Effectiveness and Safety of Edoxaban in the Routine Clinical Care of Atrial Fibrillation Patients in Brazil: Prospective 1-Year Follow-Up Study - EdoBRA.
| Title: | Effectiveness and Safety of Edoxaban in the Routine Clinical Care of Atrial Fibrillation Patients in Brazil: Prospective 1-Year Follow-Up Study - EdoBRA. |
|---|---|
| Transliterated Title: | Efetividade e Segurança da Edoxabana nos Cuidados Clínicos de Rotina de Pacientes com Fibrilação Atrial no Brasil: Estudo Prospectivo de Acompanhamento de 1 Ano – EdoBRA. |
| Authors: | Precoma DB; Sociedade Hospitalar Angelina Caron, Campina Grande do Sul, PR - Brasil.; Silva RPD; Daiichi Sankyo Brasil Farmaceutica LTDA, São Paulo, SP - Brasil.; Passos LCS; Universidade Federal da Bahia, Salvador, BA - Brasil.; Hoffman Filho CR; Hospital Regional Hans Dieter Schmidt, Joinville, SC - Brasil.; Silveira FS; JMF Clínica do Coração, Aracaju, SE - Brasil.; Vasconcelos JTM; Real e Benemérita Associação Portuguesa de Beneficência, São Paulo, SP - Brasil.; Zimmermann SL; Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP - Brasil.; Universidade Regional de Blumenau - Clínica Procardio, Blumenau, SC - Brasil.; Herdy AH; Instituto de Cardiologia de Santa Catarina, São José, SC - Brasil.; Ritter A; IQVIA Brasil, São Paulo, SP - Brasil.; Freitas-Alves D; IQVIA Brasil, São Paulo, SP - Brasil.; Saraiva JFK; Pontifícia Universidade Católica de Campinas, Campinas, SP - Brasil. |
| Source: | Arquivos brasileiros de cardiologia [Arq Bras Cardiol] 2025 Apr 14; Vol. 122 (4), pp. e20240589. Date of Electronic Publication: 2025 Apr 14 (Print Publication: 2025). |
| Publication Type: | Journal Article; Observational Study; Multicenter Study |
| Language: | English; Portuguese |
| Journal Info: | Publisher: Sociedad Brasileira De Cardiologia Country of Publication: Brazil NLM ID: 0421031 Publication Model: eCollection Cited Medium: Internet ISSN: 1678-4170 (Electronic) Linking ISSN: 0066782X NLM ISO Abbreviation: Arq Bras Cardiol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Sao Paulo : Sociedad Brasileira De Cardiologia |
| MeSH Terms: | Atrial Fibrillation*/drug therapy ; Atrial Fibrillation*/complications ; Pyridines*/therapeutic use ; Pyridines*/adverse effects ; Pyridines*/administration & dosage ; Thiazoles*/therapeutic use ; Thiazoles*/adverse effects ; Factor Xa Inhibitors*/therapeutic use ; Factor Xa Inhibitors*/adverse effects ; Stroke*/prevention & control ; Anticoagulants*/therapeutic use ; Anticoagulants*/adverse effects; Hemorrhage/chemically induced ; Humans ; Male ; Female ; Prospective Studies ; Aged ; Brazil ; Follow-Up Studies ; Middle Aged ; Treatment Outcome ; Aged, 80 and over ; Time Factors ; Risk Factors |
| Abstract: | Background: Edoxaban, an orally administered anticoagulant, has been shown to be safe and effective in preventing stroke in atrial fibrillation (AF) patients. Given its widespread use since approval, evaluating edoxaban's real-world performance in the Brazilian clinical context is crucial.; Objective: The study aimed to report the one-year safety and effectiveness of edoxaban in AF patients in Brazil.; Methods: EdoBRA is a multi-center, prospective, observational investigation conducted across 30 Brazilian research sites. Bleeding events were considered as safety measures and cardiovascular events were considered for effectiveness measures. Descriptive analyses were performed. Kaplan-Meier curves were generated for time-to-event analysis and a 95% confidence interval was used as appropriate.; Results: Among the 705 enrolled participants, 590 were included in the analysis for having at least one follow-up or one reported event. Mean (±SD) CHA2DS2-VASc risk score was 3 (3.3 ± 1.6) and the mean HAS-BLED risk score was 2 (1.8 ± 1.2). During the one-year follow-up period, nine major bleedings events were reported, including five cases of gastrointestinal bleeding (IP 0.85 [95% CI =0.82; 0.88]). Among the cardiovascular events recorded (N = 68), there were four stroke events (IP 0.68 [CI 95% 0.65;0.71]), one transient ischemic attack (IP 0.17 [CI 95% (0.16;0.18]) and 1 event was Venous Thromboembolic Events (IP 0.17 [CI 95% (0.16;0.18]). No systemic embolic event was exhibited by any patient.; Conclusion: In an elderly population with several comorbidities routinely treated with edoxaban for AF, the rates of cardiovascular event and major bleeding were low. |
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| Contributed Indexing: | Local Abstract: [Publisher, Portuguese] A edoxabana é um anticoagulante oral que se mostrou segura e eficaz na prevenção de acidente vascular cerebral em pacientes com fibrilação atrial (FA). Dada a ampla utilização da edoxabana desde sua aprovação, é crucial avaliar seu desempenho no contexto clínico brasileiro. [Publisher, Portuguese] O objetivo do estudo foi descrever a segurança e a efetividade da edoxabana no tratamento de pacientes com FA no Brasil. [Publisher, Portuguese] O EdoBRA é um estudo multicêntrico, prospectivo, observacional, conduzido em 30 centros de pesquisa no Brasil. Eventos de sangramento foram considerados medidas de segurança, e eventos cardiovasculares foram considerados para medidas de efetividade. Análises descritivas foram realizadas. Curvas de Kaplan-Meier foram geradas para análise do tempo para o evento, e um intervalo de confiança de 95% usado conforme apropriado. [Publisher, Portuguese] Entre os 705 pacientes recrutados, 590 foram incluídos na análise por apresentarem pelo menos um evento relatado ou durante o seguimento. As médias (±DP) dos escores de risco CHA2DS2-VASc e HAS-BLED foram, respectivamente, 3 (3,3 ± 1,6) e 2 (1,8 ± 1,2). Durante o acompanhamento de um ano, foram relatados nove sangramentos maiores, incluindo cinco casos de sangramento gastrointestinal [PI 0,85 (IC95% =0,82; 0,88]). Entre os eventos cardiovasculares registrados (n=68), houve quatro eventos de acidente vascular cerebral [PI 0,68 (IC 95% 0,65; 0,71)], um ataque isquêmico transitório [PI 0,17 (IC 95% 0,16; 0,18)] e um tromboembolismo venoso [PI 0,17 (IC 95% 0,16; 0,18)]. Nenhum evento embólico sistêmico foi relatado. [Publisher, Portuguese] Em uma população idosa com várias comorbidades, recebendo edoxabana como tratamento de rotina para FA, as taxas de evento cardiovasculares sangramento maior foram baixas. |
| Substance Nomenclature: | NDU3J18APO (edoxaban); 0 (Pyridines); 0 (Thiazoles); 0 (Factor Xa Inhibitors); 0 (Anticoagulants) |
| Entry Date(s): | Date Created: 20250417 Date Completed: 20250417 Latest Revision: 20260506 |
| Update Code: | 20260506 |
| PubMed Central ID: | PMC12058141 |
| DOI: | 10.36660/abc.20240589 |
| PMID: | 40243853 |
| Database: | MEDLINE |
Journal Article; Observational Study; Multicenter Study