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The safety profile of dabigatran is built on evidences from RCTs and comprehensive data from real-world studies; together these provide information to the medical practitioners about its safety compared to VKAs and other NOACs.
Professor Gregory Lip compares the approach behind conducting randomized clinical trials and real-world studies for medical intervention. He also elaborates on how real-world evidence on dabigatran therapy has provided supportive and complimentary data to RCTs and contributed to improved patient outcomes.
Results from RCTs strengthened by real-world evidences can immensely support clinical decision making. The safety and efficacy of dabigatran is studied in a broad patient population across different clinical settings.
'50 countries, 5 regions, 2200 sites': GLORIA AF – one of the largest prospective RWE study, and provides long term comparative real-world outcomes of oral anticoagulants for AF.
