Thromboembolic and bleeding events with rivaroxaban in clinical practice in Spain: impact of inappropriate doses (the EMIR study)

Author:

Fernández Marcelo Sanmartín1ORCID,Marín Francisco2,Rafols Carles3ORCID,Arribas Fernando4ORCID,Barrios Vivencio5ORCID,Cosín-Sales Juan6ORCID,Sánchez Manuel Anguita7,Pérez Cabeza Alejandro,Tercedor Luis,Gamez Lopez Antonio Luis,Ruiz Martín,Cortez Quiroga Gustavo,Arrebola Moreno Antonio Luis,Lopez Sanchez Eduardo Sebastian,Torres Llergo Javier,Motero Carrasco Juan,Sáinz Hidalgo Ignacio,Pérez Muñoz Carlos,Bolea Lafont Adolfo,Barón Esquivas Gonzalo,Francisco Monzón Jose,Renilla González Alfredo,Valverde Andre Irene,Ripoll Vera Tomás,Diez-Aja López Salvador,Melero Pita Antonio,Macias Gallego Alfonso,Duran Bobin Olga,Martin Raimondi Diego,Dominguez Calvo Jesus Ignacio,Perez Rivera Jose Angel,Costa Vazquez Juan R.,Rollán Gómez María Jesús,Freixa Romà,Roca Ivo,Mont Girbau Lluis,Valles Gros Ermengol,Manito Lorite Nicolás,Vilades David,Punti Jordi,Sarrias Axel,Paz Marco,Gomez Zamira,Darnes Sara,Roca Catalán Juan Manuel,Pindado Rodriguez Javier,Andrés Novales Javier,Umaran Juana,Natividad Andres Ruben,Recalde Del Vigo Esther,Beramendi Calero Juan Ramon,Quintas Laura,Porras Ramos Yolanda,Fernandez Mouzo Ricardo,Rodriguez Vilela Alejandro,Díaz Castro Oscar,Gonzalez Juanatey Carlos,Martinez Florez Julio,Rincón Díaz Luis Miguel,Escudier Villa Juan Manuel,Merino Lanza Esther,Antorrena Isabel,Salguero Bodes Rafael,Alegria Eduardo,Llanos Guerrero Cristina,Serra Tomás Viviana,Fuertes Beneitez Javier,Palazuelos Molinero Jorge,Del Castillo Roberto,Alvarez-Vieitez Blanco Antonio,Marin Ortuño Francisco,Ureña Isabel,Olaz Preciado Fernando,Peset Cubero Ana,Quiles Juan,Brouzet Thomas,Chamorro Fernandez Carlos Israel,Cosin Sales Juan,Ridocci Soriano Francisco,Peris Domingo Enrique,Puigdueta Vindel Belen,Parra Jimenez Francisco Javier,Estruch Catalá Gerardo,Martinez Litago Eduardo,Martinez Mateo Virgilio,Royo Gutierrez Manuel,Monzer Khanjikhatib Mohaned,Vazquez Rey Eugenia,Elduayen Gragera Javier,Garcia Aguado Marcos,Cordero Pereda David,Clares Montón Patricia,Manuel Vazquez Jose,Lekuona Iñaki

Affiliation:

1. Department of Cardiology, Hospital Ramón y Cajal, Madrid, Spain

2. Department of Cardiology, Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-Arrixaca, University of Murcia, CIBERCV, Murcia, Spain

3. Department of Medical Affairs, Bayer Hispania, Barcelona, Spain

4. Department of Cardiology, Hospital Universitario 12 de Octubre; Department of Medicine, Facultad de Medicina, Universidad Complutense de Madrid (UCM); Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12); CIBERCV, Madrid, Spain

5. Department of Cardiology, Hospital Ramón y Cajal; Alcalá University, Madrid, Spain

6. Department of Cardiology, Hospital Arnau de Vilanova, Valencia, Spain

7. Department of Cardiology, Hospital Universitario Reina Sofia, IMIBIC, University of Córdoba, Córdoba, Spain

Abstract

Aim: To analyze the frequency and variables related to inappropriate rivaroxaban dosage in clinical practice and its impact on outcomes after 2 years. Materials & methods: Postauthorization, observational, multicenter study, in which atrial fibrillation patients, treated with rivaroxaban ≥6 months were included. Results: A total of 1421 patients (74.2 ± 9.7 years, CHA2DS2-VASc 3.5 ± 1.6) were included. Overall, 22.9% received rivaroxaban 15 mg. The proper dose of rivaroxaban was taken by 83.3% (9.7% underdosed, 7.0% overdosed). Older age and renal insufficiency were associated with inadequate rivaroxaban dosage. There was a trend toward higher all-cause mortality among underdosed patients (adjusted hazard ratio 1.39; 95% CI 0.75–2.58), and more bleedings in overdosed patients (2.29 vs 0.80 events/100 patient-years; p = 0.14). Conclusion: In clinical practice, rivaroxaban is properly dosed in most patients.

Funder

Bayer Hispania

Publisher

Future Medicine Ltd

Subject

Health Policy

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