1. Thromboembolic and bleeding events with rivaroxaban in clinical practice in Spain: impact of inappropriate doses (the EMIR study)
- Author
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Marcelo Sanmartín Fernández, Francisco Marín, Carles Rafols, Fernando Arribas, Vivencio Barrios, Juan Cosín-Sales, Manuel Anguita Sánchez, Alejandro Pérez Cabeza, Luis Tercedor, Antonio Luis Gamez Lopez, Martín Ruiz, Gustavo Cortez Quiroga, Antonio Luis Arrebola Moreno, Eduardo Sebastian Lopez Sanchez, Javier Torres Llergo, Juan Motero Carrasco, Ignacio Sáinz Hidalgo, Carlos Pérez Muñoz, Adolfo Bolea Lafont, Gonzalo Barón Esquivas, Jose Francisco Monzón, Alfredo Renilla González, Irene Valverde Andre, Tomás Ripoll Vera, Salvador Diez-Aja López, Antonio Melero Pita, Alfonso Macias Gallego, Olga Duran Bobin, Diego Martin Raimondi, Jesus Ignacio Dominguez Calvo, Jose Angel Perez Rivera, Juan R. Costa Vazquez, María Jesús Rollán Gómez, Romà Freixa, Ivo Roca, Lluis Mont Girbau, Ermengol Valles Gros, Nicolás Manito Lorite, David Vilades, Jordi Punti, Axel Sarrias, Marco Paz, Zamira Gomez, Sara Darnes, Juan Manuel Roca Catalán, Javier Pindado Rodriguez, Javier Andrés Novales, Juana Umaran, Ruben Natividad Andres, Esther Recalde Del Vigo, Juan Ramon Beramendi Calero, Laura Quintas, Yolanda Porras Ramos, Ricardo Fernandez Mouzo, Alejandro Rodriguez Vilela, Oscar Díaz Castro, Carlos Gonzalez Juanatey, Julio Martinez Florez, Luis Miguel Rincón Díaz, Juan Manuel Escudier Villa, Esther Merino Lanza, Isabel Antorrena, Rafael Salguero Bodes, Eduardo Alegria, Cristina Llanos Guerrero, Viviana Serra Tomás, Javier Fuertes Beneitez, Jorge Palazuelos Molinero, Roberto Del Castillo, Antonio Alvarez-Vieitez Blanco, Francisco Marin Ortuño, Isabel Ureña, Fernando Olaz Preciado, Ana Peset Cubero, Juan Quiles, Thomas Brouzet, Carlos Israel Chamorro Fernandez, Juan Cosin Sales, Francisco Ridocci Soriano, Enrique Peris Domingo, Belen Puigdueta Vindel, Francisco Javier Parra Jimenez, Gerardo Estruch Catalá, Eduardo Martinez Litago, Virgilio Martinez Mateo, Manuel Royo Gutierrez, Mohaned Monzer Khanjikhatib, Eugenia Vazquez Rey, Javier Elduayen Gragera, Marcos Garcia Aguado, David Cordero Pereda, Patricia Clares Montón, Jose Manuel Vazquez, and Iñaki Lekuona
- Subjects
medicine.medical_specialty ,Rivaroxaban 15 MG ,Hemorrhage ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Rivaroxaban ,Internal medicine ,Atrial Fibrillation ,medicine ,Humans ,030212 general & internal medicine ,Stroke ,Aged ,business.industry ,Health Policy ,Hazard ratio ,Anticoagulants ,Atrial fibrillation ,medicine.disease ,Clinical Practice ,Multicenter study ,Spain ,Observational study ,business ,Factor Xa Inhibitors ,medicine.drug - 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, CHA 2 DS 2 -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.
- Published
- 2021
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