular significance for aging patients and those who treat them, as the elderly are at greatest risk due to the high prevalence of predisposing comorbidities and acute illnesses, making edoxaban an appropriate treatment for this population.”

The company summarized the findings as follows.

The Global ETNA-VTE subanalysis (ISTH abstract) showed that at 12 months, rates of major bleeding were low across all age groups, recurrent VTE decreased with increasing age, and all-cause mortality increased with age as would be expected. However, most of the mortalities were not cardiovascular (CV)-related.

Per year, globally:

  • VTE recurrence occurred in 3.65% of patients aged < 65 years; 2.83% of those aged ≥ 65 and < 75 years; 2.3% of those aged ≥ 75 and <85 years; and 3.07% of those aged ≥ 85 years.
  • ISTH-defined major bleeding occurred in 1.34% of patients aged < 65 years; 3.16% of patients aged ≥ 65 to < 75 years; 2.97% of patients aged ≥ 75 to < 85 years; and 5.72% of patients aged ≥ 85 years.
  • CV-related mortality occurred in 0.35% of patients aged < 65 years; 1.08% of patients aged ≥ 65 to < 75 years; 1.96% of patients aged ≥ 75 to < 85 years; and 3.04% of patients aged ≥ 85 years.

The first of two ETNA-VTE Europe subanalyses (ISTH abstract) showed low rates of major bleeding and VTE recurrence in patients with PE (with or without DVT) and patients with DVT alone. Patients with PE, with or without DVT, had a tendency toward a higher risk of mortality and bleeding events than those with DVT alone, but they also had higher-risk baseline characteristics.

Per year, in the European index VTE event group:

  • Major bleeding occurred in 2.39% of patients with PE (with or without DVT) and 1.57% of patients with DVT alone.
  • VTE recurrence of any kind occurred in 2.89% of patients with PE (with or without DVT) and 2.78% of those with DVT alone.

The second European subanalysis (ISTH abstract), which stratified patients by body mass index (BMI; 18.5 to < 25 kg/m2 [normal weight]; 25 to < 30 kg/m2 [overweight]; ≥ 30 kg/m2 [obese]), showed that obesity did not substantially affect the risks of recurrent VTE and other bleeding complications.

Per year, in the European BMI group:

  • VTE recurrence occurred in 2.67% of patients overall (2.44%, 2.83%, and 2.71%, respectively).
  • Major bleeding occurred in 1.69% of patients overall (1.75%, 2%, and 1.11%, respectively).
  • All-cause mortality occurred in 2.16% of patients overall (2.97%, 1.77%, and 2.39%, respectively).

An additional Global ETNA-VTE presentation (ISTH abstract) and another ETNA-VTE Europe presentation (ISTH abstract) showed that high versus low bleeding risk (as identified by the VTE-BLEED score) was associated with similar VTE recurrence risk but higher all-cause and cardiovascular mortality and incidences of any bleeding type or category. They also showed that edoxaban is largely used adequately in real-world practice in Europe, respecting the recommendations for treatment initiation, dosing, and dose adjustments in special patient populations, reported Daiichi Sankyo.

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