The COX-2 inhibitor Celebrex (celecoxib) causes fewer gastrointestinal complications than traditional nonsteroidal anti-inflammatory painkillers or NSAIDs, without raising the risk of cardiovascular events, according to results of a large, prospective, 3-month trial.

Some clinical trials have demonstrated increased cardiovascular risk associated with other COX-2 inhibitors, which led to the withdrawal of two from the market - Vioxx (rofecoxib) and Bextra (valdecoxib). Results of one study suggested that Celebrex, given in large doses (800 mg/day) over prolonged periods of time, may also have a worse cardiovascular risk profile than nonspecific NSAIDs, whereas other studies showed no such risk.

The SUccessive Celecoxib Efficacy and Safety Study-1 (SUCCESS-1), conducted in 39 countries, enrolled 13,194 patients with osteoarthritis of the hip, knee or hand of at least 6 months duration.

The investigators, led by Dr. Gurkirpal Singh from Stanford University School of Medicine in California, randomized patients to Celebrex (100 or 200 mg twice daily), the NSAID naproxen (500 mg twice daily) or the NSAID diclofenac (50 mg twice daily). Treatment lasted for 12 weeks.

The researchers report in the American Journal of Medicine for March that all treatments were similarly effective in reducing pain. Moreover, Celebrex 100 mg twice daily was comparable to Celebrex 200 mg twice daily.

The incidence of serious upper gastrointestinal events was 1.0 per 100 patient-years in the NSAID groups and 0.2 per 100 patient-years in the Celebrex groups (odds ratio 6.02).

Although numerical differences were seen, there was no statistically significant difference between Celebrex and NSAIDs in any cardiovascular adverse event rate, except that the rate of heart failure was higher in the NSAID group.

When making recommendations for treatment of osteoarthritis, Singh’s group advises, “clinicians should consider a number of factors, including the risk for upper gastrointestinal events, duration of therapy, as well as costs, before deciding upon individual patient treatment.”

SOURCE: American Journal of Medicine, March 2006.