Drug interactions with apixaban: A systematic review of the literature and an analysis of VigiBase, the World Health Organization database of spontaneous safety reports

Autor: Silvia Núñez Fernández, Victoria Rollason, Caroline Flora Samer, Camille Lenoir
Rok vydání: 2020
Předmět:
Male
drug safety
Databases
Factual

Review
systemic review
Bioinformatics
030226 pharmacology & pharmacy
Pharmacovigilance
0302 clinical medicine
Cytochrome P-450 CYP3A
Drug Interactions
General Pharmacology
Toxicology and Pharmaceutics

media_common
Aged
80 and over

Area under the curve
Middle Aged
Neurology
Area Under Curve
030220 oncology & carcinogenesis
Female
Apixaban
Gastrointestinal Hemorrhage
medicine.drug
Adult
Drug
anticoagulants
ATP Binding Cassette Transporter
Subfamily B

Drug-Related Side Effects and Adverse Reactions
Pyridones
media_common.quotation_subject
apixaban
MEDLINE
Reviews
World Health Organization
Risk Assessment
03 medical and health sciences
Pharmacokinetics
Thromboembolism
medicine
Adverse Drug Reaction Reporting Systems
Humans
Aged
Hemostasis
Aspirin
business.industry
medicine.disease
Pharmacodynamics
Pyrazoles
business
Platelet Aggregation Inhibitors
Adverse drug reaction
Factor Xa Inhibitors
Zdroj: Pharmacology Research & Perspectives
ISSN: 2052-1707
DOI: 10.1002/prp2.647
Popis: Apixaban, a direct oral anticoagulant, has emerged over the past few years because it is considered to have a low risk of drug‐drug interactions compared to vitamin K antagonists. To better characterize these interactions, we systematically reviewed studies evaluating the drug‐drug interactions involving apixaban and analyzed the drug‐drug interactions resulting in an adverse drug reaction reported in case reports and VigiBase. We systematically searched Medline, Embase, and Google Scholar up to 20 August 2018 for articles that investigated the occurrence of an adverse drug reaction due to a potential drug interacting with apixaban. Data from VigiBase came from case reports retrieved up to the 2 January 2018, where identification of potential interactions is performed in terms of two drugs, one adverse drug reaction triplet and potential signal detection using Omega, a three‐way measure of disproportionality. We identified 15 studies and 10 case reports. Studies showed significant variations in the area under the curve for apixaban and case reports highlighted an increased risk of hemorrhage or thromboembolic events due to a drug‐drug interaction. From VigiBase, a total of 1617 two drugs and one adverse drug reaction triplet were analyzed. The most reported triplet were apixaban—aspirin—gastrointestinal hemorrhage. Sixty‐seven percent of the drug‐drug interactions reported in VigiBase were not described or understood. In the remaining 34%, the majority were pharmacodynamic drug‐drug interactions. These data suggest that apixaban has significant potential for drug‐drug interactions, either with CYP3A/P‐gp modulators or with drugs that may impair hemostasis. The most described adverse drug reactions were adverse drug reactions related to hemorrhage or thrombosis, mostly through pharmacodynamic interactions. Pharmacokinetic drug‐drug interactions seem to be poorly detected.
Databáze: OpenAIRE