In patients with impaired renal function, DOAC therapy requires careful consideration due to increased bleeding risk, with dabigatran exhibiting the greatest level of renal elimination.
What is the clinical evidence for the safety, adherence, and cost of DOACs in patients with reduced renal function?
In patients with renal impairment, DOAC therapy requires careful selection due to bleeding risks, with dabigatran requiring particular caution and once-daily options preferred for adherence.
BACKGROUND: The use of direct oral anticoagulants (DOACs) is restricted by the limitations of clinical trials guiding therapy for patients with renal impairment, as many of these trials excluded patients with severe renal impairment. There are currently four agents available: dabigatran, rivaroxaban, apixaban, and edoxaban. The purpose of this review was to 1) describe current recommended dosing for each DOAC and published postmarketing data, including case reports, on the use of these agents in the renally impaired; and 2) discuss patient adherence and satisfaction and the cost of these agents. MATERIALS AND METHODS: A literature search was conducted using Medline and Embase with the terms "dabigatran" or "rivaroxaban" or "apixaban" or "edoxaban" and "renal impairment". Clinical trials and case reports describing the use of DOAC therapy in patients with renal impairment were reviewed. A second search was conducted to find articles evaluating patient adherence, patient satisfaction, and pharmacoeconomics of DOACs. RESULTS: There are a multitude of subgroup and post hoc analyses, as well as six case reports with dabigatran and one case report with apixaban, that provide insight for the clinical use of DOACs in patients with renal impairment. Dabigatran exhibits the greatest level of renal elimination, and there are data from clinical trials and several case reports that warrant reconsideration before use. Other DOACs may be a better option in patients with impaired renal function. Further, data from patient-adherence studies have suggested that DOACs that are dosed daily (rather than twice daily) are optimal and preferred. There does not appear to be a cost difference between DOACs and warfarin therapy. CONCLUSION: DOAC therapy in patients with impaired renal function requires more critical review of study data, as these patients may have increased risk of bleeding. It is also valuable to consider patient preferences and cost when selecting the appropriate option for oral anticoagulation.
Willett et al. (2017) conducted a review in Thromboembolic disease with reduced renal function. Direct oral anticoagulants (DOACs) vs. Warfarin was evaluated. In patients with impaired renal function, DOAC therapy requires careful consideration due to increased bleeding risk, with dabigatran exhibiting the greatest level of renal elimination.