GASTROINTESTINAL EFFECTS OF ROFECOXIB AND CELECOXIB VERSUS ACETAMINOPHEN AMONG PATIENTS ON LOW DOSE ASPIRIN

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GASTROINTESTINAL EFFECTS OF ROFECOXIB AND CELECOXIB VERSUS ACETAMINOPHEN AMONG PATIENTS ON LOW DOSE ASPIRIN

E Rahme¹, M Bardou², Y Toubouti¹, AN Barkun¹

¹Montreal General Hospital, Montreal, Quebec, ²Clinical Pharmacology Unit, Dijon, France

AIM: Potential gastrointestinal (GI) complications with nonselective NSAIDs are of major concerns, especially for the elderly who are on cardioprotective low-dose aspirin. In Quebec, acetaminophen is reimbursed by the government when used among the elderly for the management of arthritis and pain. The GI toxicity of a concomitant use of Coxibs with aspirin remain unclear. We compared GI hospitalization rates in patients taking aspirin in association with rofecoxib or celecoxib versus acetaminophen.
METHODS: Medical and pharmaceutical records of all patients ³ 65 years who used rofecoxib, celecoxib or acetaminophen from 2001-2002 were abstracted from the government of Quebec health insurance agency (RAMQ) database. Patients were followed-up for 90 days from the date of their first celecoxib, rofecoxib or acetaminophen prescription (index date). Only patients who were taking aspirin at the index date (new prescription or ongoing treatment) were included. We excluded patients with prescriptions of celecoxib, rofecoxib, NSAIDs or acetaminophen in 2000 and patients with cancer. Logistic regression models were used to compare GI hospitalizations, upper GI investigations (gastroscopy or barium swallow) and proton pump inhibitors (PPI) or misoprostol prescriptions between the three groups.

RESULTS: A total of 29,159 patients were using aspirin with one of the drugs of interest at the index date. Among these, 12,879 patients were prescribe acetaminophen, 7,202 celecoxib, and 9,078 rofecoxib. Patients with acetaminophen were older, had more renal problems, and were hospitalized for longer periods of time, while patients taking either coxib had more musculoskeletal diseases. Adjusted logistic regression models showed that older patients (>75 yrs), patients with corticosteroids, and those with prior GI conditions were at increased risk for GI hospitalizations (OR 95%CI: 2.1, 1.4–3.1; 1.5, 1.0–2.2 and 1.7, 1.3–2.3, respectively). The risks of GI hospitalization were similar for patients taking rofecoxib or celecoxib with aspirin to those taking acetaminophen with aspirin (0.89, 0.69–1.15) and (0.83, 0.63–1.09), respectively. During follow-up, PPI or misoprostol were not prescribe more frequently in either rofecoxib 1.04 (0.97–1.12) or celecoxib 0.97 (0.90–1.04) groups compared to the acetaminophen group.

CONCLUSION: This study did not find any increased risk of GI hospitalization with a concomitant use of rofecoxib or celecoxib with aspirin compared to acetaminophen with aspirin.

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