Key result
Apixaban treatment was associated with the development of a non-bleeding leg ulcer in an 83-year-old woman, which completely resolved 40 days after switching to dabigatran.
Why the study?
Concerns and safety issues remain in real-world practice regarding adverse events and drug interactions with novel oral anticoagulants.
Case Report (n=1)
Yes
Apixaban may be associated with the rare development of cutaneous ulcers, which can resolve upon switching to an alternative NOAC such as dabigatran.
Apixaban-associated leg ulcer resolved after dabigatran switch; single case leaves open causality and need for confirmation.
Nowadays, novel oral anticoagulants (NOACs) have shown improved safety profile and efficacy compared to vitamin K antagonists in the prevention of thromboembolic events occurring during different pathological conditions. However, there are concerns and safety issues, mostly related to adverse events following interactions with other drugs, in real-world practice. We report the case of an 83-year-old woman who developed a non-bleeding leg ulcer not caused by trauma or other evident pathological conditions after 10 days of treatment with apixaban 5 mg/q.d. She was switched from apixaban to dabigatran and the leg ulcer rapidly improved and completely cicatrized in 40 days. The resolution of the ulcer and the toleration of dabigatran therapy suggest an apixaban-specific reaction; however, the pathological mechanism of ulcer onset is currently unclear. Careful evaluation of hospital databases of Molise region (Southern Italy) hospitals identified two similar cases between 2019 and 2021. These cases underline the necessity of careful post-marketing surveillance, considering the rapidly increasing number of patients treated with NOACs and patient's risk factors such as old age, high polypharmacy rate, co-morbidities, and peculiar genetic background related to NOACs pharmacokinetic features.
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Medoro et al. (2022) conducted a case report in Cutaneous ulcer (n=1). Apixaban vs. Dabigatran was evaluated on Ulcer resolution. Apixaban treatment was associated with the development of a non-bleeding leg ulcer in an 83-year-old woman, which completely resolved 40 days after switching to dabigatran.
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