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

• Published in: Rheumatology (Oxford, England) England), 2007-03, Vol.46 (3), p.435-438
• Main Authors: Rahme, E., Nedjar, H.
• Format: Article
• Language: English
• Subjects: Acetaminophen - adverse effects; Aged; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Aspirin - adverse effects; Atherosclerosis (general aspects, experimental research); Biological and medical sciences; Blood and lymphatic vessels; Bones, joints and connective tissue. Antiinflammatory agents; Cardiology. Vascular system; Celecoxib; Coronary heart disease; Cyclooxygenase 2 Inhibitors - adverse effects; Drug Prescriptions - statistics & numerical data; Drug Therapy, Combination; Female; Gastrointestinal Hemorrhage - chemically induced; Gastrointestinal Hemorrhage - epidemiology; Heart; Hospitalization - statistics & numerical data; Humans; Lactones - adverse effects; Male; Medical sciences; Myocardial Infarction - chemically induced; Myocardial Infarction - epidemiology; Naproxen - adverse effects; Pharmacology. Drug treatments; Pyrazoles - adverse effects; Quebec - epidemiology; Retrospective Studies; Risk Assessment; Sulfonamides - adverse effects; Sulfones - adverse effects
• ISSN: 1462-0324; 1462-0332
• DOI: 10.1093/rheumatology/kel428

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 ≥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.