Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy

Catherine Lister, Mercer University College of Pharmacy

The Center for Disease Control and Prevention (CDC) estimates that there are 900,000 people affected by venous thromboembolism (VTE) and pulmonary embolism (PE) every year in the United States. They approximate that 60,000 to 100,000 Americans die annually from these conditions. [1]

It is suggested that patients with active malignancy are at an increased risk of VTE and an increased risk of major bleeding when they have a VTE. [2]

Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy – A Single Center Registry
Design Prospective analysis; N= 440
Objective To evaluate the efficacy and safety of rivaroxaban in patients with venous thromboembolism and active malignancy given the paucity of clinical data with the use of direct Xa inhibitors in this high risk population
Study Groups Active malignancy (n= 118), no cancer (n= 178)
Methods Consecutive patients treated with rivaroxaban for deep vein thrombosis or pulmonary embolism who were enrolled into the Mayo Thrombophilia Clinic Direct Oral Anticoagulants Registry between March 1, 2013, and April 30, 2015 were followed prospectively to evaluate the efficacy and safety of this therapy. There were 296 patients that received rivaroxaban and had at least three months of follow up.
Duration March 1, 2013 to April 30, 2015
Primary Outcome Measure Recurrence of deep vein thrombosis (DVT), bleeding
Baseline Characteristics   Cancer/ Active malignancy

(n= 118)

No cancer

(n= 178)

p value
Women, % 51 47 0.42
Mean age years 66 55 <0.0001
Body Mass Index (BMI) 29 35 0.08
DVT only, % 62 66 0.24
PE only, % 24 11 0.0002
DVT and PE, % 14 23 0.03
Hormonal therapy ,% 0 6 0.01
Results   Cancer/ Active malignancy (n= 118) No cancer (n= 178) P value
VTE recurrence 3.3% 2.8% 0.533
DVT 3 4 1.000
PE 1 1 1.000
Major bleeding 3 0 0.06
Non-major clinically relevant bleeding 4 1 0.08
Minor bleed 3 3 0.69
Death 37 0 <0.0001
Adverse Events Common Adverse Events: Minor bleed: cancer 2.5%, no cancer 1.7%; Major bleed: cancer 5.9%, no cancer 0.6%
Serious Adverse Events: Death: cancer 31%, no cancer 0%
Percentage that Discontinued due to Adverse Events: none reported
Study Author Conclusions The “real world” effectiveness and safety of rivaroxaban is similar for venous thromboembolism patients with and without active malignancy.

This article published in the American Journal of Medicine aims to investigate the efficacy of rivaroxaban for the prevention of VTE in patients with active malignancy. They found that there was no significant difference in VTE recurrence, or major bleeding in the malignant patients compared to patients without cancer.

References

  1. Centers for Disease Control and Prevention. Venous Thromboembolism Data and Statistics. Centers for Disease Control and Prevention website. http://www.cdc.gov/ncbddd/dvt/data.html. Accessed January 25, 2016.
  2. Bott-Kitslaar DM, Saadiq RA, McBane RD, Loprinzi CL, Ashrani AA, Ransone TR, Wolfgram AA, Berentsen MM, Wysokinski WE, Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy – A Single Center Registry, The American Journal of Medicine (2016), doi: 10.1016/j.amjmed.2015.12.025.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s