Thomas Lafon1, Christine Vallejo2, Mathilde Hadj3, Marie-Laure Laroche4, Hélène Geniaux5. 1. Département des urgences, service des urgences, SAMU, CHU de Limoges, 87042 Limoges cedex, France; Inserm CIC 1435, 87042 Limoges, France. Electronic address: thomas.lafon@etu.unilim.fr. 2. Département des urgences, service des urgences, SAMU, CHU de Limoges, 87042 Limoges cedex, France; Inserm CIC 1435, 87042 Limoges, France. 3. Département des urgences, service des urgences, SAMU, CHU de Limoges, 87042 Limoges cedex, France. 4. Centre régional de pharmacovigilance, de pharmaco-épidémiologie et d'information sur les médicaments, CHU de Limoges, 87042 Limoges cedex, France; Service de pharmacologie, toxicologie et pharmacovigilance, CHU de Limoges, 87042 Limoges cedex, France; Faculté de médecine, université de Limoges, 87042 Limoges, France. 5. Centre régional de pharmacovigilance, de pharmaco-épidémiologie et d'information sur les médicaments, CHU de Limoges, 87042 Limoges cedex, France; Service de pharmacologie, toxicologie et pharmacovigilance, CHU de Limoges, 87042 Limoges cedex, France.
Abstract
INTRODUCTION: The use of direct oral anticoagulants (NOAC) is complex: indications, dosage adjustments and precautions. Emergency departments (ED) are increasingly faced with patients receiving NOAC. The aim of this study was to evaluate the misuse and the adverse effects (AE) of NOAC. METHODS: All subjects with NOAC admitted to the Limoges University Hospital ED from 1/8/2013 to 1/4/2014 were included in a prospective observational study. Misuse was identified from the NOAC summary of product characteristics and from the 2014 ANSM guideline (indication, dose, co-medications, age, hepatic and renal function); adverse effects were recorded. RESULTS: A total of 198 subjects were included receiving rivaroxaban (68.7 %), dabigatran (30.8 %) or apixaban (0.5 %). Main indications were embolic prevention in patients with non-valvular atrial fibrillation (78.7 %) and curative treatment of venous thromboembolism (17.2 %). In 16.2 % of the cases, the treatment was not in according to the guidelines: 78 % for prescribing errors (incorrect dosage according to age, renal function, co-medications) and 22 % for wrong initial indication. AE related to NOAC were encountered in 25.8 % patients. Hemorrhagic events were diagnosed in 36 patients with no according to the guidelines in 11.1 % of them. Hemorrhagic events resulted in 3 deaths (8.3 %). Thrombotic events occurred in 15 patients, all these patients were issued with appropriate guidelines. CONCLUSION: Through the view of an ED, this study confirms a part of misuse and highlights the risk of spontaneous bleeding of NOAC despite appropriate use.
INTRODUCTION: The use of direct oral anticoagulants (NOAC) is complex: indications, dosage adjustments and precautions. Emergency departments (ED) are increasingly faced with patients receiving NOAC. The aim of this study was to evaluate the misuse and the adverse effects (AE) of NOAC. METHODS: All subjects with NOAC admitted to the Limoges University Hospital ED from 1/8/2013 to 1/4/2014 were included in a prospective observational study. Misuse was identified from the NOAC summary of product characteristics and from the 2014 ANSM guideline (indication, dose, co-medications, age, hepatic and renal function); adverse effects were recorded. RESULTS: A total of 198 subjects were included receiving rivaroxaban (68.7 %), dabigatran (30.8 %) or apixaban (0.5 %). Main indications were embolic prevention in patients with non-valvular atrial fibrillation (78.7 %) and curative treatment of venous thromboembolism (17.2 %). In 16.2 % of the cases, the treatment was not in according to the guidelines: 78 % for prescribing errors (incorrect dosage according to age, renal function, co-medications) and 22 % for wrong initial indication. AE related to NOAC were encountered in 25.8 % patients. Hemorrhagic events were diagnosed in 36 patients with no according to the guidelines in 11.1 % of them. Hemorrhagic events resulted in 3 deaths (8.3 %). Thrombotic events occurred in 15 patients, all these patients were issued with appropriate guidelines. CONCLUSION: Through the view of an ED, this study confirms a part of misuse and highlights the risk of spontaneous bleeding of NOAC despite appropriate use.
Authors: Abdulrhman Al Rowily; Zahraa Jalal; Malcolm J Price; Mohammed H Abutaleb; Hind Almodiaemgh; Maha Al Ammari; Vibhu Paudyal Journal: Eur J Clin Pharmacol Date: 2021-12-22 Impact factor: 2.953