Abstract

Anticoagulation with vitamin K antagonists (VKAs), including acenocoumarol, phenprocoumon and warfarin, has been the standard of care for more than 60 years, but has been associated with drug use-related hospital admissions due to bleeding events. Dosing requires close monitoring of therapeutic levels. Direct oral anticoagulants (DOACs), which have been on the market since 10 years, do not require close monitoring. DOACs include factor II inhibitors (dabigatran) and factor Xa inhibitors apixaban, rivaroxaban and edoxaban). A real-world dynamic prospective cohort of patients using DOACs and VKAs was created with the aim to set a basis for safety and efficacy outcome monitoring. Patients with recorded dispensings of DOAC or VKA between 2008 and 2017 were selected from the Out-patient Pharmacy Database of the PHARMO Database Network, resulting in the PHARMO- anticoagulation cohort. Outcome data are available from hospital admission records and for a subset of the patients, detailed patient information from the GP Database is available. During 2008-2017 a total of 77,189 patients using DOACs and 249,210 patients using VKAs were identified; 22,512 were in both groups. DOAC users were 69.9 ± 12.1 years at the time of first use; 44% used rivaroxaban, 27% dabigatran, 18% apixaban, 4% edoxaban and 7% had used multiple DOACs over time. VKA users (77% used acenocoumarol, 17% phenprocoumon and 5% used both over time) were 70.6 ± 14.1 years at the time of first dispensing in the study period; this is a mix of new and prevalent users. For about 25% of the population detailed medical information from GP records is available. The PHARMO-anticoagulation cohort provides real-world information on DOAC and VKA use in the Netherlands and delivers comprehensive insights in anticoagulation-related safety, efficacy and resource utilisation.

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