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

2021; Future Medicine; Volume: 10; Issue: 7 Linguagem: Inglês

10.2217/cer-2020-0286

2042-6313

Marcelo Sanmartı́n, Francisco Marı́n, Carles Ràfols, Fernando Arribas, Vivencio Barrios, Juan Cosı́n-Sales, Manuel Anguita Sánchez, Alejandro Pérez Cabeza, Luís Tercedor, Antonio Luis Gamez Lopez, Martín Ruiz Ortiz, Gustavo Cortez Quiroga, Antonio Luis Arrebola Moreno, Eduardo Sebastián López Sánchez, Javier Torres Llergo, Juan Motero Carrasco, Ignacio Sáinz Hidalgo, Carlos Pérez Muñoz, Adolfo Bolea Lafont, G Baron Esquivas, Jose Francisco Monzón, Alfredo Renilla, Irene Valverde Andre, Tomás Ripoll‐Vera, Salvador Diez-Aja López, Antonio Melero Pita, Alfonso Macias Gallego, Olga Durán Bobín, Diego Martin Raimondi, Jesus Ignacio Dominguez Calvo, Jose-Ángel Pérez-Rivera, Juan R. Costa Vazquez, María Jesús Rollán Gómez, Romà Freixa, Ivo Roca, Lluı́s Mont, Ermengol Valles Gros, Nicolás Manito Lorite, David Viladés, Jordi Puntí, Axel Sarrias, Marco Paz, Zamira Gomez, Sara Darnés, Juan Manuel Roca Catalán, Javier Pindado Rodríguez, Javier Andrés Novales, Juana Umaran, Ruben Natividad Andres, Esther Recalde Del Vigo, Juan Ramon Beramendi Calero, Laura Quintas, Y. Porras Ramos, Ricardo Mouzo, Alejandro Rodríguez Vilela, Óscar Díaz Castro, Carlos González Juanatey, Julio Martinez Florez, Leonardo Mejia Rincon, Juan Manuel Escudier-Villa, Esther Merino Lanza, Isabel Antorrena, Rafael Salguero‐Bodes, Eduardo Alegría, Cristina Llanos Guerrero, Viviana Serra Tomás, Javier Fuertes Beneitez, Jorge Palazuelos, Roberto del Castillo Medina, Antonio Álvarez-Vieitez Blanco, Francisco Marı́n, Isabel Ureña, Fernando Olaz Preciado, Ana Peset Cubero, Juan Quiles, Thomas Brouzet, Carlos Israel Chamorro Fernandez, Juan Cosı́n-Sales, Francisco Ridocci Soriano, Enrique Peris Domingo, Belén Puigdueta Vindel, Francisco Javier Parra Jimenez, Gerardo Estruch Catalá, Eduardo Martinez Litago, Virgilio Martínez Mateo, Manuel Royo Gutierrez, Mohaned Monzer Khanjikhatib, Eugenia Vazquez Rey, Javier Elduayen Gragera, Marcos Garcı́a Aguado, David Cordero Pereda, Patricia Clares Montón, José Manuel Vázquez‐Rodríguez, Iñaki Lekuona,

Venous Thromboembolism Diagnosis and Management

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.