ArticleJournal of clinical medicine2022
Five Years of Direct Oral Anticoagulants Use in Italy: Adverse Drug Reactions from the Italian National Pharmacovigilance Network.
Article in Journal of clinical medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
4 citing papers in PubMed, 7 citations in OpenAlex.
- Edoxaban versus Apixaban Outcomes Differences in 8,444 Patients with Atrial Fibrillation from Italy: A Real-World Use Comparison.TH open : companion journal to thrombosis and haemostasis · 2026Article
- Investigating the Benefit-Risk Profile of Drugs: From Spontaneous Reporting Systems to Real-World Data for Pharmacovigilance.Methods in molecular biology (Clifton, N.J.) · 2025Article
- Characteristics of Gastrointestinal Bleeding While Taking Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Differences Among Drugs-A Single-Center Retrospective Cohort Study.Journal of clinical medicine · 2024Article
- Risks of oral anticoagulants: Analysis of adverse drug reactions reported to the Portuguese National Pharmacovigilance System.Pharmacology research & perspectives · 2024Article
Corrections and comments
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Authors and funding
12 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDirect oral anticoagulants (DOACs) are the preferred anticoagulant drugs for the prevention of atrial fibrillation (AF)-related thromboembolic complications and for the treatment and the prevention of recurrences of venous thromboembolism (VTE). The evaluation of self-reported adverse drug reactions (ADRs) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision making.
objectiveTo assess the safety profile of DOACs by analyzing ADR rates in the real-world Italian scenario.
methodsPost-marketing surveillance data recorded by the National Pharmacovigilance Network were retrieved for the time period 2017-2021 from the AIFA online site. The following data were collected for each DOAC: total ADR number, serious ADR number, gastrointestinal (GI) ADR, intracranial hemorrhage events (ICH ADR), and more frequently reported ADR for the study year. The safety profile was expressed by the risk index (RI).
resultsRivaroxaban use was associated with consistent and stable low rates of serious ADR, GI ADR, and ICH ADR across the 5-year study period. Rivaroxaban and apixaban showed the lowest RI for serious ADR and GI ADR, while rivaroxaban use was associated with significantly lower ICH events as compared to apixaban. Dabigatran was related to the highest RIs for every ADR class, in particular GI ADRs.
conclusionsDOACs presented an acceptable safety profile in the current post-market analysis. However, rivaroxaban and apixaban were associated with more favorable safety profiles as compared to dabigatran, while rivaroxaban provoked statistically significantly fewer ICH events as compared to apixaban.
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