In this issue of the European Heart Journal – Cardiovascular Pharmacotherapy, Lee et al. compared the efficacy and safety of an off-label underdosed apixaban vs. an on-label standard dose apixaban in a population of Korean patients with non-valvular AF by analysing data from the Korean National Health Insurance Service database. The authors demonstrated that patients prescribed off-label underdosed apixaban have a higher risk of ischaemic stroke and all-cause death than those prescribed on-label standard dose apixaban, but they observed no significant differences in major bleeding between the groups. Notably, among patients who did not meet any dose-reduction criteria (age ≥80 years, body weight ≤60 kg, or serum creatinine level ≥1.5 mg/dL), off-label underdosed apixaban use was associated with a higher risk of ischaemic stroke than on-label standard dose apixaban use. In contrast, among patients who met a single dose-reduction criterion, the use of the off-label underdosed apixaban was associated with a higher risk of all-cause death than the on-label standard dose apixaban, but not with a higher risk of ischaemic stroke.
We should remember that, to date, no of the study has demonstrated the beneficial effects of an off-label reduced dose of apixaban.
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