STEPS

New Drug Reviews

Edoxaban (Savaysa) for the Prevention of Thromboembolic Events

 

Am Fam Physician. 2018 Apr 15;97(8):529-530.

Edoxaban (Savaysa) is a once-daily, oral anticoagulant used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also labeled for the treatment of deep venous thrombosis and pulmonary embolism following initial parenteral anticoagulation.1 Edoxaban is one of four marketed factor Xa inhibitors, none of which requires international normalized ratio (INR) monitoring.

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DrugDosageDose formCost*

Edoxaban (Savaysa)

60 mg daily 30 mg daily in patients with creatinine clearance of 15 to 50 mL per minute

Tablets: 15 mg, 30 mg, 60 mg

$352


*—Estimated retail price of one month's treatment based on information obtained at http://www.drugstore.com (accessed March 2, 2018).

DrugDosageDose formCost*

Edoxaban (Savaysa)

60 mg daily 30 mg daily in patients with creatinine clearance of 15 to 50 mL per minute

Tablets: 15 mg, 30 mg, 60 mg

$352


*—Estimated retail price of one month's treatment based on information obtained at http://www.drugstore.com (accessed March 2, 2018).

Safety

Edoxaban has been compared with warfarin (Coumadin) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Edoxaban has a slightly lower risk of bleeding than warfarin. In clinical trials of patients with nonvalvular atrial fibrillation, major bleeding (i.e., critical, symptomatic bleeding requiring immediate treatment) occurred in 2.75% of patients receiving edoxaban vs. 3.43% receiving warfarin (hazard ratio = 0.8; 95% confidence interval [CI], 0.71 to 0.91; number needed to treat to avoid one additional episode over 2.8 years = 30; 95% CI, 17 to 82).2 Similarly, in patients treated for deep venous thrombosis and pulmonary embolism, major bleeding occurred in 8.5% of patients receiving edoxaban vs. 10.3% of those receiving warfarin over 12 months (hazard ratio = 0.81; 95% CI, 0.71 to 0.94).3 Coadministration of anticoagulants, antiplatelet agents, and thrombolytics may increase the risk of bleeding.1 There is no anticoagulant reversal agent for edoxaban. Edoxaban is 50% renally excreted, with lower blood concentrations in patients who have better renal function.1,4 Thus, in nonvalvular atrial fibrillation, edoxaban should not be prescribed in patients with a creatinine clearance greater than 95 mL per minute because of an increased risk of stroke.1,2 Edoxaban has not been studied in children, pregnant women, or nursing

Address correspondence to Alvin B. Oung, PharmD, BCACP, at aoung@uwyo.edu. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

References

show all references

1. Daily Med. Drug label information. Savaysa—edoxaban tosylate tablet, film coated. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66. Accessed September 20, 2017....

2. Giugliano RP, Ruff CT, Braunwald E, et al.; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093–2104.

3. Büller HR, Décousus H, Grosso MA, et al.; Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism [published correction appears in N Engl J Med. 2014;370(4):390]. N Engl J Med. 2013;369(15):1406–1415.

4. FDA draft briefing document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC). Savaysa (Edoxaban) tablets. https://www.pharmamedtechbi.com/~/media/Supporting%20Documents/The%20Pink%20Sheet%20DAILY/2014/October/Edoxaban_AC_FDA_brfg.pdf. Accessed October 15, 2017.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

The series coordinator for AFP is Allen F. Shaughnessy, PharmD, Tufts University Family Medicine Residency Program at Cambridge Health Alliance, Malden, Mass.

A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.

 

 

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