Hospice Medication Alert: FDA Approves Anti-Clotting Drug Savaysa (edoxaban)

 In Anti-Coagulant, FDA

alert2The U.S. Food and Drug Administration (FDA) approved another anti-clotting drug Savaysa (edoxaban) in January 2015 for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). This medication also has the FDA approved indication to reduce the risk of stroke and blood clots in patients with atrial fibrillation, but it is not recommended for patients with CrCl greater than 95ml/minutes due to its inferior efficacy in comparison to Coumadin (warfarin) at clinical trials.

This is the third oral factor Xa inhibitors approved by FDA as an anticoagulant to treat blood clots and prevent stroke risk in the last four years. The most common side effects for Savaysa observed in clinical trial participants were bleeding and anemia.(1) Just like the other FDA-approved anti-clotting drugs, bleeding, including life-threatening bleeding, is the most serious risk with Savaysa. There is no treatment that has been proven to reverse the anticoagulant effect of Savaysa like the antidote we have for Coumadin.

Factor Xa inhibitors, like Savaysa, are likely to be reserved as a second line therapy due to its lack of antidote to the anticoagulant effect and they are cost-prohibitive compared to Coumadin. When you encounter a patient with one of the new anticoagulants in the hospice setting, it is important to ask the following questions to ensure if the anticoagulation treatment is still suitable for your hospice patients:

  1. Is the patient taking the medication for treatment or stroke prevention?
    If the patient is taking the medication for stroke prevention in atrial fibrillation, the medication should be considered for discontinuation unless the patient has a high risk for clotting. Outcome Resources provides patient-directed letters to help hospice providers to communicate the rationale of discontinuing the anticoagulant at end of life care.
  2. What is the risk vs. benefit of continuing the anticoagulation therapy? What is the likelihood of patient getting another blood clot? Did the patient have a recent clotting event even if the patient is using the medication for clotting prevention?
    A study has suggested that anti-coagulants can reduce stroke risk by about 4% per year on average for ambulatory patients with atrial fibrillation.(2) Hospice patients are more likely to suffer from the side effects of bleeding at end of life than having a blood clot event. Therefore, the risks of anticoagulation treatment are greater than the benefits in this population and should be considered for discontinuation.
  3. If the hospice patient has a high risk for clotting and has a reasonable functional level (Palliative Performance Scale >40%), why is the patient not able to take Coumadin (warfarin) versus the other anticoagulants?
    Coumadin is the most cost-effective medication in the class of anticoagulants even after taking into account for the INR monitoring cost. It is the only oral medication in this class with an antidote for its anticoagulation effects, which makes it a safer option for patients with bleeding risk, especially in the hospice setting. The only drawback to using Coumadin is the requirement of routine INR monitoring on the anticoagulation effect while the newer agents do not. However, recent studies have suggested that routine INR monitoring improves patient adherence to the anticoagulant therapy, which leads to better outcomes from Coumadin in general.(3)

If you have asked these three sets of questions above and the answers still suggested that the patient is a candidate to continue on an anticoagulation therapy, then you can consider some of the newer oral agents, like the factor Xa inhibitors. They are generally more cost-effective than the injectable anti-coagulants like Lovenox.

Here is the clinical pearl of using anticoagulants in hospice setting. 1) Consider discontinuation if possible. 2) If not, Coumadin remains as the gold standard to treat/prevent blood clots before other newer anticoagulants. 3) Reserve the injectable anticoagulants as the last resort as it is both invasive and expensive.

View a Comparison Chart of Oral Anti-Coagulants

References

  1. FDA approves anti-clotting drug Savaysa: Accessed August 27, 2015.
  2. Archives of Internal Medicine 1994; 54: 1449-1457.
  3. Comparing the New Oral Anticoagulants. Pharmacist’s Letter. June 2014.
  4. Anticoagulant Comparison Chart. North American Thrombosis Forum. Accessed August 27, 2015

Leave a Comment