Background: Rofecoxib was withdrawn in 2004.
Aim: To assess the incidence of upper gastrointestinal bleeding in the context of the changing use of cyclo-oxygenase-2 non-steroidal anti-inflammatory drugs and low-dose aspirin.
Methods: We examined the characteristics of patients developing upper gastrointestinal bleeding in a defined population in south-west Scotland. The primary comparisons were made between two calendar years, preceding and following the withdrawal of rofecoxib.
Results: The overall incidence of upper gastrointestinal bleeding rose from 98.7 in 2002 to 143 per 10(5) of the population per annum in 2005 (chi(2) = 21.1; P < 0.001). The rise in the incidence was associated with using low-dose aspirin, from 26.6 to 38.4 per 10(5) (chi(2) = 5.4; P = 0.02), other antithrombotic drugs, from 12.1 to 30.2 per 10(5) (chi(2) = 19.6; P < 0.001), and excess alcohol, from 23.5 to 36.4 per 10(5) (chi(2) = 7.1; P = 0.008), but insignificantly with using non-steroidal anti-inflammatory drugs, from 13.3 to 16.1 per 10(5) (chi(2) = 0.64; P = 0.4). After adjustment for the concomitant use of these drugs, there was no significant trend in the incidence of upper gastrointestinal bleeding associated with non-steroidal anti-inflammatory drugs over the period of 1996-2005.
Conclusion: The rise in the incidence of upper gastrointestinal bleeding was weakly related to the change in use of non-steroidal anti-inflammatory drugs. Instead, it probably reflected the increasing use of low-dose aspirin, other antithrombotic drugs and alcohol.