Results Lareb Intensive Monitoring NOACs

Adverse drug reactions (ADRs) of non-vitamin K oral anticoagulants (NOACs) mostly occur in the first week of treatment. For over half of these ADRs the patient recovered without discontinuation of the NOAC. These results were found in a Lareb Intensive Monitoring (LIM) study which aimed to gain insight into the safety profile of NOACs from a patient’s perspective.

For this study the Lareb Intensive Monitoring (LIM) system was used. Patients were recruited by their pharmacist between July 2012 and April 2017. They were invited to complete four web-based questionnaires; 2 weeks, 5 weeks, 3 months and 6 months after starting treatment. Information was collected about patient characteristics, drug use, and ADRs.

A total of 1748 NOAC users participated in this study, of which 365 used apixaban, 550 used dabigatran, 45 used edoxaban, and 788 use rivaroxaban. 661 (38%) experienced at least one ADR during the study period. 14 (2%) participants experienced a serious ADR. The reported ADRs were comparable with information described in the Summary of Product Characteristics.

Overall NOACs were well tolerated by the participants. Most reported ADRs occurred within 1 week after start. In 59% of ADRs the patient recovered from the ADR. ADRs may resolve spontaneously under continuation of the use of the NOAC; the majority (59%) of patients recovered without changes to the use of the NOAC.

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