1. Rivaroxaban Monotherapy in Patients with Pulmonary Embolism: Off-Label vs. Labeled Therapy
- Author
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Pierpaolo, Di Micco, Vladimir Rosa, Salazar, Carmen Fernandez, Capitan, Francesco, Dentali, Covadonga Gomez, Cuervo, Jose Luis Fernandez, Torres, Jose Antonio, Porras, Angeles, Fidalgo, Elvira, Grandone, Manuel Lopez, Meseguer, Manuel, Monreal, The Riete Investigators, Institut Català de la Salut, [Di Micco P] UOC Medicina y Urgencia—ASL NAPOLI 2 Nord Ospedale Anna Rizzoli di Lacco Ameno, Naples, Italy. [Rosa Salazar V] Department of Internal Medicine, Hospital Universitario Virgen de Arrixaca, Murcia, Spain. [Fernandez Capitan C] Department of Internal Medicine, Hospital Universitario La Paz, Madrid, Spain. [Dentali F] Department of Medicine and Surgery, Insubria University, Varese, Italy. [Gomez Cuervo C] Department of Internal Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain. [Fernandez Torres JL] Department of Internal Medicine, Complejo Hospitalario de Jaén, Jaén, Spain. [Lopez Meseguer M] Servei de Pneumologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
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RIETE ,Therapeutics::Drug Therapy::Drug Prescriptions::Off-Label Use [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,terapéutica::farmacoterapia::prescripciones de medicamentos::prescripción en indicaciones no aprobadas [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Hematologic Agents::Anticoagulants [CHEMICALS AND DRUGS] ,Embòlia pulmonar - Tractament ,Medicaments - Etiquetatge ,Respiratory Tract Diseases::Lung Diseases::Pulmonary Embolism [DISEASES] ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,Paleontology ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,DOACs ,acciones y usos químicos::acciones farmacológicas::usos terapéuticos::fármacos hematológicos::anticoagulantes [COMPUESTOS QUÍMICOS Y DROGAS] ,General Biochemistry, Genetics and Molecular Biology ,Anticoagulants (Medicina) - Ús terapèutic ,Space and Planetary Science ,enfermedades respiratorias::enfermedades pulmonares::embolia pulmonar [ENFERMEDADES] ,venpus thromboembolism ,oral anticoagulants ,rivaroxaban ,Ecology, Evolution, Behavior and Systematics - Abstract
Oral anticoagulants; Rivaroxaban; Venpus thromboembolism Anticoagulantes orales; Rivaroxaban; Tromboembolismo de venpus Anticoagulants orals; Rivaroxaban; Tromboembolisme de venpus Background: The use of rivaroxaban in clinical practice often deviates from manufacturer prescribing information. No studies have demonstrated an association between this practice and improved outcomes. Methods: We used the RIETE registry to assess the clinical characteristics of patients with pulmonary embolism (PE) who received off-label rivaroxaban, and to compare their 3-month outcomes with those receiving the labeled therapy. The patients were classified into four subgroups: (1) labeled therapy; (2) delayed start; (3) low doses and (4) both conditions. Results: From May 2013 to May 2022, 2490 patients with PE received rivaroxaban: labeled therapy—1485 (58.6%); delayed start—808 (32.5%); low doses—143 (5.7%); both conditions—54 (2.2%). Patients with a delayed start were more likely to present with syncope, hypotension, raised troponin levels and more severe abnormalities on the echocardiogram than those on labeled therapy. Patients receiving low doses were most likely to have cancer, recent bleeding, anemia, thrombocytopenia or renal insufficiency. During the first 3 months, 3 patients developed PE recurrence, 4 had deep-vein thrombosis, 11 had major bleeding and 16 died. The rates of major bleeding (11 vs. 0; p < 0.001) or death (15 vs. 1; OR: 22.5; 95% CI: 2.97–170.5) were higher in patients receiving off-label rivaroxaban than in those on labeled therapy, with no differences in VTE recurrence (OR: 1.11; 95% CI: 0.25–6.57). Conclusions: In patients with severe PE, the start of rivaroxaban administration was often delayed. In those at increased risk for bleeding, it was often prescribed at low doses. Both subgroups had a worse outcome than those on labeled rivaroxaban.
- Published
- 2022
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