Hospitalization for gastrointestinal adverse events attributable to the use of low-dose aspirin among patients 50 years or older also using non-steroidal anti-inflammatory drugs: a retrospective cohort study.

BACKGROUND: Use of aspirin with non-steroidal anti-inflammatory drugs increases the risk of gastrointestinal ulcers; however, it is not clear if this risk varies with the non-steroidal anti-inflammatory drug used. AIM: To assess the risk of gastrointestinal hospitalizations attributable to aspirin in patients 50 years or older also using non-steroidal anti-inflammatory drugs. METHODS: Administrative data of patients 50 years or older who received a non-steroidal anti-inflammatory drug or acetaminophen prescription between 1998 and 2004 were used. RESULTS: Study patients received 7,412,992 non-steroidal anti-inflammatory drug prescriptions and 5,614,044 acetaminophen prescriptions among which 23% and 32%, respectively, were dispensed to aspirin users. Time-dependent Cox regression models revealed that, compared to patients using acetaminophen (without aspirin), the adjusted hazard ratio (95% CI) among non-users of aspirin were: rofecoxib 1.3 (1.2, 1.5), celecoxib 0.7 (0.6, 0.8), diclofenac 1.5 (1.2, 1.7), ibuprofen 0.9 (0.6, 1.4), naproxen 2.5 (2.1, 3.0) and piroxicam 1.5 (0.8, 2.8); among users of aspirin: rofecoxib 3.2 (2.8, 3.7), celecoxib 1.8 (1.5, 2.1), diclofenac 2.8 (2.2, 3.5), ibuprofen 1.4 (0.8, 2.7), naproxen 2.2 (1.6, 3.0) and piroxicam 2.0 (0.8, 5.4). The risk attributable to aspirin varied from none with naproxen to 61% (53%, 68%) with celecoxib. CONCLUSION: The increase in gastrointestinal hospitalization attributable to aspirin differed with the non-steroidal anti-inflammatory drug used, and seemed higher with cyclo-oxygenase-2 inhibitors than with non-selective non-steroidal anti-inflammatory drugs.

Risks and benefits of COX-2 inhibitors vs non-selective NSAIDs: does their cardiovascular risk exceed their gastrointestinal benefit? A retrospective cohort study.

OBJECTIVES: The risk of acute myocardial infarction (AMI) with COX-2 inhibitors may offset their gastrointestinal (GI) benefit compared with non-selective (NS) non-steroidal anti-inflammatory drugs (NSAIDs). We aimed to compare the risks of hospitalization for AMI and GI bleeding among elderly patients using COX-2 inhibitors, NS-NSAIDs and acetaminophen. METHODS: We conducted a retrospective cohort study using administrative data of patients > or =65 years of age who filled a prescription for NSAID or acetaminophen during 1999-2002. Outcomes were compared using Cox regression models with time-dependent exposures. RESULTS: Person-years of exposure among non-users of aspirin were: 75,761 to acetaminophen, 42,671 to rofecoxib 65,860 to celecoxib, and 37,495 to NS-NSAIDs. Among users of aspirin, they were: 14,671 to rofecoxib, 22,875 to celecoxib, 9,832 to NS-NSAIDs and 38,048 to acetaminophen. Among non-users of aspirin, the adjusted hazard ratios (95% confidence interval) of hospitalization for AMI/GI vs the acetaminophen (with no aspirin) group were: rofecoxib 1.27 (1.13, 1.42), celecoxib 0.93 (0.83, 1.03), naproxen 1.59 (1.31, 1.93), diclofenac 1.17 (0.99, 1.38) and ibuprofen 1.05 (0.74, 1.51). Among users of aspirin, they were: rofecoxib 1.73 (1.52, 1.98), celecoxib 1.34 (1.19, 1.52), ibuprofen 1.51 (0.95, 2.41), diclofenac 1.69 (1.35, 2.10), naproxen 1.35 (0.97, 1.88) and acetaminophen 1.29 (1.17, 1.42). CONCLUSION: Among non-users of aspirin, naproxen seemed to carry the highest risk for AMI/GI bleeding. The AMI/GI toxicity of celecoxib was similar to that of acetaminophen and seemed to be better than those of rofecoxib and NS-NSAIDs. Among users of aspirin, both celecoxib and naproxen seemed to be the least toxic.