Early Identification of Cardiovascular Adverse Events Associated With Rofecoxib Using Real-World Data From the UK: A Nested Case-Control and Case-Crossover Study - PubMed
12 hours ago
- #pharmacovigilance
- #rofecoxib
- #real-world data
- The study investigated if real-world data (RWD) could detect rofecoxib's cardiovascular adverse effects earlier than traditional pharmacovigilance systems.
- Using nested case-control (NCC) and case-crossover (CCO) designs, researchers analyzed data from UK CPRD GOLD (1999-2004) involving adult rofecoxib users.
- Current rofecoxib use was associated with an 18% higher risk of major adverse cardiovascular events (MACE) compared to past use in the NCC design.
- The CCO design showed an 83% increased risk of MACE, with the first signal emerging after 2 years.
- The study concluded that RWD could have detected rofecoxib's cardiovascular risks within 2 years of market entry, much earlier than traditional methods.
- The findings support incorporating RWD analysis into routine drug safety monitoring for faster detection of adverse drug reactions.