Non-vitamin K antagonist oral anticoagulants (NOACs) are approved for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) as they reduce the risk of these events. However, the anticoagulant effect of the drugs must be balanced against a risk of bleeding complications especially in patients with renal impairment and elderly who represent a large group of those affected NVAF.
This population-based study will assess the effectiveness and safety of NOACs (rivaroxaban, dabigatran, apixaban) compared to warfarin in NVAF patients in Norway.
Primary objective: to assess the incidence rates of:
a) ischemic stroke (effectiveness) and b) intracranial hemorrhage (safety) in NVAF patients who are dispensed individual NOACs for the first time and compare with the corresponding rates in first-time users of warfarin.
1) To assess the incidence rates of:
- overall stroke and systemic embolism
- myocardial infarction
- all-cause mortality
- major bleeding
in NVAF patients who are dispensed individual NOACs for the first time compared with the rates in first- time users of warfarin
2) To describe and compare demographic and clinical characteristics as well as drug utilization patterns of NVAF patients who initiated an OAC in the study period.
The study population will comprise all adult NVAF patients in Norway who are new users of an OAC in the study period, and followed until outcome of interest, the end of the study period or death.
De-identified individual level data from three nation-wide registers will form the basis for the analyses, the Norwegian Census Register (FRG), the Norwegian Prescription Database (NorPD) and the Norwegian Patient Register (NPR).
Prosjektbeskrivelse med vedlegg