Clinical Pharmacy News summary

Coxibs’ benefits confirmed

Several trials have confirmed the benefits of cyclo-oxygenase-2 (COX-2) inhibitors over traditional non-steroidal anti-inflammatory drugs. These trials were presented at the EULAR meeting earlier this month.

The COX-2 inhibitor rofecoxib (Vioxx) was reported to have superior gastrointestinal tolerability than naproxen in a population that included patients taking low-dose aspirin. This was the conclusion of the ADVANTAGE trial, which involved 5,597 patients with osteoarthritis who were treated with either naproxen 500mg twice daily or rofecoxib 25mg four times a day. Patients using low-dose aspirin for cardiovascular prophylaxis were allowed to enter the trial. Of the 5,597 patients enrolled, 12 per cent used low-dose aspirin during the study period.

The researchers observed that there were fewer discontinuations in the rofecoxib group than in the naproxen group (5.9 per cent compared with 8.1 per cent, P=0.005). The proportion of patients requiring treatment for GI complications was also less in the group treated with rofecoxib than in the group treated with naproxen (9.1 per cent compared with 11.2 per cent, P=0.014). The use of low-dose aspirin did not affect the relative rates of discontinuation due to adverse events, including drug-related adverse events, the researchers say. Professor James Scheiman of the University of Michigan medical centre, United States, presented the results on behalf of Merck Sharp & Dohme, the manufacturer of rofecoxib.

In another study, the successive celecoxib efficacy and safety study, or SUCCESS 1, new data confirmed that celecoxib is associated with fewer ulcer complications and symptomatic upper gastrointestinal ulcerations than conventional non-steroidal anti-inflammatory drugs. The double-blind, 12-week trial involved 13,274 patients with osteoarthritis who were randomised to receive celecoxib 200mg daily, celecoxib 400mg daily, naproxen 1,000mg daily or diclofenac 100mg daily. Patients with any signs or symptoms of ulcer complications were evaluated by the investigators and results were reported to an independent and blinded gastrointestinal events committee (GEC).

The results showed that the reduction in risk for all GI adverse events was 20.4 per cent lower in the celecoxib groups than in the NSAID groups (P<0.001), and that there were significant reductions in abdominal pain, dyspepsia and nausea in patients treated with celecoxib. The investigators also found that significantly more NSAIDs patients than celecoxib patients were withdrawn for GI adverse events (6.8 per cent compared with 5.2 per cent).

The GEC reviewed 144 upper-GI events, of which 39 were determined to be clinically significant. Of these, nine were ulcer complications, two of which were in the celecoxib group and seven in the NSAIDs group.

Lead researcher, Dr Jay Goldstein, a professor of medicine at the University of Illinois, Chicago, United States, said: “These data support and extend the results of the CLASS trial [see PJ September 23, 2000, p438] and demonstrate that celecoxib is associated with significantly fewer ulcer complications and symptomatic ulcers than conventional NSAIDs.”

The trials reported on this page were presented at the European League Against Rheumatism (EULAR) meeting in Prague, Czech Republic, earlier this month. The Journal attended the meeting courtesy of Abbott Laboratories

Correction The dosage regimen for rofecoxib (Vioxx) was 25mg once daily, not 25mg four times daily.

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