| Summary: | Manuel E Machado-Duque,1,2 Andrés Gaviria-Mendoza,1,2 Juan Manuel Reyes,3 Alejandro Mesa,3 Natalia Castaño-Gamboa,3 Luis Fernando Valladales-Restrepo,1,2 Jorge Enrique Machado-Alba1 1Grupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira-Audifarma S.A, Pereira, Colombia; 2Grupo de Investigación en Biomedicina, Fundación Universitaria Autónoma de las Américas, Pereira, Colombia; 3Pfizer Colombia, Bogotá, ColombiaCorrespondence: Jorge Enrique Machado-Alba, Grupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira-Audifarma S.A, Calle 105 No. 14-140, Pereira, Risaralda, 660003, Colombia, Tel +57 3108326970, Fax +57 63137822, Email machado@utp.edu.coPurpose: The aim was to analyze the characteristics, treatment patterns, and clinical outcomes of Colombian patients with non-valvular atrial fibrillation (NVAF) under treatment with oral anticoagulants (OAs).Patients and Methods: Retrospective cohort in patients with NVAF identified from a drug dispensing database, aged ≥ 18 years, with first prescription of an OA (index) between January/2013 and June/2018, and a follow-up until June/2019. Data from the clinical history, pharmacological variables, and outcomes were searched. International Classification of Diseases-10 codes were used to identify the patient sample and outcomes. Patients were followed until a general composite outcome of effectiveness (thrombotic events), bleeding/safety or persistence (switch/discontinuation of anticoagulant) events. Descriptive and multivariate analyzes (Cox regressions comparing warfarin and direct oral anticoagulants-DOACs) were carried out.Results: A total of 2076 patients with NVAF were included. The 57.0% of patients were women and the mean age was 73.3± 10.4 years. Patients were followed for a mean of 2.3± 1.6 years. 8.7% received warfarin before the index date. The most frequent OA was rivaroxaban (n=950; 45.8%), followed by warfarin (n=459; 22.1%) and apixaban (n=405; 19.5%). Hypertension was present in 87.5% and diabetes mellitus in 22.6%. The mean CHA2DS2-VASc Score was 3.6± 1.5. The 71.0% (n=326/459) of the warfarin patients presented the general composite outcome, and 24.6% of those with DOACs (n=397/1617). The main effectiveness and safety outcomes were stroke (3.1%) and gastrointestinal bleeding (2.0%) respectively. There were no significant differences between patients with warfarin and DOACs regarding thrombotic events (HR: 1.28; 95% CI: 0.68– 2.42), but warfarin was associated with higher bleeding/safety events (HR: 4.29; 95% CI: 2.82– 6.52) and persistence events (HR: 4.51; 95% CI: 3.81 − 5.33).Conclusion: The patients with NVAF in this study were mainly older adults with multiple comorbidities. Compared to warfarin, DOACs were found to be equally effective, but safer and had a lower probability of discontinuation or switch.Keywords: anticoagulation, direct oral anticoagulant, non-valvular atrial fibrillation, warfarin, real-world study, pharmacoepidemiology
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