Publications by authors named "Benedikte Irene von Osmanski"
Article Synopsis
- The study aimed to analyze recent pharmacoepidemiological research using Danish registries to understand how real-world drug safety and effectiveness outcomes are assessed and reported.
- A systematic review of 210 studies from 2018-2019 found that most (96%) focused on clinical outcomes, particularly diagnosis and mortality, with the Danish Health Data Authority as the primary data source.
- The research highlighted that while a variety of outcomes are supported by these registries, most studies relied on traditional clinical data, with fewer utilizing high-quality social or healthcare cost data.
Introduction: In Denmark, physicians are legally obliged to report serious adverse drug reactions (ADRs), such as intracranial hemorrhage (ICH) following anticoagulant (AC) treatment, to the Danish Medicines Agency. We were therefore puzzled to discover a high number of reports concerning ICHs following treatment with the direct oral anticoagulants (DOACs) dabigatran, rivaroxaban, and apixaban compared with warfarin. This was surprising, as all DOACs have been found to be associated with a lower risk of ICH compared with warfarin in phase III randomized controlled trials.
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