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Real-World Studies Confirm Efficacy of Xarelto in Treating and Preventing Blood Clots

Data obtained from nearly 15,000 patients

The results from two new real-world studies have confirmed the positive benefit–risk profile of rivaroxaban (Xarelto, Janssen/Bayer) in treating venous thromboembolism (VTE) and in reducing the risk of recurrence.

One study showed that patients with VTE taking rivaroxaban for longer than three months had a lower risk of VTE recurrence without an increase in major bleeding, compared with patients treated with rivaroxaban for only three months. The second study was the first readout from the PMSS (Post-Marketing Safety Surveillance) trial of rivaroxaban in patients with VTE, which showed that the rates and patterns of major bleeding in patients treated with rivaroxaban in routine clinical practice were consistent with those reported in clinical trials.

VTE is a collective term encompassing deep vein thrombosis (DVT), a blood clot in a deep vein (usually the leg), and pulmonary embolism (PE). VTE affects more than 900,000 Americans each year, and one-third of these events will be fatal. Once a person experiences VTE, he or she is at increased risk of it occurring again.

In nearly 5,000 patients who were diagnosed with their first VTE, researchers examined the long-term safety and efficacy of rivaroxaban and found that those who continued taking rivaroxaban for up to one year had significantly lower rates of VTE recurrence at all measured time points, without an increased risk of major bleeding, compared with those who discontinued rivaroxaban after three months. Specifically:

·         At three months, recurrent VTE occurred in 0.57% of patients in the continued cohort and in 1.19% of those in the discontinued cohort (P < 0.05). Major bleeding occurred in 0.51% and 0.72% of the two groups, respectively (P > 0.05).

·         At six months, recurrent VTE occurred in 1.07% of patients in the continued cohort and in 2.10% of those in the discontinued cohort (P < 0.05). Major bleeding occurred in 0.79% and 0.72% of the two groups, respectively (P > 0.05).

·         At 12 months, recurrent VTE occurred in 1.45% of patients in the continued cohort and in 2.60% of those in the discontinued cohort (P < 0.05). Major bleeding occurred in 1.06% and 1.13% of the two groups, respectively (P > 0.05).

Clinical guidelines recommend that patients diagnosed with VTE should be treated with an anticoagulant, such as rivaroxaban, for a minimum of three months––when they are at the highest risk of experiencing a recurrence. However, the risk still remains after treatment ends, and up to 10% of patients will have a recurrent event within the first year.

The second study––the ongoing PMSS VTE trial––is following patients with DVT and PE in the U.S. who are receiving treatment with rivaroxaban. This retrospective, observational study is evaluating major bleeding in these patients in a real-world, post-approval setting, using electronic health records from the U.S. Department of Defense database.

The first data cut of 9,638 patients with VTE (5,426 with DVT and 4,212 with PE) showed the following:

  • Of the 9,638 patients treated with rivaroxaban, 130 (1.3%) experienced a major bleeding event, which corresponds to an incidence rate of 2.47 per 100 person-years, primarily in gastrointestinal sites.
  • Major bleeding was observed in 74 patients with DVT (1.4%), corresponding to an incidence rate of 2.74 per 100 person-years.
  • Major bleeding events were observed in 56 patients with PE (1.3%), corresponding to an incidence rate of 2.18 per 100 person-years.
  • Patients who experienced major bleeding were typically older and female, and had more comorbidities. Fatal outcomes were rare.

Source: PR Newswire; October 23, 2016.

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